Small or medium-scale focused research project (STREP) ICT Call 10
FP7-ICT-2013-10
Services and Knowledge based Infrastructure for defining and supporting new integrated, Personalized and efficient care pathways in COPD and its comorbidities
SKIPPER Type of project: Small or medium scale focused research project (STREP) Date of preparation: 15th January, 2013 Work programme topic addressed • Challenge 5: ICT for Health, Ageing Well, Inclusion and Governance o Objective ICT-2013.5.1: Personalised health, active ageing, and independent living Target outcomes: b) Personalised Guidance Services for management of comorbidities and integrated care Participant no. * 1 (Coordinator) 2 3 4 5 6 7 8 9 10 11 12 13 14
Participant organisation name
Part. short name
FOUNDATION FOR RESEARCH AND TECHNOLOGY HELLAS DEDALUS SPA CONSIGLIO NAZIONALE DELLE RICERCHE FRAUNHOFER-GESELLSCHAFT ZUR FOERDERUNG DER ANGEWANDTEN FORSCHUNG E.V INNOVA Technology Transfer & Valorisation Limited SIMPLE ENGINEERING FRANCE SARL T4ALL UNIVERSITA DELLA CALABRIA UNIVERSITA` DEGLI STUDI DI SIENA UNIVERSITE PIERRE ET MARIE CURIE - PARIS 6 UNIVERSITA' DEGLI STUDI DI BERGAMO RESEAU PHAST ΓΕΝΙΚΗ ΚΛΙΝΙΚΗ ΓΑΒΡΙΛΑΚΗ HL7 INTERNATIONAL FONDATION
FORTH DEDA CNR
Name of the coordinating person: e-mail: fax:
Proposal Part B
FRAUNHOFER INNOVA SEF T4ALL UNICAL UNISI UPMC UNIBG PHAST IASSIS HL7
FRANCO CHIARUGI P.O. Box 1385, N. Plastira 100, Vassilika Vouton GR 700 13 Heraklion, Crete, Greece
[email protected] +30- 2810391428
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Country GR IT IT DE UK FR IT IT IT FR IT FR GR BE
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Proposal abstract The spreading of the Electronic Health Record (EHR) is changing the vision of the European health systems, moving from a vertical approach to solutions able to organize and manage entire health care processes based on the integration of care settings. These solutions should be arranged so that even the patient can be more involved in his own care, leaving the role of passive actor. In order to make this step economically viable, it is necessary to apply new care models especially when dealing with chronic diseases. Some European Regions are successfully adopting the Chronic Care Model (CCM) that defines specific care pathways for chronic diseases and fosters the concepts of continuity of care. The SKIPPER project aims to realize a standards and knowledge based interoperable services architecture, deployed as Software as a Services on Cloud, able to support continuity and personalization of care for patients suffering from multiple chronic diseases, according to new care models such as the CCM. The SKIPPER solution integrates the concept of EHR with an extended version of Personal Health Record and allows the seamless federation of care settings applications, remote sensors, physiological and environmental data sources and sophisticated decisions support systems in a care coordination and continuity process. As case study will be considered the Chronic Obstructive Pulmonary Disease, which is becoming one of the leading causes of death worldwide with a devious course and a slow development, often accompanied by serious comorbidities such as cardiovascular diseases and diabetes. The project aims also to evaluate, through two pilots supported by the endorsement of relevant healthcare authorities, the impact of the SKIPPER solution in terms of clinical effectiveness, such as reduction of exacerbations and hospitalizations, improvement of patient’s quality of life, economic sustainability of the health systems and evolution toward really sustainable business models.
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SECTION 1:
SCIENTIFIC AND/OR TECHNICAL QUALITY, RELEVANT TO THE TOPICS ADDRESSED BY THE CALL ....... 4
1.1 CONCEPT AND OBJECTIVES ....................................................................................................................................... 4 1.1.1 Background ................................................................................................................................................... 4 1.1.2 The objectives of the SKIPPER project ........................................................................................................... 6 1.1.3 Relevance to the topics of the call .............................................................................................................. 15 1.2 PROGRESS BEYOND THE STATE-OF-THE-ART ............................................................................................................... 22 1.2.1 State of the art and on-going European initiatives ..................................................................................... 22 1.2.2 The progress beyond the state of the art .................................................................................................... 38 1.3 S/T METHODOLOGY AND ASSOCIATED WORK PLAN ..................................................................................................... 46 1.3.1 Overall strategy of the work plan ............................................................................................................... 46 1.3.2 Gantt chart .................................................................................................................................................. 50 1.3.3 Detailed work description broken down into work packages ..................................................................... 52 1.3.4 Graphical presentation of the components showing their interdependencies (Pert diagram or similar) ... 99 1.3.5 Significant risks and associated contingency plans................................................................................... 102 SECTION 2:
IMPLEMENTATION..........................................................................................................................106
2.1 MANAGEMENT STRUCTURE AND PROCEDURES ......................................................................................................... 106 2.1.1 Project Management structure ................................................................................................................. 106 2.1.2 Management Activities ............................................................................................................................. 109 2.1.3 Risk management ..................................................................................................................................... 110 2.2 INDIVIDUAL PARTICIPANTS .................................................................................................................................... 112 2.3 CONSORTIUM AS A WHOLE ................................................................................................................................... 147 2.3.1 Competences ............................................................................................................................................. 147 2.3.2 Complementarity between participants ................................................................................................... 148 2.3.3 External commitments .............................................................................................................................. 150 2.3.4 Sub-contracting ......................................................................................................................................... 151 2.3.5 Other countries ......................................................................................................................................... 151 2.4 RESOURCES TO BE COMMITTED ............................................................................................................................. 152 2.4.1 Repartition between partner categories ................................................................................................... 152 2.4.2 Repartition between RTD and Management activities ............................................................................. 153 2.4.3 Repartition between budget categories ................................................................................................... 154 SECTION 3:
IMPACT...........................................................................................................................................156
3.1 EXPECTED IMPACTS LISTED IN THE WORK PROGRAMME .............................................................................................. 156 3.1.1 Introduction .............................................................................................................................................. 156 3.1.2 Contributions towards the expected impacts listed in the work programme ........................................... 156 3.1.3 Steps necessary to bring about the impacts ............................................................................................. 167 3.1.4 Reasons for a European approach ............................................................................................................ 168 3.1.5 Assumptions and external factors influencing the achievement of the impacts ...................................... 169 3.2 DISSEMINATION AND/OR EXPLOITATION OF PROJECT RESULTS, AND MANAGEMENT OF INTELLECTUAL PROPERTY ................... 171 3.2.1 Dissemination activities ............................................................................................................................ 171 3.2.2 Exploitation activities ................................................................................................................................ 173 3.2.3 Knowledge Management and IPR............................................................................................................. 179 SECTION 4: 4.1 4.2 4.3 4.4 4.5 4.6
ETHICAL ISSUES ..............................................................................................................................181
LEGAL AND ETHICAL ISSUES IN SKIPPER ................................................................................................................. 181 POSSIBLE LEGAL AND ETHICAL ISSUES RAISED BY SKIPPER AND ITS PROPOSED ACTIVITIES ................................................. 181 IDENTIFICATION OF APPLICABLE REGULATIONS AND GUIDELINES FROM DIFFERENT LEVELS .................................................. 182 PROCESSING OF PERSONAL DATA ........................................................................................................................... 183 USE OF HUMAN BIOLOGICAL SAMPLES ................................................................................................................... 184 INFORMED CONSENT ........................................................................................................................................... 184
APPENDIX A: ENDORSEMENT LETTERS ....................................................................................................................186 Proposal Part B
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Section 1: Scientific and/or technical quality, relevant to the topics addressed by the call 1.1
Concept and objectives
1.1.1 Background The provision of infrastructure to support the Electronic Health Record (EHR) is changing the vision of the health systems of various European countries, moving from a vertical approach for organizing and managing entire health care processes which are increasingly becoming multi-professional, multidisciplinary and are based on the integration of the different levels and environments of care. In order to fully support this view it is necessary that these infrastructures are oriented to support care policies expressed as effective clinical services to the citizen/patient, both from a management and an optimization of resources standpoint. In fact care and assistance needs are changing today as a consequence of the social, economic and technological advancements occurred in the last decade. Healthcare spending has strongly increased in all industrial countries and in Europe it will potentially climb up to about 15% of the GDP (Gross Domestic Product) by 2020. This growth is largely driven by the increase in demand due to the average life expectancy and, as consequence, to the number of people affected by chronic diseases which becomes more expressed with increasing age. This new situation has three different but interconnected perspectives: 1) the managers of the clinical services are challenged to deliver effective health care services at reasonable costs; 2) the clinicians are interested to apply and improve the effectiveness of clinical guidelines, increasing the emphasis on evidence-based medicine; 3) the citizens are increasingly demanding high quality and continuity of care, they are more aware of clinical risk management and are claiming more efficient healthcare services, with reduction of waiting times and a better utilization of resources. In an increasingly digital economy 1, where the citizen is able to organize travels, buy and sell without intermediaries, and evaluate, judge and guide the choices of many types of services, healthcare cannot continue to be a service where the user is passive. This trend is reflected in EHR infrastructures which are becoming increasingly arranged and enriched so that the citizen/patient can be more involved in her/his own care, gradually moving away from a passive role. At the same time, in order to guarantee continuity of care across different care settings it is necessary to provide healthcare operators with an integrated set of services and facilities for defining, monitoring, evaluating and fine-tuning personalized care programmes. In order to make this transition technically and economically viable it is necessary to consider a definitive move towards new organizational models able to govern seamless integration across government, community and private information systems (Electronic Health Records - EHRs, Personal Health Records PHRs, Tele-care centres). Such models must be supported by distributed architecture in which users, systems, applications and devices are able to collaborate. Service oriented architectures (SOAs), based upon largely accepted standards, allow heterogeneous systems that support different care environments interacting and combining personal, social and environmental issues that affect the citizen/patient’s healthcare processes. In addition, new delivery (and business) models need to be designed that allow flexible, continuous and sustainable services.
1
W. Brian Arthur, "The second economy." McKinsey Quarterly, October 2011.
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The need to combine transversal information is of outmost importance in the care and treatment of chronic comorbid disease where personalized continuity of care relies heavily upon the way the patient/citizen understands the healthcare processes, and the family, social and environmental contexts. International studies, experiences and discussions lead the scientific community to identify and recommend specific models when dealing with chronic diseases. One such model, the Chronic Care Model, distinguishes itself through the positive results derived from its adoption in terms of both efficiency and effectiveness. In Italy, the Tuscany Region has adopted this model by defining specific care pathways for chronic disorders and fostering the integration between primary and secondary care to support the continuity of care. The model adopts a multidisciplinary approach and requires the empowerment of different healthcare professional roles (nurses, general practitioners, specialist), with emphasis on primary care. The model focuses on the collection and coordination of the patient information and contacts, on the integrated planning, scheduling and follow-up of treatments as well as on the patient empowerment. These initiatives require an adequate economic support and the definition of new governance models, and at the same time the adoption of novel information systems which move from a vertical view focused on the single care events towards an integrated view of the patients. Continuity of care and assistance pathways, especially with chronic comorbidities, result in multidisciplinary workflows able to handle patients through an iterative process that includes care planning, treatments, follow up, and assessment. Chronic Obstructive Pulmonary Diseases (COPD) is a very representative case for the chronic care model. COPD is one of the most important causes of morbidity and mortality in both industrialised and developing countries. COPD is a long-term lung slowly progressing disease in which the airways narrow over time, which limits airflow to and from the lungs, causing shortness of breath (dyspnea). In clinical practice, COPD is defined by its characteristically low airflow on lung function tests. In contrast to asthma, this limitation is poorly reversible and usually gets progressively worse over time but can be stopped. However, COPD is a preventable and treatable disease. COPD is caused by noxious particles or gas, most commonly from tobacco smoking but also from air pollution, which triggers an abnormal inflammatory response in the lung and the exposure to which can be avoided or reduced. According to the WHO, COPD will become the seventh leading cause of disability-adjusted life-years by 2030. COPD is one of the leading causes of death, due to the fact that it is recognized only at an advanced stage and can also be accompanied by serious comorbidities such as cardiovascular disease and diabetes. The frequency of clinically relevant COPD varies in European countries from 4 to 10% of the adult population. Data on the frequency of COPD in Central and Eastern Europe are very limited. Approximately 200,000–300,000 people die each year in Europe because of COPD. COPD is the only leading cause of death that is becoming more common worldwide. By 2020, COPD is likely to account for over 6 million deaths worldwide every year, making it the 3rd leading cause of death. Within the European Community (EU), the annual cost of COPD is about €38.8 milliards: • •
Direct: € 10.3 milliards are spent in hospital admissions, out-patient visits and home assistance, plus the pharmacological treatment. Indirect: COPD is the leading cause of lost work days among respiratory diseases. In the EU, approximately 41,300 lost work days per 100,000 people are due to COPD every year. This amounts to losses of a total of €28.5 milliards annually.
Last but not least COPD highly challenges quality of life. The shortness of breath experienced by people with COPD can interrupt daily activity, sleep patterns and the ability to exercise. The quality of life for a person suffering from COPD diminishes as the disease progresses. The impact that the disease has on the life of a COPD patient depends upon the severity of COPD symptoms and the existence of other co-morbid conditions (such as ischaemic heart disease, heart failure, osteoporosis, normocytic anaemia, lung cancer, depression and diabetes). Comorbid diseases potentiate the morbidity of COPD, leading to increased hospitalizations, mortality and healthcare costs. Current data Proposal Part B
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reports that, in those 65 years of age and older, up to 25% have at least two comorbid conditions, and 17% report three. Implementation of the chronic care model (CCM) has been shown to be an effective preventative strategy to improve outcomes in diabetes mellitus, depression, and congestive heart failure, but data are lacking regarding the effectiveness of this model in COPD. Yet, pro-active diagnosis and on-going multifactorial COPD management, comprising smoking cessation, influenza and pneumonia vaccinations, air pollution avoidance, pulmonary rehabilitation, and symptomatic and maintenance pharmacotherapy according to severity, can significantly improve a patient’s health-related quality of life, reduce exacerbations and their consequences, and alleviate the functional, utilization, and financial burden of COPD. Redesign of primary and secondary care according to principles of the chronic care model, which is implemented in patientcentered solutions, can shift COPD management from acute rescue to pro-active maintenance. The chronic care model and patient-centered solutions combine delivery system redesign, clinical information systems, decision support, and self-management support within a practice, linked with health care organization and community resources beyond the practice. COPD care programs implementing chronic care model components effectively reduce emergency room and inpatient utilization. 1.1.2 The objectives of the SKIPPER project Taking into account the social trends, the requirements of the national healthcare services in terms of efficiency, effectiveness and sustainability and the expectations of the new digital economy described above, the SKIPPER project aims to: 1. define, design, develop, test and validate a generic services architecture based on standard interoperability services, driven by knowledge-intensive decision support systems and geared to: o
establish, manage, control, evaluate and improve innovative, personalized and integrated care pathways,
o
support seamless continuity of chronic comorbidities care across different care settings
o
provide specialised end-users services for the management of COPD and its comorbidities, according to the chronic care model;
2. evaluate, through two experimentation pilots, the impact of the SKIPPER solution in terms of: o
clinical effectiveness and economic sustainability of the possible new organizational healthcare models
o
evolution of the eHealth market, with business models that could exploit the SKIPPER solution.
Regarding the first goal, the SKIPPER services architecture will be: •
•
•
supported by background basic healthcare generic services (data and record management, identity and demographics management, terminology management, decision support system management, service registry management, healthcare providers directory management) compliant with largely accepted standard; deploying foreground value-added healthcare generic services, compliant with accepted or on construction standards that provide configuration, planning, management, control, assessment and improvement of innovative, personalized and efficient care pathways; providing personal health record (PHR) management that is interoperable with health records handled by clinical and health organizations from the public and private sectors, general practitioners and other PHRs;
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integrating in a seamless and fault-tolerant way mobile devices and remote data sources acquisition, monitoring and integration of physiological and lifestyle parameters of patients (acquired in non-clinically controlled environments) and environmental data; driven by decision support systems for monitoring, interactive consultation, patient guidance and clinical support, based on symbolic inference, predictive models, algorithms and multimodal data fusion; supplying security services that satisfy compelling security exigencies and constraints (authentication, authorization, confidentiality, integrity, accountability, non-repudiation), such as the management of the patient informed consent; compliant “by design” with strong dependability requirements such as accuracy, robustness, availability, integrity, fault tolerance and, last but not least, active and passive testability.
In order to handle chronic comorbidities coordination and continuity of care and patient diagnosis, guidance and follow up, the SKIPPER services architecture will be able to concurrently carry out: •
•
easy, flexible and controlled on-line and real-time collaboration around a shared, lean and federated Master Care Plan, that includes sub-plans for comorbidity and specialty, can be updated in a controlled manner by multiple participants - practitioners and care settings from different specialties - and that directs the patient towards a target health state (or “maintains” her/him this state); real-time monitoring and evaluation of clinical, emotional, environmental data collected from devices and other sources (e.g. meteorological data) and interaction with the patient, her/his relatives and representatives (e.g. social workers), practitioners, healthcare settings, healthcare administrators, etc.
The SKIPPER services architecture is enabled by the SKIPPER service components platform that: •
•
is constituted of a framework of background and foreground components that are supplied by the SKIPPER partners (basic healthcare service components, value-added healthcare service components, PHR management service components, devices and data sources handlers, healthcare decision support systems, security service components, monitoring service components), including front-end components for web and mobile interfaces that enables the Software as a Service presentation to the end-users (see below). is deployed on a cloud infrastructure ensuring the elasticity of the underlying computational resources, the multi-tenancy and the concurrent execution of multiple, isolated permanent and transient versioned instances (operational, development, integration, unit testing, integration testing, non-regression testing, acceptance testing) of the same specific services architecture for chronic comorbidities care.
The end-users of the SKIPPER platform of services will be: • •
the healthcare professionals, who are organized according to care models that can be declaratively specified; the patients and their relatives and representatives (e.g. social workers) who are involved in their care programs.
A specific instance of the SKIPPER architecture for chronic comorbidities care will be presented to the endusers (professionals and patients) as a Software as a Service (SaaS). The SKIPPER generic services architecture for chronic comorbidities care can be instantiated through the declarative definition of Semantic Profiles. A SKIPPER services architecture Semantic Profile is the Proposal Part B
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definition of the set of types of the parameters, results and manipulated objects of the generic service operations that are related to a specific patient comorbidities profile. The SKIPPER project will define and implement a prototype of the Chronic Obstructive Pulmonary Disease and comorbidities Semantic Profile of the SKIPPER services architecture that will be deployed in two pilots “localized” in Italy and Greece.
Figure 1: General schema of the Skipper Platform services
The SKIPPER services architecture aims to enhance continuity and quality of care by supporting: • • • •
early diagnosis and prevention activities, integration of multi-professional and multi-disciplinary approaches within the healthcare environments, continuous monitoring, the personalization of care and the growing empowerment of patients.
In particular, the SKIPPER platform includes services that support the Care Chronic Model by providing: •
• •
the identification and the stratification of patients to be included in specific care programmes; these services will be compliant with international guidelines approved by the scientific community, such as the GOLD initiative (Global Initiative for chronic Obstructive Lung Diseases); the enrolment and the counselling of the selected patients; these services will allow the start up of the specific care programmes for the patients and training for patient empowerment; the definition, activation, continuous monitoring, evaluation and fine-tuning of personalized and evidence based care programmes for stabilized patients.
Of note, in current care patterns for COPD, health professionals and patients interact only during episodes of acute illness, such as exacerbations when worsening of COPD symptoms require a change in management. An exacerbation emergency is often the first presentation of previously undiagnosed but symptomatic COPD, which may progress to severe disease before patients seek care. Acute care for emergent COPD exacerbations is insufficient to maintain patients functioning or affect the disease course, a punctuated equilibrium in which each successive exacerbation can accelerate respiratory decline. Proactive diagnosis and management before the first exacerbation occurs can reduce exacerbation incidence and severity and improve outcomes. Chronic care redesign, to refocus primary practice toward proactive Proposal Part B
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maintenance, can improve care for COPD and other ambulatory-care-sensitive conditions (in which hospitalization rates rise as primary care becomes less accessible and/or adequate). A pertinent CCM approach thereafter has to seek to transform care delivery from a rescue orientation to a planned-care orientation and to empower patients and families to collaborate actively with the health care team.
Figure 2: Macro-phased of the clinical pathway of the COPD management
From a clinical viewpoint, according to the GOLD classification, the SKIPPER project focus on patients with moderate and severe level of COPD severity with the following objectives: • • •
preventing the advancement of the disease towards more severe stages; reducing the numbers of hospitalizations and guaranteeing to patients as much as possible a regular life in their normal environments; monitoring the status of the main comorbidities, such as cardiovascular diseases and diabetes and avoiding their advancement.
The SKIPPER platform includes also specific services for patients with very severe COPD. In this case the objective of the project is to guarantee quality and continuity of care with sustainable programmes. Concerning the impact of the SKIPPER project, the consortium includes very high level of clinical, epidemiological and public health expertise and the proposal has got the endorsement of public healthcare institutions. The commitment, skills and knowledge of these institutions, allow the project to put in place a (small-scale) validation of the SKIPPER services architecture for chronic comorbidities care and of the SKIPPER platform of service components by defining and deploying two pilot systems in real healthcare environments:
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A pilot supported by the Tuscany Region in Italy (the Public Health Service is organized on a regional basis in Italy) that involves as stakeholders and users in addition to the local Health Authority, an association of general practitioners (GPs) and an association of patients. A pilot supported by the Greek Thoracic Society in Greece that involves the private hospital IASSIS (partner of the project), the Primary Healthcare Centre of Charakas, private pulmonologists and a group of patients.
Besides the involvement of the Tuscany Region and of the some Greece healthcare associations in the pilots, the SKIPPER project acquired the endorsement of the Italian scientific and multi-disciplinary association for the study of respiratory diseases (AIMAR 2) and of the French-language Society of Pneumology (SPLF3). In addition, eminent representatives of the scientific community (in the medical and in the computer science domain) and of international standardization bodies (HL7, OMG), will constitute an external Scientific Advisory Board of the project, with the goals of advising and supporting the work in progress and of evaluating the on-going and final SKIPPER results. Moreover, the SKIPPER consortium includes directly an international standard organization, HL7 Europe, which will continuously review the compliance of the design of the SKIPPER services architecture and of the implementation of the SKIPPER service components platform with approved and in progress standards (e.g. the HSSP Care Coordination Service project 4. The design of the SKIPPER services architecture and the implementation of the SKIPPER service component platform are conferred to key European designers and implementers of standard eHealth services: FRAUNHOFER, PHAST, DEDA, UNICAL, FORTH and SEF. The SKIPPER Business Plan will be carefully established as a result of a project task, but the interest of ehealth solution for COPD and comorbidities care seems to be evident. The industrial partners of the SKIPPER consortium (DEDA, SEF and T4all) are determined to bring the SKIPPER platform first semantic profile (COPD and comorbidities) to the market as soon as possible. In order to minimize the time-tomarket, the SKIPPER project will put in place three lines of attack: •
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Reuse of a huge background - all the basic standard healthcare generic service components (data and record management, identity and demographics management, terminology management, decision support system management, service registry management, healthcare providers directory management) and the standard security service components are developed by the technical partners and supplied as project background. Dependability and security “by design” - An engineering methodology that aims at addressing all the functional and non-functional reliability (accuracy, robustness, availability, integrity, fault tolerance and active and passive testability) and security (authentication, authorization, confidentiality, accountability, non-repudiation) issues “by design” (which is a research and engineering problem per se), targeting the development of a true industrial prototype. Requirement-based continuous and concurrent testing campaign - The planning of a systematic and large coverage testing campaign, concurrent with the SKIPPER platform incremental integration and the SKIPPER pilots’ personalization, targeting the compliance with the aforementioned requirements. The testing campaign will address all the testing concerns (functional, security, performance, service unit, service composition, non-regression, acceptance) and will employ advanced testing methods (model-based, property-based, policy-based, fuzzing, fault-injection) and automation tools (automated generation of test cases and oracles, automated test execution, evaluation, scheduling) that key partners of the project (FRAUNHOFER, DEDA and SEF) have already in their background and are developing in the FP7 (call 8) MIDAS project.
2
http://www.aimarnet.it/ http://www.splf.org/s/ 4 http://hssp-carecoordination.wikispaces.com/home 3
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The industrial exploitation of the SKIPPER solution leverages the study and the definition of new organizational healthcare models which guarantee both long term sustainable care services and actual profitable business models. The SKIPPER consortium includes partners UNIBG and INNOVA who will study the economic impact and the business exploitation issues of the solution. In particular, through the definition, testing and evaluation of the SKIPPER infrastructure, the project aims at identifying a new organizational model where the SKIPPER platform of services represents the intersection between healthcare public service and private accounting initiatives for a complete and continuous management of patients. Identifying this organizational model will allow the study of new sustainable business models for the stakeholders. 1.1.2.1 The SKIPPER Solution Functional layers and components From a functional viewpoint the key elements of the architecture of the SKIPPER solution are: •
•
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The basic healthcare standard service layer based on international standards such as the HL7 HSSP services and the IHE integration profiles. This layer will guarantee both technical and semantic interoperability. This will allow easily adapting the care programs to the different European normative and to the Institutional and clinical organizations. The value-added healthcare service layer bases on acquired and in fieri international standards, about the coordination and the continuity of care. This layer is particularly important for the coordination of comorbidities care plans and allows easy, flexible and controlled collaboration around a shared Master Care Plan (Master CP). The Master CP is an up-to-date, lean and federated plan that can be updated (with change logs) from multiple participants, with mechanism of continuous supervision and publish/subscribe of updates. The master plan may contain sub-plans for comorbidity and specialty. Its elements such as goals, planned interventions, etc. evolve continuously. Where the EHR (and the PHR) accumulates the care history, the Master CP outlives all episodes of the patient follow-up and is managed as a digest. Reconciliation of a multiple specialties care plan is produced by a “virtual solution shop” through collaborative interaction. The knowledge-based decision support services core. This macro-component represents the “brain” of the SKIPPER platform, by providing: o data fusion and knowledge discovery tools for continuously analysing existing data and for updating the knowledge in the clinical domains; o standard terminology services, ontologies and knowledge representation tools, able to formalize scientific guidelines and clinical protocols; o deductive knowledge modules and innovative inference engine tools for medical decision support systems. The collection of handlers of mobile and fixed devices and remote data sources able to provide, through a secure and distributed infrastructure, a seamless, on-line and real-time collection of patient physiological data and data of the environments where the patients live.
As shown in Figure 3, these functional layers and macro-components will be compliant with a typical SOA architecture, implementing the Service Provider System, the Service Provider Skeleton and the Service Consumer proxy. They are at the basis of all the end-user services provided, as mentioned above, to both healthcare operators and patients.
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Figure 3: Functional representation of Platform architecture
End-users services for healthcare operators The end-user services for healthcare operators allow, first of all, performing the operations of identification, stratification, counselling and enrolment of patients. Those services are based on processes that involve GPs and the integration with the reference EHR. They need the usage of MPI based procedures for granting the unique identification of persons. The SKIPPER platform then enables healthcare operators to the definition, actuation, control, evaluation and tuning of follow up processes related to patients depending on their classification and according to the specific care necessities. The implementation of these services is based on the new XDW profile and follows the Care Coordination Service specification of HSSP. In particular these services will enable easy, flexible and controlled collaboration around a shared Master Care Plan, supported by a workflow management engine. The workflow management engine will be developed in the SKIPPER project through a global event manager, which is able to identify in the SKIPPER a specific workflow instance and notify the evolution of the associated care programme together with the presence of new relevant clinical documents. Because several distinct and external actors necessarily participate in the lifecycle of a care programme, the adherence of everyone to the care programme is managed through the sharing (at affinity domain level as per IHE) of a set of metadata necessary to establish the relation between care events and a specific workflow. The application level end-user services: • •
exploit the event management system to interact with platform internal (knowledge management and DSS, networked devices, telemonitoring infrastructures) and external (EHR, PHR) services. behave as Content Creator and Content Consumer in order to perform CRUD operations on the workflow documents.
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The events handled by the system relate to consolidated practices of care programs, like routine encounters at the GP, diagnostic investigations, specialist encounters with hospitalization and to novel practices like remote monitoring and remote care. The creation of a workflow configures the event manager to handle the correlation among different healthcare events (examinations, encounters, monitored data) with a specific care program and its lifecycle. The event manager will be prepared to interact with knowledge management and decision support systems in order to enable an evidence-based medicine approach to the workflow advancement. The applicative services that manage the care plan and the care record allow of course the retrieval of all the documents and the information related to the patient's care workflow tasks by accessing the EHR, the PHR and the remote monitoring observation data. In this latter case, if needed, also a real-time data access is granted. The interaction among end-user services with systems of knowledge representation is achieved through the employment of the HSSP CTS2 specification while the interactions with decision support systems are achieved through the HSSP CDSS specification. The interaction with remote monitoring systems is implemented according to IHE-HL7 standards wrapped by the RLUS specification. Finally, the patient identity management is implemented in accordance to the HSSP IXS specification. End-users services for patients With these services the SKIPPER platform extends existing PHR systems with a set of functionalities specialized for the COPD and its comorbidities. The patients will be able to access these services after the healthcare professionals activated the counselling services. These services will supports the acquisition and monitoring of patient’s various types of medical information related to COPD management, such as: • • •
the contextualized presentation of personal therapeutic treatment information and educational material related to the pathology; the personalized representation of the health status parameters measured by the devices network available at home; the possibility to note and provide personal information, regarding their care programme and their health and emotional status.
For the design of such service SKIPPER will utilize the HL7 concept of semantic signifiers for binding patientcentric services to medical documents. For integrating the services with the existing PHR systems will be adopted HL7 standards (HSSP RLUS and IXS) and/or IHE integration profiles of the Patient Care Coordination area (XPHR integration profiles). Data management in the SKIPPER platform of services Starting from the above mentioned description of the end-user services, it is important to underline the data flow in the SKIPPER platform. There will be five different data repositories: 1) All the data managed by the local healthcare institution are stored in the reference EHR 2) The data managed by the patient, including the remote home-monitoring, are stored in the database/repository of the employed PHR. In the specific case, as described, the SKIPPER platform contributes in the specialization of those systems. After proper consensus from the patient, remote monitoring data can be redirected also to the EHR. 3) The patients’ demographic data are kept in the databases of the platform. SKIPPER specific databases will hold references to the enrolled patients. However, it is important to note that: a. according to the XDW profile workflow documents are stored in the EHR; b. references to the patients operate in accordance to MPI procedures referring to the master demographic archive provided by the local healthcare institution.
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4) The data structures for the representation of clinical knowledge, handled through ontology and terminology services, are stored in repositories of the SKIPPER platform; the SKIPPER platform anyway is prepared to interact, through standard service interfaces, also with external data structures. This information is crucial for the definition and execution of decision support systems. 5) There will be a data warehouse of epidemiological data populated initially with pre-existing POCD patient databases. It will be fed with data produced by the platform after a process of extraction and anonymisation. The data warehouse is at the basis of knowledge discovery systems used to increase knowledge and awareness of the clinical domain.
Figure 4: Functional representation of the data flows within the SKIPPER Platform
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1.1.3 Relevance to the topics of the call According to the objective “ICT-2013.5.1: Personalised health, active ageing, and independent living”, the SKIPPER project aims at addressing the target outcomes: b) Personalised Guidance Services for management of co-morbidities and integrated care. The following table describes how the content and the objectives of the SKIPPER proposal relate the topics addressed by this call. Requirements SKIPPER activities Target outcome b) Personalised Guidance Services for management of co-morbidities and integrated care "The aim is the The SKIPPER project, through the SKIPPER framework, the SaaS platform on development and smallcloud and the SKIPPER PHR, engages patients as well as their relatives and scale validation of representatives (e.g. social workers) as active members of the care-team. personalised services and Moreover, the SKIPPER SaaS will offer social network capabilities that care programmes, which enhance the autonomous exchange of mutual information between patients engage patients as well as and other actors. their relatives, as active The standard-based service oriented architecture of the SKIPPER SaaS allows: members of the care team, (i) easy binding of healthcare institutions’, clinic organizations’ ad enhance collaboration practitioners’ applications to the care processes, and (ii) the virtual among carers and promote integration of the SKIPPER PHR with the institutional Health Records seamless continuity of care managed by the public and commercial sectors organizations involved in the across different care continuity of care, and data issuing from multiple sources and devices. settings.“ The SKIPPER framework and platform are based on the integration and adaptation of tried and tested software components for standardized platform functionality. These components, that are supplied as project background, are: • the HSSP services for o medical data store, based on RLUS, o terminology services based on CTS2, o demographics and patient identification management, based on IXS, o Clinical Decision Support Systems • ETSI TSL compliant service directory, • Authentication and authorization based on SAML, XACML and WS*, • IHE integration profiles such as XDS, PIX/PDQ, • IHE HPD compliant HP/HPO directory. On this basis, adaptors for intercepting data flows within resident practices and hospitals that allow automatic sharing of data between existing clinical IT systems and health records are already available or easily developed. “The focus is on patients The SKIPPER SaaS on cloud is based on a generic standard platform that who suffer from multiple allows the flexible real time follow-up of chronic diseases such as the COPD, chronic conditions and can which is accompanied by severe comorbidities such as cardiovascular disease benefit from integrated care and diabetes, by the constitution of “virtual solution shops” that involve approaches (i.e. integration specialists and organizations from diverse clinical disciplines. The platform allows integrated access to the SKIPPER PHR and to the EHRs managed by between primary, the public and commercial sector organizations involved in the continuity of secondary, home and selfcare, and can assemble data coming from devices and disparate sources, and care)." Proposal Part B
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[“Solutions will encompass:”] “(i) wearable, portable, mobile or web-based systems for monitoring of patient status and activity, therapy compliance or treatment at the point of need;”
[“Solutions will encompass:”] “(ii) auto-adaptive and selfcalibrating systems that take into account the acquisition of physiological data in non-clinically controlled environments and the variability in the population, to help select and continuously adapt appropriate services to patients;” [“Solutions will encompass:”] “(iii) decision support systems for professionals Proposal Part B
STREP proposal
SKIPPER the application of Decisions Support Systems, based upon largely accepted guidelines such as GOLD (COPD) and upon new developments of clinical and epidemiological knowledge (relating for example the COPD and its main comorbidities), to the detection, the diagnosis, the guidance, the prevention and the patient follow up. The SKIPPER framework and platform integrates an Internet of Services (managing health records, demographics, terminology) with an Internet of Things (portable and mobile patient terminals and environmental sensors). In particular, in order to foster the overall sustainability of the project supporting an easier deployment to the market, remote monitoring will include both wearable (embedded) sensors and off-the-shelf device to gather patient vital signs. This would allow the deployment of a remote monitoring kit that will be personalized basing on the specific pathology to be addressed. As an outcome the monitoring framework will be a flexible, scalable, userfriendly and cost-effective diagnostic framework, supporting a safe, consistent and reliable access to certified medical devices, to check for user health status. Health monitoring will be safe, efficient and real time, making the data acquired immediately available for EHR and medical staff. In order to face normalization and integration issues related to the data acquired from patients wearing multiple sensors, specific normalization and calibration algorithms will be developed. Patient and environmental data are continuously evaluated against the patient record and history, and alerts and messages towards patients are automatically generated at the point of need. The use of widely accepted standards on service oriented architecture guarantees the easy enrolment of new devices and services in an evolutionary architecture. SKIPPER holds to its SOA approach even with respect to the integration and non-clinical operation of sensor devices by encapsulation such devices as services. This not only allows for hiding much of the technology needed for normalizing data and calibrating devices but as well enables solution designers to select and orchestrate the required monitoring data as needed. By integrating and layering services vital data from multiple sensors can be synchronized on a lower service level including functionalities such as temporal and spatial alignment and improved fault tolerance. SKIPPER will also take into account the quality of sleep for COPD patients, and in particular the sleep apnea. This can e.g. be achieved through 3Dpositioning sensors at multiple body parts and special shirts which integrate sensors for measuring lung activities. SKIPPER solutions will provide innovative decision making services to facilitate and support integrated care management and treatment of patients with COPD at the point of need, including early detection of further complications and by making use of heterogeneous and multimodal data to
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and patients, as well as patient guidance services, which build on multimodal data fusion (involving e.g. physiological, environmental, emotional and genetic data), data and pattern analysis, and modelling and predictive algorithms of patient health status;”
[“Solutions will encompass:”] Proposal Part B
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SKIPPER build models for assessing and predicting patient health status. In particular, the relevant set of services provided by SKIPPER platform are finalized at the optimization (in terms of effectiveness and efficiency) and personalization of the health care pathways related to: • early detection of acute and worsening events, and prediction of exacerbations; • prognosis evaluation, severity and risk assessment; • planning and management of therapeutic options and patient tailoring of rehabilitation procedures; • support patients in their daily life through coaching and induce lifestyle habits modification; • improvement of patient motivation and self-care, compliance, emotional and psychological status. The most innovative services will be developed and delivered through the implementation of an active and informative decision support for the control and optimal clinical management of the chronic COPD patients, in terms of effectiveness and efficiency, in order to promote and support self-care management of the chronic COPD patient at home, and support clinicians in predicting and preventing sudden worsening of the patient condition or addressing alarms and manage crisis. More specifically, the main functionalities will be: • monitoring system: 1. alarm/alert/reminder/recommendation generated as one-way message; 2. process the multisensory data about patient’s vital signs and symptoms and timely identify the onset of disease’s exacerbations; • interactive consultation system: 1. engage user in a dialogue; 2. provide insights, consultations, assistance; 3. allow analysis and exploration; • patient guidance system: 1. offer reminder/commentary on life style and worsening preventive procedures; 2. allow empowerment and self-care management compliance; 3. allow personalization of chronic care programme; • clinical support system: 1. offer commentary on proposed/actual interventions; 2. provide timely suggestions to clinicians about patient’s health status and disease’s progression; 3. provide accurate and specialized consultation for low resources medical environments or non-clinically controlled environments. The end-users services for healthcare professionals include specific services for the identification, the classification and the enrolment of the patients in
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the care programmes supported by the SKIPPER platform. These steps are compliant with the chronic care model and the stratification will be performed according to scientific guidelines (such as GOLD), studied and selected at the beginning of the project. Moreover the SKIPPER platform will support counselling services, in order to understand the specific needs of the patient (in terms of severity of the disease, presence of comorbidities, therapeutic treatment, human factors, knowledge and awareness of the health status) and to apply a personalization of the care programme: this personalization will be allowed by the clinical workflow management services of the SKIPPER platform, based on the integration profile IHE XDW and implemented according to the HL7 HSSP Care Coordination Service. [“Solutions will The SKIPPER project aims at evaluating, through two pilot experimentations encompass:”] (in Italy and in Greece), the impact of the SKIPPER solution in terms of: “(v) innovation in care • clinical effectiveness and economic sustainability of the possible new pathways, organizational organizational healthcare models models and business • evolution of the eHealth market, with business models that could models.” exploit the SKIPPER solution. The definition, the execution and the evaluation of the pilots will be supported by the Italian and Greek local healthcare authorities that will provide all the needed settings for realistic implementation environments. These institutions are very interested in the results of the project and aims towards using the outcomes and know-how gained after the end of the proposed project. They will actively participate therefore to the identification of innovative care pathways and organizational models for the management of COPD and, in general, of chronic diseases. The study and the identification of innovative care pathways will be also carried out by the SKIPPER partners with the support of scientific associations that gave their endorsement to the project, like AIMAR 5 and SPLF 6. Concerning the organizational models, the SKIPPER project includes the expertise in • organization and management models for the healthcare delivery • study and definition of the economic impact in healthcare systems In particular, the SKIPPER project will adopt the chronic care model, an organizational model that the Tuscany Region is applying with good results. Regarding this aspect, the objective of the project is to evaluate if the SKIPPER solution is able to improve the management, the efficiency and the efficacy of the Chronic Care Model used by the Tuscany Region. Other requirements of the objective ICT-2013.5.1 Target Outcome b) “Projects will address high The SKIPPER project, including the framework and platform for healthcare risk and multi-disciplinary and its COPD & comorbidities validation, will address high risk and multiresearch, integrating and disciplinary research: developing further, where • Service oriented architecture for healthcare - the project integrates necessary, safe hardware or “(iv) stratification of patients to care programmes and personalisation of such programmes to specific characteristics of patients;”
5 6
http://www.aimarnet.it/ http://www.splf.org/s/
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“Projects shall ensure sufficient user participation, realistic implementation environments and involvement of representatives of care authorities, to support the validation of the developed solutions and adapted organizational models.”
“Validation will aim to demonstrate, with quantitative indicators, the proof of concept, quality of life and care efficiency gains and, if possible, cost effectiveness of the proposed solution.” Proposal Part B
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SKIPPER ongoing research and development on HSSP services, conducted by partners of the SKIPPER consortium – it will test the effective interoperability between different implementation of standard services such as: (i) RLUS – standard clinical data management, (ii) IXS – standard identity and demographics management, (iii) CTS2 – standard terminology management, (iv) CDSS – standard access to Clinical Decision Support Systems, (v) Advanced security services allowing low granularity patient informed consent to the access and manipulation of clinical data (based upon SAML, XACML, WSS). • Advanced devices for healthcare - EFA-in-a-Box integrated data and security services platform, fully deployable on hardware (hardened mini-PCs on the client side and XML gateway on the service side). • Automated and knowledge driven patient follow-up process. • Fault tolerant design and implementation of the real-time patient follow-up. • Advanced DSS design supporting real-time and off-line detection, diagnosis, guidance for patient, practitioners, and for driving the real-time follow-up process. • Automated conformance, interoperability, functional and security testing will carried out with the support of the result of the MIDAS FP7 (call 8) project (Testing as a Service on cloud) • Deployment of the SKIPPER platform as a Service on cloud, providing to the user self-provisioning and of elastic resources As said before, for the evaluation and the validation of the SKIPPER solution, the project will define and activate two pilot experimentations (in Italy and in Greece). The Italian pilot will be supported by the Tuscany Region that will guarantee the involvement of a local Health Authority, an association of general practitioners (GPs) and an association of patients. In particular, the Tuscany Region is adopting the chronic care model and it is very interested in verifying the impact of the SKIPPER solution for the management of this organizational model. The Greek pilot will be supported by the Greek Thoracic Society and will involve the private hospital IASSIS (partner of the project), private pulmonologists and a group of patients. The 7° Health Region of Crete gave its endorsement for the exploitation of the results. The pilots will present therefore two different healthcare organization models and will represent a very realistic validation of the SKIPPER solution. In the framework of the SKIPPER project, the WP2 has the objective to describe the clinical domain and to define clinical scenarios, guidelines and care programmes that will be supported by the SKIPPER solution. A very strategic outcome of the WP2 will be the list of the quantitative indicators that will be measured, analysed and evaluated at the end of the experimentations. These indicators will include: • the percentage of advancement of the disease towards more severe stages ,
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the numbers of hospitalizations, the evaluation of the human factors and the possibility for the patients to have (as much as possible) a regular life in their normal environments, • the impact of the main comorbidities, • the impact of the environmental factors. Concerning the Chronic Care model, in particular, the Tuscany Region evaluate periodically a set of indicators, through the support of the MES laboratory of the Scuola Superiore Sant’Anna of Pisa. This data could be used to refine the list of indicators adopted in the project and to perform a comparison with the results of the SKIPPER evaluation. “Appropriate privacy and The privacy safeguards are implemented through the guarantee of ethical safeguards should be confidentiality and patient’s consent to health record access, based on included.” generally accepted standards. The framework and platform and the COPD & Comorbidities validation will include hard- and software deployable security services for authentication, authorization, non-repudiation, and pseudonymization based on international standards (SAML, WS*, XACML, WSS, RFC3881, etc.). Moreover, methodologies for “privacy by analysis” and “privacy by design” for integrating privacy and ethical issues into the early development stages. The satisfaction of privacy and general security requirements will be confirmed and reinforced by the systematic and automated testing activity, based on advanced testing methods such as robustness testing, fuzz testing, fault injection testing, policy-based testing. Regarding ethical safeguards, the patients for the pilot experimentations in the selected towns selected, will be recruited upon the acquisition of their authorization and informed consent and with the adequate involvement of the Competent Ethical Committee. In the SKIPPER project, effective interoperability is one of the most important “The use and further objectives. In fact HL7 Europe decided to join the SKIPPER consortium. In the development of existing Internet of Services and of Things, interoperability between necessarily open platforms and open architectures is required, to heterogeneous implementations is guaranteed by the compliance with standard service contracts. The use of standard HSSP services RLUS, IXS, facilitate multiple types of CTS2, CDSS ensures that the retrieval and manipulation of clinical data, of services on interoperable identities and demographics, of terminologies and the access to Clinical infrastructure.” Decision Support Systems will be interoperable. As “proof of concept” of the effective interoperability of the services of the platform we will connect several competing implementations of the HSSP services developed by the project partners in the context of preceding research and development projects. It should be noticed that the SKIPPER project involves the main European HSSP implementers. The platform will also include IHE native standards such as XDS ansd PIX. In the FP7- (call 8) MIDAS project some SKIPPER partners realizes on the basis of the MIDAS Testing as a Service on cloud, a standard compliance and interoperability testing framework for HSSP services. It will be systematically applied to the HSSP service implementation. • •
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“Projects will also address technical and semantic interoperability issues concerning devices and heterogeneous sources of personal data related to health and wellbeing.”
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SKIPPER In addition, the SKIPPER pilot to be implemented in Tuscany could reuse the open Regional CART/TIX infrastructure for service, based on XML protocol and RFC (request for Comments) interaction modalities. This will allow a simple integration and relevant opportunities to support reuse and large scale adoption. The key to the semantic interoperability in a healthcare distributed architecture based upon the Internet of Services and Things is the correct management of terminologies. Devices as sources of data are very simple applications transmitting data that are labelled with terms or codes. The HSSP CTS2 service allows the correct handling terminologies according to best practices. Assuring latest versions of terminologies, correct binding of value sets, mapping between local vocabularies and “pivot” terminologies, and the usage of international terminologies used in European and other international projects are all corner stones to semantic interoperability. Technical interoperability in data management is ensured by the use of HSSP standards such as RLUS (SOAP) and its translation to the REST/HTTP architecture (hData RESTful Transport). Another important interoperability point is the accurate patient identification. The standard support is the HSSP IXS service that allows to manage patient demographics and identity and to map patient identifiers managed by different patient databases, included database buit upon the PIX IHE profile. Implementations of the actual version of the CTS2 standards (that enhances the capabilities of the initial CTS specification for sub-setting and mapping, and extends the specification into domains such as terminology distribution, versioning, and classification) are supplied by three SKIPPER partners as project background. The three implementations will be employed in the COPD & comorbidities validation of the SKIPPER platform as a proof of concept of their mutual interoperability. RLUS and IXS are supplied as background by Deadalus and Fraunhofer. Dedalus proposes also the Rest version of RLUS (hData Restful Transport) that is particularly interesting when dealing with Internet connected basic devices. All these aspects are addressed by the methodological framework HL7-SAIF (Service Aware Interoperability Framework) that will be carefully applied in the analysis and design phase. For technical aspects can be useful the work of OHT mdth (model driven CDA2 IG with code generation) also for the ongoing support of OMG-MDMI (Model Driven Message Interoperability). Furthermore, five SKIPPER partners are involved in the HSSP (HL7 and OMG) standardization process and will provide feedback based on the project experience and needs to the standardization bodies. The technical and semantic interoperability of devices/services will be massively tested by using standard automatic testing platform such as TTCN3 and the results of the MIDAS projects.
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Progress beyond the state-of-the-art
The SKIPPER project faces different scientific and technological areas, from the medical and clinical ones to the functional and technological aspects such as PHR systems, standard based interoperability services, devices networks for telemonitoring, knowledge management and decision support systems, from the realization of innovative end-users services on cloud infrastructures both for health operators and patients to the definition of new healthcare organizational models and business exploitation plans. For each item the section 1.2.1 describes the state of the art and related on-going initiatives, whereas the section 1.2.2 introduces the progress that the SKIPPER project intends to bring about. 1.2.1 1.2.1.1
State of the art and on-going European initiatives Guidelines and care programmes for COPD
COPD is an important leading cause of death and of illness in Europe and in the rest of the world. Because many patients are not getting appropriate care, guidelines have been implemented to help clinicians to diagnose and manage stable COPD, prevent and treat exacerbations, reduce hospitalizations and deaths, and improve the quality of life of patients with COPD. Existing guidelines make the recommendations based on spirometer, treatment, pulmonary rehabilitation, oxygen therapy. For instance, pulmonary rehabilitation is recommended in symptomatic patients with severe COPD (FEV1<50%) and may be considered in symptomatic or exercise-limited patients with less severe airflow obstruction. In patients who have severe resting hypoxemia and SpO2 () of 88% or less, continuous oxygen therapy should be used. However, these guidelines deal mainly with the medical management of established disease and its exacerbations and there is evidence for the need to shift emphasis in COPD guidelines from a predominant reliance on pharmacological treatment of COPD to a range of interventions which include treatment, patient’s education (on smoking cessation), self-management of exacerbations and pulmonary rehabilitation, Body Mass Index control (to avoid weight loss), rehabilitation and management of comorbidity. In addition, COPD guidelines have to take into account the effects of environmental exposure on COPD. COPD patients are particularly vulnerable to additional stress on the airways caused by aggressive agents. Although smoking is recognized as the most important factor for the development of COPD, over the last 10 years, an increasing number of studies have suggested that there are risk factors other than smoking in the genesis of COPD. These factors include exposure to indoor and outdoor air pollutants and occupational exposure to dust and fumes. Exposure to air pollution is associated with an increase in respiratory morbidity from COPD, including an increase in respiratory symptoms and a decrease in pulmonary function, as well as being a common cause of exacerbations leading to emergency room visits or hospitalizations (Ko). Individuals exposed to biomass burning have a significantly higher OR for the development of COPD than do those who were not exposed (Hu). Indoor biomass burning is a significant cause of COPD in non-smoking women who are exposed to high concentrations of pollutants during cooking activities, especially in rural areas of developing countries, and this significantly contributes to the global increase in the disease (Salvi). While women with COPD caused by smoking have emphysema and goblet cell metaplasia more commonly than do those exposed to biomass burning, the latter group has more severe interlobular septal thickening, more pigment deposition in the lung parenchyma, smaller airway fibrosis, and more severe intimal thickening of the pulmonary artery (Ko). Authors also suggest that chronic exposure to traffic-generated PM10 increases the risk of developing COPD and accelerates pulmonary function loss. COPD patients are also vulnerable to meteorological factors. Weather conditions can significantly increase the risk of ill health and hospital admissions for people who have COPD. In the literature, temperature has been shown to have a high impact on respiratory diseases. In winter a combination of environmental factors including virus levels can make symptoms worse. In summer, extreme heat can also pose a threat. Several publications have shown an increase in mortality associated with temperature Proposal Part B
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events. Newer research also included hospital admission rates. The effects of temperature on hospital admission rates varied between different regions in Europe (Analitis 2008, Michelozzi 2009). Data from USA have shown that higher temperature variations in the warm season was significantly associated with shorter survival time in a large multicity study of older subjects discharged alive following an admission for MI, COPD, CHF, or diabetes. Mortality risk was 1.064 (95% confidence interval, 1.044- 1.083) per 1 °C increase in yearly summer temperature standard deviation (SD) for persons with COPD, 1.052 (95% confidence interval, 1.036-1.069) per 1 °C increase for those with diabetes, 1.071 (95% confidence interval, 1.051- 1.092) per 1 °C increase for those with myocardial infarctus (MI) and 1.065 (95% confidence interval, 1.047- 1.083) per 1 °C increase for those with congestive heart failure (CHF). Based on these findings, a 1 °C increase in temperature SD would increase all-cause mortality in COPD patients by 4.4%, for example. Associations were stronger in the subjects aged ≥75 y. Interestingly, for all of the cohorts of patients, the temperature had a weaker association with survival time in the cities with a higher proportion of green surface. Based on an average of 250,000 deaths per year across Europe, a 4.4% increase in mortality would correspond to ~11,000 additional deaths per year diue to an increase of 1 °C in temperature variability in Europe, which is compatible with expected climate changes. Similar figures are expected for the other affections that constitute common COPD co-morbidities. In contrast to temperature, the impact of other meteorological factors on COPD has not been well described. However, in Bavaria an increase of daily COPD consultations (about 103 visits per day) was found to be positively associated with increasing relative humidity, wind speed, atmospheric pressure and negatively associated with the increasing of solar radiations (Ferrari). References •
Ko FW, Hui DS. Air pollution and chronic obstructive pulmonary disease. Respirology. 2012;17(3):395-401.
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Hu G, Zhou Y, Tian J, Yao W, Li J, Li B, et al. Risk of COPD from exposure to biomass smoke: a metaanalysis. Chest. 2010;138(1):20-31.
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Salvi SS, Barnes PJ. Chronic obstructive pulmonary disease in non-smokers. Lancet. 2009;374(9691):733-43.
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Ward M. Health forecasting and COPD. Chron Respir Dis. 2011;8(1):3-4.
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Iñiguez C, Ballester F, Ferrandiz J, Pérez-Hoyos S, Sáez M, López A; TEMPRO-EMECAS. Relation between temperature and mortality in thirteen Spanish cities. Int J Environ Res Public Health. 2010 Aug;7(8):3196-210.
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Ballester F, Corella D, Pérez-Hoyos S, Sáez M, Hervás A. Mortality as a function of temperature. A study in Valencia, Spain, 1991-1993. Int J Epidemiol. 1997 Jun;26(3):551-61.
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Michelozzi P, Accetta G, De Sario M, D'Ippoliti D, Marino C, Baccini M, Biggeri A, Anderson HR, Katsouyanni K, Ballester F, Bisanti L, Cadum E, Forsberg B, Forastiere F, Goodman PG, Hojs A, Kirchmayer U, Medina S, Paldy A, Schindler C, Sunyer J, Perucci CA; PHEWE Collaborative Group. High temperature and hospitalizations for cardiovascular and respiratory causes in 12 European cities. Am J Respir Crit Care Med. 2009 Mar 1;179(5):3839.
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Analitis A, Katsouyanni K, Biggeri A, Baccini M, Forsberg B, Bisanti L, Kirchmayer U, Ballester F, Cadum E, Goodman PG, Hojs A, Sunyer J, Tiittanen P, Michelozzi P. Effects of cold weather on mortality: results from 15 European cities within the PHEWE project. Am J Epidemiol. 2008 Dec 15;168(12):1397-408.
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Zanobetti A, O'Neill MS, Gronlund CJ, Schwartz JD. Summer temperature variability and longterm survival among elderly people with chronic disease. Proc Natl Acad Sci U S A. 2012 Apr 24;109(17):6608-13.
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Ferrari U, Exner T, Wanka ER, Bergemann C, Meyer-Arnek J, Hildenbrand B, Tufman A, Heumann C, Huber RM, Bittner M, Fischer R.Influence of air pressure, humidity, solar radiation, temperature, and wind speed on ambulatory visits due tochronic obstructive pulmonary disease in Bavaria, Germany. Int J Biometeorol. 2012 Jan;56(1):137-43.
Human factors impact in COPD
For decades, the psychiatric morbidity of medically ill patients has been acknowledged. However, there has been relatively little focus on psychiatric disorders in patients with chronic obstructive pulmonary disease (COPD). COPD patients constitute a substantial part of the medically ill patients, both in hospital wards and outpatients’ clinics, presenting a considerable challenge to the healthcare system. The association between COPD and psychiatric disorders, in particular generalized anxiety, panic anxiety and depression, has been acknowledged for many years. The prevalence of psychiatric comorbidity in these patients as well as the effect of treatment and the prognosis remains unsettled. The diagnostic procedure is complicated by an overlap or close association of somatic and psychiatric symptoms in COPD patients suffering from comorbid anxiety and depression. There is evidence that psychiatric comorbidity contributes significantly to the functional impairment of COPD patients and that psychiatric treatment may improve not only psychiatric status but also pulmonary function. The following review examines the comorbid panic anxiety, general anxiety and depression in COPD patients, in order to reveal the magnitude of this clinical problem and explore possible pathogenetic mechanisms. Furthermore, we have reviewed the studies and suggestions of the optimal treatment of psychiatric morbidity in this patient group. In the literature search, we used the Medline /PubMed, EMBASE and Psychlit databases. Key words used were ‘‘depressive disorders’’, ‘‘anxiety disorders’’, ‘‘lung disease, obstructive’’ and subheadings ‘‘drug treatment’’, ‘‘psychology’’ and ‘‘complications’’. Based on retrieved key articles, additional ‘‘chain-search’’ was conducted using the link ‘‘related articles’’ in PubMed. Prevalence and comorbidity The prevalence of anxiety symptoms in COPD patients varies from 2% to more than 50%. The prevalence of depressive symptoms varies correspondingly. In a recent review article on comorbid depression in the COPD patients, Van Ede et al. found a prevalence of depression, ranging from 6% to 42%. Only four of 34 studies used control groups. In these four studies, the prevalence of depression was higher in the study groups, but only in two studies was the difference significant. Two of the latest prevalence studies identified clinically significant depressive symptoms in 42-/57% of COPD patients. In comparison, Robins et al. found a lifetime prevalence for panic anxiety of 1.5% in an US study of the general population. Lifetime prevalence for anxiety in the general population amounted to 15% and for single depressive episodes 5%. Our review of comorbidity discloses a substantial overrepresentation of anxiety and depression in COPD patients, both regarding occurrence of ‘‘significant symptoms’’ and psychiatric diagnoses. Although there are large variations in prevalence figures, even the latest studies confirm earlier reports of clinical depression amounting to over 40% in this population, i.e. eight times the life time prevalence in the background population. Levels of morbid anxiety are equally elevated in some studies. The high prevalence rates are found in studies from western countries as well as from a developing country. Furthermore, both inpatients and outpatients have excess psychiatric morbidity, and studies of the elderly make no exception to this trend. The explanation for these very differing results can be several. Many studies are performed on small samples and are lacking control groups. The way the psychiatric diagnoses are obtained also varies. Some studies utilize established diagnostic criteria; other studies only use clinical assessments or self-reported symptoms. Most studies contain no formal data analysis and only simple descriptive statistics. Finally, differences in the objective characteristics and severity of COPD may contribute to the variations in prevalence figures. Clinical and social implications The clinical and social implications of comorbid anxiety and depression in COPD patients are only scarcely investigated. In the study by Yellowlees et al., the authors compared COPD patients with and without comorbid psychiatric disorders. Patients with psychiatric comorbidity were spending twice as long Proposal Part B
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time in hospital as the comparison group. McSweeny et al. found that the quality of life of the COPD patients was impaired in all dimensions compared to healthy controls. High impact was seen both on ambulation, mobility, sleep and rest. If COPD patients are further suffering from comorbid psychiatric disorder, this will add to the psychosocial dysfunction. Additionally, substantial marital problems are reported by patients and attributed to their illness. Furthermore, the role of medication side-effects should be considered. Many COPD patients are taking several medications. In the Yellowlees study, the average number of daily medications was five (range 2-/ 9). Gift et al. found in a study of 40 patients with severe COPD that 20 patients receiving steroids were significantly more depressed than a group of 20 patients not receiving steroids. This association is well known and stresses that the emotional status of COPD patients in steroid treatment needs psychiatric monitoring. Psychological and physiological explanatory models Dyspnea and hyperventilation are frequent symptoms in patients with COPD as well as patients with panic anxiety. Due to this symptom overlap, three different explanatory models have been put forward to explore possible, common pathophysiology. The hyperventilation model assumes that dyspnea and panic arise from the same clinical presentation, namely the hyperventilation syndrome. Thus, patients with COPD and with panic anxiety tend to have dysfunctional breathing patterns that may be associated with hyperventilation. The following hypocapnia may in turn be responsible for various symptoms of anxiety and for dyspnea as well, in this way producing an aggravation of symptoms. The paper bag rebreathing technique used to treat acute panic attacks is based on this model. The carbon dioxide hypersensitivity model is based on the finding that lactate can produce panic attacks in about two-thirds of patients suffering from panic disorder. The pathophysiological mechanism remains unclear, but abnormally sensitive brain stem chemoreceptors seem to elicit a ‘‘suffocation false alarm’’. The cognitive behavioural model is based on the idea that patients’ fear and misinterpretation of bodily experiences arising from dyspnea and hyperventilation are catalysing a panic reaction. It is hypothesized that persons with panic disorder interpret threats as more dangerous due to a higher awareness of interoceptive cues like dyspnea and tachycardia. This leads to catastrophic cognitions. The pathogenetic mechanisms of comorbid depression in COPD patients are also complex. The focus has mainly been on four biological factors: Hypoxia, smoking, exacerbations of COPD and untreated chronic depression, all of which factors may in turn lead to comorbid depression and neurocognitive dysfunction in COPD patients. Hypoxia is known to induce not only psychomotor slowing and memory impairment but also depressed mood. Both smoking and COPD generates hypoxia, leading to neuropsychiatric disturbances in these patients. Several pathogenetic mechanisms are suggested, ranging from direct damage of the white matter in the brain to vascular endothelial damage or simply increased oxidative stress. A correlation between cognitive dysfunction and blood gas abnormalities is described, resulting in particularly impaired memory and attention functioning. Accordingly, Brorson et al. suggest that depression and neurocognitive impairment are two different clinical manifestations of the same pathophysiological brain disturbances in COPD patients. Smoking in COPD patients is considered to have both anxiolytic and anxiogenic effect, and in a large community sample, Breslau found that smokers who met the criteria for nicotine dependence had elevated lifetime rates of anxiety disorders. Further, patients with a history of depressive and anxiety disorders report more severe nicotine withdrawals symptoms and may experience greater difficulty in smoking cessation. Smoking thus seems to play a pathogenetic role in several ways. 1.2.1.3
PHR systems
A personal health record (PHR) is a collection of various patient data, from healthcare professionals and the patient himself, which is controlled only by the individual patient. The Personal Health Record concept is patient centric, in the sense that its management is a primary responsibility of the patient. Through a PHR application the patient is able to provide daily life-status information, maintain his own record of medical exams and define the access rights to his personal data. Personal health record systems are widely used to
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maintain a dynamic and up-to-date health profile including a variety of different data 7. Data that are included in PHRs are not necessary limited to medical family history, medications, laboratory tests, diagnostic studies and vaccination, but may also contain lifestyle information, medication compliance, emotions, physical activity, etc. Due to the promotion of electronic personal health records, emerging PHR systems and their associated tools are evolving constantly. Thus, electronic personal health records are a rapidly expanding area in the field of health information technology. The continuing growth of electronic PHR systems leads to an on-going research on comparison criteria and standardization of functionality. A PHR system needs to be in compliance with high quality standards, in order to be acknowledged as a high end product. More specifically, a PHR system needs to be certified by an official, globally recognized organization that guarantees high level standards, in order to be widely accepted as a fully functional, secure product that can truly enhance the delivery of healthcare services. In this direction, there are two significant efforts that attempt to address the need for functional specification and standardization in the constantly evolving area of electronic health record systems. The first is the Personal Health Record System Functional Model that has been proposed by the Health Level Seven (HL7) organization 8, while the second is the specification of Meaningful Use criteria that have been established by the U.S. Office of the National Coordinator for Health IT Office of National Coordinator (ONC) 9. The HL7 PHR System Functional Model (PHR-S FM) specifies a set of functions and security related features that PHR systems are required to, should, or may, support in order to be effective. The model is consumer-oriented and offers guidelines that facilitate health information exchange among different systems and thus, serve as an anchor point for system interoperability. Essentially, the model does not attempt to define a PHR but rather provide a certification framework for PHR systems. The PHR-S FM model is divided into three sections and each section comprises subsections and a number of individual functions. The three basic sections are Personal Health, Supportive and Information Infrastructure. The first is associated with managing information and features related to self-care and provider-based care over time. The second assists with the administrative and financial tasks associated with healthcare delivery. This section also addresses the task of providing input to systems that perform medical research and seek to improve the quality of healthcare delivery. The last section includes privacy and security related functions and also functions that promote interoperability between PHR systems. The establishment of the Meaningful Use criteria in the United States is another significant effort in the direction of electronic health record system standardization. Meaningful Use criteria define high level requirements for functionality, privacy and security of EHR systems and have been defined as part of HITECH (Health Information Technology for Economic and Clinical Health Act) by the ONC. Currently in the literature we can find a lot of PHR systems. Most of them are commercial and partially support the stated standards. We focus on four free, open source solutions which are considered to gain momentum lately. Following we give a brief description of these PHR systems and we compare them according to a functional specification model. Tolven The Tolven10 software environment is composed of two basic UI components, an electronic Personal Health Record solution (ePHR) and an electronic Clinician Health Record solution (eCHR). The ePHR interface enables consumers to record and selectively share healthcare information about themselves and their loved ones in a secure manner and the eCHR interface enables physicians and other healthcare 7
Basdekis, I., Sakkalis, V., and Stephanidis, C. Towards an Accessible Personal Health Record. In the Proceedings of the 2nd International ICST Conference on Wireless Mobile Communication and Healthcare (MobiHealth 2011), Kos Island, Greece, October (2011). 8 http://www.hl7.org/implement/standards/product_section.cfm?section=4 9 http://healthit.hhs.gov/portal/server.pt/community/healthit_hhs_gov__home/1204 10 http://home.tolven.org/ Proposal Part B
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providers to securely access healthcare information (collated from any number of trusted sources) relating to an individual patient in a structured and easily accessible way. The healthcare data are stored in a healthcare informatics platform and are accessed via the ePHR and eCHR solutions. From operational point of view Tolven complies with Meaningful Use criteria that have been established by the U.S. Office of the National Coordinator for Health IT (ONC). From technical point of view Tolven utilizes state of the art, industry-standard technologies such as Java, EJB3, Faces, Facelets, AJAX and relational database and supports various data formats such as CDD, CCR, and CDA documents and standardized HL7 messages. Moreover, Tolven is built upon an architecture that is plugin-based down to the core module. This is an important advantage for maintenance, customizations and extensions that are often required from electronic health systems in order to meet specific healthcare environment needs. OpenMRS OpenMRS is a Java-based, web-based electronic medical record. Started from a simple (at least it used to be simple) data model, wrapped that into an API, and then built a web-based application that uses the API. The OpenMRS API works like a "black box," hiding the complexities of the data model beneath it and ensuring that applications and modules using the API work with a similar set of business rules for managing the electronic medical record system data. Initially, OpenMRS was built to support HIV care in a couple of settings (in Kenya and Rwanda); however, from the very beginning we knew that it would be artificial to create a vertical HIV-specific solution, since patients with HIV also have other medical problems. Then designed OpenMRS to be a generic medical record system that can support the care of patients, gathering observations, encounters, notes, and other data from the healthcare system and rendering those in summaries, reports, and data views that would improve the effectiveness of the people using the system. OpenMRS is constructed to support modules. Using modules, implementations are able to modify the behaviour of the system to meet their local needs without everyone having to agree on a single approach. The current PHR module allows the creation of a patient controlled health records application. It gives the patient the full control of his/her own health records and other personal information, and enables him/her to share part or all of those information to any one in his/her social network such as a family member, a doctor, or any other caregiver he/she trusts 11. Indivo-X The Indivo project has its roots in the Guardian Angel project, a collaboration between Harvard and MIT that envisioned a web-based, automated guardian to manage health data and decisions. The Indivo model has inspired a number of commercial efforts throughout its evolution. Indivo is the original personal health platform, enabling an individual to own and manage a complete, secure, digital copy of her health and wellness information. Indivo integrates health information across sites of care and over time. Indivo is free and open-source, uses open, unencumbered standards, including those from the SMART Platforms project and is actively deployed in diverse settings. Indivo is a specific implementation of a PCHR that is Internet based, provides a World Wide Web interface, and is built to public, open standards. Indivo allows the ready integration of diverse sources of medical data under a patient's control through the use of standards-based communication protocols and APIs for connecting PHRs to existing and future health information systems. Indivo-X comprises multiple components, each running as its own web server. The Indivo X Server is the core of the system; other components, including the Indivo User Interface, can be easily substituted by custom implementations. The Indivo X server: • • • 11
stores all Indivo account information, as well as the medical records and documents, is responsible for authentication and authorization before granting access to Indivo data, exposes an API for access by administrative and user applications, and by the Indivo User Interface.
https://wiki.openmrs.org/display/docs/PHR+Module
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Indivo has two classes of security policies. The first is institutionally-oriented, server-based and explicitly permits or denies certain actions. The second policy type is user based, enabling a patient to indicate which other users have particular privileges on specific portions of his/her record. FORTH-PHR The FORTH-PHR (FPHR) is a multiplatform web-based PHR that is currently focused on diabetes management. The FPHR supports the acquisition and monitoring of patient’s various types of medical information related to diabetes management such as: • • • • •
capture of life-style data, capture and monitoring of measurements and medication data, graphical contextualized representation of measurements data, feedbacks for the patient, educational material related to diabetes disease.
The FPHR has been designed in order to promote patient empowerment and self-management of diabetes. The graphical user interface uses state of the art technologies such as ASP.NET v4, HTML5 and CSS3 in order to provide usability and accessibility to non-computer experienced people. Because of the web-based nature, FPHR has been developed in order to be accessible from a various types of devices such as tablets and personal computers that are compatible with W3C standards. Among the above features the FPHR has a multilingual support following internationalization for interoperability in many different countries. Evaluation Based on the research of PHR Functionality Standards and the study of numerous PHR systems we have distinguished five function categories of a powerful personal health record system. • • • • •
PDT Basic category encompasses Problem, Diagnosis and Treatment (PDT) related functions. Self-Health Monitoring includes functions that help the patient to monitor his own health status. Communication Management includes functions that help the patient manage his communications with other individuals that are related in his healthcare. Access Control includes all the functions that are related to the access control of a PHR system, such as Authentication, Authorization, Audit (AAA) and Delegation of access rights. Intelligence Factors includes all functions that illustrate intelligent behaviour.
Figure 5 summarizes the results of the evaluation for four open source PHR systems according to the PHR functional categories. PHR SYSTEMS Evaluation
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Tolven
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PDT Basic
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Intelligence Factors
Figure 5: Comparison between existing open source PHR systems Proposal Part B
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As for the architectural design of PHR systems, there are three commonly used categorizations: • Standalone PHR systems do not automatically interact with other EHR systems, and patients are responsible for keeping them up to date. • Tethered PHR systems are provided as part of a larger EHR system which contains a patient portal. These systems are tethered in the sense that they are usually linked to a clinician-controlled health system, and the records can be transferred easily, within the system's infrastructure. • Interconnected PHR systems are systems that support integration with other vendor's (EHR, EMR etc.) health systems and applications. The following table shows the architecture of the four selected PHR systems. PHR Systems 1. Tolven 2. Indivo-X 3. OpenMRS 4. FORTH-PHR 1.2.1.4
Architecture Tethered Interconnected Tethered Tethered
Security policies
Security for Cloud systems is a hot topic, since the main peculiarities of the Cloud introduce new security issues besides the usual ones of (distributed) systems on the Internet. Moreover, Cloud services are very attractive targets for attacks, because they store a very large quantity of data belonging to a large number of customers, and execute many computational processes, possibly concerning valuable data, on behalf of many customers. In particular, in the SKIPPER reference scenario, Cloud services will deal with health data, that are personal data and should be disclosed only to authorized subjects. In addition, laws and regulations of many countries define constraints on the protection of health data. As an example, the Italian Data Protection Authority defined a set of constraint concerning health data protection in [IDP09]. The Cloud Security Alliance (CSA) and the European Network and Information Agency (ENISA) investigated the security issues specific of the Cloud environment, and they summarized their results in the reports: “Top Threats to Cloud Computing” [CSA10], “Security & Resilience in Governmental Cloud” [EN11] and “Cloud Computing, Benefits, Risk and Recommendations for Information Security” [EN09]. The authors of [CPK10] and [MKL09] also described in their papers the main security aspects of Cloud computing as well. A review of the main results concerning security in healthcare systems can be found in [AJ10], and a proposal concerning the security the Italian Federated Health Information Systems is shown in [CDE12]. References •
[IDP09] Garante per la protezione dei Dati Personali, Linee guida in tema di Fascicolo sanitario elettronico (FSE) e di dossier sanitario. 16 July 2009, G.U. n. 178, 3 August 2009.
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[CSA10]
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[EN09] European Network and Information Security Agency, Cloud Computing. Benefits, Risks and Recommendations for Information Security, 2009.
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[EN11] European Network and Information Security Agency, Security and Resilience in Governmental Clouds, 2011.
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[CPK10] Y. Chen and V. Paxson and R.H. Katz: What's New About Cloud Computing Security?, Technical Report n. UCB/EECS-2010-5, EECS Department, University of California, Berkeley, 2010, available at http://www.eecs.berkeley.edu/Pubs/TechRpts/2010/EECS-20105.html.
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[MKL09] T. Mather, S. Kumaraswamy, and S. Latif: Cloud Security and Privacy: An Enterprise Perspective on Risks and Compliance. O'Reilly Media, Inc., 2009.
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Cloud Security Alliance, Top Threats to Cloud Computing, 2010.
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[AJ10] A. Appari and M. Johnson: Information security and privacy in healthcare: current state of research, International Journal of Internet and Enterprise Management, vol. 6, no. 4, pp. 279–314, 2010.
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[CDE12] M. Ciampi, G. De Pietro, C. Esposito, M. Sicuranza, P. Mori, A. Gebrehiwot, P. Donzelli: On Securing Communications among Federated Health Information Systems. In proceedings of SafeComp 2012, Lecture Notes in Computer Science 7613, Springer, 235-246, 2012.
1.2.1.5 Innovative Service Oriented Architecture and Interoperability Standards for Healthcare The state of the art in the domain of service oriented architecture and interoperability for healthcare is essentially represented by the achievements, in terms of standards and tools, of the Healthcare Services Specification Program (HSSP - http://hssp.wikispaces.com/). HSSP is a joint standards development activity driven by Health Level 7 (HL7 - http://www.hl7.org/) – probably the most important organization in the Healthcare sector - and the Object Management Group (OMG - http://www.omg.org/), and is supported by Integrating the Healthcare Enterprise (IHE http://www.ihe.net/) – the organization that includes the most important providers of healthcare software and digital services - and Open Health Tools (OHT - http://www.openhealthtools.org/). Since its inception, other organizations in the healthcare sector have joined the initiative. HSSP organizes a collective effort towards three main objectives: 1) To create useful, usable healthcare standards that address business functions, semantics and technologies. 2) To complement existing work and leverage existing standards, such as IHE. 3) To capitalize on industry talent through open community participation. The standardization cycle of HSSP is based upon a division of work between the HL7 and the OMG. On each project, HL7 is in charge of the functional specifications that are produced through its own standardization process. When the functional specifications are sufficiently consolidated, the OMG starts its own cycle in order to produce the technical specifications (the development of implementations “proof of concept” accompanies in the OMG process) that are taken into account by HL7 in the final process of functional specification approbation. This cycle guarantees that the produced standards are on one side congruent with the healthcare needs and constraints and, on the other side, are technically sustainable. HSSP produces generic services specifications. Roughly speaking, a generic service is a service that (i) exposes a reduced number of generic operations, i.e. operations whose definitions are independent from the types of the operation arguments, result, and handled objects, and (ii) specifies a procedure that allows detailing specific types of the operation arguments, result, handled objects. This collection of types is conventionally referred as a Semantic Profile. The generic service endowed with a Semantic Profile is an executable service. A HSSP service provider is able to enact as a provider of at least one Semantic Profile. The HSSP approach takes into account basic healthcare services that are involved in each healthcare process. Interoperability, which is the top level goal in a distributed world such as healthcare, is achieved by the compliance of the implementations with standard services. A HSSP executable service is easily usable by any application that is aware of its Semantic Profile. The projects about basic services that are reported in the list below are completed or almost completed: 1) The retrieval and manipulation of health data and records (HL7-RLUS, OMG-RLUS, HL7-hData, OMG-hData). 2) The management of patient (and other actors) identities and demographics – including the mapping between identifiers (HL7-IXS, OMG-IXS). 3) The management of terminologies, including terminology mapping, distribution, versioning and classification (HL7-CTS2, OMG-CTS2). 4) The uniform access to decision support systems (HL7-DSS, OMG-CDSS). Proposal Part B
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There are a number of implementations for each HSSP service in Europe, USA and Australia. Some of the SKIPPER partners are involved in the HSSP standardization processes and are within the group of the European developers of HSSP services: 1) Dedalus has developed RLUS, hData, IXS and CTS2 services in the context of the Italian national research project HealthSOAF. 2) Fraunhofer has developed RLUS, IXS and CTS2 services. 3) Phast has developed the tool Standard Terminology Service, an implementation of the HL7 CTS2 Service Functional Model. 4) Unical has developed the CDSS service in the context of the Italian national research project HealthSOAF. All these developments are included in the SKIPPER background. References •
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(HL7-RLUS) S. Lotti, J. Koisch, K. Rubin, A. P. Honey, S. Robinson, and K. Kawamoto, HL7 Version 3 Standard - Service Functional Model Specification - Retrieve, Locate, and Update Service (RLUS) - Normative ballot - Release 1. Health Level Seven International, Nov. 2011. [Online]. Available: http://www.hl7.org/v3ballot/html/infrastructure/rlus/RLUS_SFM-R1-FinalNov2011.pdf. (OMG-RLUS) OMG Retrieve, Locate, and Update Service(RLUS) Specification - Version 1.0.1. Object Management Group, Jul. 2011. [Online]. Available: http://www.omg.org/spec/RLUS/1.0.1/PDF/. (HL7-hData) G. Beuchelt, HL7 V3 ITS HDATA RF, R1 HL7 Version 3 Specification: hData Record Format, Release 1 Last Ballot: DSTU Ballot 1 - September 2011, G. Beuchelt, Ed. Health Level Seven International. [Online]. Available: http://www.hl7.org/v3ballot/html/infrastructure/hdata/hdatadf.html. (OMG-hData) OMG hData RESTful Transport. Object Management Group, Jan. 2012. [Online]. Available: http://www.omg.org/spec/HData/1.0/Beta1/PDF/. (HL7-IXS) A. Honey, P. Gilbert, A. Kirnak, D. Ries, and G. Teichrow, HL7 Service Functional Model Specification - Identification Service - Version 2.0 - Normative Ballot - 5 September 2009. Health Level Seven International, Sep. 2009. [Online]. Available: http://www.hl7.org/v3ballot/html/infrastructure/eis/IS_Service_Functional_Model_v2.pdf. (OMG-IXS) OMG Identity Cross-Reference Service (IXS) - Version 1.0.1. Object Management Group, May 2011. [Online]. Available: http://www.omg.org/spec/IXS/1.0.1/PDF/. (HL7-CTS2) R. Hamm, C. Stancl, K. Eckerson, D. Gabriel, A. Honey, J. Landgrebe, J. Carter, S. Nachimuthu, H. Solbrig, H. Grain, T. Klein, and B. Knight, HL7 Service Functional Model Specification Common Terminology Services Release 2 (CTS 2) - Version 1.1 (Draft Standard for Trial Use). Health Level Seven International, Mar. 2009. [Online]. Available: http://www.hl7.org/v3ballot/html/infrastructure/cts_r2/CTS%202%20SFM%20DSTU%20FINAL %2020090322_v1.1.pdf. (OMG-CTS2) o OMG CTS2 Code System and Code System Version Catalog Services - FTF Beta 1. Object Management Group, Sep. 2011, www.omg.org/spec/CTS2/1.0/Beta1/20110902/11-09-02.pdf. o OMG CTS2 Concept Domain and Concept Domain Binding Services - FTF Beta 1. Object Management Group, Sep. 2011, www.omg.org/spec/CTS2/1.0/Beta1/20110903/11-09-03.pdf. o OMG CTS2 Core Model Elements - FTF Beta 1. Object Management Group, Sep. 2011, www.omg.org/spec/CTS2/1.0/Beta1/20110904/11-09-04.pdf.
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OMG CTS2 Entity Description Services - FTF Beta 1. Object Management Group, Sep. 2011, www.omg.org/spec/CTS2/1.0/Beta1/20110905/11-09-05.pdf. o OMG CTS2 Map Services - FTF Beta 1. Object Management Group, Sep. 2011, www.omg.org/spec/CTS2/1.0/Beta1/20110906/11-09-06.pdf. o OMG CTS2 Statement Model and Services - FTF Beta 1. Object Management Group, Sep. 2011, www.omg.org/spec/CTS2/1.0/Beta1/20110907/11-09-07.pdf. o OMG CTS2 Value Set Services - FTF Beta 1. Object Management Group, Sep. 2011, www.omg.org/spec/CTS2/1.0/Beta1/20110908/11-09-08.pdf. (HL7-DSS) K. Kawamoto, O. Young, D. Boaz, D. Shields, B. Esler, K. Rubin, M. Koethe, A. Kirnak, G. Del Fiol, R. Jenders, H. Strasberg, C. Curtis, R. Hausam, and A. Honey, HL7 Decision Support Service (DSS), Release 1 - HL7 Project #757 Normative Ballot. Health Level Seven International, May 2011. [Online]. Available: http://www.hl7.org/v3ballot/html/infrastructure/dss/HL7_Decision_Support_Service_%20Nor mative_Specification_Release_1.pdf. (OMG-CDSS) OMG Clinical Decision Support Service (CDSS) - Version 1.0. Object Management Group, Jul. 2011. [Online]. Available: http://www.omg.org/spec/CDSS/1.0/. (HL7-HDS) M. Walker, A. Honey, and B. Laidlaw, HL7 Service Functional Model Specification Healthcare, Community Services and Provider Directory - Version 1.9, M. Walker, Ed. Health Level Seven International, Jul. 2009. [Online]. Available: http://www.hl7.org/v3ballot/html/infrastructure/hcspdir/Healthcare%20Community%20Servic es%20and%20Provider%20Directory%20Specifications%202009SEP.pdf. (OMG-ServD) OMG Service Directory (ServD). OMG, Aug. 2012. [Online]. Available: http://hssp-provider-services-directory.wikispaces.com/file/view/ServD% _spec%20v1.2.pdf/358052397/ServD_spec%20v1.2.pdf. (HL7-PASS-Access) D. Jorgenson, T. Page, G. Pyke, P. Pyette, M. Davis, and E. Coyne, HL7 Privacy, Access and Security Services (PASS) - Access Control Services - Conceptual Model Draft Standard for Trial Use Ballot - Release 1.0. Health Level Seven International, Jan. 2010. [Online]. Available: http://hssp-security.wikispaces.com/file/view/PASS+Alpha++Access+Control+Conceptual+Model+Release+1.0+-+Post-Ballot+Reconciliation.pdf. (HL7-PASS-Audit) D. Jorgenson, HL7 Privacy, Access and Security Services (PASS) - Healthcare Audit Control Service - Patient Privacy Capabilities - Release 1 Draft 0.60, P. Pyette, Ed. Health Level Seven International. [Online]. Available: http://hssp-security.wikispaces.com/PASS_Audit. o
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1.2.1.6
Decision support systems and knowledge management tools for the support of chronic disease care COPD is among the most serious and disabling pathologies that affect the middle-aged and elderly population in the industrialized countries. As such it can greatly benefit from Chronic Care Models. Several dedicated health programs endowed with decision support functionalities are being developed for COPD patients to provide a long-term care option, which is mainly based on Remote Patients’ Monitoring (RPM) to reduce disease impairment and exacerbation episodes. Recently, several trials have been carried out, especially based on teleassistance via phone calls of qualified nurses, and have demonstrated the real advantages of patients’ telemonitoring [1]-[3]. In some settings, ICT-based paradigms are used to RPM by a dedicated sensorized infrastructure, deployed in patients’ long-stay settings, to continuously acquire and monitor key health indicators (disease signs and symptoms, patients’ behaviour and activity, environmental conditions). In these settings, there is the strong demand for intelligent applications able to support clinical professionals to analyse and correlate the multi-parametric sensed data. Such applications should be able to recognize worsening signs, alert care provisioners and support them in the consequent decision making processes. Only few attempts to tackle this problem have been just reported in the literature [4]-[6], as this is an emerging clinical decision support domain. In addition, there is a growing demand of smart services oriented not only to the health care operators but also to self-management and patient empowerment; such services dedicated to the patient can greatly benefit from the seamless integration with advanced sensor infrastructure. In this context, classical clinical decision support systems are evolving, trying to Proposal Part B
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encompass also adaptive and personalized services dedicated to the patients, as also witnessed by reference publications (see e.g. [7]). In practice, the implementations of the DSS have been mainly focused on the incorporation of high quality, evidence-based medical knowledge, suitably formalized and incorporated in automated reasoning processes in order to obtain diagnostic, prognostic and therapeutic conclusions that can be supplied to clinicians. Symbolic approaches have been often selected as the knowledge representation method, and – among the different solutions available (most of which refer to logic for a formal semantics [8]) – hybrid solutions based on the use of formal ontologies and rules have appeared to be the most promising. Indeed, ontologies appeared in artificial intelligence as computational artefacts used for building conceptual models of a domain of discourse [9]. They can come in different forms with increasing levels of complexity, ranging from simple catalogues of terms, to thesauri, to complex models with logical constraints that allow automated reasoning. In the latter case, an ontological model is developed according to the description logics theory and hence consists of concepts, individuals and their properties and relations. Despite their advantages, ontologies present some limits and deficiencies, owing to their foundation in descriptive logics (e.g. complex or derived relations cannot be induced from an ontological artefact). In this case, rule-based formalisms have been employed for filling these gaps, and for encoding procedural knowledge, i.e. not only declarative information about the existence of domain concepts but also actions to be performed when specific conditions are met. References • • • • • • • • • • • •
•
[1] J Polisena, K Tran, K Cimon, B Hutton, S McGill, K Palmer, and RE Scott, Home telehealth for chronic obstructive pulmonary disease: a systematic review and meta-analysis. J. Telemed Telecare.;16(3):120-7, 2010. [2] G. Paré, M. Jaana, C. Sicotte. Systematic Review of Home Telemonitoring for Chronic Diseases: The Evidence Base JAMIA, 14(3): 269-277, 2007. [3] M. Vitacca, et al., Tele-assistance in chronic respiratory failure patients: a randomised clinical trial, Eu. Resp. J. 33:411–418, 2009. [4] F. Chiarugi, et al, Decision support in heart failure through processing of electro- and echocardiograms AIiM, Elsevier 50:95 – 104, 2010. [5] J. Basilakis, NH Lovell, SJ Redmond, and BG Celler, Design of a decision-support architecture for management of remotely monitored patients, IEEE Trans Inf Tech. Biomed. 14(5), pp.121626, 2010. [6] F. Paganelli, D. Giuli, An Ontology-Based Context Model for Home Health Monitoring and Alerting in Chronic Patient Care Networks, in Proc. 21th AINAW’07, 838 – 845, 2007. [7] Berner, Eta S., ed. Clinical Decision Support Systems. New York, NY: Springer, 2007. [8] Sowa JF. Knowledge representation: logical, philosophical, and computational foundations. Pacific Grove, CA, USA: Brooks Cole Publishing; 2000. [9] Gruber TR. A translation approach to portable ontology specifications. Knowledge Acquis 1993;5(2):199–220. [10] K Vijayasaratha, and RA Stockley. Reported and unreported exacerbations of COPD: analysis by diary cards. Chest 133:34–41; 2008. [11] IS Woolhouse, SL Hill, RA Stockley. Symptom resolution assessed using a patient directed diary card during treatment of acute exacerbations of chronic bronchitis. Thorax 56(12):947-53, 2001. [12] R. Rosso, G. Munaro, O. Salvetti, S. Colantonio, and F. Ciancitto. CHRONIOUS: an open, ubiquitous and adaptive chronic disease management platform for COPD, CKD and Renal Insufficiency. In Proc. of EMBC 2010 - pp. 6850 - 6853. R.L. Armentano, J.E. Monzon, D. Hudson, J.L. Patton (eds.), 2010. [13] S. Colantonio et al., A Knowledge Editing Service for Multisource Data Management in Remote Health Monitoring, to appear in IEEE Trans Inform. Tech. in Biomed, 2012.
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1.2.1.7 ICT and remote monitoring in Chronic Care Management Enhancing research cooperation for the convergence of ICT applications towards sustainable chronic care models is one of the objectives of the project. This strategic orientation will take into account the policy framework established in the European Union and Member States on e-health. In particular, the following sets of policies or initiatives will be considered as part of the framework in which project activities will evolve: •
The e-Health Action Plan, Commission Communication (SEC-2004-539) on e-Health – making healthcare better for European citizens: An action plan for a European e-Health Area. The eHealth Action Plan sets expectations and targets for interoperability, services standards, new infrastructure and more in general for the coordination of activities aimed at making e-health as efficient and sustainable as possible in the European arena.
•
The ECHI Initiative – the European Community Health Indicators, which aims at standardising information and procedures for its collection and processing so as to make health related matters as comparable as possible among different healthcare systems.
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The Commission Recommendation of 2nd July 2008 on cross-border interoperability of electronic health record systems, to enable the free flow of patients as well as eHealth products and services.
•
The Lead Market Initiative7 launched by the European Commission following the EU’s 2006 Broad based innovation strategy. The Lead Market Initiative for Europe will foster the emergence of lead markets of high economic and societal value. eHealth was chosen to be one of the six markets of the LMI initiative due to its market potential in terms of growing demand and market growth opportunities, changing demographics and disease patterns, and healthcare capabilities. Chronic diseases, such as diabetes, asthma, heart disease, and chronic obstructive pulmonary disease, are pervasive, burdensome, and costly in the older adult population. An analysis from the Center for Technology and Ageing in USA reported interesting data about the impact of chronic diseases and the same results have been gathered in Europe: • • • •
Eight out of ten older Americans are faced with the health challenges of one or more chronic diseases (CDC). Chronic disease is responsible for 60% of deaths worldwide. Chronic disease accounts for three-quarters of Europe and America’s direct health expenditures. People with chronic disease cost 3.5 times as much to serve compared to others, and account for 80% of all hospital bed days and 96% of home care visits.
Many people have the potential to live long, active lives despite the presence of a chronic health condition. If detected early, managed and monitored diligently, many can avoid serious health complications and avoid the attendant costs. Because of the significant opportunity to maintain independence, prevent health complications and reduce expenditures, chronic disease management has been the focus of many recent health and home care innovations. Remote Patient Monitoring (RPM) technologies have enabled or supported many of these innovations. According to Coye et al. 2009, RPM technologies can facilitate six components of chronic disease management: (1) early intervention—to detect deterioration and intervene before unscheduled and preventable services are needed; (2) integration of care—exchange of data and communication across multiple co-morbidities, multiple providers, and complex disease states; (3) coaching—motivational interviewing and other techniques to encourage patient behavioural change and self-care; (4) increased trust—patients’ satisfaction and feelings of “connectedness” with providers; (5) workforce changes—shifts to lower-cost and more plentiful health care workers, including medical assistants, community health workers, and social workers; and (6) increased productivity—decreased home visit travel time and automated documentation.
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1.2.1.8 Evaluation of the economic impact Cost-effectiveness evaluations are increasingly important in health care settings where budgets are limited and the introduction of a new therapy may divert resources from other existing therapies. The principal audiences for these assessments vary in different countries. They include national pricing and reimbursement decision makers, regional health authorities, and local budget-holding prescribers. When reviewing health economic evaluations, payers have to balance cost-effectiveness against affordability. Many therapies can be shown to be cost-effective to a greater or lesser extent, but it is unlikely that a health care community can afford all of them. Cost evaluations can help establish priorities for what should be funded and what may not be affordable. •
•
•
•
Cost-Minimization Analysis. It is the simplest cost-evaluation method. It takes therapies with equal efficacy and compares their costs. Ideally, this should include all aspects of the costs of therapy, including acquisition, storage, administration, and monitoring costs. Cost-Effectiveness Analysis. It involves calculating the costs of different therapies that achieve different clinical outcomes and comparing these costs on the basis of the cost to achieve a particular outcome. The difference between therapies is often expressed as the incremental costeffectiveness ratio—that is, the additional cost to achieve a better outcome. Cost-Benefit Analysis. It calculates the cost of particular interventions and relate these to the cost savings that result from that approach. The time over which costs are spread is an important factor in such analyses. When viewed from the perspective of the whole health care budget, the cost savings can sometimes be virtual rather than real. For example, saving hospital bed days may be very important to allow other patients to be admitted, but rarely reduces overall costs to the health care system as another patient will be admitted to that bed. Nevertheless, this does allow more patients to be treated for the same expenditure and so is a more efficient use of resources. An example of cost-benefit analysis is a study of the number of patients with COPD needed to treat with a combination of budesonide and formoterol compared with formoterol alone to prevent an exacerbation, and relating this to the costs saved by preventing that exacerbation. Cost-Utility Analysis. It is becoming the most widely used form of cost evaluation for new therapies. It is essentially a subtype of cost-effectiveness analysis but uses utility to measure the effectiveness as a way of comparing therapies in different disease areas or therapies that achieve different types of outcomes within a disease (e.g., increased exercise capacity vs. reduced exacerbation rates).
Each has a well-established methodology, but there are still a number of important technical issues that must be considered when evaluating the conclusions of these studies; particularly how uncertainty is handled and the time frame of the evaluation. Until recently, uncertainty in the analyses was almost always addressed by performing a simple one-way sensitivity analysis that varied individual parameters on a oneby-one basis over a range of values to determine what effect this had on the overall conclusions. In many circumstances, this approach fails to quantify the uncertainty of the analysis in the same way that confidence intervals or measures of variance of the mean quantify the uncertainty about the effects seen in a clinical trial. 1.2.1.9
Methods for technology transfer and business exploitation
There are many definitions of technology transfer. Technology transfer is usually defined a commercial or non-commercial transaction between a developer and a user aimed at the proactive adoption of a technology. Particularly, technology transfer- beyond to transferring knowledge- has the aim to satisfy a specific personalized need of the Industry. This need has to be identified on a case by case basis. The consequence of this statement is that the object of the transaction is not only a patent or a product but an effort has to Proposal Part B
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be made and a service has to be rendered in order to adapt, engineer, integrate the knowledge to a specific client’s need which cannot be identified a priori. Technology transfer initiatives and business plan, within the health domain and particularly referred to chronic diseases, such as COPD, consists of a general commitment of public authorities both at national and regional level in deploying telemedicine services as long as the demographic trends will rise health services demand. It includes the identification of new mechanisms and better use of existing ones to facilitate transfer of technology and technical support to European and developing countries. In order to exploit a platform of services dedicated to improve care pathways, including early diagnosis and co-morbidities of COPD, main involved target actors should be: • • • •
Local/national public authorities managing health services (PHA); Private hospitals and/or business organisations working in the health sectors (PHO); Insurance companies; Other public territorial authorities (PTA).
Typically the technology transfer process is implemented through 4 alternative approaches: open science, licensing, interactive model and spin off creation The Open science -still the most widespread model adopted by European Universities- is the model which is characterised by the fact that Universities do not retain any IP rights. Usually, this model provides with little incentive to invest in applications and has no direct impact on the regional economy in which the Industry and the University are located. The Licensing model is based on the valorisation of the Patent, the legal title that recognizes the intellectual property of an invention (product or process) to its’ inventor. The interactive model builds on the Licensing Model: the Background technology and the Paten become tools to seed development and eventually the proof of principle is made in collaboration with industry. In Europe this model is very popular, even in ICT for health domain, since the Demonstration funded in part by public grants (EU Framework programs but also national and regional R&D Programmes). A public financial scheme can provide appropriate project co-financing between an industry’s R&D staff and university personnel. The technology transfer will take place within the project life. In the spin-off model the background technology is used as platform to develop new business concepts. The development housed in company structure funded by seed capital and virtual capital and this is the only alternative when no industry partner in sight .It should be said that the Spin-off model strongly contributes to regional development and to rejuvenating economy. In fact, the spin-offs are usually hosted by the University Incubators and tend to enhance collaboration between local Industry and local researchers. Prototyping, engineering, production marketing and sales phases are carried out by the spinoff in collaboration with the University and this shows the strong link of this model with the Interaction model. 1.2.1.10 Related European Projects The SKIPPER project will take into account the results and the state of the art of European R&D projects and activities that are on-going, in order to foster the international collaboration in the eHealth and, in particular, in the management of chronic diseases though integrated care. The objective of the collaboration is to contribute at increasing the international competitiveness of European Healthcare Information Services and Software Industry. In particular, the SKIPPER consortium is already in contact or intends to activate possible collaborations with the European initiatives, related to eHealth, described in the following table. INITIATIVES RICHARD project
http://www.richardproject.eu
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DESCRIPTION The RICHARD project focuses its analysis on the pathologies-specific ICT applications being implemented in leading European regions and
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REACTION project
http://www.reactionproject.eu/
DREAMING project
www.dreaming-project.org
CHRONIOUS Project
http://www.chronious.eu/
EPSOS project
http://www.epsos.eu
MIDAS Project
http://www.midas-project.eu/
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SKIPPER elaborate a Joint Action Plan oriented to the integration of those technologies for the deployment of sustainable chronic care models for European regions. This requires a strong coordination of research resources and innovation stakeholders (clearly identified in the first phase of the project) to design new research paths and innovation models. The Italian cluster of the Richard project includes the University of Siena, partner of the SKIPPER proposal, and the Tuscany Region, that will support the Italian SKIPPER pilot. The REACTION project develops an integrated ICT platform that supports improved long term management of diabetes based on wearable, continuous blood glucose monitoring sensors and automated closed-loop delivery of insulin. The REACTION platform consists of an interoperable peer-to-peer communication platform based on Service Oriented Architecture (SoA) using cloud-enabling midddleware. It features a Model Driven Application Development environment based on extensive use of dynamic ontologies. The REACTION consortium includes FORTH that is coordinator of the SKIPPER consortium. DREAMING brings together a set of services which, packaged together, allow extending the independent life of elderly people while providing them with an equivalent level of safety as that they would enjoy in a protected environment such as an elderly home, and offering them a way of staying in touch with their loved ones even when the latter are away. The consortium includes two partners that have strong collaboration with Dedalus SpA, partner of the SKIPPER consortium. CHRONIOUS addresses a smart wearable platform, based on multiparametric sensor data processing, for monitoring people suffering from chronic diseases in long-stay setting. It is constantly monitoring their activity using audio observation methods and activity sensors while at the same time tracking their medical condition via vital signs sensors. The SKIPPER proposal is interested in integrating in the SKIPPER platform of services the systems produced by the Chronious project. The CHRONIOUS consortium includes CNR that is partner of the SKIPPER consortium. An Open eHealth initiative for a large scale European pilot of patient summary and electronic prescription) is a Europe-wide project organized by 27 beneficiaries representing twelve EU-member states, including ministries of health, national competence centres and numerous companies. This makes it the first European eHealth project clustering such a large number of countries in practical cooperation. The MIDAS project aims to implement an integrated framework for the automation and intelligent management of SOA testing. The framework is available as a Platform as a Service (PaaS) on a cloud infrastructure that supports all the testing activities – test generation, execution, result analysis, planning and scheduling – on the main testing domains such as functional, interactional, fault tolerance, security and usage-based testing. The MIDAS consortium includes Dedalus (as coordinator) and
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HEALTHSOAF project
http://www.healthsoaf.it/
HEARTHCYCLE
http://www.heartcycle.eu/
PERFORM
http://www.perform-project.eu/
DIADVISOR
www.diadvisor.eu
1.2.2
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SKIPPER Simple Engineering France, partners of the SKIPPER proposal. The MIDAS testing platform could be used to test the SKIPPER platform of services Italian research project, cofunded by the Italian Ministry of Education and Research in the frameworkof the National Research Program and through the European Regional Development Fund. The HealthSOAF project aims at developing a plug-and-play service architecture framework of SOA services for the second generation of e-health, based on HSSP international standards. The HealthSOAF framework will allow integration of distributed back-end medical functions and front-end advanced interaction (Web 2.0) in with and between users - patients, clinicians, advanced operators, and citizens. DEDALUS and UNICAL, partners of the SKIPPER proposal, are involved in the Healthsoaf project. Compliance and effectiveness in HF (Heart Failure) and CHD (Coronary Heart Diseases) closed loop management, a large scale research project coordinated by Philips Germany, to provide management solutions to serve both HF and CHD patients, including hypertension, diabetes and arrhythmias as possible comorbidities. A sophisticated multi-parametric system for the continuouseffective assessment and monitoring of motor status in Parkinson's disease and other neurodegenerative diseases, coordinated by Siemens Spain. Personal glucose predictive diabetes advisor, a large scale project aiming at the development of a prediction based tool which uses past and easily available information to optimise the therapy of type I and developed type II diabetes. Coordinated by Novo Nordisk in Denmark.
The progress beyond the state of the art
In this paragraph, the most important research and innovation issues of the SKIPPER project are highlighted. 1.2.2.1 Guidelines and care programmes for COPD Implementation of the chronic care model (CCM) has been shown to be an effective preventative strategy to improve outcomes in diabetes mellitus, depression, and congestive heart failure, but data are lacking regarding the effectiveness of this model in preventing complications in patients with chronic obstructive pulmonary disease. In addition, the environmental dimension that constitutes a hazard to COPD patients has not been integrated in it. The SKIPPER project aims at implementing a COPD care model and guidelines taking into account all the dimensions of COPD and to be addressed to the health care system/practitioners and COPD patients. This should contribute to a tool for the prevention of COPD worsening and exacerbations. To this extent a sample of COPD patients will be followed-up in time and their health status monitored in relation to major environmental exposures. 1.2.2.2 Human factors impact in COPD The SKIPPER project will evaluate how the SKIPPER solution can reduce the human and psychological impact in COPD patients, by assessing life event stress, depressive and anxiety symptoms and the cognitive function. Proposal Part B
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1.2.2.3 PHR systems There are various future directions for research and analysis in the promising area of personal health record systems and it is clear that these systems will play a critical role in patient centred healthcare. FPHR currently supports and manages patients with diabetes. It has been tested and operates in a clinical site at UK (Chorleywood Health Centre: http://www.chorleywood.org/) and in the near future it will operate in a primary care centre in the region of Crete – Greece. Future developments and evolutions will be focused on: • • •
1.2.2.4
extend the system to support other chronic diseases (e.g. chronic obstructive pulmonary disease and chronic cardiovascular diseases), thus going towards a multi-disease management system; to be compliant with the main interoperability standards and to be fully interoperable using standard interface with a generic EHR; add intelligence to the system in order to analyse the collected data in the personal health record and to provide personalized guidance to the patient with various types of chronic diseases and comorbidities.
Security policies
In order to define a proper security support for the SKIPPER framework, authentication and authorization play a central role. A secure user authentication is a critical concern, due to the recent increase in the frequency and complexity of cyber-attacks. Many solutions for authentication exist in scientific literature [DUN03], e.g. solution based on the Public Key Infrastructure (PKI) or on Biometric features [KHP00]. Authorization is also critical to ensure that each subject acting in the framework performs only the accesses for which he holds the specific right. Many approaches have been proposed to implement access control. As an example, the Role-Based Access Control model (RBAC) [FSG01] assigns roles to subjects, and each role gives the right to execute a given set of accesses on some resources. Some standards have been proposed for expressing access control policies, for the design of access control architectures and for the related communications, the most notable ones being XACML [XACML10] and SAML [SAML09]. These standards should be taken into account in the design of the SKIPPER security support in order to easily achieve interoperability among the architecture components. Recently, the concept of "usage control" has been defined [PS04], which extend the notion of access control by enforcing the security policy not only at access request time, but also during some action execution. The model has been extended and implemented for distributed and mobile systems, including the Cloud, see, e.g. [MM10], [LMM12], and the innovative features of this model could be successfully exploited in the SKIPPER Cloud services scenario. The SKIPPER project will design an enhanced security support tailored for the reference scenario. In particular, this support will address the security issues due the adoption of Cloud services, in order to provide an adequate security level to protect health data, as well as satisfying constraints imposed by laws and regulations. The adoption of the usage control model will also be investigated to further enhance system security by interrupting on-going accesses when the corresponding rights do not hold any more. References •
[DUN03] R. Duncan: An Overview of Different Authentication Methods and Protocols: SANS white paper October 31, 2003, available at http://www.sans.org/reading_room/whitepapers/authentication/overview-authenticationmethods-protocols_118.
•
A. K. Jain, L. Hong, and S. Pankanti, Biometric Identification, Communications of ACM, vol. 43, no. 2, pp. 90-98, February 2000.
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[KHP00]
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[FSG01] D. Ferraiolo, R. Sandhu, S. Gavrila, D.R. Kuhn and R. Chandramouli, Proposed NIST Standard for Role-Based Access Control, ACM Trans. on Information and System Security (TISSEC), 4(3): 224-274, 2001.
•
[XACML10] apr 2009.
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[SAML09] OASIS, Assertions and Protocols for the OASIS Security Assertion Markup Language (SAML) V2.0 – Errata Composite Working Draft 06, 23 December 2009.
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[PS04] J. Park and, R. S. Sandhu: The UCONABC usage control model. ACM Trans. Inf. Syst. Secur. 7(1): 128-174, 2004.
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[MM10] F. Martinelli, P. Mori: On Usage Control for GRID Systems. In Future Generation Computer Systems 26(7): Elsevier Science, 1032-1042, 2010.
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[LMM12] A. Lazouski, G. Mancini F. Martinelli, P. Mori. Usage Control in Cloud Systems. In Procedings of the 7th International Conference for Internet Technology and Secured Transactions (ICITST-2012), IEEE Computer Society, 202-207, 2012.
OASIS, eXtensible Access Control Markup Language (XACML) Version 3.0. 16
1.2.2.5 Innovative Service Oriented Architecture and Interoperability Standards for Healthcare The HSSP basic services sketched in the paragraph above constitutes a very solid architectural basis for the design and the developments of more sophisticated architectures of healthcare services. In the HSSP initiative, the new projects concern the standardization either of complex data structures, such as the Medication Statement Service (a RLUS Semantic Profile) project, or of healthcare services based on complex and unstructured care processes. In October 2012, the Care Coordination Service (CCS) project has been started whose objective is the management of the coordination of care. The CCS HSSP “thread” is particularly relevant for the SKIPPER project. The business case of the CCS initiative is a patient moving through the continuum of care. The patient has a care plan pursuing specific health goals with progress being measured over time. The care team is composed of the patient her/himself that plays an active role, family, healthcare practitioners and providers, public and private sector administrators, social workers, etc. The care team composition is constantly in flux. The Chronic CCS is a specific CCS storyboard or CCS Semantic Profile and, for example, the COPD & comorbidities CCS is a specialization of the Chronic CCS. The main objective of CCS is to enable easy, flexible and controlled collaboration around a shared Master Care Plan (Master CP). The Master CP is an up-to-date, lean and federated plan that can be updated (with change logs) from multiple participants, with mechanism of publish/subscribe of updates. If foundational sharing agreements are made, then interactions can grow by invitations across care settings. The collaboration is also controlled: the context of care plan change discussions must be clear, and priorversion views of the plan are available. The Master CP is a guide to the patient target health state and the CP owner manages the retention of items of lasting significance. The master plan may contain sub-plans for comorbidity and specialty. Its elements such as goals, planned interventions, etc. evolve continuously. Where the EHR accumulates the care history, the Master CP outlives all episodes of the patient follow-up and is managed as a digest, i.e. a collection of previously published material in edited or condensed form. In fact, the plan is only the skeleton that holds references to summaries and outcomes. The CCS Process Model is un unstructured process model based upon collaborative interactions of the evolving care team (invite, propose change, accept …) that specifies (i) the association of a provider and organization with a patient; (ii) how to contribute updates to the Care Plan and Care Record; (iii) how to actively receive update notifications in a decentralized world. Basic plan operations are authoring (initializing and maintaining) and retrieval of CPs and CP templates, but the CCS will support fragmented care plans reconciliation by directly helping the care team coordinate Proposal Part B
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plans. More advanced operations are: (i) harmonization of two plans for consistency, triggering change proposal; (ii) virtualization of two plans as one for integrated viewing; (iii) consolidation of two plans, yielding one; (iv) refactoring modules like disease management protocols that can be defined once. CCS is “naturally” handled by Clinical Decision Support Services that can propose changes to be accepted by the human stewards, support CP creation and reconciliation, select CP template for patient based on patient factors, suggest individualizations, suggest missing activities & rule violations. Of course, plan reconciliation should be able to use CTS2 Terminology Services. Concerning, in particular Standard Terminology Service (STS), it distributes via an API and cloud technology all the terminological resources it has currently available under the same format, regardless of their sources of truth and their original format. For example a software application managing the supplies in the operating room can display the complete name of prosthesis by reading the barcode on its packaging via the STS services. The software application in question does not need to maintain locally a table with all the medical devices implantable in France while assuring at the same time the most updated version of the code systems used in their description. The same functionality can be extended to the SKIPPER project, allowing for seamless integration between disparate sources of information and mapping between local and standard terminologies, functionalities which are of paramount importance in a decision support system. STS is based on international standards (HL7 CTS2 Service Functional Model) and being aligned with the OMG CTS2 specifications and fully interoperable with standardized technical platforms. The SKIPPER framework will be a “proof of concept” implementation of the CCS, exercised on a Chronic Care “storyboard” such as the follow-up of COPD & comorbidities. The CCS approach will be integrated with the real time follow-up of the patient, and the SKIPPER services architecture will be able to continuously integrate clinic and environmental data from devices and other sources (e.g. meteorological data) with information gathered from the EHR and the PHR. In order to complete the healthcare service architecture infrastructure as a support to the continuity of care and the real-time patient follow up, it is necessary to provide security and healthcare provider directory services. The security services will be based on the generally accepted standards such as SAML, XACML, WS Policy, WS Security Policy, WSS, WS Trust, WS Secure Conversation, used in order to implement a critical security function such as the patient informed consent to access her/his clinical data. The healthcare provider directory services will be based upon the IHE HPD profile implementation (FRAUNHOFER). 1.2.2.6
Working Interoperability/Computable Semantic Interoperability
A critical key factor involved in implementing large-scale (i.e. enterprises-level) service-oriented architectures, with a focus on achieving both intra- and inter-enterprise interoperability, is the Computable Semantic Interoperability (CSI). The CSI is intended as the capability of partners of interacting to achieve one or more business goal, preserving the semantic of the information exchanged. Precondition for achieving this goal are the well-known CSI pillars. The innovative approach proposed by this project is to get this result through the adoption of the HL7 Service-Aware Interoperability Framework (SAIF), that provides a way of producing specifications that explicitly describe the governance, information, and behavioural semantics that are needed for that purpose; including also a Conformance and Compliance Framework (ECCF) for supporting all the validation and verification activities needed. In this context the HSSP (OMG/HL7) services proposed provides already a set of artefacts in line with that framework, facilitating the development of SAIF coherent semantic and functional profiles. This force moreover the good practice of lose coupling between services behaviour and semantic content (Semantic Signifier in HSSP jargon), with the separation between services behaviour specifications and Semantic Signifiers IG. Semantic Signifiers will be based on HL7 RIM and data types in order to fulfil the CSI pillars requirements. 1.2.2.7 Testing of distributed healthcare environments With the advent of the industry-driven International Software Testing Qualifications Board (ISTQB) (http://www.istqb.org), the terminology, education and general approach to conduct testing has been Proposal Part B
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standardized [1]. Following their recommendation, a test process consists of five steps: test analysis & design, test execution & realization, test result analysis, achieving and the cross-cutting task test control & management. Furthermore, testing and test activities can be distinguished regarding their level, their type and their design technique. As test level, ISTQB sees in accordance to IEEE 829:2008 [3] and the upcoming ISO 29119 the unit level, integration level, system level and acceptance level. The testing type corresponds the applied quality model (such as ISO 9126, ISO25010 [2] or FURPS/FURPS+ [4]) to the quality criterion that is targeted by the test cases, e.g. interoperability testing refers to testing the interoperability of a software product. As general test design techniques, white box and black box techniques are mentioned in the first place. A white box design techniques leverages internal knowledge about the software under test to derive test cases, whereas black box techniques rely solely on information taken from other sources (such as the system specification, user manuals etc.). Most solutions in the healthcare environment are heterogeneous systems made up from different solutions and devices from varies vendors. It is very important to define and establish communication standards for such eHealth systems (e.g. HL7, IHE profiles, etc.) in order to connect these isolated systems and devices in such a way that information and data can be transferred securely without suffering a loss. For this project the following testing types are particularly of interest: • • •
Interoperability testing: To test the capability of the software to interact with one or more specified components or systems [after ISO 9126]. Conformance testing: To test the capability of the software product to adhere to standards, conventions or regulations in laws and similar prescriptions [ISO 9126]. Security testing: To test the attributes of software that bears on its ability to prevent unauthorised access, whether accidental or deliberate, to programs and data [ISO 9126].
References 1. International Software Testing Qualifications Board (ISTQB): ISTQB/GTB standard glossary for testing terms. http://www.software-tester.ch/PDF-Files/CT_Glossar_DE_EN_V21.pdf. 2. International Organisation for Standardisation (ISO): ISO/IEC 25010, Systems and software engineering – Systems and software Quality Requirements and Evaluation (SQuaRE) – System and software quality models , http://www.iso.org/iso, First edition 2011-03-01. 3. IEEE Standards Association (IEEE): 829-2008 – IEEE Recommended Practice for Software Requirements Specifications, 2008. 4. FURPS: http://en.wikipedia.org/wiki/FURPS. 1.2.2.8
Decision support systems and knowledge management tools for the support of chronic disease care In SKIPPER several progresses beyond the state are foreseen in the field of clinical and personalized decision support systems. Indeed, an innovative flexible and modular decision support architecture will be designed and developed. The architecture will be able to deploy both (i) deductive knowledge modules, elicited from guidelines and formalized into ontologies augmented with basis of rules and (ii) inductive knowledge modules, extracted by advanced data mining and machine learning methodologies. In this way, we aim at developing an informative DSS able to assist semi-structured or unstructured decision making by combining comprehensive analysis and exploration of current and historical patient data, and sophisticated analytical models and tools. A key component in the DSS architecture is represented by the strategy controller, an intelligent module capable of selecting and triggering the best problem solving strategy for each decisional task submitted to the DSS. The strategy controller itself will include a base of meta-rules describing procedural knowledge needed to properly orchestrate the suitable knowledge modules. With respect to other state of the art solutions, in which update, revision and extension of the knowledge modules require the intervention of specialized technical staff and extensive consistency checks, in SKIPPER methodologies for agile knowledge maintenance will be studied and developed, by extending the ideas presented in [13]. For example, after a new inductive knowledge module becomes available for solving a particular decisional task, it will be sufficient to include this new resource thorough a dedicated procedural Proposal Part B
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Knowledge Editing Service (KES). The KES will also allow for customizing proactive services, particularly useful for continuous patient monitor. 1.2.2.9 ICT and remote monitoring in Chronic Care Management Remote patient monitoring devices have been shown to increase the patients’ role in the management of their own health, improved chronic disease management, and reduced acute episodes. Using a variety of integrated or standalone RPM devices, up-to-date information on patients’ chronic disease and/or postacute care status (including vital signs, heart rate, blood glucose levels, medication management, mental health, physical and cognitive fitness) and other data can be transmitted to family caregivers, providers, and other third parties. Clinicians or other properly trained individuals can then intervene by providing coaching or adjusting the course of treatment. Currently, several different types of integrated RPM devices exist. These devices act as an aggregator of information from multiple peripheral devices (e.g., blood pressure cuff, scale, glucose monitor, pulse oximeter, prothrombin time/international normalized ratio (PT/INR) meter, thermometer, electrocardiogram (ECG), peak flow meter, stethoscope, pedometer) that transmit or plug directly into integrated technologies. Many integrated devices are activated daily by the patient or caregiver. They ask patients to answer a series of questions, collect and report peripheral device data, provide educational information, and even support audio or visual contact with clinicians for real-time intervention or assistance. Some instruments can also self-activate and alert patients and caregivers that a test or medication must be taken. Data are subsequently transferred to health care professionals, where they are triaged through patient-specific algorithms to categorize risk and alert appropriate caregivers and clinicians when answers and/or data exceed predetermined values. Many of these tools store previous test results through a specific device program or a web-based program. RPM devices also provide patient education via reading or hearing health tips. Devices can be a conduit of communication between patients and healthcare professionals through audio and/or visual settings allowing for real-time intervention, coaching, and patient education. The SKIPPER approach to tele-monitoring implies the integration of the ultimate achievements in telecare with a modern SOA oriented service architecture. This will allow higher system flexibility and scalability, fostering personalization of services basing on the specific pathologies. Dealing with COPD and taking into account potential comorbidities, the monitoring kit will be able to integrate both standard offthe-shelf devices and innovative embedded sensors in wearable sensor network, maximizing monitoring results with a relevant overall cost reduction. 1.2.2.10 Evaluation of the economic impact The economic impact of SKIPPER on COPD will be declined into four basic approaches: costminimization analyses, cost-effectiveness analyses, cost-benefit analyses. We underlined above that there are still a number of important technical issues that must be considered when evaluating the conclusions of these studies; particularly how uncertainty is handled and the time frame of the evaluation. The approach that addresses uncertainty in the analyses by performing a simple one-way sensitivity analysis (see above) in many circumstances fails. In response to these deficiencies, more sophisticated qualitative and statistical methods have recently been proposed to deal with parameter and model uncertainty. Multivariate sensitivity analyses, where two or more parameters are varied simultaneously are a more accurate way of assessing uncertainty than univariate sensitivity analysis. An alternative form of sensitivity analysis involves using a set of extreme values for each parameter to give the highest and lowest cost-effectiveness ratios; however, this approach has been criticized as it is unlikely in practice that all extreme values would occur at the same time. Neither of these techniques allows the calculation of an estimate of the uncertainty of the costeffectiveness, such as a confidence interval. Probabilistic sensitivity analysis permits the examination of joint uncertainty in the variables without resorting to the extreme conditions specified in extreme scenario Proposal Part B
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analysis. Statistical methods of handling uncertainty include the delta method, the calculation of joint confidence intervals, bootstrapped estimates, and Markov Monte Carlo simulations. The delta method applies a mathematical technique known as second-order Taylor series expansion to the estimation of the variance of a function such as the cost-effectiveness ratio. This uses estimates of the variance of the variables determining the cost-effectiveness ratio to determine the variance of the ratio itself. In response to legitimate concerns about the use of parametric approaches to confidence interval estimation given the unknown nature of the sampling distribution of the cost-effectiveness ratio, a number of nonparametric approaches have been developed. Bootstrapping is a computational technique that allows the distribution of the cost-effectiveness ratio to be constructed empirically, whereas Markov Monte Carlo simulations are based on a model’s disease progression. In these models, the disease is defined in terms of different states that are chosen to represent clinically and economically important events in the disease process. Transition probabilities are assigned for movement between these states over a discrete time period known as a “Markov cycle”. Markov Monte Carlo simulations follow a large number of patients through the model, thereby allowing an overall profile of costs and outcomes to be generated for each patient according to the path that they follow through the model. As well as giving an overall estimate of the average costs and effects in each arm, averaging these costs and effects over a large number of patients also gives an estimate of the likely variance associated with the parameters estimated by the model. This representation of uncertainty in the estimated costs and effects relates simply to the inherent uncertainty of the probabilistic structure of the model. The time frame over which costs and benefits are to be calculated is critical for cost-effectiveness evaluations in long-term conditions. To be clinically meaningful, the costs and benefits must be calculated over a time period that reflects the longevity of the effects of the intervention. For example, in COPD, the benefits derived from a course of pulmonary rehabilitation last longer than the duration of the program, whereas the costs of running the program only occur during the time that it is running. There may also be delayed benefits from an intervention that need to be taken into account. When appraising economic evidence it is essential to consider both the quality of the clinical studies that have been used to assess the effectiveness of a therapy as well as the quality of the economic analysis and costing methods that have been used. Not infrequently, the clinical studies that underpin the economic analysis are of poor methodological quality whereas the economic analysis itself is of sound methodology. It is also important to ensure that the analysis was based on costings and a model of health care that is relevant to the country of interest. When assessing published economic studies, there is now a tool for analysing the quality of the economic methods that have been used, but this is relatively new. All four approaches to cost evaluation have been used in COPD. 1.2.2.11 Methods for technology transfer and business exploitation The aim of SKIPPER is to build and exploit an infrastructure which supports personalized services and care programs for patients suffering from COPD and the major co-morbidities of this disease. In order to achieve this goal, we intend to validate new business models (and a model framework) and collaborations, such as public-private partnerships that bring together payers, providers and patients, for sharing costs and revenues; identify actors and roles and the value created in terms of health, socioeconomic aspects and commercial benefits. Skipper further investigates the issues of designing ideal specialist services to support activities that are community based. The project plans to identify common service delivery paradigms (business models), and explore how these are delivered in the scenarios to determine optimum clinical models, by considering the European and different health sector dimensions. The consortium will carry out standard formal technology transfer techniques to fully research the proper business plan, including full feasibility study, sectoring, costs, income/profits, return on investment (ROI) etc. This will study all aspects of the marketplace, the technology, staff costs and the deployment Proposal Part B
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aspects including the presence of market barriers. The work will also take into account the involvement and returns for individual partners and provide all with a convincing case for proceeding to deployment. The added value, with respect to state of the art, builds on a business model based on a public-private partnership – to adopt an ontological perspective on exploration of innovative service concepts and value creation based on the analysis of economic value creation and exchange of value objects between stakeholders. The business models will include and measure values created by: • • •
Primary end-users: improved quality of living and health, mobility, staying longer in the workforce for patient suffering of COPD. Secondary end-users: improve case management, effectiveness, better resource utilisation, etc. Tertiary end-users: cost-benefit, quality of healthcare, interaction of health and social carers
The main objectives will be then: (i) enhancing innovation and business potential in European healthcare industry through testing available (commercial and/or open-source), platforms and exploitation models; (ii) improving the sharing of know-how, process and tools between countries. The major added value will result in high quality of health services delivered offset by savings of investments and recurring costs related to the delivering process of traditional health services. However, In addition to the basic offer, SKIPPER may also provide a number of add-on capabilities, based its platforms capabilities. In fact new devices and sensors network can be added to meet specific needs and therefore new services can be deployed.
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S/T methodology and associated work plan
1.3.1 Overall strategy of the work plan As already mentioned, SKIPPER research project aims at: •
•
designing and developing a services architecture geared to establish, manage, control, evaluate and improve innovative, personalized and efficient care pathways, based on standard interoperability services, driven by knowledge-intensive decision support systems specialised for COPD and its comorbidities; evaluating, with two pilots, the impact of the SKIPPER solution in terms of: o clinical effectiveness and economic sustainability of the possible new organizational healthcare models, o evolution of the eHealth market, with business models able exploit the SKIPPER solution.
The overall strategy of the SKIPPER work plan has been devised in order to fully accomplish these goals. In fact, the activities will be organised in ten work packages, from WP1 to WP10. In Figure 6, a “synoptic” view of the definition, organization and functional scheme of the work packages is provided including their interactions. The “core” of the overall project activities is characterized by the development activities required for effectively deploying the SKIPPER end-user services (WP4), and by the enabling technologies WPs (WP5, WP6), which will develop and deploy the required methodologies and technologies for the knowledge management and decision support, and the infrastructure for the remote and secure data acquisition, transmission and integration. Following the general services architectural organization, designed and developed within WP3, the core parts are suitably “wrapped” by the WP7, aiming at defining, designing and developing the integration and testing services and their deployment into a private SaaS-model cloud. All these activities will be appropriately supported by WP2, where the clinical partners will perform, with reference to relevant clinical scenarios, an accurate, systematic and structured analysis of the clinical domain and the related care organizational models. SKIPPER will give particular attention to the clinical evaluation and validation (WP8), by defining and activating two pilots (in Italy and in Greece) to follow-up, in a field survey, a group of COPD patients through the SKIPPER platform, in order to evaluate the results according to the selected indicators and to contribute to implement innovative integrated care model of pertinence for COPD. The overall impact of the proposed solutions will be further assessed through the activities of WP9, where the economic impacts and innovation in organizational models and business exploitation will be provided. Specific target of this WP is to define and carry out the necessary activities towards the identification of the exploitation potential of the project results and further defining the conditions under which SKIPPER could be launched to the market. Finally besides the management work package (WP1), the work plan includes another horizontal work package (WP10) for the dissemination activities and for the involvement and collaboration of the SKIPPER project in international standardization initiatives.
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Figure 6: Work plan schema and interactions of the WPs
The general work plan of the SKIPPER project adheres to a classical waterfall approach based on the following macro-phases: • • • • •
Domain analysis and systematic description of the related processes (WP2); System requirements, functional and technological specifications of SKIPPER general architecture (WP3); Design and development of the core components of the SKIPPER platform (WP4, WP5 and WP6); Integration and testing (WP7); Evaluation, validation (WP8) and final impacts (WP9);
Figure 8 in the following section shows the Gantt of the project. In terms of specific scheduling of the overall activities, it is worthwhile to emphasize that the development of the SKIPPER platform will exploit also the integration and adaptation of tried and tested software components for standardized platform functionality. These components, provided by DEDA, FRAUNHOFER, PHAST, SEF, UNICAL, FORTH, will be supplied as project background. This asset of the consortium will allow: • •
early starting of the continuous integration of the available components, by allowing the project's activities to follow an iterative approach; activating the pilot experimentations within the first half of the project.
This means that the macro-phases described above will be partially overlapped in the Gantt in order to allow the partners to report, towards the previous phase, useful feedbacks about the on-going activities. In general, the technological activities will be stretched in the Gantt project, by bringing forward their start up and postponing their conclusion in order to: Proposal Part B
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guarantee to have a preliminary demonstrator of the SKIPPER solution; have the possibility to refine and increase in an incremental way the development, the integration and the deployment of the SKIPPER platform of services on a SaaS cloud infrastructure.
The work plan includes: •
•
two “development activities” macro-iterations, regarding the work packages WP2-WP7. The first macro-iteration will end at month M15 with the release of a preliminary integrated and tested SKIPPER solution on a SaaS-model infrastructure. The second macro-iteration will carry out to the final release of the SKIPPER platform components (M27) and to the release of the final deployment of the SKIPPER platform of services on the real environments of Pilots (M32); two “pilot experimentations” macro-iterations, related to WP8. The first macro-iteration will start at month M10; it includes the activation of the preliminary experimentation at month M16 and will end at month M24. The second macro-iteration will carry out to the evaluation and final validation of the SKIPPER solution (M36).
The following schema describes the iterative approach of the SKIPPER work plan.
The following Figure 7 shows the iterative approach of the work plan, while in the next section we will show the details of the Gantt (Figure 8) and the milestones of the SKIPPER project.
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Figure 7: Iterations representation in the Gantt of the Project
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1.3.2
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Gantt chart
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Figure 8: SKIPPER project Gantt
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Detailed work description broken down into work packages Work package list
Work package list Work package title
Work package 12 No
1 2 3 4 5 6 7 8 9 10
Management
Type of 13 activity
MGM
Clinical domain and care models analysis Architecture of the SKIPPER platform of services End-users services for supporting COPD care programmes Knowledge management and Decision support core services Devices network infrastructure and core services Integration and testing of SKIPPER services on the SaaS platform Evaluation and validation of the SKIPPER solution: the pilots Economic impacts, organizational models and business exploitation Dissemination, collaboration and standardization
RTD
Lead partic 14 no.
Lead partic. short name
Personmonths 15
Start month 16
End 16 month
1 FORTH
37,5 M1
M36
10 UPMC
50,0 M1
M22
86,0 M3
M24
RTD
6 SEF
RTD
2
DEDALU S
91,0 M7
M30
RTD
8 UNICAL
68,0 M4
M30
RTD
9 UNISI
56,0 M4
M30
RTD
4
91,0 M10
M32
86,0 M10
M36
41,0 M4
M36
55,0 M1
M36
RTD RTD RTD
FRAUNH OFER
10 UPMC 5 INNOVA 12 PHAST
TOTAL
661,5 Table 1: SKIPPER project Work package list
12 13
14 15 16
Workpackage number: WP 1 – WP n. Please indicate one activity per work package: RTD = Research and technological development; DEM = Demonstration; MGT = Management of the consortium. Number of the participant leading the work in this work package. The total number of person-months allocated to each work package. Measured in months from the project start date (month 1).
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Deliverable List
List of Deliverables Del. no. Deliverable name 17
D1.1 D1.2 D10.1 D2.1 D3.1 D1.3 D1.4 D2.2 D3.2
D2.3 D1.5 D10.2 D2.4
D2.5
17
18
19
20
Consortium agreement Quality control and assurance plan Dissemination plan Definition of the protocol of the field survey SKIPPER service components framework implementable model basic services Plan for knowledge and IPR management Half-period internal progress reports Clinical domain analysis: guidelines, protocols and the chronic care model SKIPPER generic services architecture motivational, conceptual, logical and interoperability models Identification of relevant exchangeable clinical data Annual management reports Periodic Dissemination and Collaboration Report Clinical scenarios, care programmes and evaluation indicators for the SKIPPER solution realization and validation Definition of the human factors for the evaluation of the SKIPPER solution
Nature 18
Delivery date 20
WP1 WP1 WP10 WP2
R R R R
Dissemination level 19 CO CO CO CO
WP3
R
CO
M4
WP1
R
CO
M6
WP1 WP2
R R
CO PU
M6, M18, M30 M6
WP3
R
CO
M8
WP2
R
CO
M10
WP1 WP10
R R
CO CO
M12 M12
WP2
R
PU
M12
WP2
R
CO
M12
WP no.
(proj. month) M1 M3 M3 M3
Deliverable numbers in order of delivery dates. Please use the numbering convention
.. For example, deliverable 4.2 would be the second deliverable from work package 4. Please indicate the nature of the deliverable using one of the following codes: R = Report, P = Prototype, D = Demonstrator, O = Other. Please indicate the dissemination level using one of the following codes: PU = Public. PP = Restricted to other programme participants (including the Commission Services). RE = Restricted to a group specified by the consortium (including the Commission Services). CO = Confidential, only for members of the consortium (including the Commission Services). Measured in months from the project start date (month 1).
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D2.6 D3.3 D6.1
D9.1 D10.3 D3.4
D3.5 D4.1 D5.1
D7.1 D7.2 D9.2 D5.2 D10.4 D4.2 D5.3 D6.2
D7.3 D7.4 D8.1 D9.3 D4.3
Organizational and management models for the healthcare delivery SKIPPER service components framework implementable model value-added and front-end services Design of the SKIPPER device network infrastructure: interoperability and security specifications Market analysis Assessment report for adopting and for contributing to interoperability eHealth standards SKIPPER services architecture for COPD & comorbidities – motivational, conceptual, logical and interoperability model SKIPPER services platform security and performance requirements for cloud infrastructure Specifications and design of the SKIPPER end-users services Functional and technical specifications of the knowledge management and decision support services SKIPPER ITIL-based processes Test methodology and test framework description Preliminary evaluation of the economic impact DSS Knowledge Modules Toolbox Periodic Dissemination and Collaboration Report SKIPPER end-users guide DSS Strategy Controller Wearable sensor network for realtime patient monitoring and algorithms for calibration and normalization Specification and design of the cloud environment for the SKIPPER platform for services Specification of the test scenarios and test cases for the SKIPPER platform of services Description of the Pilots Preliminary Business Plan Development of the SKIPPER endusers services for the healthcare professionals
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WP2
R
CO
M12
WP3
R
CO
M12
WP6
R
CO
M12
WP9 WP10
R R
PU PU
M12 M15
WP3
R
CO
M15
WP3
R
CO
M15
WP4
R
CO
M15
WP5
R
CO
M15
WP7 WP7
R R
CO CO
M15 M18
WP9
R
CO
M18
WP5 WP10
P R
CO PU
M20 M24
WP4 WP5 WP6
R P P
PU CO CO
M24 M24 M24
WP7
P
CO
M24
WP7
R
CO
M24
WP8 WP9 WP4
R R P
CO CO CO
M24 M24 M27
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D4.4 D4.5 D5.4 D6.3 D6.4 D7.5 D7.6 D8.2 D9.4 D1.6 D8.3 D9.5 D10.5 D10.6
Development of the SKIPPER PHR services Development of the security support Final implementation of the DSS Networking and interoperability of the devices network infrastructure for patient remote monitoring Security and core services of the integrated remote control systems SKIPPER SaaS Prototype Test implementation and result analysis Deployment and configuration of the final SKIPPER platform of services on the pilots Final evaluation of the economic impact Final project report on activity, management and financial outcomes Study of the pilots results and validation of the SKIPPER solution Final Business and Deployment plan Report on the impact of the SKIPPER platform of services on test standards development Periodic Dissemination and Collaboration report
WP4
P
CO
M27
WP4
P
CO
M27
WP5 WP6
P P
CO CO
M27 M27
WP6
P
CO
M27
WP7 WP7
R R
CO CO
M32 M32
WP8
P
CO
M32
WP9
R
CO
M32
WP1
R
CO
M36
WP8
R
CO
M36
WP9 WP10
R R
CO PU
M36 M36
WP10
R
PU
M36
Table 2: SKIPPER project deliverables list
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1.3.3.3
Milestones List
List of Milestones Milestone number MS1
MS2 MS3 MS4 MS5
MS6
Milestone name Functional requirements and definition of the clinical scenarios Design of the SKIPPER architecture Definition of the Pilots configurations Release of the SKIPPER platform components Final deployment of the SKIPPER platform of services on the real enviroments of Pilots Evaluation, validation and exploitation of the SKIPPER solution
Work package(s) involved WP2
Expected date 21 M12
Means of verification 22
WP3
M15
D3.1- D3.5
WP8
M24
D8.1
WP4-WP6
M27
WP7-WP8
M32
D4.2-D4.5, D5.4, D6.3, D6.4 D7.1-D7.6, D8.2
WP8-WP9
M36
D8.3, D9.4, D9.5
D2.1-D2.6
Table 3: SKIPPER project Milestones list
21 22
Measured in months from the project start date (month 1). Show how you will confirm that the milestone has been attained. Refer to indicators if appropriate. For example: a laboratory prototype completed and running flawlessly; software released and validated by a user group; field survey complete and data quality validated.
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Work package Description
Work package number Work package title Activity type 23 Participant number Participant short name Person-months per participant
1 Start date or starting event: Management MGT 1
2
FORTH DEDA
18
1,5
3 CNR
1,5
4 FRAUNHOFER
1,5
5 INNOVA
1,5
6 SEF
1,5
M1
7 T4ALL
1,5
8 UNICAL
1,5
9 UNISI
1,5
10
11
12
13
UPMC
UNIBG
PHAST
IASSIS
1,5
1,5
1,5
1,5
Objectives The main objectives of this WP are to: •
Establish and implement the expected project management structure.
•
Effectively deal with all risks as they arise by constantly updated risk analysis and contingency plan.
•
Ensure proper management of the knowledge and the intellectual property rights (IPR).
•
Secure high quality of the project outcomes (deliverables, software, prototypes, etc.) by established quality control and assurance processes.
•
Establish an optimal collaboration between all partners making available a set of tools and platforms for supporting multi-modal communication, empowering collaboration and sharing knowledge.
•
Ensure a cost-effective development of technical and scientific activities, matching milestones, deadlines and obligations of the consortium and preventing or overcoming critical situations from a technical point of view.
•
Ensure the correct course of financial and administrative procedures, matching deadlines and obligations of the consortium and preventing or overcoming financial/administrative critical situations.
•
Ensure proper interaction with the EU commission.
•
Timely prepare all the periodic progress reports.
Description of work (possibly broken down into tasks) and role of partners T1.1 Management structure and risk management FORTH is responsible for the overall co-ordination, administration and organisation of the project management structure and will deploy the organisational structure and procedures to ensure the smooth and efficient operation of the project from both the strategic and tactical perspectives. The first task within this workpackage will be the effective initiation of the project and the implementation of the management structure. This will be performed at the “kick-off” meeting by setting out a plan for the project, agreed by all partners, which includes the project presentation and timetable, the establishment of the project management structure with detailed assignment of roles, responsibilities and resources, and 23
Please indicate one activity (main or only activity) per work package: RTD = Research and technological development; DEM = Demonstration; MGT = Management of the consortium.
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the assignment of each deliverable to be produced. In this task the risk management will also be performed. All risks and issues will be initially identified at the beginning of the project, and then updated during its course. All project participants and external advisors will be responsible for raising any risk or issue they feel. All such risks and issues will be registered via the project’s risk register. The status and mitigation of each risk identified will be reviewed regularly as a working document and formally at each General Management Board meeting. The Project Manager will manage and maintain the risk register. T1.2 Knowledge and IPR management Knowledge and IPR management is a key issue of each project and has to be properly agreed and performed in order to assure smooth and effective progresses of the project. Background and foreground knowledge management ensures that relevant project information (technical, process or other) is made available by the owner/generator of knowledge (e.g. via a process) and those who need this knowledge or information have easy access to it. The goal is to ensure an appropriate transfer of required information within the project. Any details concerning the access rights to Background and Foreground knowledge beyond the duration of the project will be defined in the Consortium Agreement which will be agreed among all partners at the beginning of the project. The IPR derived by the development of foreground knowledge will be properly handled, patents will be filed where and when necessary and the required legal advice for handling this will be provided within this task. The activity related to IPR management will reflect the interests of all the partners. It will seek unanimously agreement at Consortium level, while taking into account relevant partners positions and interests. Any partner that contributed to such knowledge or invention would have the right to make the final decision on that. A plan for knowledge and IPR management will be produced very early in the project. T1.3 Quality assurance and control This task will manage the quality assurance and control of the entire project and its deliverables as well as any other output. The responsibility for all quality-related activities will be carried by the SKIPPER Quality Manager in strict cooperation with the General Management Board. The implementation of quality assurance processes will involve a set of specific activities that will establish the processes, procedures and policies used during the development of the project and will ensure that they will contribute to the desired outcomes and expected results. A Quality Plan will be produced very early in the project and this document will govern the quality procedures for the whole project. This plan will contain (among the others) a set of rules for the organisation of the work, all the procedures with regard to the communication between the partners, the standard templates of all deliverables and presentations related to the project, the full detailed workplan, and any other relevant standards to conform to. The quality control is achieved through internal and, when necessary, external reviews. Internal reviews are carried out by partners not directly involved in the production of the relevant deliverable. Each deliverable will be reviewed by at least two internal partners before being signed off. External reviews are envisaged from the Advisory Boards for major deliverables that are disseminated outside the Consortium. The external reviewers will consist of experts in appropriate fields and from industry and will focus on the independent evaluation of the project’s on-going work. Their role will be to review the project’s work and outcomes, make recommendations and advise the Quality Manager. In addition to deliverable reviews other reviews may be planned, e.g. mid-term audits, milestone reviews, technological audits. T1.4 - Internal communication infrastructure To achieve an effective collaboration and cooperation among the partners, various tools and platforms will be adopted to support multi-modal communication, empower collaboration and share knowledge. The main features will be: Proposal Part B
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Mailing services for broadcast communications among registered users.
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A file repository where authorized users can share documents/spread sheets/presentations/multimedia/etc, with upload/download and other features.
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Software repositories where authorized users can share code/snippets/etc. with upload/download and other (e.g. versioning) features.
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A collaborative calendar to share events and agenda among all partners.
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An electronic conference platform for electronic meetings among partners with features like document and desktop sharing, conference recording, etc.
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An activity/task manager to add ToDo tasks, general milestones, issues, bugs, etc.
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Project Wiki: users can read and contribute to a dedicated Wiki in collaborative way.
T1.5 Coordination and project reporting This task aims at: (a) coordinating the joint efforts of the consortium during the project execution, (b) ensuring the smooth progress of the work plan and the fulfilment of the consortium's contractual obligations, and (c) providing the necessary liaisons between the consortium and the EU commission. The responsibility for all management-related activities will be carried by the SKIPPER Project Coordinator with the assistance of the General Management Board. More specifically, the task includes: coordination and monitoring of the scientific and technical activities, organization of periodic Project Board meetings for project progress review, decision making and conflict resolution, reporting activities (half-period internal progress reports (HPIPR), annual management reports (AMR), final project report), and interface with the EU Commission for all issues related to the project on behalf of the consortium. Finally, this task includes establishing and maintaining financial records, coordination of costs submission, preliminary checks of individual costs against known criteria (contractual commitments, scientific and technical progress, and delivery of results) and consolidation of cost, follow-up of EC payments, and distribution of partner shares.
Deliverables (brief description) and month of delivery D1.1 Consortium agreement (M1) - FORTH D1.2 Quality control and assurance plan (M3) - FORTH D1.3 Plan for knowledge and IPR management (M6) - FORTH D1.4 Half-period internal progress reports (HPIPR) (M6, M18, M30) - FORTH D1.5 Annual management reports (AMR) (M12, M24, M36) - FORTH D1.6 Final project report on activity, management and financial outcomes (M36) - FORTH
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Work package number Work package title Activity type 24 Participant number Participant short name Person-months per participant
2 Start date or starting event: Clinical domain and care models analysis RTD 1 FORTH 1,5
3 CNR 4,0
5 INNOVA 4,0
8 UNICAL 7,0
M1
10 UPMC 17,0
11 UNIBG 3,0
12 PHAST 6,0
13 IASSIS 6,5
14 HL7 1,0
Objectives The objectives of this WP are to: • provide an accurate analysis of the COPD medical domain, with: o
the identification of the more appropriate scientific guidelines and clinical protocols,
o
the definition of the clinical scenarios that could be supported by the SKIPPER solution and
o
the definition of the clinical and medical practices and the objectives of the Chronic care model for COPD;
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perform a preliminary field survey by collecting existing or real-life data of exposure and health in COPD patients, in order to evaluate the relationships between exposures and health outcomes as a function of time and space;
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identify clinical scenarios, care programmes, relevant data and indicators for the realization of the SKIPPER platform and its experimentation, evaluation and validation in the pilots to be applied to the case of COPD;
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perform an accurate study and evaluation of the human factor;
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study organization and management models for the healthcare delivery.
Description of work (possibly broken down into tasks) and role of partners T2.1 Clinical domain analysis: scientific guidelines, clinical scenarios and the chronic care model (UNICAL, UPMC, IASSIS) (M1-M6) Using a scenario approach, the network of clinical partners will start the operative activities performing an accurate, systematic and structured analysis of the COPD medical domain. They will be focused on: • detection and assessment of pathological events;
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relation between the significance of the clinical features and the possible pathological outcome;
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relation between pathological outcomes and environmental exposures;
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prognostic stratification and prevision on the evolution of the pathological conditions;
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optimal planning of the therapy;
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identification of all the biomedical data, signs and symptoms relevant to the COPD domain.
Please indicate one activity (main or only activity) per work package: RTD = Research and technological development; DEM = Demonstration; MGT = Management of the consortium.
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The objective of this task is to select the scientific guidelines and the clinical protocols that will be followed for the implementation of the SKIPPER solution. According to these guidelines and protocols, the clinical partners will define the clinical scenarios that will be supported by the SKIPPER platform of services. The scenarios will be compliant with the clinical and medical practices and objectives of the Chronic care model for COPD. In this phase the activities will be assisted by the Italian and Greek government institutions that gave their endorsement for supporting the project and the experimentation pilots. In order to have additive information regarding the health status of COPD patients, during this task will be performed a preliminary field survey by collecting data of exposure and health in COPD patients. Only patients with moderate and severe level of COPD severity according to the GOLD classification will be included. For each patient, the following data will be collected and analysed: 1. Health data on respiratory symptoms, breathlessness and dyspnea among others, medicine intakes and compliance, co-morbidity, consultations, hospitalisations and well-being and psychological conditions (emotions, anxiety, depression…), as recorded directly by the patients through a device 4 times per day. 2. Physiological data on lung function, pulse, blood pressure, SpO2 (peripheral oxygen saturation as assessed with saturometry), body temperature, electrocardiogram (EGC) (1 channel), skin resistance (typical stress indicator), breathnessness and oxygenotherapy. 3. Environmental exposure to major air pollutants (fine particulate matter, Volatiles Organic Compounds…) and comfort parameters (temperature and humidity) as directly recorded by the device during the day with remote sensors or using available datasets when available. In situ assessments at home of fine PM, VOCs, T, H and moulds will be also performed in order to see correlations with individual assessments. A huge amount of data relating environment and health being expected, data mining will be used for the analyses the relationships between patient’s health and physiological data on one hand and exposure to environmental factors (air pollutants, comfort parameters…) on the other hands. An example of existing COPD-related data that will be used result from the investigation of the French “Echantillon généraliste de bénéficiaires (EGB)”, which is a permanent representative sample of the population protected by French health insurance. It contains anonymous information on the sociodemographic and medical characteristics of beneficiaries and the benefits they have received. This sample is usually used to conduct longitudinal studies and to recreate the care pathway of patients over a long period, both in hospitals and other medical environments. It also makes it possible to estimate the patient rate of access to health care and the characteristics of personal healthcare expenditure. The EGB is based on a survey at the 97th percentile on the social security (national health insurance) number of French health insurance beneficiaries, whether they have received healthcare reimbursements or not. It currently gathers together some 500,000 beneficiaries of the scheme for salaried workers, other than civil servants and students (general scheme). The number of people protected by the general scheme, estimated using the EGB, is 46,891,934 in 2008, and breakdown per age and sex is very similar to that of the exhaustive population. Moreover, the mean expenditure reimbursed per consumer in the EGB in 2007 is very similar to the one calculated in the exhaustive population. Improvement in chaining between the different information systems and their trends should make the estimations even more reliable, particularly for the overall sum of expenditure. UPMC has access to the EGB database. Moreover the partners will investigate the availability in the scientific community of computer based models for COPD, in order to integrate them in the knowledge management and decision support layer of the SKIPPER solution. COPD guidelines and care model will be implemented as a result of the analysis of the obtained data and of the discussion with a panel of pulmonologists. T2.2
Problems statement and definition of evidence based care programmes (INNOVA, UPMC, PHAST,
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IASSIS) (M3-M22) As a result of the analysis performed in the task T2.1 and of the discussion with the panel of pulmonologists, variables able to statistically and clinically describe deterioration or improvement of health status of the COPD patients will be used to configure the SKIPPER platform. More in detail, several clinical scenarios will be defined on the basis of relevant COPD criteria and related variables. These clinical scenarios will guide the SKIPPER health care practices platform to improve COPD care workflows, highlighting the contributions of multidisciplinary collaborative team care, care coordination, and patient engagement. The SKIPPER solution will devise a COPD care workflow addressing risk awareness, spirometric diagnosis, guideline-based treatment and rehabilitation, Body Mass Index control (to avoid weight loss) and selfmanagement support, to improve patient outcomes in COPD. This will be based on the application of CCM to COPD. Core aspects of the CCM within the health system will include delivery system redesign (e.g. for advanced access to same-day primary care appointments), clinical information systems, decision support for clinicians (such as point-of-care guideline reminders), and support for patient self-management. Additional aspects concern coordination with health care organizations outside the practice (e.g. accountable care organizations integrating specialty and inpatient care with chronic primary care to achieve care coordination and cost savings) and linkage to community resources. Simultaneously, guidelines will be developed. Guideline-based management of spirometrically diagnosed stable COPD will comprise risk reduction, symptomatic and maintenance pharmacotherapy, and pulmonary rehabilitation, as well as additional interventions for severe or very severe disease (oxygen therapy, surgery, and palliative care). Pharmacotherapy will be prescribed according to COPD severity and symptoms for symptoms relief or as maintenance therapy. Risk reduction measures appropriate throughout the course of COPD will include smoking cessation, and air pollution avoidance, influenza vaccination for all patients and pneumonia vaccination for senior patients. Metrics for tracking improvement in COPD care processes and outcomes will be used to validate the Skipper solution. Possible metrics for COPD care include levels of utilization of the COPD-Population Screener™ or other risk-awareness questionnaires, spirometry utilization, treatment guideline adherence (e.g. maintenance inhaler treatment for patients at or beyond moderate COPD), and primary care followup rates promptly after an exacerbation-related emergency room (ER) or inpatient episode. Presentation of metrics in chronological order with effective graphics will allow immediate visualization of trends and areas needing improvement. T2.3 Study of the human factors (UPMC, UNIBG, IASSIS) (M1-M22) Evaluation of human and psychological impact of SKIPPER will be developed assessing the following parameters: •
Life event stress. Life event stress will be measured by an 11-item life events inventory-that excluded personal illness experiences directly related to COPD. The participants will be asked to indicate yes or no as to whether any of 11 life events had occurred over the past year and during the experimentation (‘spouse or partner die, a close friend or family member die or have a serious illness (other than your spouse or partner), major problems with money, a divorce or break up, family member or close friend have a divorce or break up, major conflict with children or grandchildren, major accidents, disasters, muggings, unwanted sexual experiences, robberies, or similar events, a family member or close friend lose their job or retire, physically abused, verbally abused, or pet die’). If the participant indicates (a) life event(s) had occurred, he/she will be asked to appraise the event and indicate on a scale of 1 (did not upset me) to 3 (upset me greatly) the extent it upset them. Frequency of life event stress was calculated. The scale also provides a life event stress score appraised by the participant that ranges from 0 to 33 with a higher score indicating a participant experienced a greater number of more stressful events.
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Depressive and Anxiety symptoms. The presence of depressive symptoms will be determined by a depression screening scale for elderly populations, the 15-item Geriatric Depression Scale (GDS-15) with scores ranging from 0 to 15. The GDS will be well suited for the study because it is largely free of the measurement artefact due to overlapping somatic symptoms of physical illness(es) and depression. In validation studies, translated versions of the GDS-15 have been found to be a valid and reliable screening tool for depression: Cronbach's α of 0.80, and intraclass coefficients of test−retest reliability of 0.83 and inter-rater reliability of 0.94. Using a GDS cut-off of ≥5, the GDS-15 has a sensitivity of 0.97 and specificity of 0.95 (area under curve of 0.98) for determining major depressive disorder according to DSM-IV criteria. Depressive symptoms defined as such by GDS≥5 is clinically significant, and such cases including ‘subthreshold’ depression, had been shown in the same population to be associated with significantly poorer mental and physical health and functional status, and more healthcare resource utilisation compared to non-cases and were similar to or worse than syndrome threshold cases of depression.
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Cognitive function. Cognitive function will be measured using the Cognitive Failures Questionnaire (CFQ) and the mini-mental state examination (MMSE) which were validated and widely used instruments to assess global cognitive functioning. The CFQ uses a five-point Likert-type scale (1=Never, 5=Very often) to evaluate self-reported cognitive problems (e.g. ‘Do you need to re-read instructions several times?’). Higher CFQ scores indicate more frequent cognitive problems and higher MMSE scores (0−30) indicate better global cognitive functioning, and MMSE scores of 23 or less are considered to be cognitively impaired.
The task will be organized by the following steps: • Define indicators associated with the parameters •
Define the time of the assessment of the indicators
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Build a database for the collection and organization of indicators
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Determine indicators in different time phases
T2.4 Organization and management models for the healthcare delivery (INNOVA, UNICAL, UPMC, IASSIS) (M5-M22) Health care service providers have to plan, organize and manage several challenging tasks, such as orchestrate, in more efficient and effective way, several care processes often with conflicting goals, taking into account that both demand for care and expenditures are steadily increasing. Under this respect, patients with chronic diseases exhibit specific peculiarities: often multiple chronic diseases coexist and the care procedures require coordination and consultation of multidisciplinary specialists and multiple treatments. Usually specialists may not work together but to be effective it is required a careful coordination of consultations/examinations/treatments since a care fragmentation could potentially be of risk for patients. To this aim, to improve the care and quality of life of these patients, the developing of optimization mathematical models is quite effective for scheduling patient procedures (consultations/examinations /treatments) on one hand and planning and controlling patient flows on the other hand, on the basis of the available limited resources (clinical, medical, financial, human, etc.). This implies an effective and efficient delivering of health care by planning and coordinating multiple health care professionals involved in a patient treatment chain. In such a way it is possible to select in advance patients who have to perform defined procedures and decide therefore how and when to do them. In particular, the patient routing problem, which consists in defining a sequence of “stages” as a route of a patient, can be efficiently addressed by matching capacity requirements and restrictions (e.g., on medical equipment and physicians who are being assigned at the same time) facility layout, and patient availability. The goal is to reduce Proposal Part B
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waiting time and queue length from a patient perspective and maximize resource utilization or minimize resource overtime from a financial perspective. For providing high quality care, the defined appointment schedules provide for each patient a specific time and date for patient consultation/examination. In this specific task, scheduling of a single appointment, combination appointments and appointment series of a single patient will be addressed improving coordination of health professionals and quality of patient and families life. Task 2.5 - Identification of the exchangeable coded data elements based on the use cases (FORTH, CNR, UNICAL, UPMC, PHAST, HL7) (M5 – M22) This task consists of identifying all the data elements (all the pieces of information that are being exchanged) across the SKIPPER platform between the various applications, EHRs, PHRs, GPs, EMRs, applications for citizens and healthcare professionals respectively that might contain coded elements. A coded element is a piece of information that uses a code from a vocabulary (standard or not) to express a concept. This is done so that an inventory of the terminologies in use is established for further processing by the Standard Terminology Service provided by Phast.
Deliverables (brief description) and month of delivery D2.1 Definition of the protocol of the field survey (M3, UPMC) D2.2 Clinical domain analysis: guidelines, protocols and the chronic care model (M6, UPMC) D2.3 Identification of relevant exchangeable clinical data (M10, PHAST) D2.4 Clinical scenarios, care programmes and evaluation indicators for the SKIPPER solution realization and validation (M12, UPMC) D2.5 Definition of the human factors for the evaluation of the SKIPPER solution (M12, UNIBG) D2.6 Organizational and management models for the healthcare delivery (M12, UNICAL)
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Work package number Work package title Activity type 25 Participant number Participant short name Person-months per participant
3 Start date or starting event: M3 Architecture of the SKIPPER platform of services RTD 1
2
3
4
6
7
8
9
12
14
FORTH
DEDA
CNR
FRAUNHOFER
SEF
T4ALL
UNICAL
UNISI
PHAST
HL7
4,0
16,0
11,0
10,0
22,0
4,0
4,0
5,0
7
3,0
Objectives The SKIPPER generic services architecture organizes the collaboration of distributed and independent healthcare systems, devices and remote sources of data in order to support the chronic comorbidities coordination and continuity of care and real-time patient follow-up. The service components of the architecture that are directly implemented by the SKIPPER project (the SKIPPER service components framework) are deployed on a Platform as a Service (PAAS) cloud infrastructure. In the context of the project, the SKIPPER services architecture is specialized for COPD & comorbidities (SKIPPER services architecture COPD & comorbidities Profile) and this profile is instantiated in two pilots. The “Architecture of the SKIPPER platform of services” WP organizes the design activity in compliance with the recommendations of the OMG Model Driven Architecture (MDA) and the HL7 Services-Aware Interoperability Framework (SAIF). The objectives of the WP are: 1) The definition of the Business Motivation Model (BMM). The BMM is the result of the application of means/ends analysis to the SKIPPER services architecture, expressed in the notation standardized by the OMG Business Motivation Model (BMM) 1.1 specification (http://www.omg.org/spec/BMM/1.1/). The BMM is supported by the Business Vocabulary and Rulebook. 2) The definition of the Computation Independent Model (CIM). The CMI is a declarative model of the business supported by the SKIPPER services architecture, established as a business vocabulary and a collection of structural and behavioural business rules, expressed in controlled English natural language compliant with the OMG Semantics of the Business Vocabulary and Business Rules (SBVR) 1.1 specification (http://www.omg.org/spec/SBVR/1.1/ ) and the OMG Date-Time Vocabulary (DTV) FTF – Beta 1 specification (http://www.omg.org/spec/DTV/). Note that model of the business means model of the real-world activities supported by the SKIPPER platform without any detailed formalization of the clinical and public health knowledge that supports the SKIPPER DSSs (WP1, WP5). 3) The definition of the Platform Independent Model (PIM). The PIM is an abstract computational model of the SKIPPER services architecture that is independent from the implementation platforms. The PIM is a structured, detailed and complete model covering all the operation, interaction, security and performance aspects of the SKIPPER services architecture. The PIM is expressed in the OMG UML 2 notation, with the support of the OMG UML Profile and Metamodel Service oriented architecture Modeling Language (SoaML) Specification 1.0.1 and of the OMG UMLTM Profile for Modeling Quality of Service and Fault Tolerance Characteristics and Mechanisms Specification 1.1 (QFTP). 4) The definition of the Interoperability Platform Specific Model (Interoperability PSM). The Interoperability PSM is a model of the services interfaces and external behaviors in terms of elements and functionalities of the SOAP (WS) and REST interoperability platforms, that is expressed in standard notations such as XML, XSD, WSDL, WS-Security, WS-Policy, WSSecurityPolicy, WS-Trust, WS-Secure Conversation, etc. 25
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5) The definition of the Implementation Platform Specific Model (Implementation PSM). The Implementation PSM is a model of the SKIPPER software components framework and platform, expressed in the Service Component Architecture (SCA) notation. The framework is organized in three layers: (i) the basic healthcare service components, that implements the HSSP RLUS, IXS, CTS2, DSS, ServD, services, some IHE profiles, standard security services (SAML, XACML, WSS) and other services – that are supplied by the SKIPPER partners as project background, (ii) the value added healthcare service components for coordination and continuity of care, such as HSSP CCS, device and data source handlers; (iii) the front end components that implement the Software as a Service (SaaS) web application for patients, relatives, representatives (e.g. social workers) and healthcare professionals (practitioners, administrators, care setting operators). Description of work (possibly broken down into tasks) and role of partners T3.1 Model driven design of the SKIPPER services architecture (FORTH, DEDA, FRAUNHOFER, SEF, PHAST, HL7) (M3-M18) Service Oriented Architecture (SOA) is a design and implementation style that allows putting in place the cooperation of independent and heterogeneous systems as exchange of services. A service is an activity that has an effect in the real/digital world, carried out by a system acting as a service provider for or on behalf of another system acting as a service user. A service architecture is an architecture of service exchange among systems (applications, devices ...) called participants. The services exchanged in the architecture are disciplined by formal contracts that regulate all the aspects of these activities: (i) the services’ functions - what these activities are intended to provide, (ii) the participants’ interfaces – the external structures they expose each other, and (iii) the participants’ external behaviors - in the scope of their service relationships. The services’ functions are realized by the behaviors that are visible at the interfaces. The characterizing trait of the service orientation is that the service contracts are loosely coupled with the specific systems that provide and use the services. In other terms, the service contract is an abstract model that can be grasped independently from the concrete systems that enacts the provider and the user roles in an instantiated service relationship. The service contract/model first purpose is to explicitly state agreements between the business and technical stakeholders about the terms and conditions of the service operations (what the providers do that is valuable for the users) and of the modalities of invocation, deliberation (are the conditions for service provision satisfied?), execution (or refusal) and reporting of the service provision, including the security and performance aspects. The service contract/model is a service formal specification that should be considered as a bundle of rights and duties by the service parties and that acts as a collection of functional and nonfunctional requirements for the service parties’ implementations. According to the separation of concerns standpoint, service contract/models are organized into four relatively independent sections: 1. the operation section describes what the provider is intended to carry out for (or on behalf of) the user; each service operation can be defined through its signature (its designation, arguments and result), its pre-condition – conjunction of logical expressions on relevant properties of the state immediately before the operation execution and the operation argument values - and its post-condition – conjunction of logical expressions on relevant properties of the state immediately after the operation execution, on their relationships with properties of the state immediately before and on the operation result values. 2. the interaction section describes how the provider and the user interact in order to carry out the invocation, commitment (or refusal) and reporting of the service provision/use; this part includes: (i) conversation protocols (specifications of the legal sequences of interactions between the provider and the user, each interaction being equipped with pre/post-conditions) and (ii) choreographies, control structures that disciplines for each role the relationships between the provider/user interactions and the service operation execution; 3. the security section describes the security exigencies and constraints on the service interaction and Proposal Part B
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provision/use (authentication, authorization, confidentiality, integrity, accountability, non-repudiation); 4. the performance section describes the nonfunctional exigencies and constraints on the service interaction and provision/use (volume, throughput, speed, scalability, availability, reliability, integrity, maintainability). In a well-designed contract the four sections discipline orthogonal aspects of the service relationship that can be conceptually organized in a specialization hierarchy. At the root we’ll find the operation section. The operation contract clauses are loosely coupled with the interaction, security and performance clauses. This means that (i) the service operation can (should) be defined firstly and independently from the interaction, security and performance clauses and (ii) the same service operation can be requested, undertaken, declined, executed and reported through different conversation protocols and, consequently, the invocation, commitment/refusal, delivery/use and reporting of the service provision can be driven by different choreographies. Moreover, the same service interaction can be submitted to completely dissimilar security and performance exigencies and constraints. In the SKIPPER project, we will adopt the generic service approach inspired by the HSSP 26 project. The generic service contract defines generic operations (operations that are abstracted by the types of their arguments, results and manipulated objects) and generic interactions (interactions that are abstracted by their payload types). An instantiated service contract is obtained by the definition of a Semantic Profile, i.e. the collection of the service operations and interactions types. Hence we will distinguish between the SKIPPER generic services architecture and the SKIPPER services architecture for COPD & comorbidities that will instantiate the generic architecture by means of the COPD & comorbidities Semantic Profile. The model-driven architecture (MDA) approach allows establishing an explicit formal contract as a formal model of the service. The layered structure of the service contract/model is summarized in the table below. Service Business Motivation Model – BMM – Motivational model BMM Service Computation Independent Model – CIM – Conceptual model SBVR Vocabulary & Business Rules Service Platform Independent Model - PIM – Logical model UML 2, SoaML, QFTP, UML Testing Profile Service Interoperability Platform Specific Model – Interoperability PSM – Interoperability model SOAP platform: XSD, WSDL, WS-SecurityPolicy, WSRM Policy… REST platform: HTTP, HTML, XML, JSON, … Service Implementation Platform Specific Model – Implementation PSM – Implementable model JEE, .NET, C++, Python, PHP … The target of this task are the “contractual” models, i.e. the motivational, conceptual, logical and interoperability models. The implementable model will be the target of the task T3.2. The fundamental assumptions of the contract/model based approach that act as general requirements on every service implementation are:
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Accuracy – the service provision shall be compliant with the contract/model, including security and performance aspects.
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Robustness – the service may be provided only if all the enabling conditions are satisfied.
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Atomicity - the service provision is “all or nothing” and does not show intermediate states - only the initial and the final ones are accessible.
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Isolation - the service provision execution is conducted as the only one that accesses the resources that are referred to in the service contract.
http://hssp.wikispaces.com/
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Durability - the effects of the service provision are permanent “all things being equal”.
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Integrity - the service provision does not produce any collateral effect that is not explicitly defined in the service contract.
Fault tolerance – the partial fault of resources involved in the service provision should not lead the services architecture to an incorrect state. Last but not least, the SKIPPER services architecture contracts and implementations shall be designed for testability, with the support of the “Recommendations for SOA testability” issued by the MDAS FP7 (call 8) Project. The participants to the T3.1 are: DEDA, FORTH, FRAUNHOFER, SEF, UNICAL, PHAST, HL7. The coordinator is DEDA. The results of the task T3.1 are the motivational (BMM), conceptual (CIM), logical (PIM), interoperability (Interoperability PSM) models of the SKIPPER generic services architecture and of the SKIPPER services architecture for COPD & comorbidities profile (D3.1, D3.2) . •
T3.2 Model-driven design of the SKIPPER service components framework (FORTH, DEDA, CNR, FRAUNHOFER, SEF, T4ALL, UNICAL, UNISI, PHAST, HL7) () The task arranges the SKIPPER service components framework design activities. The SKIPPER service components framework is structured in three layers: L1.Basic service components layer. This layer includes the components that implement the standard basic healthcare generic services – data and record management, identity and demographics management, terminology management, decision support service access management, service registry management, healthcare provider directory management, healthcare setting resource reservation management, security service management. L2.Value-added service components layer. This layer includes the components that implement the standard value-added healthcare generic services – coordination and continuity of care management, care plan management, medication statement management, personal health record management, device and remote data source handlers, decision support system engines. L3.Front-end service components layer. This layer includes the components that implement the front-end of the services architecture for chronic comorbidities SAAS and allow the end-user interaction as a SaaS web application on cloud. The L1 components are supplied by the project partner as project background. The activity on L1 entails: (i) the inventory of available service components, (ii) the assessment of the components compliance with standard services specifications, (iii) the assessment of the sustainability of the implementations, (iv) the identification of the evolutions that are necessary to improve standard compliance and implementation sustainability. The L1 layer model is expressed as a Service Component Architecture (SCA). The L2 components are the core of the SKIPPER development. The activity about L2 consist of the design of the service components implementations on the basis (i) of the logical and interoperability models of the generic services architecture and of the services architecture COPD & comorbidities profile and (ii) of the services provided by the L1 layer. This activity includes also the eventual design of the identified L1 components evolutions. The L2 layer model is expressed as a Service Component Architecture (SCA). The L3 components allow the deployment of the web application for SKIPPER end-users as a SaaS on cloud, on the basis of the L1 and L2 service portfolios. The activity includes the design of the components that handle the interaction with the different end user profiles and their GUIs. Proposal Part B
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The participants to the T3.2 are: FRAUNHOFER, DEDA, PHAST, CNR, T4ALL, SEF, T4ALL, UNICAL, UNISI, PHAST. The coordinator is FRAUNHOFER. The results of the task T3.2 are the L1 and L2 SCA models (D3.3, D3.4) and the UML model of the SAAS front-end (D3.4). T3.3 Security and performance requirement definition for cloud infrastructure (FORTH, DEDA, CNR, FRAUNHOFER, SEF, T4ALL, UNISI, HL7) (M6-M24) This task aims at integrating a proper security support in the design of the SKIPPER architecture. The first step of the task will investigate the security requirements of the SKIPPER services scenario. Then, a first version of the architecture will be released. The feedback received by the integration process and by the testing phase could lead to a refinement of the architecture and hence to further releases. The main components of the security support will be the authentication and authorization ones. The authentication support will be able to check the identity of the subjects that request to access the services provided by the SKIPPER platform. Subjects are paired with their attributes, which describe their features and capabilities, such as the roles in the COPD care programme that define their responsibilities and the tasks that they can/must perform. Hence, the security support should be able to represent and manage these attributes, that could have been issued by distinct administrative domains. The authorization support regulates accesses to the services provided by the SKIPPER platform enforcing a security policy that assigns the proper set of rights to each subject (or sets of subjects). The security policy will be able to express access rules taking into account the subject role in the COPD care programme, and all the other attributes paired with subjects, as well as the security support architecture will be able to retrieve these attributes and exploit them in the access decision process. Furthermore, the possibility of extending the authorization support for regulating the usage of the SKIPPER services, instead of the access only, will be investigated. The usage control enhances the tradition access control models by continuously performing the policy enforcement while the access to the service is in progress, in order to interrupt it as soon as the corresponding access right does not hold any more because of some changes in the user's or resource's attributes. Finally, in the design phase the adoption of well-known standards will be privileged, e.g., the SAML protocol could be exploited for the communications among the modules of the security support for what concern both authentication and authorization, and the XACML standard could be taken into account both for defining the components of the authorization support and for expressing security policies. The participants to the T3.3 are: CNR, DEDA, FRAUNHOFER, SEF, UNICAL, PHAST. The coordinator is CNR. The results of the task T3.3 is the deliverable D3.5.
Deliverables (brief description) and month of delivery D3.1 SKIPPER service components framework implementable model - basic services – (M04, SEF) The deliverable is the implementable model of the framework of service components that are supplied by the partners as project background. It highlights the eventual evolutions that are needed to ensure full compliance with the service standards and implementation sustainability. D3.2 SKIPPER generic services architecture motivational, conceptual, logical and interoperability models – ( M08, SEF) The deliverable is a BMM, CIM, PIM & Interoperability PSM model of the SKIPPER generic services architecture for chronic comorbidities care. D3.3 SKIPPER service components framework implementable model - value-added and front-end services – (M12, SEF) Proposal Part B
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The deliverable is the implementable model (i) of the framework of value-added service components to be developed; (ii) of the framework of the front-end components needed to implement the SaaS user interface for SKIPPER end-users (patients, relatives, representatives, professionals). It includes the eventual evolutions of the basic service components that are needed to ensure full compliance with the service standards and implementation sustainability. D3.4 SKIPPER services architecture for COPD & comorbidities – motivational, conceptual, logical and interoperability model – (M15, SEF) The deliverable is a BMM, CIM, PIM & Interoperability PSM model of the SKIPPER services architecture for COPD & comorbidities profile care. D3.5 SKIPPER services platform security and performance requirements for cloud infrastructure – (M15, CNR) This deliverables is a requirement definition document that includes the requirements of the SKIPPER platform for the underlying cloud infrastructure and a preliminary version of both the security support architecture and the general integration architecture.
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Work package number Work package title Activity type 27 Participant number Participant short name Person-months per participant
4 Start date or starting event: M7 End-users services for supporting COPD care programmes RTD 1
2
3
4
7
9
10
11
13
FORTH
DEDA
CNR
FRAUNHOFER
T4ALL
UNISI
UPMC
UNIBG
IASSIS
23,0
32,0
16,0
4,0
5,0
4,0
2,0
2,0
3,0
Objectives The objective of this WP is to design and to develop the SKIPPER end-users services, that will allow: •
the healthcare professionals to define and manage new integrated, personalized and efficient care pathways in COPD and
•
the patients to participate and to increase their empowerment in their care programmes.
The end-user services for healthcare professionals will support the operations for: •
the identification, stratification, counseling and enrolment of COPD patients;
•
the assessment of the severity level of the disease and of its comorbidities and the definition of personalized care programmes;
•
the definition, actuation, control, evaluation and fine-tuning of follow up workflows related to patients, depending on their classification and according to the specific care needs.
The end-users services for the patients will extend the PHR systems, through patient-centered functionalities specialized for the COPD and its comorbidities. In particular, the objective of these services is to support the patients in the self-management of the COPD through: •
the contextualized presentation of personal therapeutic treatment information and educational material related to the pathology;
•
the personalized representation of the health status parameters measured by the devices network available at home;
•
the possibility to note and provide personal information, regarding their care programme and their health and emotional status.
The WP4 aims also to provide all the SKIPPER end-users services through a proper security support. Description of work (possibly broken down into tasks) and role of partners The end-users services developed in the framework of the WP4 will exploit the knowledge management and decision support tools developed in the WP5, the remote telemonitoring infrastructure, realized in the WP6 and the interoperability layer designed in the WP3 and deployed in the WP7. Security policies for the authentication and the authorization will be developed and integrated in the SKIPPER solution for the access to the end-users services. From a clinical viewpoint the SKIPPER end-users services aims to: • •
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support healthcare professionals in early diagnosis, allow the integration of multi-professional and multi-disciplinary approaches within the healthcare environments
Please indicate one activity (main or only activity) per work package: RTD = Research and technological development; DEM = Demonstration; MGT = Management of the consortium.
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•
guarantee continuous monitoring of patients and the personalization of their care programmes
• support the empowerment of the patients, by extending the functionalities of the existing PHRs. The first months of the WP will be focused on the definition of the functional and technical specifications and on the design of the end-users services. The end-users services for the healthcare professionals will be developed in the tasks T4.1 and T4.2, whereas the end-users services that allow to specialize the PHR systems for the COPD and its comorbidities will be developed in the task T4.3 The task T4.4 includes the telemonitoring services based on the devices networks available at home of patients. These services will be specialized both for the healthcare professionals and for the monitored patients. The task 4.5 regards the development of a security support tailored for the SKIPPER scenario. All the artefacts that will be developed in this WP will be designed in such a way as to be integrated according to Figure 3, that is implementing the Service Provider System, the Service Provider Skeleton and the Service Consumer proxy. T4.1 Services for patients enrolment (FORTH, DEDA, IASSIS) (M7-M30) The objective of this task is the development of end-users services for supporting the healthcare professionals in the operations of identification, stratification, counselling and enrolment of patients. The identification procedure requires the involvement of the GPs, who will produce and send to the reference EHR the specific identification reports. Through notification mechanisms, the SKIPPER platform will start the identification process: the SKIPPER database is updated with the patient reference, by using Master Patient Index (MPI) based procedures for granting the unique identification of persons. HSSP IXS services will be adopted. For the stratification of patients, the SKIPPER services will interact with the knowledge management and decision support services of the SKIPPER platform. In this case the HSSP CDSS services will be used for the implementation. With the counselling end-users services, the healthcare professionals can offer to the patient the access to PHR functionalities specialized for the COPD. The implementation of these services will require the integration of existing PHR systems. Finally, the enrolment services allow the healthcare professionals to open an personalized COPD care programme for the patient. T4.2 Clinical Workflow management services (DEDA, UPMC, IASSIS) (M10-M30) This task aims at developing the SKIPPER end-users services for supporting the definition, actuation, control, evaluation and fine-tuning of follow up processes. In particular, the objective of this task is to create a workflow engine, based on the IHE XDW profile and implementing Care Coordination Service specification. In particular these services will enable easy, flexible and controlled collaboration around a shared Master Care Plan, supported by a workflow management engine. To implement the workflow engine an innovative event managers will be designed and developed, compliant to the HSSP Care Coordination service (CCS). According to the CCS, in fact, the objective is to develop end-users services able to support patient care coordination across the continuum. The viewpoint of these capabilities is the patient as he/she crosses care settings and interacts with care givers with different focus and specialties. The context is episodes of care spanning multiple organizations, the interactions at the boundaries of care transitions, and the subset of information necessary and sufficient to support these interactions. For the implementation of this kind of services, refer to the following figure
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The figure depicts an idea for an architecture that considers the flow of clinical or, in general, healthcare related documents to be the actual backbone of the medical history of a patient. This vision applies to a scenario where a set of possibly preexisting client applications (C) feed healthcare documents like prescriptions, referrals, reports but also patient identity information into repositories and registries that expose interfaces at a service level according to a modern SoA approach. Those interfaces might be based on currently developing standards for SoA in healthcare like the HSSP specification for Retrieval, Location, Update or Storage of documents (RLUS) or identity management (IXS). Other workflow aware clients (XC) may be participating in the scenario and convey a workflow oriented view to the user. In either case documents are created, stored updated or retrieved from the proper repositories. Every repository is characterized by a so called Semantic Signifier which is actually a specification of the valid documents it may contain. In the example all the repositories for identity management, Electronic Health Record (EHR) and Personal Health Record (PHR) are able to store CDA 2 documents. In the described scenario, a clinical workflow is represented by an XDW document. XDW models a workflow data structure as a constraining specification of CDA 2 for keeping track of tasks, task lifecycles and task related documents or authoring information. This makes it easy to imagine the management of CRUD operations on a clinical workflow exactly in the same way as for other documents and possibly through the same service level interfaces. In the SKIPPER services architecture the XDW Event Manager will be therefore able to intercept the event stream and the related documents and then to update accordingly the XDW document which the events relate to. Updating the XDW document corresponds actually to the advancement of the workflow lifecycle. In the SKIPPER ambitious scenario, the Event Manager module will cooperate also with clinical decision support systems in order to automatically augment the information related to a task of the workflow (for instance adding a severity or a relevance to an examination), suggest task addition or removal on the related workflow or decide upon notification of particular conditions to responsible decision makers. T 4.3: Specialization of PHR Systems for COPD patients (FORTH, DEDA, FRAUNHOFER, UNIBG, IASSIS) (M10M30) SKIPPER will allow for an active participation of patients in the care process through patient centric-services on top of existing PHRs. These services will supports the presentation, acquisition and monitoring of patient’s various types of Proposal Part B
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medical information related to COPD management, such as: •
Access personal health data in the EHR systems.
•
Provide and share personal data related to the care process, with appropriate terminologies and clinical data structures.
•
Activate regular and frequent contacts with the healthcare team, which can include specialists, but also family doctor. Since COPD is a long-term condition, a good relationship with the team allows to easily discuss symptoms or concerns; at the same time, regular meetings with healthcare team may also mean that any complications of COPD are spotted early.
•
Access, present and integrate patient personal data acquired and monitored by the personal devices network.
•
Access information services and use a well formalized clinical knowledge and information for improving education and awareness about lifestyle and correct behaviors during the disease. Repeated endurance training - supervised by an expert - is one of the most effective rehabilitation methods for patients with chronic obstructive pulmonary disease (COPD) to improve physical function. Monitoring of vital signs in combination with an automatic intelligent training control and emergency detection facilitates supervised training without the physical presence of an expert as well as training optimization through personal plans.
•
Patient-friendly multimodal and adaptive user interfaces. The SKIPPER applications will feature personalized multimodal user interfaces maximizing usability and acceptability at an individual level. Adaptation should address different types of interaction needs: (a) user’s skills and expertise, (b) the context of use (e.g. desktop PC, mobile device) and (c) possible functional limitations of the patients (e.g. vision or motor impairments). To this end, SKIPPER applications will encompass a library of multimodal and adaptive UIs that will be developed in the context of the project and will address the aforementioned three levels of interaction needs.
•
Games for patient guidance and health education. Two interactive games will be developed aiming to users’ guidance and education concerning their health issues. These applications will interoperate with the patients’ online health record and system’s knowledge management mechanism in order to acquire the necessary information related to the patients’ health issues, exploit existing predictive models and algorithms and provide thus patients’ health literacy advancement and health guidance through a multimodal and entertaining user experience.
•
User profiling mechanism for adaptation. A user profiling mechanism for adaptation will be developed, containing data regarding users’ interaction preferences and behaviour. This mechanism is fundamental for the personalization support to be provided by the project’s applications. The profiling mechanism will be built on top of an ontology-based adaptation model providing the basis for the design and development of the SKIPPER’s patient-friendly multimodal and adaptive user interfaces.
For the design of such service SKIPPER will utilize the HL7 concept of semantic signifiers for binding patientcentric services to medical documents. Within this task patient-centric services will be designed and developed as functional specializations of existing PHRs that allow for a specific processing of medical documents as classified by a semantic signifier. For this SKIPPER will develop two classes of services: •
Transformation Services: These services allow for a transformation and transcoding of PHR data considering the special needs of COPD patients. Examples of such services include the o
Proposal Part B
patient-friendly rendering of care plans, medication overviews and health reports for
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visualization and print-out
•
o
rendering of care plans and medication therapy guidelines into schedules (e.g. as calendar entries that can be imported as reminders into a mobile phone) and checklists
o
“translation” of medical codes within documents into a wording that is understandable to the patient (this service will as well make use of the terminology services developed with SKIPPER)
Web Link Services: These services allow for patients and carers to link information within PHR data to existing and newly build information services. Examples of such services include o
Linking medication information within a PHR medication plan to Drug registries managed by governmental authorities
o
Linking HP identity data with health professional registries (e.g. for retrieving up-to-date contact data)
For allowing the patients to provide through the PHR systems useful information for their care programme, the task will implement lexicon based mechanisms, based on linguistic units that may be attached to controlled vocabularies and or coding systems developed in WP5; the linguistic units may include linguistic information such as synonyms, preferred linguistic units, different languages translations and other added features, such as images and sounds (see figure below). These mechanisms will therefore exploit the semantic interoperability services of the SKIPPER architecture, by allowing the patients to provide semantically correct clinical and health information and appropriated respect to the different phases of the care/assistance process.
The concrete selection and design of these services will be done as part of the SKIPPER requirements analysis where the sketched services will as well be adapted to the specific needs of COPD patients. T4.4 Telemonitoring and Telecare services (FORTH, DEDA, T4ALL, UNISI, UPMC, UNIBG) (M10-M30) The objective of this task is to provide services for continuously controlling and assessing the clinical, physiological and psychological conditions of the patient and to manage efficiently and effectively arising alert and alarm situations, based on the scientific evaluation. This application will exploit the personal Proposal Part B
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devices network realized in the WP6, able to automatically monitor physiological data, according to the requirements defined in the WP2. The acquired data will be remotely accessible by the healthcare professionals involved in the care/assistance process of the patient. Through the services of the SKIPPER platform, the patient and/or his caregiver can access directly this data and can contribute to enhance the content of the information for a better understanding of the health condition of the patient. In particular, the health status monitoring services will provide appropriate functionality to insert other physiological data and/or the arising of specific symptoms. By exploiting the Knowledge management layer of the SKIPPER platform, these services will use appropriate decision support services to continuously evaluate the adopted score, by correlating the heterogeneous sources of information such as the home data acquisition systems, the data provided by the patient, actual clinical exams performed by the patient and reported in the EHR. In general, for the COPD management is very important also monitoring indoor and outdoor spaces to maintain a safe environment. Safety both inside and outside the home will help to preserve health and assist patient in carrying out activities of daily living in a safe manner. Moreover, in COPD patients, measurement of long term physical activity level, combined with physiological parameters such as heart rate and respiration rate can be used for early detection of exacerbations. Currently, the common approach for quantifying the physical activity of COPD patients is based on questionnaires or diaries, analysis of video recordings, or data from movement sensors, but these methods presents many drawbacks. However, nowadays several different devices are available to monitor physical activity, giving more reliable data; a typical example are devices measuring the average heart rate or the duration of the individual heart cycles. T4.5 Implementation of the security support (FORTH, DEDA, CNR) (M7-M30) This task concerns the development of the specific security support of the end user services implementing the functionalities of the SKIPPER platform. This task will take advantage of the outcome of Task T3.3, where the general architecture of the security support will have been defined. The main aspects that will be covered in the implementation of the security support will be authentication and authorizations, in order to guarantee that only authorized subject will be able to access and use the SKIPPER end user services, and confidentiality and integrity of communications and data. An attribute management system, able to deal with subjects' attribute, such as their roles in the COPD care programme (e.g. healthcare professional or patient), will also be part of the security support. Given that the main standards concerning security policy languages and security protocols, such as XACML and SAML, will have been adopted in designing the security support architecture, the use of open source libraries implementing such protocols or tools will be privileged, in order to guarantee the interoperability and the interchangeability of the components that will be adopted/developed with others developed by third parties.
Deliverables (brief description) and month of delivery D4.1: Specifications and design of the SKIPPER end-users services (M15, DEDA) D4.2: SKIPPER end-users guide (M24, DEDA) D4.3: Development of the SKIPPER end-users services for the healthcare professionals (M27, DEDA) D4.4: Development of the SKIPPER PHR services (M27, FORTH) D4.5: Development of the security support (M27, CNR)
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Work package number Work package title Activity type 28 Participant number Participant short name Person-months per participant
5 Start date or starting event: M4 Knowledge management and Decision support core services RTD 1 FORTH 5,0
3 CNR 24,0
5 INNOVA 3,0
8 UNICAL 27,0
10 UPMC 2,0
12 PHAST 7,0
Objectives The general objective of WP5 is to provide enabling and effective technologies for the development and delivery of end-user decision support services within the COPD innovative care programmes. This will be accomplished mainly in terms of design and implementation of appropriate and advanced methodologies for: •
the development of a “tool box”, composed of innovative “knowledge modules”, through knowledge representation and management, knowledge discovery and extraction, multimodal data fusion and analysis;
•
the development of “inference based meta-controller” able to set up the most effective and efficient ensemble of “knowledge modules” for implementing the final end-user decision support services.
The architectural configuration and the development of the several components will be compliance to HL7/OMG standards, with specific reference to HSSP international standards. Description of work (possibly broken down into tasks) and role of partners All the artefacts that will be developed in this WP will be designed in such a way as to be integrated according to Figure 3, that is implementing the Service Provider System, the Service Provider Skeleton and the Service Consumer proxy. The specified objective will be achieved through the accurate performance of the following tasks. Task 5.1 - Requirements analysis and general functional specifications (FORTH, CNR, INNOVA, UNICAL, UPMC, PHAST) (M4-M22) The main goals of this task are to elicitate and collect the requirements related to the knowledge management and the decision support services for the medical domain addressed by this project, also identifying suitable datasets and tools to be used for knowledge discovery and representation, specifying the functionalities and identifying eventual constraints. •
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T5.1-a) Medical domain requirements. Healthcare professionals in COPD are beginning to explore more fully the tremendous potential of the integrated disease management, which implies a wide strategy for proactively managing COPD and its comorbidities across the entire continuum of care. International disease management strategies guide diagnoses and treatments based on evidencebased medicine and scientific advancement. This subtask will explore the advances in COPD management and translate them in basic and advanced requirements for the knowledge management and decision support services.
Please indicate one activity (main or only activity) per work package: RTD = Research and technological development; DEM = Demonstration; MGT = Management of the consortium.
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•
T5.1-b) Technical functional specifications. Functional specifications are related to the identifications of the main functionalities expected from the knowledge management and the decision support services in the SKIPPER platform. They will address the user expectations taking into account the outcomes of the clinical domain analysis collected in WP2 and the architecture of the SKIPPER platform of services identified in WP3. The aim of this task is to capture functional requirements in such a way that they can drive architectural and technical decisions for all other tasks of this WP.
Task 5.2 - Knowledge elicitation, representation and management (CNR, INNOVA, UNICAL, PHAST) (M6M30) Starting from the deep analysis of the medical domain and the results from WP2, the aim of this task is to identified, represent and manage the COPD deductive medical knowledge. •
T5.2-a) Standard Terminology Services (STS). The terminological resources which are used in the project will be shared through standard terminology services. These terminological resources include (but are not limited to) the following: o
Code systems, code system versions and their contents, mainly coded concepts.
o
Associations between coded concepts (i.e. mappings).
o
Value sets based on code systems and referred to in documents/messages templates.
o
Definitions for the concept domains referred to in documents/messages templates.
o
The templates themselves together with their relationships (for example one section level template X is reused in two documents types defined by templates A and B).
o
Binding information: in that document, for coding that notion, one must use a code belonging to that value set.
The STS content will tend to be “complete”, i.e. to make it easy to conceive semantic validation tools for documents/messages. The terminological resources (the STS content) will be retrievable through standard web-services. Many of the terminological resources used in the project may already exist, but some of them will have to be created, extended or translated. The STS functions will include (but will not be limited to) the following: o
Create and maintain associations between coded concepts (i.e. mappings).
o
Translate coded concepts designations in any language.
o
As a general rule, edit any terminological resource (depending on user rights).
The STS will be able to import a local/proprietary code system and provide functions for managing the mappings between those local/proprietary code systems and standard/shared code systems. •
T5.2-b) Ontologies and medical knowledge representation. The task concerns acquisition of all types of existing medical and expert knowledge related to the COPD domain and its integrated clinical management. Special attention will be devoted to medical guidelines, existing taxonomies, and documents received as input from WP2. Literature mining will be used for screening scientific papers. In this work strong cooperation of medical and technical partners is expected. Formalization of the collected descriptive knowledge will be implemented by constructing an ontology that will include all concepts related to signs, symptoms, testing, severity assessment, prognosis, treatment, therapy, dosages, contraindications, lifestyle and environmental conditions. STS will help include terms from different existing taxonomies and links to large publicly available taxonomies, like UMLS. Procedural knowledge will be collected in the form of rule sets and
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workflows. This will contain procedures for patient conditions assessment, treatment, therapy, dosage titration, health behaviour change, and various alerting conditions. Special attention will be devoted to procedural knowledge necessary for the implementation of the innovative integrated clinical workflows proposed by the project. Procedural knowledge will be formalized in the ontological form and integrated into the descriptive ontology as its additional root class. Ontological form will be used for the communication with medical experts and for validation tasks. There is possibility to implement decision support algorithms directly based on this ontological form but also special procedures will be developed for automatic transformation of the ontological form into rules usable by different expert systems and for the transformation into Bayesian networks form. The goal is formal representation of all knowledge relevant for the COPD domain that can be reused by various decision support tools and tasks. The result is expected to be relevant also outside the scope of the project. •
T5.2-c) Deductive Knowledge modules. This task is aimed at embedding all the constructed and represented deductive knowledge into the Knowledge Base developed as a collection and integration of distinctive Knowledge Modules, each one characterized by its own properties and functionalities. In order to allow easily upgrading and maintenance of the domain knowledge base, specific tools will be developed for semi-automatic transformation and migration of new knowledge. This process will require particular attention to maintain consistency, non redundancy and coherency of the overall knowledge base. This activity will be carried on using advanced tools for format conversion and logic integration of the several knowledge modules. The final implementation of the modules will follow the development framework provide by the model driven methodologies for service architectures.
Task 5.3 - Data fusion, analysis and knowledge discovery (FORTH, CNR, UNICAL) (M6-M30) •
T5.3-a) Core and extended data sets, data warehousing. The task will organize the collection and integration of multimodal data coming from the heterogeneous patterns of patient data (clinical, genetic, emotional, socio-economic) and environmental data. Input will be both data collected in the regular health care practice (provided by EHR and PHR) as well as retrospective databases of different types (e.g. health records and history from the national and regional health systems). The work will mainly include the design and development of a novel data warehousing model that, in contrast to standard transaction based approaches, will be completely patient centric. The model will integrate various data forms including repeated visits and findings, and continuously monitored multimodal data. For a specific patient drill down and drill up functions will work on the time scale. It means that clinicians will be able to select time granularity and time range of their interest with different levels of information concentration. For automatic decision support services the warehouse will enable functionalities like ‘last information of this type’, ‘mean value for this type’, and ‘min/max values of this type’. A unique property of the constructed warehouse will be explicit connection of complex data structures with features extracted in the process of their off-line analysis. Also, the warehouse will be able to transform and deliver data in the form that may be direct input for various statistical and knowledge discovery tools.
•
T5.3-b) Knowledge discovery tasks. Among all collected data, those relevant for statistical analysis, different knowledge discovery tasks, and predictive modelling tasks will be carefully designed and developed. The process will include context-based data fusion in order to provide contextualized structured information, data cleansing, data transformation, and data integration. The process will
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require cooperation with domain experts in respect of the definition of relevant goals of the data analysis that will determine conditions of the medically justified data integration. For the process of data cleansing, among others, novel noise detection approaches will be used. Data preparation task will be performed on data from the warehouse by their loading into tabular forms as appropriate inputs for standard statistical and Machine Learning tools. Feature construction techniques will be used to enhance the datasets with information that may facilitate the subsequent modelling and knowledge discovery tasks. Several “off-line” Knowledge Discovery tasks will be performed adopting the most updated techniques. In particular, respect to the Machine Learning problems that will be identified and formalize, both approaches able to conceptualize results in a “human interpretable form” and “black-box” approaches will be used (such as Decision Trees and Rule Learning for the first category and Artificial Neural Networks, Support Vector Machines, Bayesian and Instances-based Classifiers for the second one). Active mining framework will be used in order to include domain experts in each iteration of the process: the role of end-users will be both in the selection of relevant input data and goals, as well as in the interpretation of the results. For this reason approaches able to conceptualize results in a human interpretable form may be preferable because provide, as further result than decision support, a more deep understanding of each specific decision making problem and application domain. •
T5.3-c) Hyper-solution framework for Machine Learning. Furthermore, strategies and tools for optimizing the Learning processes in Knowledge Discovery tasks will be designed and developed, with the aim to reduce computation time while improving performance of the final extracted knowledge models. A high-level Machine Learning framework will be designed and realized, aiming at combining parameters optimization for a single learning strategy (Model Selection) with Ensemble Learning among different learning schemes, via meta-heuristics. More specifically, Support Vector Machines (SVM) will be mainly adopted as learning technique but several others methodologies will be also explored, taking advantages from a multi-strategy learning environment. The meta-heuristics that will be selected and compared are Genetic and Memetic Algorithms (GA and MA), Tabu-Search (TS) and Ant Colony Optimization (ACO), and ad-hoc variations will be developed and tested according to the learning process needs. For SVM, and other kernel-based learning strategy, parameter optimization usually concerns both searching for optimal parameters value of a SVM with a fixed kernel (Model Selection) or with a combination of basic kernels (Multiple Kernel Learning), both approaches will be taken into account. Adopting meta-heuristics avoids performing time consuming grid-approach for testing several learning strategy configurations. Performing all the macro-strategies (Model Selection, Multiple Kernel Learning and Ensemble Learning) at the same time, while optimizing the related internal parameters, will provide more accurate and reliable knowledge models.
•
T5.3-d) Inductive Knowledge modules. Similarly to the activity of T5.2-c, here we aim at embedding all the constructed and represented inductive knowledge by the development and integration of distinctive Knowledge Modules, each one characterized by its own properties and functionalities, strictly related to the specific extracted knowledge models. Also in this case we provide suitable tools for upgrading and maintenance of the overall knowledge base. The final implementation of the modules will follow the development framework provide by the model driven methodologies for service architectures.
Task 5.4 - Inference based Strategy Controller and DSS architectural design (FORTH, CNR, UNICAL) (M10M30) Proposal Part B
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The main goal of this task is to design a general architecture of the DSS capable of deploying and orchestrating both the deductive and inductive knowledge modules to be developed in T5.2 and T5.3. To this end, an inference based strategy controller will be included for selecting and triggering the most appropriate modules for solving the decisional problem at hand. •
T5.4-a) Inference engine modelling. In this subtask, the inference engine will be modelled and designed. Multiple basic paradigms for performing inference on different deductive knowledge modules will be considered, if needed. Capabilities for forward, backward and two-way chaining will be included for properly and efficiently answering to various decisional tasks.
•
T5.4-b) Architectural configuration of Strategy Controller. To better exploit the modularity of the provided decisional services and improve the scalability and extensibility features of SKIPPER, a strategy controller will be included in the general architecture of the DSS. The strategy controller is in charge of managing all the requests made to the DSS and for each of them to define the best problem-solving strategy. A strategy may consist into a sequence of calls both to the deductive and inductive knowledge modules, interleaved by steps in which the strategy itself is revised or corrected on the basis of partial results. To this end, also the strategy controller is equipped with configurable and editable procedural meta-knowledge modules deployed by a dedicated inference engine.
•
T5.4-c) DSS architectural design. The designed components of the DSS will be integrated into the general DSS architecture. Paying attention to semantic and interoperability standards, typologies of inbound/outbound messages for each component of the DSS will be defined and high level interfaces will be designed. The architectural organization of DSS will be configured and deployed according to the innovative approaches provided by “model driven engineering of services architectures” methodologies.
•
T5.4-d) Enabling end-user DSS services. Finally, also considering the activities to be carried out on WP7, suitable interfaces for enabling the DSS service on the SaaS platform will be designed. In addition, particular attention will be given to convey, thanks to a so-called explanation facility, human understandable information explaining and motivating the output of the DSS to decisional problems. Different levels of explanation will be provided for patients and health care operators.
Task 5.5 - DSS implementation and prototype development, testing and integration (FORTH, CNR, UNICAL) (M13-M30) •
T5.5-a) Implementation and development. The main efforts of the task will focus in developing the prototype of decision support system. This is a core activity of the project since it is aimed at designing the brainpower of the platform that will provide the end-users with the most appropriate informative and decision support. The design and the implementation of the DSS will follow two different stages. In the first one, one or more use-cases, concerning the most innovative functionalities, will be selected as paradigms and used for the accurate development of the system components. This will concern data and processes flows, user interface, knowledge modules and the set-up of mock-up after a usability study. Finally, during the second stage, after a first evaluation, the use cases will be completed and all system components, including their interactions, will be extended, generalized and developed in order to fulfil all the requirements and functional specifications of the decision support system.
•
T5.5-b) Internal testing. In this task, a suitable test environment will be identified, set up and used for the purpose of internal testing. In particular, an automated black-box test environment based
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on TTCN-3 will be designed and developed, following the interoperability test framework for HSSP services. •
T5.5-c) Platform integration issues. On the basis of the technical specifications and integration policies provided by the WP3 and in order to contribute to integration of services of SKIPPER platform (WP7), in this task all the integration issues, DSS side, will be analysed and appropriately solved.
Deliverables (brief description) and month of delivery D5.1 Functional and technical specifications of the knowledge management and decision support services (M15, UNICAL) D5.2 DSS Knowledge Modules Toolbox (M20, UNICAL) (R+P) D5.3 DSS Strategy Controller (M24, CNR) (R+P) D5.4 Final implementation of the DSS (M27, UNICAL) (R+P)
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Work package number Work package title Activity type 29 Participant number Participant short name Person-months per participant
6 Start date or starting event: M4 Devices network infrastructure and core services RTD 2 DEDA 8,0
4 FRAUNHOFER 12,0
7 T4ALL 9,0
9 UNISI 21,0
10 UPMC 2,0
11 UNIBG 4,0
Objectives The ultimate goal of this work package is to define, design and implement the whole network infrastructure to support devices’ connectivity and core monitoring services. WP6 will take into account functional requirements and technical constraints for integrating both wearable sensors and off-the-shelf devices in the SKIPPER service platform. Activities will be targeted to solve issues related to device network requirements in terms of communication protocols, bandwidth, throughput, network capabilities, synchronizations issues along with algorithms for data normalization, calibration and security Description of work (possibly broken down into tasks) and role of partners The SKIPPER service infrastructure lays on the availability of a reliable, flexible and efficient remote monitoring platform implementing healthcare and telemedicine features, to support chronic care. In order to properly manage comorbidity, the platform scalability and flexibility will be achieved through the integration of monitoring kits that will include both off-the-shelf monitoring devices and, where needed, wearable embedded sensors. Different kinds of devices imply different requirements in terms of networking and communication infrastructure. The Work Package will investigate such network requirements and will support the implementation of the device network infrastructure to support SKIPPER core services granting reliability, interoperability and security. All the artefacts that will be developed in this WP will be designed in such a way as to be integrated according to Figure 3, that is implementing the Service Provider System, the Service Provider Skeleton and the Service Consumer proxy. The involvement of UPMC and UNIBG in the WP will allow a better definition of the specifications of the adopted devices and of the core services developed for the remote control system. T6.1 Wearable sensors network for real time monitoring of patients (FRAUNHOFER, UPMC, UNIBG) (M4-M27) Among other monitoring devices SKIPPER will use wearable sensors for real time monitoring of body functions, e.g. pulse, blood saturation, skin resistance, 3D orientation, and ECG on the health side and major air pollutants, temperature and humidity. The respective sensors will be provided or purchased by the SKIPPER partners and need to be integrated into a Body Area Network (BAN), which will be subject to this task. The specific challenge is that even though ISO/IEEE 11073 gets more and more adopted it must be assumed that not all of the sensors used for SKIPPER will already implement this standard. Therefore dedicated interfaces to the specific sensors need to be designed and implemented for retrieving data and for sending control commands. Following the SKIPPER approach each sensor will be wrapped by a service that provides sensor specific high level functionalities and transforms sensor raw data into a format that is suited for further processing by SKIPPER services.
29
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T6.2 Devices network for remote control of health status (DEDA, T4ALL, UNISI, UPMC, UNIBG) (M4M27) The integration of different devices for vital signs' monitoring requires the assessment of a set of issues related to the communication networking. This task will address such issues, identifying a standard networking infrastructure to support the implementation of a flexible, vendor-independent remote monitoring platform. A set of digital medical devices (Digital scale, Blood Pressure monitor, glucometer, Pulse- Oximeter, Spirometer, ECG) will be integrated in the platform, and a set of different connection technologies (Wireless, Bluetooth, USB, Ethernet, …) will be taken into account, so to allow services to be tailored on customers' needs. A similar approach will be used for environmental exposures. T6.3 Normalization and calibration algorithms (FRAUNHOFER) (M6-M27) With patients wearing multiple sensors that may as well provide multiple monitors to the same body function, the incoming raw data needs to be normalized and integrated. This sensor fusion process includes the •
temporal synchronization of data in order to allow to relate data in time
•
spatial synchronization, e.g. for relating data to specific parts of the body
•
automatic recalibration in case of inaccurate data
•
integration of sensor raw data into higher and processable data models that may be oriented towards specific areas of interest (e.g. blood circulation and heart)
Within this task the sensor fusion technologies required to satisfy the needs of the project with respect to throughput and accuracy of sensor data will be designed and implemented. A special focus will be a proper architectural layering of the sensor nodes in order to allow for a seamless integration with the SKIPPER sensor services developed in task 6.1. In addition this task will provide means for the calibration of the body sensors which can be automatically triggered and configured through the sensor services which are developed in task 6.1. T6.4 Infrastructure and standard interoperability of remote control systems (DEDA, FRAUNHOFER, T4ALL, UNISI) (M10-M30) The SKIPPER service framework will be designed according to the SOA architectural model. In this task, technical and semantic interoperability for remote control systems will be investigated, identifying standards and requirements for service interoperability. This assumes a crucial role in such a heterogeneous service context, since different actors, roles, stakeholders and clinical pathways dealing with chronic care have to be taken into account. Existing standards will be analysed (EHR, EMR, PHR, …) and a solution for software interoperability between different subsystems and distributed data sources will be implemented. T6.5 Security and core services of remote control systems (FRAUNHOFER, T4ALL, UNISI) (M10-M30) Security is a key feature of a e-health platform and this will be milestone of the SKIPPER framework. This task will investigate security requirements and will identify the proper hardware and software solutions to grant a secure end-to-end communication of patient's sensitive data. Every single service interaction will be checked against data security issues, in order to grant that patient data will be managed accordingly, from the monitoring device up to the final destination (being an hospital database, the SKIPPER cloud, an EHR, a GP, a specialist, …). Deliverables (brief description) and month of delivery D 6.1 Design of the SKIPPER device network infrastructure: interoperability and security specifications (M12 UNISI) Proposal Part B
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D6.2 Wearable sensor network for real-time patient monitoring and algorithms for calibration and normalization (M24, FRAUNHOFER) D 6.3 Networking and interoperability of the devices network infrastructure for patient remote monitoring (M27, UNISI) D 6.4 Security and core services of the integrated remote control systems (M27, UNISI)
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Work package number Work package title Activity type 30 Participant number Participant short name Person-months per participant
7 Start date or starting event: M10 Integration and testing of SKIPPER services on the SaaS platform RTD 1
2
3
4
6
7
8
12
14
FORTH
DEDA
CNR
FRAUNHOFER
SEF
T4ALL
UNICAL
PHAST
HL7
15,0
18,0
9,0
21,0
10,0
1,0
8,0
6,0
3,0
Objectives The main goals of this work package are the integration and testing of the SKIPPER services and their deployment into a private SaaS cloud. Given the prototypical status of many of the developed services and the high degree of parallel development, the major challenge to service integration is to setup and operate a stable version of SKIPPER with continuous updates, bug fixes and functional extensions to single services and the platform as a whole. Furthermore, the SKIPPER platform of services has to gain the trust of people who will be using the system. This can only be achieved by proper testing of the SKIPPER services and service interactions. In more detail, the objectives of WP 7 are: •
All previously in other WP developed services have to be integrated into the SKIPPER platform of services by following an adapted set of ITIL practices for Service Transition and Service Operation,
•
the SKIPPER platform of services will be deployed into the SaaS cloud infrastructure to simplify its usage for the consumer,
•
the SKIPPER platform of services needs to be tested with respect to functional tests (special attention to interoperability, conformance and security tests) and operational tests, and
•
finally, the SKIPPER platform of services has to pass some integration tests to ensure that the platform fulfills all given requirements.
Description of work (possibly broken down into tasks) and role of partners The services developed in the work packages 4 to 6 are services for the end-user (WP4) for telemonitoring, telecare, clinical workflow management, specialized PHR, etc., for supporting COPD care programs, services for the knowledge management and the decision support system (WP5) as well as services for the remote control of devices (WP6), i.e. sensors, etc. This work package is responsible for integrating these services into the SKIPPER platform and for always keeping a stable version of SKIPPER up and running. In order to achieve this goal this WP will define and enforce appropriate management processes which are derived from the ITIL Service Transition and Service Operation practices guides. Users as well as healthcare operators have to be able to interact with the SKIPPER platform directly or via devices. Furthermore, the users, healthcare operators or the system itself have to be able to remotely control devices with sensors. Therefore, it is very important that they are able to communicate with each other, which implies the correct and seamless communication between the services of the SKIPPER platform, and between the platform and the devices. Hence, this work package will test the interoperability between the different devices, services and the platform. Security tests for the interface of the SKIPPER platform to external devices are the best way to increase the 30
Please indicate one activity (main or only activity) per work package: RTD = Research and technological development; DEM = Demonstration; MGT = Management of the consortium.
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trust of people in such a platform managing very sensitive data. Integration tests will verify the correct processing, i.e. that the system fulfils the given requirements. Finally, this Work Package is responsible for defining the requirements on the SaaS cloud environment and the maintenance of the cloud infrastructure. Afterwards, the SKIPPER platform of services will be deployed into the cloud infrastructure. T7.1 Continuous integration of the SKIPPER platform of Services (FORTH, DEDA, CNR, FRAUNHOFER, SEF, T4ALL, UNICAL, PHAST, HL7) (M10-M30) In this task ITIL processes on Service Transition and Service Operation will be adapted to the needs of the SKIPPER research project and its small scale pilot operation. This particularly affects processes for change management, service asset and configuration management, release and deployment management, IT operations management, incident management and problem management. Together with project management and the WP3 technical team the respective processes will be instantiated and enforced. T7.2 Deployment on a SaaS cloud infrastructure (FORTH, DEDA, CNR, SEF, UNICAL, HL7) (M13-M31) In this task, the SaaS cloud infrastructure will be designed and implemented. Afterwards, the SKIPPER platform with the integrated services (Task 7.1) will be deployed on the cloud infrastructure. The outcome of this task is a prototypal implementation of the SKIPPER platform for services in the cloud. T7.3 Integration, interoperability and security testing of the SKIPPER platform of services (FORTH, DEDA, CNR, FRAUNHOFER, SEF, UNICAL, PHAST, HL7) (M13-M32) This task develops functional and interoperability tests to ensure the correct and seamless communication of the services of the SKIPPER platform and between the platform and the devices. Only if the interoperability layer and all systems and devices in the SKIPPER project fulfill the requirements verified by the interoperability tests, the whole system will be able to work seamlessly. Because the healthcare sector is very sensitive with respect to the protection of private patient data, i.e. every little failure could lead to a great problem for a patient, both patients and people in the healthcare sector need to be convinced to trust in using this environment. This leads to the development of security tests in order to increase the trustworthiness of this platform.
Deliverables (brief description) and month of delivery •
D7.1: SKIPPER ITIL-based processes (M15) This deliverable describes processes on Service Transition and Service Operation for the SKIPPER research project and its small scale pilot operation
•
D7.2: Test methodology and test framework description (M18) This deliverable describes the test methodology, the test framework and the test architecture.
•
D7.3: Specification and design of the cloud environment for the SKIPPER platform for services (M24) This deliverable describes the cloud infrastructure needed for deploying and running the SKIPPER platform in the cloud.
•
D7.4: Specification of the test scenarios and test cases for the SKIPPER platform of services (M24) The specification of the test scenarios and the test cases for the SKIPPER platform will be described in this deliverable.
•
D7.5: SKIPPER SaaS Prototype (M32) Preliminary prototype of the SKIPPER SaaS implementing the cloud environment for the SKIPPER
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platform for services as specified in Task T7.1. •
D7.6: Test implementation and result analysis (M32) This deliverable provides the executable implementation of the tests specified in deliverable D7.5 and the analysis of the results of these tests
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Work package number Work package title Activity type 31 Participant number Participant short name Person-months per participant
8 Start date or starting event: M10 Evaluation and validation of the SKIPPER solution: the pilots RTD 1
2
3
FORTH
DEDA
CNR
8,5
12
5
4 FRAUNHOFER
6
5 INNOVA
2
6
7
SEF
T4ALL
6
2,5
8 UNICAL
6
9
10
11
12
13
UNISI
UPMC
UNIBG
PHAST
IASSIS
HL7
6
12
12
2
2
4
14
Objectives The objectives of this WP are to: •
define and activate two experimentation pilots to follow-up in a field survey a sample of COPD patients through the SKIPPER platform
•
to refine the indicators associated with health, physiological and psychological status/wellbeing status, defined and assessed in the WP2
•
to collect follow-up data on health status of COPD patients, some of which objectively assessed, taking also into account both comfort parameters (related to the healthcare settings) and the environmental exposures of these COPD patients to air pollutants
•
to evaluate the results of the pilots according to the selected indicators and to contribute data to implement a care model of pertinence for COPD, i.e. taking into account all the dimensions of the disease.
Description of work (possibly broken down into tasks) and role of partners T8.1 Definition of the Pilots (DEDA, INNOVA, UPMC, UNIBG, IASSIS, HL7) (M10-M24) The objective of this task is to define, according to the government or NGO institutions that gave their endorsement to the project, the features of the two experimentation pilots, taking into account the clinical scenarios, the scientific guidelines, the features of the chronic care model and the evaluation indicators, defined and assessed in the WP2. The task will define the procedures for the involvement of the external bodies of the projects in the monitoring and in the evaluation of the pilot results. In particular, specific roles will be defined for: •
The Italian and Greek government institutions that will host and support the pilots
•
The scientific associations that gave their endorsement to the project
• The External Advisory board, responsible for the final validation of the SKIPPER solution. In particular, the task will define the set of COPD patients that will be followed-up during the evaluation of the SKIPPER platform in the two different geographic zones. In general, only patients with moderate and severe level of COPD severity according to the GOLD classification will be included. They will be recruited in respiratory medicine department of hospitals in the selected towns, upon the acquisition of their authorization and informed consent and with the adequate involvement of the Competent Ethical Committee. In each patient, different types of data will be recorded during this period by wearable portable, mobile or web-based systems. In particular: •
31
Health data on respiratory symptoms, breathlessness and dyspnea among others, medicine intakes and compliance, co-morbidity, consultations, hospitalisations and well-being and
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psychological conditions (emotions, anxiety, depression, …), as recorded directly by the patients through a device 4 times per day. •
Physiological data on lung function, pulse, blood pressure, SpO2 (peripheral oxygen saturation as assessed with saturometry), body temperature, electrocardiogram (EGC) (1 channel), skin resistance (typical stress indicator), breathlessness and oxygenotherapy.
•
Environmental exposure to major air pollutants (fine particulate matter, Volatiles Organic Compounds, …) and comfort parameters (temperature and humidity) as directly recorded by the device through the day through remote sensoring or using available datasets when available. In situ assessments at home of fine PM, VOCs, T, H and moulds will be also performed in order to see correlations with individual assessments. This task has also the objective to define the procedures for the data collection and for the results evaluation. Specific databases and questionnaires will be realized for these topics. T8.2 Deployment and configuration of the SKIPPER platform of services for the two pilots (FORTH, DEDA, CNR, SEF, T4ALL, UNICAL, UNISI, PHAST, HL7) (M13-M32) The objective of this task is to deploy the SKIPPER platform of services in the two pilot sites, to perform the necessary configurations, to provide the necessary manuals and guidelines for all the involved end users and to perform the training needed in order to assure a smooth start of the validation in the pilot sites. Software updates will be provided in order to solve bugs and/or problems and to extend the available functionalities according to the established user requirements. Similar approach will be used in all iteration loops and an incremental approach will be used in such a way that no collected data will be lost at any software update. T8.3 Activation, execution and monitoring of the pilots (FORTH, DEDA, CNR, FRAUNHOFER, SEF, T4ALL, UNICAL, UNISI, UPMC, PHAST, IASSIS) (M16-M36) The objective of this task is to start-up the pilots in such a way that the objectives set in T8.1 may be achieved. The technical partners will monitor strictly the start-up phase and then more loosely the subsequent phases always guaranteeing a prompt intervention in case of any problem. Technical assistance will be provided and problems solved in a reasonable timeframe. Similar approach will be used in all iteration loops assuming a more heavily involvement at the beginning and when major release or changes will be provided. If necessary, as detailed in Section 1.3.5 - Significant risks and associated contingency plans, in order to guarantee to adequate experimentation of the project results and in case of lack or objective difficulties in integrating the systems in use by the pilots, the Consortium will integrate the existing solutions developed by DEDA, FORTH and FRAUNHOFER who will provide their own EHR and PHR for the successful achievement of the project goals. T8.4 Results collection and evaluation (FORTH, DEDA, FRAUNHOFER, INNOVA, UPMC, UNIBG, IASSIS) (M19-M36) The objective of this task is to collect the data of the experimentation, apply the procedures defined in the task T8.1 for the production of the results and perform the evaluation of the results. These activities will be coordinated by UPMC with the involvement of the External Advisory Board, the government institutions that will support the pilots’ experimentation and the scientific associations that gave their endorsement. The final goal of the task is to validate the SKIPPER solution and to provide useful information for the possible industrial exploitation. The validation will take into account the indicators defined in the WP2 and refined in the task T8.1. The evaluation of the pilots will verify therefore if the SKIPPER solution could support innovative healthcare organizational models for chronic patients, by guaranteeing continuity and effectiveness of care and Proposal Part B
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sustainability of the healthcare service.
Deliverables (brief description) and month of delivery D8.1: Description of the Pilots (M24, UPMC) This deliverable presents the clinical scenarios implemented in the pilots, the involved actors and healthcare authorities and the objective of the experimentation D8.2: Deployment and configuration of the final SKIPPER platform of services on the pilots (M32, FORTH) D8.3: Study of the pilots results and validation of the SKIPPER solution (M36, UPMC)
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Work package number Work package title Activity type 32 Participant number Participant short name Person-months per participant
9 Start date or starting event: M4 Economic impacts, organizational models and business exploitation RTD 2 DEDA 14,0
5 INNOVA 15,0
6 SEF 4,0
7 T4ALL 2,0
11 UNIBG 4,0
13 IASSIS 2,0
Objectives Target of this WP is to define and carry out the necessary activities towards the identification of the exploitation potential of the project results and further defining the conditions under which SKIPPER could be launched to the market. Specific objectives are: •
To analysis the European market at a country level and understand its barriers, trends as well as the majors competitors;
•
To evaluate the economic impact of the SKIPPER solution for the health authorities and their healthcare policies
•
To define the business approach and organizational models as technology or service provider;
•
To explore and evaluate all the business models and choose the most suitable for SKIPPER market deployment;
•
To investigate country legislation in order to find out opportunities and drawbacks for SKIPPER solution deployment;
•
To carry out a preliminary business and deployment plan and assess its availability during the project;
•
To dress a final business and deployment plan that will permit to attract investors;
•
To identify a common approach related to the SKIPPER IPR management.
Description of work (possibly broken down into tasks) and role of partners T9.1 Study and evaluation of the economic impact of the SKIPPER solution (DEDA , INNOVA, UNIBG) (M4-M32) Cost-effectiveness evaluations are increasingly important in health care settings where budgets are limited and the introduction of a new therapy may divert resources from other existing therapies. The principal audiences for these assessments vary in different countries. They include national pricing and reimbursement decision makers, regional health authorities, and local budget-holding prescribers. When reviewing health economic evaluations, payers have to balance cost-effectiveness against affordability. Many therapies can be shown to be cost-effective to a greater or lesser extent, but it is unlikely that a health care community can afford all of them. Cost evaluations can help establish priorities for what should be funded and what may not be affordable. Cost evaluations can be divided into four basic approaches: cost-minimization analyses, cost-effectiveness analyses, cost benefit analyses, and cost-utility analyses (Table 2). 32
Please indicate one activity (main or only activity) per work package: RTD = Research and technological development; DEM = Demonstration; MGT = Management of the consortium.
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Specifically for the economic impact of SKIPPER on COPD will be declined into four basic approaches: costminimization analyses, cost-effectiveness analyses, cost benefit analyses, and cost-utility analyses following the steps below listed: • Define parameters for measuring the economic impact for each type of evaluation •
Define indicators associated with the parameters
•
Define the time of the assessment of the indicators
•
Build a database for the collection and organization of indicators
•
Determine indicators in different time dimensions
•
Collection of data in the data base
•
Preparation of the report
•
Conference Presentations
T9.2 Market analysis and methods for technology transfer of the innovative ICT solutions (DEDA, INNOVA, SEF, T4ALL, IASSIS) (M4-M32) This task will be dedicated to an in-depth analysis of the market, which is very important to ensure a successful deployment of SKIPPER solution across European markets. Project experts will fix a methodology to identify major market segments. This will permit a better positioning of SKIPPER solution to analysis competitors forces and weaknesses and define a marketing strategy later, able to highlight the project distinguishing features comparing to its major competitors. The objective of this task is to: •
Analyze the current trends in the field, identify the market segmentation and investigate about market barriers;
•
Survey the existing technology, potential competitors and their distinctive features;
•
Assess all possible business and technology transfer models in the different EU countries and define a deployment strategy as a service provider or technology provider.
•
Perform a SWOT analysis, and highlight distinguishing features that can be provided with SKIPPER technology to achieve a competitive advantage.
•
This task will widely contribute to highlight the key aspects that make the commercialized solution more successful, and how the European industrial position in eHealth and independent living would be strengthened in new business areas founded on relevant standardisation efforts
T9.3 Definition of business models for the results exploitation (DEDA, INNOVA, SEF, T4ALL, IASSIS) (M13-M36) A Preliminary Business Plan will be released at month M18 of the project plan. Such a report will investigate potential business models suitable for SKIPPER services deployment. The business model analysis will take care of SKIPPER business organisation models, including a preliminary analysis of the whole value chain and the role of key stakeholders working in SKIPPER business model. The aim of the Proposal Part B
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report is to demonstrate the long term viability of the project results. At the end of the project (month M36) the Final Business and Deployment Plan (FBDP) will be delivered. This report will address potential business models to be implemented, including an analysis of infrastructure costs, ownership and maintenance, IPR strategy. Such a deliverable will also include an analysis of the whole value chain of key stakeholders working in the eHealth sectors playing a strategic role for the long term viability of the project results. INNOVA and WP partners will carry out standard formal business techniques to fully research the business plan for the whole project and consortium, including full feasibility study, sectoring, costs, income/profits, return on investment (ROI) etc. This will study all aspects of the marketplace, the technology, staff costs and the deployment aspects including the presence of market barriers. The work will also take into account the involvement and returns for individual partners and provide all with a convincing case for proceeding to deployment. The final Business Plan and Deployment report will incorporate final results of users test and peer reviews and will clearly outline the actions needed for deployment and the investment plan. A country analysis on health systems legislations will be included in the Final Business Plan, to investigate existing national legislations and policies managing eHealth services in EU countries where SKIPPER is expected to be deployed. More specifically, the country analysis will investigate national actors involved in the health reimbursement process, useful to understand how to design the SKIPPER revenues model. The document will include all the necessary elements for the Consortium to take a final consensus on the deployment actions to undertake. A possible shift from a Consortium to a Partnership running as a start-up is a challenging issue that would be taken, by carefully considering IPR, business role of partners and financial capabilities. In the final Business and exploitation report the final deployment scenario will be set: the deployment model (start up or consortium agreement), the potential partnership
Deliverables (brief description) and month of delivery D9.1 Market analysis (M12) (Responsible: INNOVA) Dissemination level: PU Nature: R D9.2 Preliminary evaluation of the economic impact (UNIBG, M18) D9.3 Preliminary Business Plan (M24) (Responsible: INNOVA) Dissemination level: CO Nature: R D9.4. Final evaluation of the economic impact (UNIBG, M32) D9.5 Final Business and Deployment plan (M36) (Responsible: INNOVA) Dissemination level: CO Nature: R
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Work package number Work package title Activity type 33 Participant number Participant short name Person-months per participant
10 Start date or starting event: M1 Dissemination, collaboration and standardization RTD 1
2
FORTH
DEDA
3
8
3 CNR
2
4
5
FRAUNHOFER INNOVA
3
4
6 SEF
4
7 T4ALL
2
8 UNICAL
2
9
10
11
12
13
UNISI
UPMC
UNIBG
PHAST
IASSIS
4
4
3
12
2
14 HL7
2
Objectives The main objective of WP10 is to ensure that the goals, progress and outcomes of the SKIPPER project are opportunely disseminated. This involves addressing all the relevant target groups such as citizens/patients, healthcare professionals, healthcare organizations, industries, decision makers / Governmental / Health care authorities, standardization bodies and media. Collaboration strategies with other large-scale projects such as epSOS, SemanticHealthNet, Thematic Network CALLIOPE and other projects and initiatives for dissemination purposes are to be established. Moreover, this WP will look at the best ways to represent the project’s needs and possible proposals in various SDOs and increase its visibility. In particular, it will aim to: - Involving the Consortium in the European and worldwide standardization initiatives that could improve the relevance of the activities and the results of the project; - defining and applying the better strategies for the dissemination of the activities and the results of the project; - planning and activating initiatives aiming at strengthening the collaboration with projects focused on complementary topics. Concerning the standardization activities, the objectives of this WP are: - to directly participate to the HL7/OMG Health Services Specification Program (HSSP) Care Coordination Service (CCS) project; - to assess the impact of the SKIPPER approach and results towards the European existing standardization activities, carried out by key standardization institutions such as ETSI (European Telecommunication Standardization Institute) and CEN (European Committee for Standardization), and interoperability initiatives in IT domains, for example the IHE-Europe (Integrating the Healthcare Enterprise - Europe); - to feed-in the standardization bodies with the key findings and developed methodologies of the SKIPPER project with the goal to advance the methodologies of standards production within the standardization bodies. Concerning the dissemination activities, the objective of the WP is to carry out a set of initiatives in order to build developers’ community around the SKIPPER project and to ensure its sustainability and further development. These initiatives should provide also a specific platform to facilitate and stimulate the dialogue for the development of skills and knowledge. Description of work (possibly broken down into tasks) and role of partners T10.1 – Dissemination This task will make an inventory of available dissemination channels and target groups. Continuous dissemination activities will be carried out throughout the entire project duration, via the channels 33
Please indicate one activity (main or only activity) per work package: RTD = Research and technological development; DEM = Demonstration; MGT = Management of the consortium.
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determined in the inventory. In order to achieve the work package objectives concerning dissemination, this task will include the following activities: 1. Definition of the strategy for dissemination of project results. The consortium will draw up a detailed dissemination plan, outlining the various tasks and responsibilities; 2. Development of new and dedicated dissemination tools and channels. The consortium will fortify their identity to the external world in the form of a common name and logo. Also, the creation of a project web site will be considered as an important channel for the distribution of the information of the project. In addition, it will serve as an internal work tool. Furthermore, dissemination material such as a brochure, newsletter, poster, CD-ROM, video, will also be created, and press releases will be distributed to the mass media; 3. Participation to conferences, paper submission and seminars. Several project events will be organized throughout the duration of the project. Also, the consortium members will participate in external events in order to present the activities of the project. T10.2 Collaboration The activities of this task are aimed at exchanging information and experience with other R&D projected thus fostering the correct exploitation of the results achieved not only within the SKIPPER project but also outside with the benefit of taking advantage from the results of other projects in the same context field. T10.3 Contributions to the standards Some of the SKIPPER partners are already deeply involved in key standardization initiatives such as the joint OMG/HL7 HSSP standardization effort and are involved in a project (HealthSOAF) aiming at the development of an industrial quality implementation of the HSSP generic services. A main standardization activity will be promoting the SKIPPER services and data representation within the HSSP initiative as candidates of different implementations of the HSSP standards. The relationship between standards development, service and/or product development is very tight. Services or/and products and standards are often developed in parallel, each providing feedback to the other. The main standardization effort in which the SKIPPER project will be directly involved is the HL7/OMG HSSP Care Coordination Service 34. The Care Coordination Service is a standards development/specification effort being undertaken by HL7 to be followed by SOA specification work at the OMG. The project will be done in collaboration with the HL7 Patient Care and HL7 Clinical Decision Support work groups. The main task activity will be the intermediation between the T3.1, T3.2 activities (the specification of the value-added CCS service and the design and implementation of the service components) and the HSSP CCS workgroup activity. The SKIPPER vision of the care process the care plan and the care record will be confronted with the on-going standardization effort. Note that the HSSP CCS work is more “generic”: the chronic care is one of the “storyboards” (use cases) of the Care Coordination Service, the others being acute disease care, paediatric care, etc. Besides the HSSP CCS initiative, the project will verify the possibility to have relations with other international organisms and initiatives such as the IHE (IHE, ETSI, the European initiative epSOS). Finally, based on the .results from the pilots, the standardization bodies will be feed-in with the key findings. These cooperation initiatives could include the joint organization of events/workshops in order to improve the effectiveness of the standardization activities in the SKIPPER project and to strengthen the role of the 34
http://hssp-carecoordination.wikispaces.com/home.
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consortium in the standardization initiatives.
Deliverables (brief description) and month of delivery D10.1 Dissemination plan (PHAST, M3, R) This deliverable establishes a dissemination strategy and liaison plan and will plan on how to generate information on project scope goals and plans for communication. This must contain the overall strategy to communicate within the project as well as with the outside correspondents and make provisions for the articulation with SDOs as well. This deliverable refers to Task 10.1. D10.2 Periodic Dissemination and Collaboration Report (PHAST, M12, R) This deliverable is a periodic report indicating all promotional and dissemination activities, channels and media which are been executed from M12 to M24. This deliverable refers to Task 10.1. D10.3 Assessment report for adopting and for contributing to interoperability eHealth standards. The deliverable will assess the alignment issues of the SKIPPER platform of services with the requirements for test standards development of the standardization bodies and interoperability initiatives. This deliverable refers to Task 10.3 (HL7, M15, R). D10.4 Periodic Dissemination and Collaboration Report (PHAST, M24, R) This deliverable is a periodic report indicating all promotional and dissemination activities, channels and media which are been executed from M12 to M24. This deliverable refers to Task 10.1. D10.5 Report on the impact of the SKIPPER platform of services on test standards development (HL7, M36, R) The report will review the current practices of test standards development within standardization bodies, e with the purpose to assess the impact and align the SKIPPER approach and methodology with standardization efforts. This deliverables refers to Task 10.3. D10.6 Periodic Dissemination and Collaboration report (PHAST, M36, R) This deliverable is a periodic report indicating all promotional and dissemination activities, channels and media which are been executed from M24 to M36. This deliverable refers to Task 10.1.
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1.3.3.5
Summary Effort Table
Summary of effort Partic. no. 1 2 3 4 5 6 7 8 9 10 7 8 9 10 Total
Partic. short name FORTH DEDA CNR FRAUNH OFER INNOVA SEF T4ALL UNICAL UNISI UPMC UNIBG PHAST IASSIS HL7
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WP2
WP3
WP4
WP5
WP6
WP7
WP8
WP9
WP10
18 1,5 1,5
1,5 0 4
4 16 11
23 32 16
5 0 24
0 8 0
15 18 9
8,5 12 5
0 14 0
3 8 2
1,5 1,5 1,5 1,5 1,5 1,5 1,5 1,5 1,5 1,5 1,5 37,5
0 4 0 0 7 0 17 3 6 6,5 1 50
10 0 22 4 4 5 0 0 7 0 3 86
4 0 0 5 0 4 2 2 0 3 0
0 3 0 0 27 0 2 0 7 0 0 68
12 0 0 9 0 21 2 4 0 0 0 56
21 0 10 1 8 0 0 0 6 0 3 91
6 2 6 2,5 6 6 12 2 4 12 2 86
0 15 4 2 0 0 0 4 0 2 0 41
3 4 4 2 2 4 4 3 12 2 2 55
91
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Total person months 78 109,5 72,5 57,5 29,5 47,5 27 55,5 41,5 40,5 19,5 43,5 27 12,5 661,5
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1.3.4
Graphical presentation of the components showing their interdependencies (Pert diagram or similar)
The Figure 6 shows the schematic graphical presentation of the interdependencies of project WPs, while in the next pages we report the detailed Pert diagram, related to the Gantt of the project presented in Section 1.3.2.
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Figure 9: SKIPPER project Pert diagram (a)
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Figure 10: SKIPPER project Pert diagram (b)
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Significant risks and associated contingency plans
The significant risks for the implementation of the project were defined for each work package and respective contingency measures planned. They are described in the following table: Risks Contingency plans WP1 - Management Resource or financial risk: Overspending or under- In both cases the coordinator will ensure the spending partner corresponding partner provides proper justification. In case this justification is missing or not adequate, the corresponding resources may be reallocated to other partner(s) according to the general rules defined in the Consortium Agreement. Consortium risk: 1. The GMB specifies a clear and fair limit for 1. One or more partners do not perform their the improvements after consulting the WP duties at all, in part or in time. The quality of leaders. In case of failure, the partner will be a task result is insufficient considered underperforming and the related 2. One partner withdraws from the project procedures described in the Consortium Agreement will be applied. 2. The partner will be replaced as soon as possible with capacities from other partners when possible. In case the partner’s responsibilities cannot be delegated to other partners, a new partner will be included in the consortium in accordance to the procedures described in the Consortium Agreement Technological Risk: due to the complexity of the project one of the main project management risks is the capability to merge the existing different technological and scientific parts of the project. Different scientific methodologies are stressed and promoted, for each of the involved science domains. A critical task will be the management team capabilities to support the harmonisation of these different approaches.
To ensure deliverables can be integrated, defined standards are set in WP1 and maintained and improved throughout the project with regular version updates. In order to maintain the research group homogeneous and cohesive, SKIPPER has setup an organisational structure that on the one hand divides technological issues in the Technical Management Committee and evaluation and exploitation issues in the Validation&Exploitation Committee. On the other hand a regular exchange, monitoring and discussion platform is guaranteed in the General Management Board and a periodic supervision on the progress of the project is performed by the external Advisory Board.
WP2 - Clinical domain and care models analysis Low acceptance rate Additional patients will be recruited. Low compliance of the patients with the field survey Patients will be informed on the importance of the protocol survey and trained to execute the protocol. In addition, they will be contacted periodically by the clinical team in order to check the availability of data and measure. Proposal Part B
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WP3 - Architecture of the SKIPPER platform of services 1) As a result of the assessment of the project 1) Interoperability is a must for the SKIPPER project background service components (T3.2), the service and is the result of the compliance with standard quality (compliance level with the standards) of the specifications. A basic interoperable solution is service components supplied by the project better than a sophisticated non-interoperable one. partners is low. Part of the project effort will be rerouted to correct 2) As a result of the assessment of the project faults of the project background that causes service background service components (T3.2), the discrepancies or failures. software quality (sustainability of the 2) The project partners commit to improve the implementation) of the service components software quality for their background at no cost for the project and in the schedule. supplied by the project partners is low. 3) The specification of the SKIPPER value-added 3) The SKIPPER CCS design team will finalize in the service Care Coordination Service, that is concurrent project schedule a service specification that realizes with the HSSP CCS standardization cycle but aligned the team’s own vision of the CCS specification and with the standardization results, is retarded because try to “sell” this vision to the HSSP workgroup. The of the slowness of the aforementioned re-alignment of the project foreground with the standardization process. A standard specification standard specification adopted after the cannot be finalized in the project schedule. implementation of the SKIPPER service components will be effected after the end of the project. WP4 - End-users services for supporting COPD care programmes The main risk of this WP is that the successful Although the excellence of the expected results achievement of the expected results is strictly might be influenced by possible limitation of EHR or dependant from the availability of EHR/PHR as well data availability or by interoperability obstacles, the as from the accessibility to adequate repositories of Consortium have certainly all the needed patients’ data, in use in the context of real clinical components to setup a framework matching the scenario. minimum requirements thanks to the participation As a consequence of these requirements, relevant of important institutions, such as DEDA, FORTH or interoperability issues among different systems and FROUNHOFER, with key roles in the project, who service protocols will need to be faced. have developed interoperable clinical systems, compliant with communication and data representation standards, that can be used for our purposes. WP5 - Knowledge management and Decision support core services We envisage three main risk categories: 1. This is perhaps one of the main risk of the 1. The proposed architectural framework and the project, especially since most part of the project components/modules of the Knowledge hinges on a successful development of the DSS management and DSS system are too complex architecture, the relevant components/modules and the related end-users services. The only to develop. 2. The required decision support applications and feasible mitigation approaches, beyond ensuring end-user services cannot be developed within that the task is handled by high qualified the time and resource constraints of the competence, are allocation of sufficient project. resources, close follow-up and continuous 3. The internal testing process for validating the monitoring of the work in progress, and a strict DSS prototype fails to produce consistent coordination and control of the partners evaluation feedback. involved in the WP. 2. The amount of resources/funding is the most likely challenge when it comes to the physical design and implementation of SKIPPER end-user decision support services. Being aware of this, the WP5 and task leaders will emphasize efficient resource utilization when executing work. Moreover, a tight cooperation with the Proposal Part B
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clinical partners will be planned and maintained along all the project duration. Another mitigation approach is to keep open an option for transferring resources from other work packages or task activities as well as the use of effective methodological planning and scheduling tools. 3. Both the evaluation criteria and testing and validation plan will be rigorously represented and detailed before the pilot implementations start. This means that any variations in the feedback received should provide valuable information about real differences in the potential of SKIPPER decision support services within each of the foreseen scenario arenas WP6 - Devices network infrastructure and core services The network infrastructure will have to deal with a Technical requirements from every single device (in widespread set of devices (wearable embedded terms of networking, accuracy, time response, …) sensors and off-the-shelf medical devices), each of will be properly analysed when choosing devices to them implementing different technical be included into the monitoring and communication specifications, communication protocols, and framework. A compatibility matrix among technical network requirements. This could introduce some requirements will be designed to ensure complexity in integrating and harmonizing harmonization and consistency and every eventual heterogeneous hardware specs into a seamless new device/sensor to be integrated during the service experience. project lifetime will be checked against the matrix. The task will be performed taking into account existing and on-going communication standards to get to a reliable and efficient service platform. WP7 - Integration and testing of SKIPPER services on the SaaS platform Due to the large number of components/services to All interfaces among SKIPPER services will be based be developed in parallel the single development on well documented standards. Developed teams cannot implement against each other’s components will undergo respective conformance components’ interfaces. This imposes risks on the testing as soon as possible. Detected ambiguities of integration into the platform as interoperability standards with respect to implementation details testing can only be performed after all will be published on an internal Wiki and resolved developments reached to a stable status. immediately. Respective conformance and interoperability guidelines for developers will be published on the Wiki. By this the risks on the final integration and interoperability testing can be minimized. Due to the tight schedule not all developed SKIPPER WP7.1 service integration and operation components will be mature and stable with their will be based on ITIL Service Transition and Service first release. This demands for a continuous further Operation practices guides. This will provide clear development and continuous updates of the structures, processes and schedules for service services and the service platform. This again bears updates and increases the responsiveness to risks for version incompatibilities and huge efforts in incidents and problems. service operation at the points of care. Additionally each update will require downtime for integration, configuration and testing which negatively affects the availability of the service platform for pilot operation. WP8 - Evaluation and validation of the SKIPPER solution: the pilots Proposal Part B
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-
-
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Difficulties in implementing the pilots
-
This should be a rare event if the survey conducted in WP2 is conclusive. Of note, the same contingency plans as in the case of the WP2 field survey will be applied for the recruitment and the follow-up of COPD patients participating in the pilots.
-
Also this should be a rare event. CCM, clinical scenarios and related guidelines have been developed in other chronic diseases. In addition, several data are available in the literature for COPD.
-
Both statistical and clinical validations will be used which reduce the risk of error and biases.
Difficulties in implementing the CCM, the clinical scenarios and the guidelines.
Difficulties solution
in
validating
the
SKIPPER
WP9 - Economic impacts, organizational models and business exploitation The market, EU policies and organizational models WP9 is structured for monitoring all market and change over the project running, and initial policy changes. Initially, we provide a market exploitation plan could not be suitable any more for analysis, then we carry out a preliminary business new market requirements plan, at the end of the project, the final business plan will consider all feature and indicators for a successful SKIPPER deployment. WP10 - Dissemination, collaboration and standardization The main risk of the dissemination package is not to The mitigation of all these risks are provided via be synchronized with the other work packages and careful and continuous articulation with: to communicate in a non-synchronized fashion with • the other work packages as to be aware of regards to the SKIPPER activities. the status of work The second risk is to miss the opportunity to participate with the necessary project material (needs and discoveries via implementation) to a developing standard approaching ballot and having to make amends in communication and integration with SDOs.
•
the relevant work within the concerned SDOs
•
national programs via the participants involved
The last risk is that the SKIPPER project would have major divergences with national programs. Table 4: Risks and contingency plans for the SKIPPER WPs
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Section 2: Implementation 2.1
Management structure and procedures
The basic purpose for project management is to supervise the overall activities and to ensure the proper level of co-ordination and co-operation amongst the project consortium members. The management of the projects objectives will be realised through the object oriented WPs in which each Principal Contractor shares the responsibility. Reporting periods on Financial Statements and on Technical Progress Reports will be supplied to the Commission every 12 months, at month M13, M25 and M37. Moreover a status check at the beginning of the project will be set at month M7. 2.1.1
Project Management structure
The Project management of SKIPPER will be carried out by FORTH, which will have the overall responsibilities of the project. The FORTH management structure includes a Project Coordinator (PC) and a Project Manager (PM), who will closely collaborate with PC for the overall operative co-ordination activities and the management of the various steps of the project. Figure 11 shows the schema of the SKIPPER Management organization. The Quality Manager will be responsible for the coordination of the SKIPPER quality assurance and control processes, by giving guidance and support to the activities of each of the participating partners. The quality evaluation work will be planned, co-ordinated and monitored from the start of the project. He will define the Quality Plan, which will govern the quality procedures for the whole project, in collaboration with the General Management Board and the WP leaders. He will supervise the quality control nominating for each deliverable the internal reviewers and, when recommended by the Advisory Boards, the external reviewers. He will also be responsible of other reviews which may be planned, e.g. mid-term audits, milestone reviews, technological audits. For any relevant issue the Quality Manager will report to the General Management Board. The General Management Board (GMB) is a decisional organ in SKIPPER, which is chaired by the Project Coordinator and includes different representatives from the Consortium (see details below). The GMB aims to decide strategies, politics, implementation and exploitation plans, links with other projects and users, etc., to be taken within SKIPPER, in accordance to the advices of the Quality Control Manager. The GMB shall meet periodically, two to three times per year as needed. In addition, regular communications among the members of the GMB will be based on e-mail, telephone, videoconference, and on the use of the restricted part of the web page of the project. The next table shows the structure of the General Management Board and its functions.
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General Management Board Members The Project Coordinator and the Project Manager (FORTH) The Exploitation Responsible (INNOVA) The Dissemination Responsible (PHAST) One representative from the Technical Management Committee (to be selected by the TMC) One representative from the Validation&Exploitation Committee (to be selected by the VEC) One representative from the Committee on Intellectual Property (TBD) Activities Decide strategies and politics, Supervise the implementation activities and the exploitation plans, Guarantees links with other projects and users, Reports to the project Coordination about the activities carried out and the progresses towards objectives and milestones Table 5: General Management Board schema
The Technical Management Committee (TMC) is the body responsible for making and overseeing all technical decisions made within the project, in agreement with the Project Coordinator. The TMC is composed by the leaders of the technical WPs (i.e. WP3-WP7), who are authorized and responsible for summarizing the results and progress of the respective WPs during the TMC meetings. The TMC will be chaired by a representative selected among the WP leaders. The TMC shall meet periodically, two to three times per year as required. In addition, regular communications among the members of the TMC will be based on e-mail, telephone, videoconference, and on the use of the restricted part of the web page of the project. In the next table the composition of the Technical Management Committee and its activities are detailed. Technical Management Committee Members (WP Leaders) SEF (WP3) DEDALUS (WP4) UNICAL (WP5) UNISI (WP6) FRAUNHOFER (WP7) Activities Assisting the GMB in keeping the overall scientific strategy concerning the Project Monitoring the progress of each WP Reporting on the Technical Activities to the GMB Reviewing and validating Deliverables of WP to be submitted by the Project Coordinator to the EC Table 6: Technical Management Committee Schema
The Validation&Exploitation Committee (VEC) is the body responsible for supervising all the activities related to the standardization of the services, the exploitation of the project results, as well as to coordinate the activities of testing, validation and assessment of the developed services, including the setting of the pilots. Validation of the services will be performed taking into account the following aspects:
Usability;
Effectiveness;
Feasibility, related to the capability of a user to adopt the developed framework.
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The VEC is composed by the WP2, WP8 and WP9 leaders as well as IASSIS, who are authorized and responsible for summarizing the results and progress of WP during the VEC meetings. The VEC will be chaired by a representative selected among the participating WP leaders. The VEC shall meet periodically, two to three times per year as required. In addition, regular communications among the members of the VEC will be based on e-mail, telephone, videoconference, and on the use of the restricted part of the web page of the project. In the next table the composition of the Validation&Exploitation Committee and its activities are detailed. Validation&Exploitation Committee Members UPMC & IASSIS (WP2-WP8) INNOVA (WP9) Activities Supporting the Technical Dissemination and Exploitation activities Supervising the standardization process Supervising the validation activities and reporting on the results achieved to the GMB Assisting the GMB in keeping the overall scientific strategy concerning the Project Monitoring the progress of each WP Reviewing and validating Deliverables of WP to be submitted by the Project Coordinator to the EC Table 7: Validation&Exploitation Committee schema
The Intellectual Property Rights, Use, and Dissemination Committee (IPC) will be composed of up to four partners with different expertise, interests and skills. It will deal with the decisions regarding SKIPPER protection during the project. This committee will report its decisions to the Project Management Committee through one representative of the Group. The External Advisory Board is in charge to provide a super partes advice on the objectives pursued by the SKIPPER Consortium and on the expected outcomes. This Board will be composed of eminent representatives of the scientific community, both technical and medical. To this purpose, the SKIPPER Consortium has already collected the availability of some distinguished scientist, although the composition of this Board will be accurately defined by the GMB after the project starts. The following scientists are in contact with the Consortium and could be involved as members of the Board: -
-
Prof. Bosse LUNDBACK (Svezia), Head of the Assembly of Occupation and Epidemiology of the European Respiratory Society, Prof of Respiratory Medicine University Hospital GOTEBORG Prof. Alain DIDIER, Head of the Francophone Society of Pneumology, Prof of Respiratory Medicine University Hospital Prof. Karl-Christian BERGMANN (Germany), Prof of Respiratory Medicine, CHarité Hospital Ken Rubin. Ken Rubin co-chairs and founded the HL7 SOA Workgroup, co-chairs the OMG Healthcare Domain Task Force, and established the Healthcare Services Specification Project (HSSP) (a collaboration between standards bodies to produce health industry SOA standards). Mr. Rubin is also the Chief Healthcare Architect for the Federal Healthcare Portfolio for HP Enterprise Services. Stefano Lotti, editor of RLUS Service Functional Model Normative Specification and deeply involved in several Healthcare Service Specification Project (HSSP) specifications development. Since 2009 he is the Chair of HL7 Italy and co-chairs the HL7 International SOA Workgroup. Mr. Lotti works at INVITALIA (Government Agency for Inward Investment Promotion and Enterprise Development) as responsible and Chief Enterprise Architect in several modernization projects of Regional health systems and he’s also involved in epSOS as one of the main authors in the architectural design. Previously, Mr. Lotti worked as Technical Program Manager on the definition of the National eHealth strategy and leads the national technical specifications with the use of MDA approach and HL7 standards.
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Management Activities
Management activities will be twofold: they will be important for the internal technical evaluation of the research results and also deal with the external activities related to the dissemination and exploitation plans. The main important management activities to be performed by the Project Coordinator (PC), in collaboration with GMB and all the involved partners, are reported below: Deliverables handling and quality assurance The main objective is to assure a high technical and scientific quality level of the results (deliverables and work) of the work-packages. This task aims to contact and manage the procedures of the interaction with the peer reviewers and to supervise the quality of the delivered documentation. Quality control procedures will be applied in deliverables handling and in review meetings. The quality procedures will be described in a manual by the Project Management based on mutually agreed Table of Content with the Commission. The manual will be used during six-monthly reviews by Project Management and external reviewers. The manual will be shared with both the project partners and the evaluators. All the deliverables will be reviewed against performance indicators. Quality issues will be part of the specifications of technical achievements. Information and Documentation flow and supervision The communication between partners will be managed via periodic meetings and constant electronic communication. The supervision of the quality and completeness of all the documentation has to be assured. In order to harmonize internal communication, a standard for documents will be agreed. Periodic meetings will be held also to present partial results and to stimulate ideas exchange and problem solving. Administrative and financial management This activity aims at supervising the distribution of work and resources, the fulfillment of the work described by each WP and the proper use of the resources allocated to each partner. A Project Administrator will ensure the production of control reports, cost claims and other administrative statements that need to be communicated to the EC. This role will be done by FORTH, which has experiences in managing several EU funded projects. Each SKIPPER Partner will appoint a Partner Administrator who will be the primary point of contact to the Project Administrator. The interface to the EC on all issues relating the project will be the Project Coordinator, while administrative project issues may be delegated to the Project Administrator.
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Figure 11: SKIPPER management organization
Contacts with the Commission The Commission will be provided with annual progress reports, agreed deliverables, annual reviews, and final report, as well as six-monthly reports if requested by the EC Reviewers. Promotion and definition of Gender Issues Plans Different activities will be promoted and undertaken within SKIPPER in order to promote gender equity in science and technology, both in academia and industry. Promotion and definition of intellectual Property Rights, Use, and Dissemination A detailed procedure will be defined by the IPC, which will be followed by the partners before submitting a paper to Scientific Journals or Reviews and Conferences in order to raise awareness of Intellectual Property issues and to provide any relevant information which may be of assistance to partners with Intellectual Property queries or concerns. 2.1.3
Risk management
Risks may have an impact on the project schedule and outcomes, and may eventually lead to contractual issues. The management process shall identify and monitor those risks and shall take appropriate measures to limit and/or mitigate their effects.
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In SKIPPER, internal risks can result from too ambitious technical objectives, poor integration of competences from the participants, deviation from good project management rules, strategy evolutions or defaulting partners. The most important risks and associated contingencies are described Section 1.3. Risk assessment and management will be an item of the GMB meeting agenda. As qualitative method for risk management the following procedure will be applied by all Task leaders, under the guidance and responsibility of the GMB: (i) risks identification, (ii) evaluation and ranking, (iii) mitigation and residual risks follow-up. The identified risks will be integrated in the project web-office tool and updated on a regular basis (typically every six months). In any project in which several partners from different institutions participate and even though all present participants have shown their seriousness in the past, there always exists a risk, even minimal, related to the deficiency of a partner in fulfilling his/her commitments. In such a case, although any redundancy will be strictly avoided, any field to be studied in the proposal domain is fortunately covered by at least two participants. In other words, any deficiency from any participant will be easily overcome by appointing the activity to another competent participant. However, if it appears that no solution can be found for a very specific competence, the Project Coordinator will assess the impact of his/her withdrawal from the project and will take into account the possibility to sub-contract the missing activities in agreement with the EC.
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Partner n.1 (Coordinator): Foundation for Research and Technology Hellas - FORTH (Greece) Brief Description The Foundation for Research and Technology – Hellas (FORTH) is one of the largest research centres of Greece under the supervision of the General Secretariat for Research and Technology of the Hellenic Ministry of Development. The Institute of Computer Science (FORTH-ICS), one of the seven institutes of FORTH, since its establishment in 1983 is conducting basic and applied research, developing applications and products, providing services, and playing a leading role in Greece and internationally, in the fields of Information and Communication Technologies. FORTH-ICS’s activities cover important research and development areas, taking into consideration new perspectives, emerging fields of research and technological challenges. FORTH-ICS has recently introduced its Ambient Intelligence (AmI) Programme, which aims at improving the quality of life of all citizens of the emerging Information Society promoting the vision of independent living through the creation and provision of safe, efficient and user-friendly technologies. The Computational Medicine Laboratory (CML) at FORTH-ICS has established a tradition of internationally acknowledged excellence in conducting high-level R&D work and in developing innovative systems and services. Its research activities focus on the development of innovative computer methods and tools in the area of computational medicine, eHealth, mHealth, medical imaging, and medical and biomedical informatics. The Human Computer Interaction Laboratory (HCI Lab) of FORTH-ICS, established in 1989, is an internationally recognised centre of excellence, with accumulated experience in user interface software technologies, design methodologies, and software tools. The Laboratory carries out leading research activities rooted in the principles of Universal Access and Design for All, and focused on developing user interfaces for interactive applications and services that are accessible, usable, and ultimately acceptable for diverse users in the Information Society, addressing a wide variety of technological platforms. The HCI Laboratory also operates the Centre for Universal Access and Assistive Technologies (CUA&AT). The main objective of the Centre is to support equal participation and socioeconomic integration of people with disabilities in the Information Society. Role in the project and previous relevant experience One of the main tasks of FORTH in this project will be the coordination and management of all the project activities. However, FORTH will significantly contribute to the technical activities and more specifically to the design and development of end-user services for the integrated management of the chronic diseases, to the integration and testing of the services in the SaaS platform and to the set-up and smoothly execution of the Greek pilot. FORTH will also contribute to the clinical domain analysis, the definition of the care model, the architectural design of the platform of services, the design of the knowledge management and decision support services, and the dissemination activities. The CML at FORTH-ICS has been involved in several projects and initiatives at EU level related to the topics of this project. REACTION aims at developing an integrated approach to improve long term management of diabetes, continuous blood glucose monitoring, clinical monitoring and intervention strategies, monitoring and predicting related disease indicators, complemented by education on life style factors such as obesity and exercise and, ultimately, automated closed-loop delivery of insulin (http://www.reaction-project.eu/). REMOTE was a pan-European research project concerned with the needs of elderly and individuals with chronic conditions. The focus is to support independent living with the aid of AmI technologies and telehealthcare with various kinds of monitoring and automation services for tracing activity, fall detection and health condition, as well as detecting risks or critical situations of citizens (http://www.remote-project.eu/). HEARTFAID was another successful project aimed at devising, developing and validating an innovative knowledge based platform of services, able to improve early diagnosis and to make more effective the clinical management of heart failure diseases within elderly population. In addition, our laboratory has been involved in several Virtual Physiological Human (VPH) related projects both as coordinator like in ACGT and ContraCancrum - aiming at the development of the European Biomedical Informatics Grid for Proposal Part B
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cancer research or as principal contractor like in TUMOR - focusing on model interoperability for cancer research (international collaboration with the Center for the Development of a Virtual Tumor, Massachusetts General Hospital, Boston, USA), INTEGRATE - focusing on model and collaborative tools development, and pMedicine - to bring together international experts for creating an infrastructure that will facilitate the translation from traditional practice to personalized medicine. The HCI Laboratory has participated in more than 50 R&D projects in the field of HCI. Current projects are ICT-HOBBIT, ICT-CARDIAC, ICT-VERITAS, AAL-REMOTE, and ICT-ACCESSIBLE. In the context of the AmI Programme, FORTH-ICS develops and applies pioneering AmI technologies in everyday living contexts. FORTH-ICS has a state-of-the-art AmI Facility, which occupies a three-floor 3,000 square meters building and comprises six simulated AmI-augmented environments, including a smart home, a smart doctor's office and a smart hospital rool. Key Personnel Professional CVs Franco Chiarugi is a senior staff member at the CML of FORTH-ICS. He holds a M.Sc. and a B.Sc. in Electronic Engineering from the University of Pisa, Italy and the qualification to practice as an engineer. He has been working in the field of biomedical engineering for more than 20 years with main focus on communication protocols, implementation and development of interoperability standards in the health domain, bio-signal processing, and clinical decision support systems. In 1999, he joined the Computational Medicine Laboratory (CML) at FORTH-ICS. He has contributed to several ICT R&D projects like PICNIC, OpenECG, TWISTER and HEALTHWARE. He was FORTH’s scientific responsible for the HEARTFAID ICT FP6 STREP project (a platform for the management of heart failure patients) and is currently FORTH’s scientific responsible for the REACTION ICT FP7 IP project (a platform for the management of diabetic patients). He has published more than 70 papers in international journals and conference proceedings related to his fields of expertise. His current research activities concentrate on the seamless integration of medical equipment in eHealth and mHealth systems, communication protocols, telemedicine, vital sign monitoring, bio-signal processing and decision support systems. Stelios Sfakianakis received a M.Sc. with highest distinction in Advanced Information Systems in 1998 and a B.Sc. in Computer Science in 1995 from the University of Athens. In January 2000 he joined the CML at FORTH-ICS. His interests include the semantic integration and composition of services in state of the art computational environments such as the Grid and the Semantic Web and the employment of statistical and computational approaches based on machine learning and data mining techniques for the analysis of highthroughput experiments, such as gene expression profiling and genomic sequencing. On the technical side his experience spans the application design and development using the Unified Modeling Language (UML), the development of distributed systems using CORBA, Web/REST Services, and Grid Services, and the design of OWL/RDF-S ontologies and their employment in the semantics-based description of services. He has also experience in the integration of medical and biomedical applications through the use of common health services and the adoption of international standards, such as HL7 and the IHE integration profiles. Dr. Angelina Kouroubali is a Collaborating Researcher at the CML of FORTH-ICS. She holds a Ph.D. in Management of Medical Informatics from the University of Cambridge, UK, a Masters in Medical Informatics from Columbia University, NY, USA, and a BA in Biology from Bard College, USA. Her research interests include evaluation of health information systems; innovative management practices for the coordination of care; social and organizational issues in eHealth implementation; applications of complexity theory in organizations; innovation in education, health care and enterprises. She collaborates with EuroRec, representing Greece in the EHRQ-TN project. Her activities include helping software vendors to prepare for the EuroRec Seal, and promoting quality labelling and certification of EHRs at a National level. Vasilis Kontogiannis is a technical staff member at the CML of FORTH-ICS. He holds a M.Sc. (Eng.) in Radio Communications and High Frequency Engineering and a B.Sc. in Electronics Engineering from Leeds University, U.K. In 1999 he joined the CML at FORTH-ICS. He has been working in the field of biomedical engineering with focus to analysis, design and development of medical information systems and network infrastructure for the implementation of telematics in health. He participated in several national and EU projects in the healthcare domain, contributed in data modeling, integration and design of teleconsultation Proposal Part B
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systems, homecare platforms, telemedicine applications for ambulatory care and emergency management, clinical information systems, evaluation of continuous medical education platforms as well as disaster and emergency management solutions and applications for civil protection. Lefteris Koumakis is a technical staff member at the CML of FORTH-ICS. He received a M.Sc. and a B.Sc. degrees in Computer Science from the University of Crete, Greece in 2004 and 2001 respectively. His research interests focus on Web Services and Scientific Workflows, intelligent data-analysis and mining of clinical and genomics data. He has participated in various international and national R&D projects including WS-Talk, ACGT, GEN2PHEN, P-Medicine and Eureca. Dr. Margherita Antona is member of the HCI Laboratory of FORTH – ICS since 1993. Since 2004, she is Coordinator of CUA&AT, managing the day-to-day activities of the Centre. Since 2009 she is member of FORTH - ICS AmI Programme Steering Committee and Coordinator of the AmI Classroom activity. Her research interests include universal access, design for all, computer-supported user interface design, adaptive and intelligent interfaces, assistive technologies, eLearning and Ambient Intelligence. She has participated in more than 20 European and national R&D projects and has co-authored more than 60 scientific publications. She is member of the program or review committee in various international conferences and workshops, and member of the Editorial Board of the UAIS Journal. From 1988 to 1992 she was researcher at the Institute of Computational Linguistics of CNR in Pisa. Relevant publications •
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V Lagani, L Koumakis, F Chiarugi, E Lakasing, I Tsamardinos. A systematic review of predictive risk models for diabetes complications based on large scale clinical studies. Journal of Diabetes and Its Complications (accepted, in press). EG Spanakis, F Chiarugi, A Kouroubali, S Spat, P Beck, S Asanin, P Rosengren, GT Gergely, J Thestrup. Diabetes Management Using Modern Information and Communication Technologies and New Care Models. i-JMR interactive Journal of Medical Research, 1(5), 2012. I Karatzanis, V Kontogiannis, EG Spanakis, F Chiarugi, J Fursse, RW Jones. Empowering Patients through a Patient Portal for an Improved Diabetes Management. Proceedings of Mobihealth 2012. L Koumakis, F Chiarugi, V Lagani, A Kouroubali, I Tsamardinos. Risk Assessment Models for Diabetes Complications: a Survey of Available Online Tools. Proceedings of Mobihealth 2011. S Spat, B Holl, P Beck, F Chiarugi, V Kontogiannis, EG Spanakis, D Manousos, T Pieber. A Mobile Android-based Application for in-hospital Glucose Management in compliance with the Medical Device Directive for Software. 2nd International ICST Conference on Wireless Mobile Communication and Healthcare, Kos Island, Greece, 5-7 October, 2011. A Kouroubali, F Chiarugi. Developing advanced technology services for diabetes management: User preferences in Europe. 2nd International ICST Conference on Wireless Mobile Communication and Healthcare, Kos Island, Greece, 5-7 October, 2011. B Höll, S Spat, J Plank, L Schaupp, K Neubauer, P Beck, F Chiarugi, V Kontogiannis, T Pieber, A Holzinger. Design of a mobile, safety-critical in-hospital Glucose Management System. Stud Health Technol Inform, User Centred Networked Health Care, Proceedings of MIE 2011, vol. 169, 950-4. F Chiarugi, S Colantonio, D Emmanouilidou, M Martinelli, D Moroni, O Salvetti. Decision Support in Heart Failure through Processing of Electro- and Echocardiograms. Artificial Intelligence in Medicine, 2010, vol. 50, issue 2, 95-104. C Chronaki, SG Sfakianakis, Y Petrakis, G Charalambakis, L Hinterbuchner, M Radulescu, B Mulrenin, C Lüpkes, M Eichelberg, E Arbelo, Y Kabak, G Laleci, A Dogac. Tomorrow’s Integrated Care: Interoperability Testing in Guideline-driven Cardiac Telemonitoring. In Proceedigs of IHIC2011, Orlando Florida, May 2011. MN Tsiknakis, SG Sfakianakis, G Zacharioudakis, L Koumakis. A framework supporting sharing and reuse of data and tools in translational cancer research: Lessons learned for VPH research. 4th International Advanced Research Workshop on In Silico Oncology and Cancer Investigation (IARWISO). September 2010, Athens, Greece SG Sfakianakis, ME Blazadonakis, IN Dimou, ME Zervakis, MN Tsiknakis, GA Potamias, D Kafetzopoulos, D Lowe. Decision Support Based on Genomics: Integration of Data and Knowledge Driven Reasoning. International Journal of Biomedical Engineering and Technology, 3(3/4), 287-307.
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H Kondylakis, L Koumakis, E Genitsaridi, MN Tsiknakis, K Marias, G Pravettoni, A Gorini, M Mazzocco. IEmS: A collaborative Environment for Patient Empowerment. IEEE International Conference on BioInformatics and BioEngineering (BIBE). A Kouroubali, D Katehakis, A Berler, M Tsiknakis. Electronic Health Record: Luxury or Need? Forthcoming in Health Review (Επιθεώρηση Υγείας) [in Greek], 2013. D Katehakis, S Halkiotis, A Kouroubali. Materialization of Regional Health Information Networks in Greece: Electronic Health Record Barriers & Enablers, 2012. L Esterle, A Kouroubali. Political and organizational factors influencing large scale implementation of electronic health records: Recommendations for a realistic plan. Report of the European Project EHRImplement. http://www.ehr-implement.eu/, 2010. A Kouroubali, L Esterle, G De Moor, M Bruun-Rasmussen. Large Scale EHR- implementations: The Other Side of the Story: Social, Organizational & Cultural Aspects. MEDINFO 2010. September 13-16, Cape Town, South Africa. H Papagiannakis, S Ntoa, M Antona, C Stephanidis. Learning by Playing in an Ambient Intelligent Playfield. In J Bravo, D Lopez-de-Ipina, F Moya (Eds.), Proceedings of the 6th International Conference on Ubiquitous Computing & Ambient Intelligence (UCAmI 2012), Vitoria-Gasteiz, Spain, 3-5 December (pp.486-498). Berlin Heidelberg: Springer (LNCS: 7656). A Mourouzis, A Leonidis, M Foukarakis, M Antona, N Maglaveras. A novel design approach for multi-device adaptable user interfaces: concepts, methods and examples. In C. Stephanidis (Ed.), Universal Access in Human-Computer Interaction. Design for All and eInclusion - Volume 5 of the combined Proceedings of the 14th International Conference on Human-Computer Interaction (HCI International 2011), Orlando, FL, USA, 914 July, pp. 400-309. Berlin Heidelberg: Lecture Notes in Computer Science Series of Springer. N Partarakis, C Doulgeraki, M Antona, C Stephanidis. The Development of Web-based Services. In G. Salvendy & W. Karwowski (Eds), Introduction to Service Engineering (pp. 502-532). Hoboken, NJ, USA: John Wiley, 2010.
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Partner n.2: Dedalus S.p.A. – DEDA (Italy) Brief Description Dedalus S.p.A. is a big enterprise active in the Healthcare ICT sector, with almost 30 years of experience in providing innovative solutions to support the always increasing requirements of a continuously changing context such as the e-Health. Established in Florence in 1990, Dedalus is today at the head of a leading national healthcare software industrial Group, with many important roles in all public and private health market segments, a sector that has a strategic importance for the national economy. Dedalus mission is to improve quality and access to clinical and health services by offering specific services and solutions to healthcare professionals, to healthcare expense managers and to service providers (hospitals, health centers, cure houses, diagnostic centers). Dedalus activities started in the early 80s following an intuition: the introduction of ICT in the health system could have been the way to guarantee excellent results both in terms of quality optimization of the healthcare processes and in terms of savings. The strategy adopted to rapidly acquire advanced competencies in the eHealth sector was an acquisition and merger process involving the best Italian players, which helped Dedalus becoming the reference company in this sector. Technology evolution, introduction of data transmission and improvements of medical-informatics culture are, in the Dedalus vision, the best starting points to allow the qualitative leap that the healthcare system certainly needs. Dedalus has also a proven experience in R&D projects. In particular, the R&D Division of Dedalus inherits the research and development experience of Synapsis S.r.l., established in 1996 in Livorno as a spin-off company of the Scuola Superiore Sant’Anna of Pisa. Thanks to this experience, Dedalus has nowadays a strong scientific activity, with a solid network of partnership with both industrial and scientific national and international collaborations. The technical and scientific expertise of the computer scientists in the R&D Division has been achieved through the participation to many national and European funded projects and technology transfer initiatives, starting from the III Framework Programme of the European Commission. Role in the project and previous relevant experience Dedalus is the leader participant for the activities carried out within the WP4 - End-users services for supporting COPD care programmes. Dedalus has a consolidated experience concerning interoperability among web-based services and SOA platforms, as well as concerning standards and standard compliancy being member of HL7 Italia and having certified its own products against several IHE standard profiles. Moreover, Dedalus is involved in the HSSP initiative with both an Italian project, HEALTHSOAF-A Service Oriented Architecture Framework for the Healthcare, and an European project co-funded by the EC in the context of the FP7, MIDAS-Model and Inference Driven, Automated testing of Services architectures, of which Dedalus is Coordinator. From a technological point of view, the role of Dedalus within the SKIPPER project is to define, realize and coordinate the development of the end-user services. The Healthcare sector represents nowadays a critical as well as vital domain, and each clinical and/or administrative act is the result of complex processes involving several heterogeneous actors. From a technological and business point of view the SOA approach represents a significant opportunity. In this context, Dedalus can provide its experience in developing and distributing innovative healthcare solutions within both public and private scenarios; Dedalus will contribute to the identification of the functional requirements and the evaluation of the SKIPPER framework architecture in terms of technological needs for evolving existing business solutions to the requirements of the platform of services. Furthermore, Dedalus will be involved in the integration and interoperability of the SKIPPER services on the SaaS platform, as well as in the setting up of the pilots thanks to the tight collaboration with local healthcare governmental bodies.
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Being a large enterprise active in both nation and international markets, Dedalus will contribute to economic impact analysis and to the definition of potential business models for the exploitation of the project achievements. Key Personnel Professional CVs Dr. Marco Bechini ([email protected]) is the managing director of the R&D Division of the Dedalus S.p.A. and responsible of the company Offers Department. He is CEO of the following enterprices controlled by Dedalus: Dedalus Clinic S.r.l. (IT clinical solutions), HIM.IT S.r.l. (telemedicine solutions). From 1999 to 2006 he was Sales Manager for Siemens S.p.A. Medical Solutions, with the roles of commercial manager for the Italian eHealth market, product and services manager for the healthcare solutions, project manager of the relevant project on the Diagnostic though Images of the Tuscany Region (54 Million euros). From 2006 to 2009 he was executive manager of Fujifilm Medical System S.p.A. with the roles of Department Director of the Healthcare Information Technology Division, Profit & Loss Responsabile, special Prosecutor, Technical Director and Responsabile for Marketing & Knowledge, Products, Solutions and eHealth Services. He was member of the International Engineering Committee of Siemens AG from 2002 to 2006, member of the IHE (Integrated Healthcare Enterprise) Italia Committee from 2001 to 2004, Member of several international R&D groups of Siemens AG from 2000 to 2006. He is the author of several scientific papers and, at present, he is involved in several European projects mainly in the field of the e-health. Dr. Davide Guerri ([email protected]) is a senior software engineer of Dedalus S.p.A., coordinator of the R&D Division of Dedalus S.p.A. Graduated in Computer Science at the University of Pisa with full marks and honours, he got his specialisation in High Perfomance Computing (HPC) with an I.N.F.N. (Istituto Nazionale di Fisica Nucleare) Grant for research and development within the PQE2000 project. From 1996 to 1999, he’s been collaborating with the “parallel architecture” team of Department of Computer Science of Pisa, co-ordinated by Prof. Marco Vanneschi, in the context of PQE2000 Project, funding by QSW (Quadrics Supercomputing World), a Company of Alenia Spazio. He participated then to the national R&D and technology transfer project ASI-PQE for the development of Earth observation applications using HPC systems and tools, funding by ASI (Agenzia Spaziale Italiana) within the COSMO-SkyMed program. Currently, as coordinator of the R&D Division of Dedalus, he is managing and participating to proposals of several national and international R&D and technology transfer projects in the applicative areas space, biomedical informatics, domotics and telematics and in the technology sectors high perfomance computing, telemedicine and intelligent computing. Dr. Sergio Di Bona ([email protected]) is a senior software engineer of Dedalus S.p.A., Project Manager of the R&D Division of Dedalus S.p.A. He obtained his Ph.D. honours degree in Computer Science at the University of Pisa in 2002. He performed his doctorate researches within a scientific collaboration with the Italian National Research Council, the Bavarian Research Center for Knowledge Based Systems of Erlangen (Forwiss) and with the Chair of Pattern Recognition at the Friedrich-Alexander-University of Erlangen-Nurenberg, working in the field of three-dimensional image segmentation and classification. He is now Project Manager of the R&D Division of Dedalus S.p.A., being in charge of both national and international research projects, and associate researcher at the Institute of Information Science and Technologies of the Italian National Research Council of Pisa (ISTI-CNR). His main interests include image understanding and pattern recognition, neural network applications in computer vision, 3D modelling and deformation analysis in the field of Medical Imaging, Data Mining and Knowledge Discovery processes, biomedical informatics, domotics and telematics, telemedicine and intelligent computing. He is the author of several scientific papers and, at present, he is involved in several European projects mainly in the field of the e-health.
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M.Sc. Marco Lettere ([email protected]) is a R&D senior software engineer at Dedalus SpA since the acquisition of Synapsis Srl where he formerly was employed as technical leader. He graduated in Computer Science at the University of Pisa in 2001. From 2001 to 2002, he's been collaborating with the “Parallel Architectures” team coordinated by Prof. Marco Vanneschi. During his working period he acquired know-how in several computer science branches like parallel and high performance computing, system and application integration, web and Rich Internet applications, robotic control, geo-spatial and environmental software development. This know-how has been built through the participation of several breaking through EU and Italian projects like ASI-PQE2000, GoodFood, Heartfaid, Dustbot and Hydronet. He also actively participated in the publication of several technical and scientific papers about the subjects of his work at major conferences like Europar2004, AIIA2005, IHIC2008 and ICRA2010.
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Partner n.3: Consiglio Nazionale delle Ricerche - CNR (Italy) Brief Description The Italian National Research Council (CNR) is the main public research organisation of Italy, whose aim is to perform, promote, spread, transfer and improve research activities in the main sectors of knowledge. The CNR consists of about 100 different research institutes that span from human sciences to engineering sciences. In Skipper, two CNR units are involved belonging to the Istitute of Information Science and Technologies (ISTI) and to the Institute of Informatics and Telematics (IIT), which are two of the main ICT institutes of the CNR. Both institutes are located in Pisa. The ISTI unit is lead by the “Signals & Images” Lab, a research group working in the fields of signal acquisition and processing, image understanding, artificial intelligence, medical imaging, knowledge representation and modelling, high performance and distributed computing. The general goal of the Lab is to increase the knowledge in the above mentioned fields, in both theoretical and applicative contexts. This is achieved by studying and developing models, computer-based methods and machines for the formation, elaboration, analysis and recognition of images and signals, and by applying these methods and techniques to several sectors of the public and private society having strategic, scientific and technological interests. Around 30 people are working at the SI Lab, both researchers and technologists and engineers, covering expertise in computers science, engineering, physics and mathematics. The lab aims at developing its activities dynamically, fully becoming a part of the national and international, academic and industrial network in the field of automated vision and information technologies. The Lab has actively participated in several EU projects from the 80’s (both as partner and coordinator) (BRITE, ESPRIT, CRAFT, INTAS, FP4, 5, 6 and 7). During the last years, the Lab has been involved in three projects related to the provision of decision support services, namely FP6 Heartfaid, FP7 Chronious (www.chronious.eu/) and FP7 Argomarine (www.argomarine.eu). In connection with these activities, the Lab has gained strong expertise in designing, developing, integrating and validating decision support systems for disparate applicative contexts. In particular, in Chronious, decision support services were developed for the provision of personalized health system monitoring in the COPD and Renal Insufficiency domain. In addition, methods for medical-clinical knowledge representation, formalization and authoring have been studied and are current research fields of the lab. Great attention has always been paid to interoperability and semantic web technologies, also actively participating to W3C initiatives. Other core activities of the Lab include information systems, sensor networks for home and environmental monitoring, as well as interactive multimedia environments for rehabilitation and education. The IIT unit is lead by the “security group” which runs research and development activities in security for the future Internet. The group consists of about 20 people, including researchers, Ph.D. students, and software engineers. The group has a significant expertise on formal models for security and trust, secure software engineering, data sharing agreements, language-based security, access and usage control for distributed and mobile systems (e.g. Grid, Cloud and mobile devices such as smatphones and PDAs), security metrics and risk management. The group is currently leading the FP7 funded project: Network of Excellence of Engineering Secure Software and Systems (NESSoS). Moreover, the group coordinates the CNR Interdepartmental Security Project, for the prevention of actions that may be harmful to society, humans, and organizations in Italy, with special emphasis to cyber security and critical infrastructure protection. Also, they lead the technological platform for national security (SERIT, SEcurity Research in ITaly). The researchers of the group are (or have been) involved, with several roles, in European projects: NESSoS, Aniketos, Connect, Contrail, SESAMO, Consequence, Bionets, Sensoria, S3MS, GridTrust, ARTIST2. Moreover, some researchers are also involved in a national project funded by the Department for the digitization of public administration and technological innovation of the Italian Government concerning ehealth, OpenInFSE, where they are studing the security aspects of the Electronic Health Record in the Italian healthcare system scenario. Proposal Part B
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Role in the project and previous relevant experience The ISTI unit will mainly contribute to the activities of WP5 and will lead the design of the decision support service architecture. In particular, a strategy controller and a meta knowledge base consisting of procedural rules will be studied and designed with the goals of best orchestrating all the computation resources available in Skipper decision support services. The strategy controller, endowed with a suitable knowledge editor, will also facilitate the integration of new services, making the DSS more reconfigurable, extensible and suitable for deployment on SaaS architecture. The IIT unit will contribute to the activities of WP3 where it will participate to the design of the architecture of the SKIPPER platform by designing the security support. In particular, a proper authentication and authorization support will be designed, taking into account the security requirements collected by the use cases. Security of communications and storage will also be addressed. Moreover, the IIT unit will participate also in T4.5 for what concerns the implementation of the security support of the SKIPPER services. Key Personnel Professional CVs Sara Colantonio M.Sc. (Hons.) in Computer Science and Ph.D. in Information Engineering from the University of Pisa, Italy, researcher at SI-Lab, ISTI-CNR. In 2004 and 2006, she received a grant from Finmeccanica for studies in the field of image categorization with applications in medicine and quality control. Her research interests include machine learning, image understanding and decision support theory. She is co-author of more than 50 scientific papers and co-editor of a special issue on “Intelligent signal and image processing in eHealth.” She is currently involved in a number of European research projects regarding image mining, information technology, and clinical and environmental decision support systems. Fabio Martinelli received his M.Sc. in 1994 and his Ph.D. 1999. He is currently a senior researcher at IITCNR, and he coordinates the CNR Interdepartmental Security Project. He is co-author of more than one hundred scientific papers. His main research interests involve security and privacy in distributed and mobile systems and foundations of security and trust. He usually teaches at graduate level courses in computer security. He is involved in several Steering Committees of international conferences, workshops, and working groups, like the ERCIM STM WG. He usually manages R&D projects on information and communication security. Fabio Martinelli is the coordinator of the EU FP7-NoE NESSoS on Engineering Secure Future Internet Services, and he is (has been ) involved in many other European and Italian projects, such as Aniketos, Contrail, Connect, and Consequence, S3MS, and GridTrust. Paolo Mori received his M.Sc. in Computer Science from the University of Pisa in 1998, and his Ph.D. in Computer Science from the same University in 2003. He is currently a researcher of IIT-CNR, and where leads the Trustworthy and Secure Future Internet module. He is co-author of more than 50 papers on international journals and conference/workshop proceedings. His main research interests involve high performance computing and security in distributed and mobile systems, such as Grid and Cloud. He is (has been) involved in European and Italian projects on information and communication security concerning access and usage control in Grid, Cloud, and in the Italian healthcare system scenario, such as NESSoS, Contrail, S3MS, GridTrust, and OpenINFSE. Davide Moroni, M.Sc. in Mathematics honours degree from the University of Pisa in 2001, dipl. at the Scuola Normale Superiore of Pisa in 2002, Ph.D. in Mathematics at the University of Rome 'La Sapienza’ in 2006, is a researcher at the ISTI-CNR. His main interests include geometric modelling, computational topology, image processing, medical imaging and pattern recognition. At present he is involved in a number of European research projects working in discrete geometry and scene analysis. He is co-author of more than 30 scientific papers.
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Marinella Petrocchi received her M.Sc. in 1999 and her Ph.D. in 2005 from the University of Pisa. She is a researcher at IIT-CNR. Her main research interests include formal models for security and trust analysis, data sharing analysis in service oriented architectures, and aspects of trust in social networks. She coauthored several papers on international journals and conference/workshop proceedings, and she is (has been) involved in some European and Italian projects on information and communication security, such as NESSoS, Connect, and Consequence, Bionets and Sensoria. Ovidio Salvetti, Director of Research at the Institute of Information Science and Technologies (ISTI) of the National Research Council of Italy (CNR), in Pisa, is working in the fields of image analysis and understanding, multimedia information systems, spatial modelling and intelligent processes in computer vision and information technology. He is co-author of four books and monographs and more than three hundreds technical and scientific articles and also owner of ten patents regarding systems and software tools for real-time signal and image acquisition and processing. He has been scientific coordinator of several National and European research and industrial projects, in collaboration with Italian and foreign research groups, in the fields of computer vision, multimedia semantics and high-performance computing for diagnostic imaging. Member of the Editorial Boards of the International Journals Pattern Recognition and Image Analysis and Forensic Computer Science, of IEEE and of the Steering Committee of a number of EU Projects. He is Head of the ISTI 'Signals and Images' Lab.
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Partner n.4: FRAUNHOFER FOKUS – FRAUNHOFER (Germany) Brief Description Fraunhofer-Gesellschaft is Germany‘s leading organization for applied research. The Fraunhofer Institute for Open Communication Systems (FOKUS) participating in this project conducts research in e-health, model-driven engineering and quality assurance, communication technologies, intelligent multimedia, and embedded and automotive systems. FOKUS maintains cooperation with a large number of national and international industrial partners (e.g. Deutsche Telekom, Hitachi, NTT Data, NTT DoCoMo, Daimler, Microsoft, Nokia, Eutelsat, Motorola, Samsung, Siemens), and participates in international research programmes (e.g. of the European Commission, European Space Agency, Eureka/ITEA, Eureka/CELTIC) as well as in national R&D programmes. Fraunhofer FOKUS develops holistic platforms and solutions for a future oriented healthcare system in order to involve all players in healthcare processes – from patients to physicians, up to hospitals, nursing staff and physiotherapists. The E-HEALTH Competence Center at Fraunhofer FOKUS contributes the concept of cross-sector solutions for a more efficient information exchange for physicians. For example Fraunhofer FOKUS specified and tested the implementation of electronic case records (eCR), which is being supported on behalf of numerous hospitals and clinics as well as the German Hospital Association and is recently leading the R&D activities for a German national PHR infrastructure. Within the European epSOS LSP Fraunhofer FOKUS is responsible for the work package on architecture, design and components specification and is leading the epSOS Security Expert Group. In the application area of Ambient assisted living (AAL) the main focus of Fraunhofer FOKUS lies on the development of new ICT solutions for patient guidance and monitoring as well as their integration into existing documentation systems. Within the projects SmartSenior and MyRehab several applications for activation and rehabilitation of elderly people at home have been implemented. The eHealth interoperability lab of Fraunhofer FOKUS is the research partner for testing in the SKIPPER project accomplishing functional tests as interoperability, conformance and security tests. The eHealth interoperability lab is part of the Competence Center “Modeling and Testing for System and Service Solutions” (MOTION), which provides processes, methods and tools to enable a continuous end-to-end approach in the development and testing of software systems and services from design models through testing to operation. The Competence Center MOTION is developing general and domain-specific test solutions for functional tests including conformance tests and interoperability tests as well as system tests and acceptance tests. The eHealth Interoperability Lab provides the operators and developers of eHealth systems as well as processes with the possibility to test the efficiency of new applications and communication infrastructures. Further, they are enabled to assure their interoperability with other systems even before they are offered as a product on the market or before their first use. In addition, the experts of Fraunhofer FOKUS provide the suppliers of ICT systems in the healthcare sector with the opportunity to analyze the conformance and interoperability of new or existing systems and to automate the testing of these systems Role in the project and previous relevant experience In the SKIPPER project Fraunhofer FOKUS will contribute to: • SKIPPER architecture and design (WP3): Fraunhofer FOKUS has long years of experience in serviceoriented architectures in healthcare and managed many successful national projects in this domain (e.g. electronic Case Records which are operational in different health networks around Germany and the German PHR which will be piloted within two Germane areas in 2013). FOKUS had been among the first to integrate new standards such as RLUS and CTS-2 into eHealthcare solutions and therefore a special focus of the Fraunhofer contribution will be on the profiling of existing international standards. • SKIPPER End User Services (WP4): Fraunhofer FOKUS will participate in the design and implementation of patient-centric end user services on top of existing PHR solutions. The basis for Proposal Part B
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the contribution will be the running R&D PHR prototype for the German national healthcare infrastructure. SKIPPER Devices Network Infrastructure (WP6): Fraunhofer FOKUS will contribute to this WP by the integration of wearable sensors into a body area sensor network that can be connected to the SKIPPER monitoring services. In addition Fraunhofer FOKUS will lead the task on sensor data normalization and calibration where existing experiences from other projects (SmartSenior, MyReHA) will be provided to the project. Integration and Testing of SKIPPER Services (WP7): Fraunhofer FOKUS will have the lead of WP7. We will verify the compatibility of the services and the platform by interoperability tests. Furthermore, FOKUS will develop security tests in order to increase the trust into this platform.
The role of the eHealth interoperability lab within the SKIPPER project is to contribute to the development of an interoperability testing methodology and its realization concepts for addressing SOA services from technological and business point of view and apply it in particular to Healthcare Information Systems. In this context, the eHealth interoperability lab will design and apply a TTCN-3 based testing framework in the medical domain in order to achieve a collaborative and sustainable exchange of patient records and data. Additionally, a second building block of the eHealth interoperability labs contribution to SKIPPER project will go into the direction of security. Security is one of the prime concerns for Healthcare Information Systems. Healthcare IT applications running in SOA/WebService environments do require a secure infrastructure that should be subject of security testing. Fuzzing is a security testing approach based on injecting invalid or random inputs into a program in order to obtain an unexpected behavior and identify errors and potential vulnerabilities. Key Personnel Professional CVs Dr. Jörg Caumanns, Head of E-HEALTH Competence Center: After receiving a diploma in computer science from the Technical University Berlin Jörg Caumanns started working at the Free University of Berlin where he designed and implemented various interactive eLearning environments. In 2000 he received a PhD from the Technical University of Cottbus for his studies about the automated generation of adaptive multimedia textbooks. In the same year he took an offer from the Fraunhofer-Institute for Software and Systems Engineering (ISST) for establishing an eLearning department within the institute. In 2007 Jörg Caumanns took over the department on Secure Business-IT Infrastructures where he developed the eHealth domain as a new business segment. After the integration of Fraunhofer ISST Berlin into the Fraunhofer-Institute for Open Communication Systems (FOKUS) in 2012 he became the head of the newly founded eHealth department at Fraunhofer FOKUS (30+ staff). The major research interests of Jörg Caumanns are on platforms and solutions for cross-enterprise health data sharing, with a strong focus on issues related to patient privacy, data security and semantic interoperability. Jörg Caumanns is member of IHE International and the co-editor of an IHE White Paper (Access Control) and an IHE Profile (Cross-Community Fetch). He is project manager of the German national R&D project for the design of a nation-wide patient record infrastructure and involved in the European epSOS Large Scale Pilot as the work package leader for the epSOS architecture, design and technical specification. Andreas Hoffmann has received his Master's degree in Computer Science from the Humboldt University of Berlin in 1997. Before graduating he was a member of a project team developing design tools for distributed applications at Fraunhofer FOKUS. Since 1997 he has been working as a researcher at Fraunhofer FOKUS in the area of modeling, deploying, testing and benchmarking distributed systems. He is experienced in model driven architecture (MDA), test methods including model based testing (MBT) and test extensions for MDA, test process optimization, and conformance and interoperability testing. He led many projects and work packages in many national and international research and industrial projects. Some of the major projects were conducted in cooperation with Microsoft, Intel, IBM, ESA, Deutsche Telekom, Siemens, Nokia Siemens Networks and German ministries. Currently, he is he is leading the Proposal Part B
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eHealth interoperability lab and is involved in the development of interoperability testing and model-based testing approaches for complex software systems. Andreas Hoffmann is an active member of several standardization bodies. At OMG, he initiated and led the standardization task forces for deployment and configuration of component-based distributed systems and supports the standardization of the UML Testing Profile (UTP). At ITU he was involved in standardization activities of ITU-ODL, eODL and SDL. At ETSI TISPAN he supported the standardization of IMS benchmarking and MBT methods. Between 2002 and 2004, he was the deputy head of the competence center for Testing, Interoperability and Performance. From 2005 to 2009, he was heading the Test Solutions group at FOKUS. In 2010, he became deputy head of the modeling and testing competence center of FOKUS. Dr. Christian John studied Economic Mathematics at the Technical University of Berlin and got his diploma in 2007. After his graduation he has worked as a scientific assistant at the TU Berlin (SFB 557, “Control of complex turbulent shear flows”) for three years. During this time he did research on the theoretical background and numerical computation of mathematical optimization problems based on partial differential equations and model reduction (POD, ROM) of complex systems. At the end of the following Doctoral scholarship (FAZIT-Stiftung) in 2011 he did his PhD on “Optimal Dirichlet boundary control problems of high-lift configurations with control and integral state constraints". After he has worked as a software developer for web applications for one year, he started his career as a researcher at Fraunhofer FOKUS in July 2012. Currently, he is developing interoperability tests for HL7 and several IHE profiles for the eHealth interoperability lab.
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Partner n.5: INNOVA Technology Transfer & Valorisation Ltd - INNOVA (United Kingdom) Brief Description INNOVA Technology Transfer & Valorisation Ltd (IUK) (http://innova-eu.co.uk/) is a business support agency specialised in delivering public sector contracts and research projects, based in London, England. The company is part of Innova group, established in 1993 and covering a broad geographical area in Europe and in the United States. The organisation is focusing its efforts on core organisational competencies before following a carefully structured growth plan. Current work and key skills are centred around ICT innovation, Innovation policy studies, R&D project management and dissemination, technology brokerage and the mobilisation of an international network of experts. Our experts, both in house and external, are capable of a wide range of specialities and command an extensive list of languages. INNOVA assists industrial and research organisations in the implementation of their innovation strategies for the assessment and exploitation of advanced technologies and the valorisation of R&D results; it provides consultancy services to qualified European companies, to leading research centres and universities and to the European Commission for the development and exploitation of innovative solutions to improve processes, products, management and organisational structures. Since 1998 INNOVA group is involved in the coordination of the Innovation Relay Centers (IRCs), the largest TT Network in the world. Since 2004, INNOVA coordinates the IRE Secretariat, the Coordination Unit of the Innovating Regions in Europe for the valorisation of regional experiences and innovation practices. In addition, since 1996 INNOVA has a great experience in managing European research projects having promoted, managed and participated to over 200 EC funded projects. Listed below there are some relevant European-funded projects in the area of IST and international co-operation INNOVA participates or has participated: BEINGRID, SOLAR-ICT, HYDRA, EU-Domain, ICT Cluster priority assessment and project identification, IST-Mentor, BASiC, Tristan-East, ECOSELL, GO4IT, SINC-PRO The individuals employed by the organisation are highly skilled and well known individuals, with strong experience of work of this nature. In particular, within the ICT area expertise in knowledge management, Semantic Web Services (SWS), requirements engineering, validation and exploitation activities are present in the company. Role in the project and previous relevant experience INNOVA is leader of WP9: “Economic impacts, organizational models and business exploitation”, as the Enterprise holds a long experience in knowledge and technology transfer as well as Market analysis and Business Plans. Easy access to R&D institutions, internal investment in R&D and constant support to University/Industry bridging initiatives are the visible indications of INNOVA commitment to Technology Transfer and Innovation, its main priority and mission. So far, over 2,000 European companies and development agencies/Universities benefited from INNOVA services in project development, management, technology transfer and support in the innovation process in general. In particular, it provides consultancy services to highly qualified European companies (Aventis, Natuzzi Industries, IFREMER, Telecom Italia, Praxair), to leading research centres and universities (Fraunhofer, JRC, CSM, TNO, ENEA, Alenia, Pôle Leonardo da Vinci, University of Cambridge) and to the European Commission for the development and exploitation of innovative solutions to improve processes, products and management and organisation structures and to Governmental representatives. Moreover, Innova carried out business plans in several relevant European co-funded projects and international co-operation, such as In-CASA, INTRAREGIO, HYDRA, SOA4All, BEinGRID, SOLAR-ICT. Moreover, INNOVA provides support in different SKIPPER activities, especially within WP2- “Clinical domain and care models definition”, WP5- “Knowledge management and Decision support core services”. INNOVA, particularly individuals working in ICT area, have been actively involved in user requirements, validation tasks, knowledge management activities, for EU co-funded projects, as DIP, SUPER, LHDL, inCASA, some of them operating within e-health domain. Key Personnel Professional CVs Proposal Part B
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Eng. Osvaldo Summaria, has a degree in Engineering Management at the Università della Calabria (2004). In 2005 attended a master degree in "Knowledge Engineering" at Centro di Ingegneria Economica e Sociale (CIES). Since 2006 is a consultant for Innova Group in ICT area, working on several European and Italian R&D projects, ICT, security fields. In current FP7 he is working on SecureCHAINS project (SA, 2010): “Integration of Security Technology Supply Chains and identification of weaknesses and untapped potential”. In the past he has been involved in different EU research projects (INTRAREGIO, eFESTO), or national frameworks, CRESCITA, Icona, INLOCO, where he dealt especially with market analysis, business modelling, and validation. Dr. Alessio Gugliotta holds a Ph.D. in Computer Science from the University of Udine (Italy). Since January 2009, he is a consultant for Innova Group in ICT sector, working on European R&D projects. He carried out an intense research activity in the area of Knowledge Modelling and Representation, Service Oriented Architectures, Semantic Web Services and their application within multiple domains, such as e-Government and e-Learning. His works has been published throughout major conferences, journals and workshops in the area of Semantic Web, Web Services and SOA. He has previously worked in EU IPs DIP, SUPER, SOA4All, HYDRA, COMPOSE, and EU STREP LUISA, and he is currently involved in a EU PSP-ICT INCASA. Dr. Stefania Galizia has a master’s degree in Mathematics and a PhD in Mathematics and Computer Science, both from University of Calabria (Italy). From 2004 to 2009 she has been a Researcher at the Knowledge Media Institute, The Open University (UK). Currently she has a position at INNOVA, in the ICT area. Her research interests include Knowledge representation, reasoning by logic formalisms, ontologies and semantic Web; particularly, her research activity concerns Semantic Web Services choreography and trust modeling. She published several papers on international journals and conferences, and has been involved in a number of EU research projects (e.g. ICONS, DIP, LHDL, inCASA, VALUE-AGEING, COMPOSE) where she mainly dealt with SWS communication patterns and applications to different domains such as biomedical data management, user requirements, validation, business modelling.
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Partner n.6: Simple Engineering France – SEF (France) Brief Description Simple Engineering (www.simple-eng.com) is a European group of micro-firms focused on Service Oriented Architecture model-driven design and testing. Simple Engineering France is a subsidiary of the group, specialized in research and development activities. The Simple Engineering group: •
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operates as an architecture & engineering firm and provides a complete range of professional services - advising, planning, analysis, design, requirement definition, capacity planning, service implementation, test, validation, verification, governance, audit and assessment of SOAs for the healthcare, government, transportation, manufacturing sectors; has developed simpleSOA™ (formerly simpleSOAD®), a complete, detailed and proven methodological framework for analysis, requirement definition, design, implementation and test of SOAs, based on a model-driven approach; runs an architecture & engineering school, providing education, tutoring and technology transfer to companies and administrations and grants commercial licenses of the simpleSOA™ methodological framework to certified companies and professionals; manages an architecture & engineering Lab and provides deployment, configuration, consulting, support services on COTS (Commercial off-the-shelf) and FOSS (Free Open Source Software) SOA technological infrastructure frameworks; provides support and consulting services on Test and Test Control Notation (TTCN-3) - grants licences of TTworkbench (the TTCN-3 engine licensed by Testing Technologies) – supplies TTCN4SOA, a TTCN-3 framework for SOA testing; is specialized in healthcare services architecture standards and is involved in ongoing international standardization programs (HL7/OMG Healthcare Services Specification Program - HSSP); participates to national and European research programs on SOA for healthcare and on methods and tools for model-driven design and model-based automated testing of services architectures, in cooperation with prestigious European universities, research centres and innovative companies.
Simple Engineering is member of HL7. simpleSOAD® is a Registered trademark of Simple Engineering. simpleSOA™ is a trademark claimed by Simple Engineering (ongoing registration). Role in the project and previous relevant experience Simple Engineering France is the coordinator of the SKIPPER WP3 (“Architecture of the SKIPPER platform of services”). It will lead (and supply methodological support to) the model-driven design of the SKIPPER generic services architecture for chronic comorbidities care, the SKIPPER services architecture for COPD & comorbidities profile, and the SKIPPER service components framework. Simple Engineering France is also strongly involved in the SKIPPER WP7-T7.3 (“Integration, interoperability and security testing of the SKIPPER platform of services”) where it will design, with the support of the outcomes of the MIDAS project, the interoperability and conformance testing framework for the SKIPPER added-value standard services (e.g. HSSP CCS) for the generic SKIPPER platform and for the COPD & comorbidities. Simple Engineering France is also concerned by the SKIPPER WP8 (“Evaluation and validation of the SKIPPER solution: the pilots”), WP9 (“Economic impacts, organizational models and business exploitation”) and WP10 (“Dissemination, collaboration and standardization”). The Simple Engineering group has been and is currently involved in the following research projects: Proposal Part B
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BN4SAT – Bayesian Networks for Services Architecture Testing - partially funded by the French Association Nationale de la Recherche et de la Technologie (ANRT) – in cooperation with the Laboratoire d’Informatique de Paris VI - research and development on the application of probabilistic inference (Bayesian networks) to the scheduling of SOA testing campaigns. HealthSOAF – Healthcare Service Oriented Architecture Framework - Italian national research project (PON_02934) – partially funded by the Italian Ministry of Reseach – main partners: Almaviva S.p.A, Dedalus S.p.A., University of Calabria (UNICAL) - research and development of a complete healthcare services suite compliant with the HL7/OMG Healthcare Services Specification Program (HSSP) standards – the HealthSOAF service suite is is the supporting basis of a pilot implementing the integrated clinical management of cephalalgic and migraine patients (chronic disease). MIDAS – Model and Inference Driven, Automated testing of Services architectures – FP7-ICT-2012-8 project n°318786, partially funded by the European Commission – research and development of a framework and platform on cloud for the automation of all the SOA testing activities – test case and oracle generation, test execution, test evaluation and scheduling – by a testing tool available as Software as a Service on cloud.
Key Personnel Professional CVs Libero Maesano is Founder & Managing Partner of Simple Engineering and CEO of Simple Engineering France. He has more than thirty years of experience in research, development, consulting and management of high technology firms in France and Italy. His research interests span the areas of software engineering, knowledge engineering, operating systems, intelligent systems, industrial systems, distributed systems. He worked at the Bull Research Center and at the Bull Artificial Intelligence Research and Development Center. He is the author of over fifty international communications and articles and the first author of a volume on Web services technologies (Maesano L. et al., Services Web in J2EE et .NET, Eyrolles Paris 2003) considered as a reference book on the subject. He is the author of the SOA analysis and design methodology simpleSOA™ (formerly simpleSOAD®). He was appointed as associated teacher at the Conservatoire National des Arts et Metiers (Paris), the University of Pierre et Marie Curie (Paris VI), the University of Milan Bicocca. Currently, he is associated professor of "Model Driven Engineering of Service Oriented Architectures" at the Engineering School Leonard de Vinci (ESILV - Paris - La Defense), one of the France's top ten engineering schools. He is also the editorial director of the series "Software Architect" at Editions Eyrolles (Paris). He is the coordinator of the MIDAS project WP1 (“SOA testing framework architecture”). Fabio De Rosa has got a PhD in Computer Science at the University La Sapienza (Rome (I) - Over 10 years of experience in research, design and development of IT (distributed) system, he has acquired competences on different enterprise and methodological frameworks (RUP, OMT™, Zachman, ecc. – NAF only theoretical knowledge), languages (SBVR, UML™, TTCN-3, ...) and tools about distributed system and network architecture design, development and testing, and skills on a range of proprietary and open source components and products on different technological platforms (i.e., XML/WS-*, .NET, Java EE, LAMP, ...) that support Enterprise Integration Architecture (he is an official trainer of ORACLE SOA Suite 10g and 11g for Oracle University Italia). He is co-author of the Simple Engineering methodological framework simpleSOA™ (formerly simpleSOAD©). Recently, he has actively participated to the Health Level Seven (HL7) - Italian Chapter - standardization process of the digital signature of clinical documents (CDA2 - in PDF/XML format). In particular, he has been involved, with ADOBE™, and Lombardia Informatica (Italy) the main standard proponent - in the successful proof of concept about interoperable exchange of signed (standard-compliant) clinical pdf documents, and he is the author of the first programming library for standard-compliant CDA2 injection and digital signature of pdf documents. He is the chief architect of TTCN4SOA, the Simple Engineering TTCN-3 framework for SOA testing. He is involved as chief architect in the HealthSOAF research project and leads the MIDAS project WP26 T2.3 “General Architecture of the MIDAS framework”. Relevant publications Proposal Part B
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De Rosa, F., Maesano, A. P., & Maesano, L. (2012). Service contract clauses as business rules. In 24th International Conference on Software & System Engineering and their Applications (ICSSEA '12), Paris - Oct. 23-25 (2012).
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Maesano, A. P., & De Rosa, F. (2011). Towards stochastic inference driven SOA testing - bayesian networks for services architecture testing (BN4SAT). In IEEE 22nd International Symposium on Software Reliability Engineering (ISSRE 2011), Nov 29 - Dec 2, 2011 Hiroshima, Japan.
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Maesano, A. P., De Rosa, F., Maesano, L., & Wuillemin, P. H. (2011). Steps towards model-based, inferencedriven SOA testing. In 23rd International Conference on Software & System Engineering and their Applications (ICSSEA '11), Paris - Nov 29 - Dec 1 (2011).
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Maesano, L., & De Rosa, F. (2010). simpleSOAD® 2.0 - architecture & governance. In 22nd International Conference on Software & Systems Engineering and their Applications (ICSSEA 2010) - Paris Dec 7-9, 2010.
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Partner n.7: T4ALL (Italy) Brief Description T4A - Technology for All - is a start up company providing IT solutions in a widespread set of domains, including some relevant economical and social fields such as healthcare, homecare and tele-assistence for people with special needs. T4ALL is using pervasive ICT to realise a continuous assistance to ageing people and individuals affected by disabilities and/or chronic diseases, fostering independence and active life. The core business of the company lays in the design and development of innovative wireless solutions providing remote monitoring through wireless sensor networks. In this area, the company developed solutions in healthcare, info mobility, cultural heritage and, since 2008 in the environmental monitoring. T4ALL engineers own a solid background in setting up complex ICT monitoring platforms, having been involved in several R&D projects in the healthcare domain (FIDES, PRESENCE, T-SENIORITY, ...). The company has developed remote monitoring in a multi-channel approach, implementing e-health solutions on Web, IPHN and Mobile networks. T4ALL key products in healthcare are: • an innovative health-care platform, including a low cost hi-tech corner to be hosted in pharmacies, medical labs, transport stations, supermarkets, etc. to support remote monitoring of people affected by chronic diseases; • a mobile platform, fostering home assistance, telemedicine and tele-consultancy, potentially involving patients, nurses, care givers, General Practitioners and Specialists; • an innovative platform to deal with clinical risk management. T4ALL develops custom-made solutions for patient identification supporting people and assets tracking with barcode, QRcode and RF-Id technologies supporting the reduction of clinical risk in such a domain. The company is the Italian exclusive distributor of Laserband products, being Laserband the worldwide leader in wristbands for patient Identification in hospital. Being generated as a spin-off company of a University Department, T4All owns a strong expertise in evaluating market opportunities from research activities, supporting knowledge transfer into products through engineering processes. Role in the project and previous relevant experience T4ALL will be mostly involved in SKIPPER R&D activities concerned with patient remote monitoring to support chronic care. To this extent, the company will support the overall design of the general service oriented architecture along with the interoperability layer for service interoperability (WP3). In WP4 T4ALL will be engaged in the design and implementation of Telemonitoring and telecare services, supporting the definition of service features and requirements for wireless remote monitoring through portable devices. Still in service design, T4ALL will contribute to implement and integrate the network infrastructure (WP6 and Wp7) enabling the communication between sensors and devices, supporting the service evaluation in the Italian pilot (WP8). Along with other private companies, T4ALL will be partially involved in the definition of reliable exploitation plan in WP9. Key Personnel Professional CVs Giovanni Luca Daino Giovanni Luca Daino graduated in Telecommunication Engineering at University of Siena (Italy) and started his activity as IT professional, being member of the Association of Professional Engineers 24 (Province of Livorno). His main research area refers to wireless communication networks, IT service platforms, mobile services and Digital Terrestrial Television. Since 2002 he has been working as an IT consultant at University of Siena - Department of Information Engineering, in charge of Project management activities both on National R&D projects (SORRISO, DTToscana, NEMO-Infomobilità, DIGINET, SAFECARE, AMICA, MEDEA, PRIMA, RUMR, Blue Sign 3) and European ones (PALIO, MToGuide, SM-PAYSOC, EIE-SURVEYOR, SETRIC, BEACON, T-SENIORITY, RICHARD). From March 2006 to March 2008 he worked as IT consultant at Bassnet S.r.L., an Italian high tech SME, on the basis of a grant from a Public Administration, being involved in an innovative research project on Digital Proposal Part B
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Terrestrial Television (DTT) framework. In the meanwhile and on the same topics, he was involved in setting up the Tuscany Region’s Competence Centre on Digital Terrestrial Television. In 2006 he started working on Wireless Sensor Networks and, in particular, on RF-Id and Zigbee technologies applied to e-health services. After two years, on March 2008, he founded T4ALL (Technologies for All), a startup company providing E-Health and E-Inclusion solutions based on wearable sensor networks, to foster quality of life of ageing people and individuals affected by any kind of disabilities. The company is incubated in the Toscana Life Science Technological park, (http://www.toscanalifesciences.org), a foundation supporting research activities in the field of Life Sciences, fostering the development of projects from basic research to industrial applications. In T4ALL, he’s involved as Chief Executive Officer and Project manager. Riccardo Zambon Riccardo Zambon received the graduate degree and the master degree (“cum laude”) in Telecommunication Engineering at University of Siena, Italy, in 2002 and 2005 respectively. In 2009 he received the Ph.D. in Information Engineering from the same university, discussing a thesis on QoS enhancements over 802.11 networks. From 2010, he has worked as a research fellow at the Faculty of Engineering, University of Siena, where he had also teached a course on Wireless and Mobile technologies. He also assists Prof. Benelli in a course on Telecommunication Networks. He is still collaborating with University of Siena, and his current research interests are in the area of QoS for wireless environments (WiFi, WiMAX, etc..), wireless MAC protocols and multimedia communications, TCP algorithms analysis and Mobile Applications for e-inclusion and accessibility. He also collaborated in several European Projects for the Department focusing on ehealth and social inclusion for ageing people (TSENIORITY, RICHARD). Since 2010 he joined T4ALL R&D team, supporting the definition of innovative network infrastructures to foster the development on ehealth services on mobile networks. He’s actually working as R&D Manager, in charge of promoting the design and implementation of ehealth services on desktop platforms (PC and Kiosks) and mobile devices (iOS and Android).
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Partner n.8: UNIVERSITA’ DELLA CALABRIA - UNICAL (Italy) Brief Description University of Calabria (http://www.unical.it), situated in Southern Italy, was initiated in 1972. It is a medium size university with about 35,000 students. The University is organized into 14 different Departments and university staff and students are encouraged to live on campus, when accommodation is available. Teaching staff amounts to over 800 units and there are more than eighty degree courses and advanced PhD courses. Its academic and scientific achievements are remarkable and the university graduates can easily compete with those from the greatest Italian and World Universities. All departments do research at national and international level and in a number of sectors have achieved international standards. Many outside research contracts and commitments to provide scientific backup for projects in the Calabria Region are being developed together with a number of joint scientific projects with other prestigious Institutions both in Europe and in the United States of America. The University of Calabria has a good experience in Research Projects at international level, as it is confirmed by its participation (as partner or coordinator) in 25 projects funded in the framework of the FP7. Furthermore, UNICAL has a Technology Transfer Office named Liaison Office (LIO) that has specific expertise and competences concerning both Promotion and Valorisation of Research and Technology Transfer. Role in the project and previous relevant experience The research activities of the project will be mainly faced by the Laboratory on DECISION ENGINEERING FOR HEALTH CARE DELIVERY, whose scientific coordinator is Prof. Domenico Conforti. This research unit is currently working on developing models, methods and techniques for the optimal support of decision making in health care. This activity is doing in collaboration with several health care institutions. In particular, the overall activities cover the following two broad research items: Knowledge based decision support systems for medical diagnosis, prognosis and therapy - Decision support systems for health care planning and management. The contribution areas in the SKIPPER project will be mainly related to the: • analysis and systematic description and representation of the medical domain; • identification of the care processes and analysis and design of innovative clinical workflows; • development of quantitative models and methods for medical knowledge representation, discovery and management relevant for the medical domain; • design and implementation of medical decision support services; • technical support during testing of the prototype and clinical validation; • development of decision making models, methods and new approaches for health care delivery policy, organization and management; • development of models for health care services performance evaluation and cost-effectiveness analysis. Key Personnel Professional CVs The scientific responsible of UNICAL within this project is Domenico Conforti Associate Professor of Operations Research. His areas of research activities and expertise are the design and development of computational models and numerical algorithms for the solution of decision making problems. In particular, he is carrying out research activities regarding the development of decision support systems for health care and clinical problems, the development of optimization models for the effective and efficient organization and management of health care delivery, the design and development of new algorithms for the solution of large scale nonlinear stochastic programming problems. He has been and is currently involved in research projects sponsored by the National Research Council of Italy, by EC, and by Italian Ministry of Research. In particular, he has been member of the of the EC funded project called EUROMED, that proposed a webbased standard for telemedicine applications, and is currently involved in the EC funded project called COLLABORATIVE MODELS AND TECHNOLOGIES FOR SUPPORTING DISTRIBUTED HEALTH CARE SYSTEMS, Proposal Part B
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which proposes the development of a peer-to-peer platform for collaborative decision making within oncology domain, and the Italian Ministry of Research funded project called MIMERICA, on the development of intelligent environments and decision support systems for the clinical management and rehabilitation of patients affected by traumatic brain injury. He was coordinator of the FP6 ICT Strep Project named HEARTFAID, which proposed the design and develop of a knowledge based platform of services for the medical-clinical management of the heart failure within the elderly population. He is co-author of several papers in refereed journals on numerical methods for nonlinear optimization, computational engineering and parallel algorithms, and models and methods for the health care organization and management. Patrizia Beraldi is Associate Professor of Operations Research at University of Calabria. In 1999 she received the PhD in Operations Research from University of Calabria. Her main research interests are related to the field of stochastic programming and combinatorial optimization with applications to finance, energy, logistics and health care. She has been involved in many European founded research projects and she is at present the responsible of a research unit of a national founded project. She has published in a variety of international journals, including Operations Research, Networks, Optimization Methods and Software, Computers and Operations Research, European Journal of Operational Research, Parallel Computing. Maria Elena Bruni is Assistant Professor in Operations Research at the University of Calabria (Italy). She graduated in Management Engineer at the University of Calabria (summa cum Laude), and achieved a P.h.D. in Operations Research in 2005 and a Master in Health Care Mangement at the University La Sapienza, Rome (Italy) in 2002. Her research activity is mainly devoted to the development and application of stochastic programming. Her scientific activity is demonstrated by the participation to numerous workshops and conferences and by the flourishing scientific production. In this respect one of her papers has been considered the first classified in Italy for the EURO Summer Institute "OR in Health", Southampton (UK). Rosita Guido is Assistant Professor in Operations Research at the University of Calabria (Italy). She graduated in Management Engineer at the University of Calabria and achieved a P.h.D. in Operations Research in 2006. Her research activity is mainly devoted to the development and application of optimization models and methods to health care services delivery, and the development of advanced machine learning techniques for supporting medical decision making. She has been and is currently involved in many research projects, at national and international level, concerning the development of decision support services for effective and efficient health care delivery. Relevant publications •
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D. Conforti, F. Guerriero, R. Guido, "Non-Block Scheduling with Priority in Radiotherapy Treatments", European Journal of Operational Research 201 (2010) 289-296, DOI: 10.1016/j.ejor.2009.02.016 D. Conforti, R. Guido, "Kernel based Support Vector Machine via Semidefinite Programming: Application to Medical Diagnosis", Computers and Operations Research 37 (2010) 1389-1394, DOI: 10.1016/j.cor.2009.02.018 Candelieri, D. Conforti, “A Hyper-Solution Framework for SVM Classification: Application for Predicting Destabilizations in Chronic Heart Failure Patients”, The Open Medical Informatics Journal 4 (2010) 135-139, ISSN: 1874-4311 D. Lofaro, S. Maestripieri, R. Greco, T. Papalia, D. Mancuso, D. Conforti, R. Bonofiglio, “Prediction of Chronic Allograft Nephropathy using Classification Trees”, Transplantation Proceedings 42 (4) (2010) 1130-1133 , DOI: 10.1016/j.transproceed.2010.03.062 O. Kaloudi, F. Bandinelli, E. Filippucci, M.L. Conforti, I. Miniati, S. Guiducci, F. Porta, A. Candelieri, D. Conforti, G. Grassiri, W. Grassi, M. Matucci Cerinic, “High frequency ultrasound measurement of digital dermal
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thickness in systemic sclerosis”, Annals of the Rheumatic Diseases 69 (6) (2010) 1140-1143. DOI: 10.1136/ard.2009.114843 F. Riganello, A. Candelieri, M. Quintieri, D. Conforti, G. Dolce, “Heart rate variability: An index of brain processing in vegetative state? An artificial intelligence, data mining study”, Clinical Neurophysiology 121 (12) (2010) 2024-2034, DOI 10.1016/j.clinph.2010.05.010 P. Beraldi, M.E. Bruni, D. Conforti, “A Two-Stage Stochastic Model for Planning and Scheduling Operating Rooms under Uncertainty”, 6th IMA Int. Conf. on Quantitative Modelling in the Management of Healthcare, London (UK), March 29 – 31, 2010. D. Conforti, M.E. Bruni, P. Beraldi, “Scheduling Operating Rooms under Uncertainty: a Stochastic Programming Approach”, 36th ORAHS – Int. Conf. of the EURO Working Group on Operational Research Applied to Health Services, Genova (Italy), July 18 – 23, 2010. D. Conforti, F. Guerriero, R. Guido, M. Veltri, "An Optimal Decision Making Approach for the Management of Radiotherapy Patients", OR-Spectrum 33 (1) (2011) 123-148, DOI: 10.1007/s00291-009-0170-y D. Conforti, F. Guerriero, R. Guido, M. Matucci Cerinic, M.L. Conforti, “An Optimal Decision Making Model for supporting Week-Hospital Management”, Health Care Management Science 14 (2011) 74-88.
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Partner n.9: UNIVERSITY OF SIENA – Department of Information Engineering - UNISI (Italy) Brief Description University of Siena is engaged in research concerning Information Technologies (IT) for communication, learning and teaching. The activity is oriented toward the development, analysis and evaluation of IT tools. Research is funded both by the University core funds and by external sources. The group comprises competencies in Computer Science, Telematic Engineering, Telecommunication Wireless and Wired Networks, Communication Psychology, Cognitive Ergonomics. For more than ten years personnel involved have been active in issues associated with cognitive ergonomics, telematics engineering, and human factors, mainly concerning decision making, learning processes, telematic networks, human error. In the last years, the Telecommunications Research Group (TRG) of the Information Engineering Department of the University of Siena considerably grew in size and amount of research activity. The group now consists of 7 permanent members (two full professor, three associate professor, three assistant professors), two PhD. students, and several external consultants, who collaborate with the TRG on a regular basis. As a result of the augmented size of the group, the number of research topics has increased too. Research is now carried out in the fields of: • mobile communication systems; • remote sensing; • image processing and transmission; • design and development of network services; • cultural heritage and multimedia; • signal and image processing for bio-technology and biomedicine; • digital terrestrial television; • RF-Id and sensor networks. The quality of the research is witnessed by the number and quality of publications and by the numerous international and national research projects the TRG is involved in. Those are a selection of European projects where University of Siena (DII) has been involved from 2000 on: • FASME – “Facilitating Administrative Services for Mobile Europeans”, IST, 2000 – 2001. • PALIO – “Personalized Access to Local Information and services for tOurists”, IST, 2000 –2002 facilitating mobile services for tourists and citizens http://palio.dii.unisi.it/. • SM-PAYSOC – “Secure Mobile PAYments and Services on Chip”, IST, 2002 – 2004 , whose object is to develop a new generation of user-friendly and personalized information services for citizens as well as students, businessmen and bank customers accessible anywhere and anytime with any technology, realizing a mobile and trusted secure access to information services (www.smpaysoc.org) . • M-ToGuide – “Mobile tourism guide“, IST, 2002 – 2003, whose object is to implement a multidisciplinary location based tourist service, which provides profiled and filtered contents from multiple content Providers, providing the end-user with a PDA equipped with a GPS receiver and a GPRS radio system. • BEACON – “Brazilian-European Consortium for DTT Services”. Between 2007 and 2010 BEACON will develop innovative t-learning pilot services related to social inclusion in the State of Sao Paulo (Brazil) on the basis of pioneering research on interoperability between the European (DVB) and the Brazilian (SBTVD) Digital Terrestrial Television standards and the definition of a pedagogically sound methodology for distance learning through digital television. Ultimately the project will result in the establishment of a Brazilian-European Consortium that will manage the exploitation of the assets and the services implemented by the project. FP6, IST 2007-2010. Proposal Part B
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Since 2004, the Laboratory of Telecommunications and Telematics University of Siena has initiated research within the Wireless Sensor Network, with particular emphasis on its applications in the domain of health, environmental monitoring and alternative transport systems. The University of Siena has been involved in several national and regional projects on issues linked to issues of social inclusion, e-health, environmental monitoring and information systems for mobility. In particular the following European projects will represent a relevant background to be properly adopted in the SKIPPER project activities: − T-Seniority - “Expanding the benefits of Information Society to Older People through digital TV channels”. T-Seniority offers a flexible combination of citizen-centric and personalized e-Care Services according to user’s preferred or available ICT media: primarily via digital and digital interactive TV. ICT-PSP 2008-2010 Since 2003, the Department of Information Engineering has been involved in the design and development of Service infrastructure on Digital Television platform. We have been working on iTV application design and implementation, to provide interactive services in different service scenarios (learning, e-health, Tgovernment, tourism, etc.). − RICHARD – “Regional ICT based Cluster for Healthcare Applications and R&D Integration”. The RICHARD project intends to define and implement innovative models for the management of chronic conditions based on Information and Communication Technology (ICT) in four different European Regions. The scope of RICHARD is the definition of new scenarios of care and the design of innovative ICT based territorial clinical pathways that, through the use of technology and the integration of resources and capabilities of the territory, enable patients to be supported outside the hospital, guaranteeing a better quality of life. Role in the project and previous relevant experience Key Personnel Professional CVs Giuliano Benelli: Prof. Benelli received his degree in Physics from the University of Florence, Florence, Italy in 1973. In 1975, he joined the Electrical Department of the University of Florence, first with a Researcher Fell -ship and from 1981 to 1987 as a Researcher. From 1987 to 1990 he was an Associate Professor at the Engineering Department of the University of Florence, where he taught Telecommunications Systems. From 1990 to 1993, he was a Full Professor at the Electrical Department of the University of Pavia, where he taught Electrical Communications. He is currently Full Professor at the Engineering Faculty of the University of Siena, where he teaches Electrical Communications and Telecommunication Networks. Since 1994 is the head of the Computer Centre of the University of Siena. From 1999 to 2005 he has been the head of the Department of Information Engineering at the University of Siena; from2005 to 2008 he was the dean of the Engineering Faculty of the University of Siena. He coordinates the design and the development of the information services and technologies for the University of Siena. His main research interests are telecommunication networks, wireless networks and sensors, knowledge-based information engineering, development of e-services, e-government. Professor Benelli is author of about 300 publications on books, journals and international conferences.
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Partner n.10: Université Pierre et Marie Curie - UPMC (France) Brief Description Université Pierre et Marie Curie - Paris 6 (UPMC), devoted to science and medicine, is one of the largest universities in France: 4 000 researchers and teachers, 180 laboratories, 30 000 students, 700 scientific PhD delivered per year. UPMC is involved in numerous European and International partnership agreements (European research projects, international Masters, etc.). This gives access to facilities only found in the largest institutions: France's largest scientific library, scientific infrastructures facilities, large conference venues and strong intellectual environment. The EPAR (Epidemiology of Allergy and Respiratory Diseases) department at UMR-S 707 UPMC and INSERM, Medical School St-Antoine, Paris is one of the France’s leading centres for research on Epidemiology and public health of Allergic and Respiratory diseases. Role in the project and previous relevant experience UPMC will lead the WP2 and will be partner in WP8 by providing extensive experience in: • The fields related to epidemiology of COPD (description and etiology (outdoor and indoor air pollution, pollens, allergens, moulds, climate chang) and related methodology (statistical methodology, data analysis, interpretation). Quantification of human exposure to environmental factors and their allergic and respiratory impacts. Biomarkers of exposure to air pollutants and validity of biomarkers to estimate exposure (e.g. by comparing them to exposure estimates based on environmental measurements) and their association to health. • Modelling of: 1) atmospheric chemical and biological pollution exposure and related health effects. Practical experience in development and application of air pollution models for various scales and compounds – acidifying, toxic, aerosols, allergenic species, pollens moulds, etc. and the related fields – model verification, statistical methodology, data analysis, interpretation, etc.; 2) exposure to multipollutants mixture; 3) Spatial and temporal data. • Respiratory physiology. Previous Experience: EPAR has conducted several surveys in order to investigate genetic, individual, socioeconomic, and environmental (indoor and outdoor air pollution) risk factors for allergic and respiratory diseases. Project to which EPAR contributed as WP leader are : at international level the GERIE Study (Geriatric Study of health effects of air pollution in elderly people), HESE Study (Health Effects of School Environment), the HESEINT (Intervention Study in School) SINHONIE (Schools Indoor Pollution and Health: Observatory Network in Europe) and PHASE (Public Health Adaptation Strategies to Extreme weather events ) funded by EU DG-SANCO) and MedALL (Mechanisms of the Development of ALLergy) supported by EU FP7; and at the national level the FERMA Study (Facteurs environnementaux des maladies allergique et respiratoires du milieu rural), EDEN Birth Cohort Study (French cohort study on the pre and early postnatal determinants of child healthand development), EGEA Study (Epidemiological study on the Genetics and Environment of Asthma, bronchial hyperresponsiveness and atopy), ), the effects of early life environment on the development of immunity, asthma and allergy in new-borns aetiology of wheeze bronchitis (WB Study) and PID 93 (Epidemiology of interstitial diseases of the lung in 93 county). Key Personnel Professional CVs Isabella Annesi-Maesano is presently Director of the Department of Epidemiology of Allergic and Respiratory Diseases (EPAR) UMR-S 707 (http://www.epar.fr/) at the French NIH and University Pierre and Marie Curie, in Paris, France, where her team conducts research on the distribution and the aetiology of allergic and respiratory diseases. Dr Annesi-Maesano is a respiratory epidemiologist by training having obtained her PhD and DSc in Epidemiology and Public Health from the Medical School, University Paris XI in 1987, She had previously obtained a Master of Epidemiology and Public Health from the Medical School, University Paris XI in 1982 and a Master Degree on Aerosols from the Medical School, University Paris XII, in 1983, She completed her training in epidemiology and public health thanks to a post-doctoral fellowship at the Department of Public Health Sciences at St George’s Hospital, in London, UK in 1993-4. In 2010, she spent a sabbatical period at Health Initiative of the Americas (HIA) Department at the School of Public Proposal Part B
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Health at the University of Berkeley, California. Dr Annesi-Maesano was initially educated in physics at the University La Sapienza, in Rome, and medicine at the Medical School, University Paris XI. Dr AnnesiMaesano’s personal research interests are currently focused on; the epidemiology of asthma, COPD, IPF, rhinitis and the effects of air pollution and other environmental factors on allergic and respiratory diseases in both urban and rural settings taking into account the entire lifespan; gene-environment interactions in asthma, allergies and COPD; the effects of early life environment on the development of allergic response; asthma and allergies in new-borns; aetiology of wheezy bronchitis and the epidemiology of interstitial diseases of the lung. More recently, she has started to consider the respiratory health effects of climate change and wildfires, a climate-related event. Dr Annesi-Maesano’s international collaborations include: GA2LEN network, WHO ARIA and GARD initiatives, epidemiological studies on the prevalence, severity and environment determinants of allergic and respiratory diseases in Africa (Afrique francophone, Algeria, Mozambique and Cap Vert), French Polynesia, New Caledonia, and China and Viet-Nam. She serves as a consultant for many national and international institutions such as WHO, EC, Sociétés Savantes, ... Dr Annesi-Maesano is Professor of Environmental Epidemiology (Master level) at University Paris VI, of Respiratory Epidemiology (PhD level) at University Paris VI; and director of PhD and Master Students. Dr Annesi-Maesano is presently member of the Environmental & Health Committee of the European Respiratory Society (ERS) and Chair of the Interest Group Aerobiology and Air Pollution of the European Academy of Allergy and Clinical Immunology (EAACI). Previously she served the ERS as member of the Executive Committee and Chair and Secretary of the Occupation and Epidemiology Assembly and the International Union Against Tuberculoses and Lung Diseases as Chair and Programme Secretary of the Respiratory Diseases Section. Dr Annesi-Maesano has published almost 300 international articles and book chapters and received two National Research Awards and one from the Medical Research Council, UK. She has h-index=34, sum of times cited=5276, and average citations per year=188.43. Dr Annesi-Maesano serves as Associate Editor of the editorial boards of: European Respiratory Journal, International Journal of Tuberculosis and Lung Disease, BMC Public Health, European Respiratory Review, Therapeutic Advances in Respiratory Disease, Respiratory Multidisciplinary Review and at the national level of La lettre du pneumologue. She has also served as Associate Editor of Allergy. Dr Jean-François Vibert, « Professeur Emérite », expert in respiratory physiology and computer sciences. Jean-François Bertholon: MCU-PH, Director of the LGDA (Granulometry of Aerosols) Laboratory at Hôpital Pitié, a well-known expert of respiratory medicine. Soutrik Banerjee: biostatistician expert in statistical modeling and epidemiological methods. Nour Baïz: epidemiologist and biostatistician. A Post-doctoral fellow will be recruited for analysing data. Relevant publications in the field of COPD •
Degano B, Bouhaddi M, Laplante JJ, Botebol M, et al. [COPD in dairy farmers: Screening, characterization and constitution of a cohort. The BALISTIC study]. Rev Mal Respir. 2012 Nov;29(9):1149-56. doi: 10.1016/j.rmr.2012.08.007. Epub 2012 Oct 15. French. PubMed PMID: 23200591.
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Bentayeb M, Simoni M, Baiz N, Norback D, Baldacci S, Maio S, Viegi G, Annesi-Maesano I; Geriatric Study in Europe on Health Effects of Air Quality in Nursing Homes Group. Adverse respiratory effects of outdoor air pollution in the elderly. Int J Tuberc Lung Dis. 2012 Sep;16(9):1149-61. doi:10.5588/ijtld.11.0666. Review. PubMed PMID: 22871325.
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Hulin M, Simoni M, Viegi G, Annesi-Maesano I. Respiratory health and indoor air pollutants based on quantitative exposure assessments. Eur Respir J. 2012 Oct;40(4):1033-45. Epub 2012 Jul 12. PubMed PMID: 22790916.
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Partner n.11: Università degli Studi di Bergamo - UNIBG (Italy) Brief Description Università degli Studi di Bergamo (UNIBG) was established in 1968. It currently includes 6 faculties, 17 degree courses, 330 professors and researchers and more than 15.000 students. The UNIBG strong points are: • the wide range of academic programmes offered • the excellent facilities available to students: Language Centre, Computer Labs, Library services • the diversified and increasing number of International Student Exchanges • numerous PhDs, Masters, and post-graduate Specialization Programs • well organized work placement though the Student Placement Office. The consolidation of scientific activities which reach beyond national boundaries is also important. At the University of Bergamo, research activities is carried out by the 12 Departments afferent to the different Faculties and by the numerous Research Centres that work on projects related to specific areas. The research center HUMAN FACTORS AND TECHNOLOGY IN HEALTHCARE - (HTH) aims to develop knowledge that will help to improve the nature and availability of health services, community health and welfare. The center will be a meeting point of excellence that characterizes the university and our region in health, community health, health technology, management and science to the person. The University of Bergamo aims at internationalizing education in order to: I. enhance its graduates' abilities and career opportunities II. facilitate the exchange among students as well as professors in line with the purpose of the Bologna Process, which was the creation of the European Higher Education Area III. equip students with the necessary competencies to efficiently deal with territorial development needs and to elaborate effective strategies to face global competition. This international preparation will enable bachelor's graduates, master's graduates and PhD's doctors to: I. use their competencies in any European country and worldwide, working in their home country or abroad II. develop their professional skills and be highly innovative thanks to the wide, international network of relationships built during their academic years III. be receptive to new technologies; this flexibility will result in more job opportunities to choose from contribute to the growth and development of the territory of Bergamo by applying global strategies UNIBG’s Department of Information Technology and Mathematical Methods promotes research and didactics for the Faculty of Engineering in the areas of Statistics, Pure and Applied Mathematics and wide sense Information Technology. The related multi-disciplinary competence covers both theoretical research and technology transfer with special focus for local private and public stakeholders. The Department is an associated member of the Ph.D. School in Mechatronics, Information Technology, New Technologies and Matematical Methods - Bergamo University, and the Ph.D. program in Methodological and Applied Statistics - Milano Bicocca University. Role in the project and previous relevant experience Demonstration: • Innovative methods for economic and human factors impact Proposal Part B
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Key Personnel Professional CVs Angelo Compare PROFESSIONAL PROFILE: Bach., Psychology, University of Trieste. Rating: 110/110 cum laude (1998) - MS, Clinical and social psychology, Catholic University of Milan. Rating 110/110 cum laude. AgostinoGemelli Prize: The Best Graduated of Catholic University of Milan (2001) - Ph.D, Clinical and social psychology, Catholic University of Milan. Rating: excellent (2003) - Admitted at Collegio di Milano: CollegiodelleUniversitàMilanesi, www.collegiodimilano.it (2003) - Internal Fellow, University of Glasgow, UK (2004) -Internal Fellow, Boston College, University of Boston, US (2005) - Assistant Professor Catholic University of Milan (2007) - Assistant Professor - Clinical Psychology, Dept. of Human Sciences - University of Bergamo (2008). AWARDS: Research Prize: Ernst & Young - RegioneLombardia - Catholic University of Milan (2000) AgostinoGemelli Prize: The Best Graduated of Catholic University of Milan (2001) - AIP-National Congress Clinical Psychology section: Best Junior Italian Research (2002) - Special Prize CNR-Public Administration, eHealth Clinical Psychology for Heart Failure, (2005) SUMMARY OF SCIENTIFIC ACTIVITY He is author of about 100 of publications under the form of full papers with an overall citation index of 122. Recent specific research interests: Stress and psycho-physiological condition; organization context and stress risk; clinical psychology in medical setting; psycho-cardiology; artificial neural networks and psychological risk profile; well being and clinical psychology; positive psychology and clinical setting; mindfulness and clinical application; psychotherapy and psychosomatics. Paolo Malighetti He is Assistant Professor of Engineering Management at University of Bergamo. Scientific director of the Research Center “Human Factors and Technology in Healtcare” is also involved in research activities within the management and economics of public sector with a specific focus on transport and health care. His research interests and expertise include competitiveness studies in the aviation industry, the design of information systems for health-oriented business intelligence and the analysis of the risks and costs associated with health policies for the care and prevention. He is currently involved in direct collaborations with the Hospital in Bergamo “Papa Giovanni XXIII” with his involvement in the design and management of an international web-database for the Hypoplastic Left Heart Syndrome (http://www.hlhs-project.org) that includes the collaboration of University Medical Center Göttingen in Germany (http://www.med.unigoettingen.de/index_en.html). He is also involved in research projects with the team of Medical Genetics at “Papa Giovanni XXIII” Hospital (Bergamo).
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Partner n.12: Reseau PHAST – PHAST (France) Brief Description Phast is an Association of French Healthcare Professionals based in Paris, France, focused on improving the overall interoperability in HealthInformation Exchange (HIE). Created in 1989, Phast was mandated by the French Ministry of Health to set the basis for an unambiguous exchange of information in hospital, clinics and long-term care facilities concerning medications and their management. This activity has extended later onto medical devices. Phast has developed three cornerstone national interoperability implementation guides used in nearly all healthcare facilities in France, namely PN13/SIPh2 (message infrastructure), and CIOsp and CIOdm (extended terminologies concerning medication and medical devices, respectively). Other notable works by Phast are the complete translation of the Unified Code for Units of Measure (UCUM), the contribution to the translation of Logical Observation Identifiers Names and Codes (LOINC®) in French for localization purposes, and the recent production of the national “Functional Interoperability Framework for Automated Systems Integration in Electronic Medication Management Processes”. The strength of Phast are the Subject Matter Experts and the direct feedback received from real-life implementations, as well as its international involvement and keeping up to speed with the latest standards and adapting them to the national needs. Phast’s participation and leadership in IHE, HL7, ISO and recently OMG shows the alignment with the international standards community. Role in the project and previous relevant experience Phast will provide its expertise and tools in terminology management through its Standard Terminology Service. Phast will take the clinical data elements and analyse the terminologies relevant terminologies involved. In order to provide a transversal, seamless integration between the various applications (both healthcare professionals and patient-oriented) as well as the EHRs and PHRs through the SKIPPER platform service a robust mechanism of handling terminologies is needed, assuring semantic unambiguity. Phast will provide the analysis of the existing terminologies and investigate the need for their translation and their mapping. According to the context of use, binding information may be determined. All needs for semantic interoperability will be examined and carried out using a SOA-based web-service via the Standard Terminology Service. Phast is also the WP leader for WP10 - Dissemination, collaboration and standardization. Key Personnel Professional CVs Nicolas Canu Research & Development Director. Nicolas has been working in the healthcare IT sector as a consultant since 1999. He has contributed in the implementation of the national standard used for messages in the medication workflow in the hospitals and to the creation of HL7 France. Nicolas is the president of HL7 France, and he is also CDA and RIMcertified. Convinced of the importance of service-oriented architecture in healthcare systems, he created the Standard Terminology Service (STS), a Common Terminology Services 2 (CTS2) terminology server active since May 2011. He initiated the French translation of The Unified Code for Units of Measure (UCUM). Ana Estelrich International Standardization Manager at Phast. Ana Estelrich is the International Standardization Manager at Phast, where she oversees the articulation between Phast’s national activities and the international standardization organizations. Ana has been very active in the international standards community, holding the co-chair position for the IHE Quality, Research and Public Health Domain from 2007 to 2010. She is also CDA-certified and the author of several IHE profile in the IHE Patient Care Coordination (PCC) and Information Technology Infrastructure (ITI). Ana’s involvement in semantic interoperability started with the Sharing Value Set Proposal Part B
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profile, and then continued in the largest European eHealth project epSOS (European Patients – Smart Open Services), partly funded by European Commission as the leader of the Semantic Service group.
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Partner n.13: IASSIS HOSPITAL - IASSIS (Greece) Brief Description Iassis Hospital, Gavrilakis General Clinic S.A. was established in 1977 by the company’s President and Managing Director, Dr. Gavrilakis Ilias. Up to 1992 the facility operated as an Obstetrics – Gynecology Clinic. In 1993 the building facility expanded and became a Mixed Surgical Clinic. In 1994 the facility was transformed into a General Clinic, while between 2002 and 2004 it expanded further to an adjacent bordering plot, where a new wing of 2.000 sq.m. was constructed. Thus, with the initial building combined, the two facilities comprised a modern, unified architectural and operational unit of more than 3200 sq.m. Currently, the privately owned Iassis Hospital – Gavrilakis General Clinic S.A., having been equipped with state of the art new Medical technology, comprises a model Diagnostic – Therapeutic – Surgical & Research Centre with a capacity of 70 beds, that has ensured the cooperation of over 100 physicians, in addition to the permanent medical, nursing, administrative, auxiliary and technical personnel, of all specialties and ranks, thus covering the local community’s fundamental needs, both in terms of primary and secondary health care, ensuring high quality health services The scientific “core” of Iassis Hospital is constituted by a group of distinguished surgeons and specialists. Their work is supported by specialized and experienced nurses that have been chosen not just for their professional skills, but also for their commitment to giving a high standard of personal care to all our patients. At Iassis Hospital exists extensive experience across a wide range of surgery, and offer facilities for all kinds of tests. In order to ensure service provision of the highest standards Iassis Hospital uses last generation medical equipment, which includes X-Ray, CT scanning, MRI, endoscopic procedures, Mammography, Spirometry, Ultrasound, Triplex of the vessels, blood tests etc. The therapeutic services is provided by the following medical departments: Surgery (Vascular, abdominal and general, laparoscopic, obesity, cardiosurgery, neurosurgery, ophthalmic), Oncology – chemotherapy, Urology, Orthopaedics, Surgical, Pathological, Obstetric and Pulmonary dept, Intensive Care Unit, Hemodynamic Laboratory etc. Role in the project and previous relevant experience Iassis Hospital, in collaboration with various private physicians in Chania District will supply its infrastructure to execute the pilot in order to evaluate the skipper solution. Iassis will collaborate also with the Hellenic Thoracic Society for the validation of the pilot study results. The sample of patients for the study will come from a pool of patients with obstructive pulmonary diseases, mainly asthma and COPD who are receiving care from Iassis General Clinic and the cooperative pulmonologists. Key Personnel Professional CVs Manos Kokkolakis Mr Kokkolakis has the degree of Electrical and Computer Engineering from National Technical University of Athens and a Post Graduate Diploma in Business Administration from the School of Management / University of Surrey. He participated in the earlier stage of his career, with NTUA, as a researcher in various European Programs mainly in the field of Energy Modelling. Then, he worked as a management consultant addressing a variety of economical and organizational aspects, with emphasis on Quality Management Systems, in many Greek Companies and Organizations, such as the Greek TelCo (OTE), Ericsson Hellas, Kodak Near East. Price Waterhouse Coopers, Greek Standardization Organization (ELOT), Forth, National Centre for Scientific Research – Demokritos etc He participated also in the development and implementation of Quality Management Systems and other relevant projects (e.g. Information Security, Food Security, etc.) in many public and private hospitals, medical and diagnostic centers. He has also the responsibility for the Quality Management issues for the members of the cooperative of Laboratory physicians in the island of Crete. He is responsible for the European Programs Department in the IASSIS Hospital. Helen Fournaraki Proposal Part B
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Mrs Fournaraki has a Bachelor in Political Sciences & Public Administration from the University of Athens and a Master in Business Organisation & Administration from the Technical University of Crete. She worked as an executive secretary for the Federation of Agricultural Collective of Prefecture of Chania and for the General Director of Hellenic Post. In 1995 she was employed from Gavrilakis General Clinic with many responsibilities regarding administrative tasks such as Accounting, Public relations, Development of new Departments, negotiations and agreements with Insurance Companies in Greece and abroad, TourOperators, Doctors, etc. From 2010 Mrs Fournaraki acts as the General Manager of “IASSIS-GAVRILAKIS GENERAL CLINIC S.A.”. Stylianos Vittorakis Mr Vittorakis graduated from the Medical School of the University of Athens with a Medical Degree and he finishes now his PhD course in the National and Kapodistrial University of Athens. He is member of Chania Medical Association, member of the European Respiratory Society, full member of the Hellenic Thoracic Society and fully registered with the Athens Medical Council. He is now a Senior Registrar in Respiratory Medicine and in 2001 acquired the European Diploma in Adult Respiratory Medicine E.R.S – H.E.R.M.E.S (Harmonized Education in Respiratory Medicine for European Specialists). He operates a Private Practice in Pulmonology and he collaborates with Gavrilakis General Clinic. He has experience in Research, especially in Asthma and Allergic Diseases, and he participated in various scientific papers, oral and thematic presentations. Emmanouil Liodakis Mr Liodakis has a degree in Medicine from the Crete Medical School and the specialty of Cardiology from the University of Athens. He has also the following accreditations: • Level II Accreditation of the Society of Cardiovascular Computed Tomography • Level III Accreditation of the Society of Cardiovascular Magnetic Resonance • Congenital Heart Disease Echo of the European Society of Cardiology • Adult Echocardiography of European Society of Cardiology He is now a Consultant Cardiologist working within IASSIS Hospital, specializing in cardiac imaging (echocardiography and CMR), congenital heart disease and pulmonary hypertension. He has participated in scientific papers and published books, and he made oral presentations as invited speaker in various congresses.
Proposal Part B
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Partner n.14: HL7 International Foundation - HL7 (Belgium) Brief Description Founded in 1987, Health Level Seven International (HL7) is a not-for-profit standards developing organization (SDO), founding member of the JIC for Global Health Informatics Standardization dedicated to providing a comprehensive framework and related standards for the exchange, integration, sharing, and retrieval of electronic health information that supports clinical practice and the management, delivery and evaluation of health services. HL7 International and its 33 national or regional affiliates number 4,000+ members from 55 countries include approximately 1000 corporate members who represent more than 90% of the information systems vendors serving healthcare. HL7 International provides standards for interoperability that improve care delivery, optimize workflow, reduce ambiguity and enhance knowledge transfer among all of our stakeholders, including healthcare providers, government agencies, the vendor community, fellow SDOs and patients. The HL7 International private foundation is non-profit organization established in Brussels in June 2010 to support the creation of health information technology standards that are widely and easily used enabling interoperability in healthcare. Specifically the objectives of HL7 International in collaboration with the Affiliates currently established in 18 European Countries (36 worldwide) are: (a) to promote and encourage the use of HL7 frameworks and protocol specifications that serve the needs of the European community by health systems and service providers; (b) to seek formal accreditation for these HL7 protocol specifications where necessary; and (d) in general to enable high quality, cost-effective use of information systems in the widest variety of health and healthcare related environments. In this spirit, HL7 participates in the eHealth governance initiative, Semantic Healthnet, and the ANTILOPE project. Role in the project and previous relevant experience As described above HL7 is one of the most important standards developing organization (SDO) for healthcare interoperability, many worldwide eHealth solutions are based on its standards, it will therefore contribute to the SKIPPER project with its consolidated expertise in: • organization and clinical modeling [SKIPPER Clinical domain and care models definition (WP2)]; • services; this proposal is based on HL7 Services Standard, and HL7 has developed these standards (with OMG) in the Healthcare Service Specification Program [SKIPPER architecture and design (WP3); Integration and Testing of SKIPPER Services (WP7); Evaluation and validation of the SKIPPER solution: the pilots (WP8) ] • HL7 CDA and message profiling, necessary for the implementations of the Semantic Signifiers exchanged through the above mentioned services [SKIPPER architecture and design (WP3); Integration and Testing of SKIPPER Services (WP7); Evaluation and validation of the SKIPPER solution: the pilots (WP8) ] • the adoption of interoperability, service oriented, frameworks based on HL7-SAIF (Service Aware Interoperability Framework). [SKIPPER architecture and design (WP3)] • the adoption of enterprise framework - coherent with the above mentioned interoperability framework - for the evaluation of the artifacts conformance and compliance. The HL7 Enterprise Conformance and Compliance Framework (ECCF) in fact enable the identification, the definition, and the organization of a set of artifacts that collectively specify the relevant semantics of a software component specification or other system-of- interest. [Integration and Testing of SKIPPER Services (WP7)] Moreover, as SDOs directly involved in these services specification and profiling may support the formal accreditation for this project results [Dissemination, collaboration and standardization (WP 10), task Contributions to the standards]. Proposal Part B
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Key Personnel Professional CVs Giorgio Cangioli, Senior Consultant of ICT in Health and Social Care, Degree in Physics, PhD in Energy Engineering, Master in ICT for Radiology. He worked for several years for private ICT companies covering different roles (Production Manager, QMS Responsible, R&D Responsible). Consultant since 1999. He has more than 15 years of experience in ICT, standards and Business Process Reengineering applied to Health and Social Care. Involved in several European, National and Regional projects of telemedicine; teleradiology, social care, primary care, Regional/National/Cross-Country HIE (Health Information Exchange), eGov projects; including eHealth Regional projects assessments on behalf of an Italian governmental agency. He provides coaching and learning services about modeling, methodologies and standards applied to the Health and Social Care. Responsible of the Clinical and Semantic Experts Group for the European project epSOS. Involved in the past in IHE and DICOM WG 5 (author of the DICOM Supp 88), he‘s currently CTO of HL7 Italy and elected for the 2012 as International Affiliate Representative to the HL7 Technical Steering Committee. Carlos Gallego Pérez, Responsable Oficina d'Estàndards i Interoperabilitat TicSalut. Born on April 8, 1969, computer profession, he has directed projects for health of the mutual accident and occupational disease Asepeyo, since 1992 until 2009 where you have to highlight history clinic electronics only the mutual projects and corporate PACS. Recent years has focused on norm-setting and development and adoption of standards where it has been a founding member of IHE Spain and HL7 Spain where he was head coach from 2004 to 2007. He is currently member of the Board of Directors IHE Spain, President HL7 Spain, Member of AENOR Committee technical standardization 139, Secretary of Group II of CT139 (terminology) of AENOR, AENOR in CEN TC\/251 European representative, and member of ISO 215, Member of the semantic interoperability of the Ministry of health and social policy advisory group, Coordinator of the técnologica eVIA platform interoperability, member of Continua Alliance. D'estandards i interoperability of Foundation TICSALUT where carries out is currently Director of the Office projects of interoperability and standardization among the shared clinical history of Catalunya Central Cancer Registry, electronic prescription, Plan of medical imaging, and EpSOS.
Proposal Part B
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Consortium as a whole
The consortium represents a highly interdisciplinary team with outstanding expertise from different disciplines. It was set-up in order to meet the objectives of the project in the best possible way. The consortium possesses an exceptionally strong and uniquely diversity and excellence of research teams from across Europe, and is composed of 14 partners from 6 different Member Countries. Project Co-ordination and Management will be taken by FORTH. The project combines different skills and resources both in scientific, technological and financial terms. The consortium includes software engineers, computer scientists and mathematicians with long-term experience in the field of their competences. The following skills/competences concur in the definition of a successful project, and in the following realization of the project activities: 2.3.1
Competences
The competences of the consortium can be classified into three major areas of expertise: Clinical, technological and Business exploitation and dissemination. Clinical competences The consortium includes one of the world leading centres for research on Epidemiology and public health of Allergic and Respiratory diseases, including outdoor and indoor air pollution, pollens, allergens, moulds, climate changes, and related methodology (statistical methodology, data analysis, interpretation); Modelling of atmospheric chemical and biological pollution exposure and related health effects; Access to Biobanks including genomic DNA, placenta, cord blood saliva, maternal milk, meconium, serum, plasma, hair; Technological competences eHealth related expertise Development and introduction of regional-broad Electronic Health Records (EHR) and Personal Health Records (PHR); Integration between healthcare structures and territory, including General Practitioners, Paediatricians and citizens; Development of integrated solutions able to support patient empowerment and continuity of care; Enabling technologies Interoperability Adoption of protocols and software architectures for the design and development of interoperable platform; Easy integration with external unknown modules compliant with interoperability standards; Standardization Evaluate the matching of the SKIPPER approach and methodologies with the requirements of the standardization bodies (e.g. ETSI, CEN) and interoperability initiatives (e.g. IHE-Europe) in the area of eHealth service, knowledge based decision support and chronic care pathway.; Assess the impact of the Cloud-based interoperable services to the European eHealth standardization institutions and interoperability initiatives (ETSI, CEN, IHEEurope and so on); Proposal Part B
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Feed-in the standardization bodies with the key findings and testing methodologies, to advance the standards definition and diffusion process Knowledge management and Decision engineering Implementation of decision support systems, with wide experiences in the medical and healthcare fields, based on knowledge based systems, inference engine and models. Internet of things Sensor network and remote monitoring Software architecture Research and design the overall architecture of a complete SOA framework Design of Service Oriented interoperable platform compliant with integration standard; Adopt knowledge management models for supporting health professional in the chronic care programmes; Implement Saas models for the innovative services developed.
Business exploitation and dissemination Assessment Evaluation and validation of the developed services with respect to usability, effectiveness and feasibility of the adoption of the framework within a real context; Economic impact of the project achievements; Exploitation Wide experience on technology transfer; Specific actions for the analysis of the potential market, and the possible competitors; Business plan for the industrial exploitation of the results of the project; Design of specific models for business exploitation; Dissemination Managing the information flow to/from stakeholders and the general public; Granting a suitable level of visibility to the project, through web site, scientific publications, conference presentations, press etc. The consortium also includes a broad variety of research partners such as universities, research institutions and industries. This combination assures direct experience and engagement with relevant stakeholders, thus meeting the key project objective of supporting European research bringing together different subject areas and stakeholders to achieve a multi-layered and interdisciplinary challenging result. The research teams have been brought together because of their shared interests in and commitment to the research covered by the project. The research partners share a common experience and expertise in the relevant areas and topics and have been carefully selected on the basis of their fit within the consortium as well as their own individual and collective expertise. Several partners share common research networks and have experiences of working together. 2.3.2 2.3.2.1
Complementarity between participants Technical complementary
The participants of the SKIPPER Consortium are highly skilled and are fully complementary. Indeed, a complementary partnership is a way to ensure a successful team performance by increasing its diversity. The diversity means an appropriate mixture of different organization competences, size, type (public, private), and country. In more details, from the Partners profiles it emerges that the participants perfectly cover the necessary skills to successfully achieve the ambitious goals of the project.
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Concerning eHealth, that is the core challenge of this project, DEDA is one of the Italian major actors for the development and commercialization of innovative solutions for the healthcare, with important roles in all public and private health market segments. Moreover, during the last 5 years DEDA started an internationalization process, especially concerning EHR, Hospital-Territory integration systems and software systems for General Practitioners and primary care, with the main goal to guarantee continuity of care through interoperability among health actors and systems. Also FORTH and FRAUNHOFER are very active within both national and international initiatives aimed at the innovation of the eHealth and the adoption at national level of innovative solutions related to EHR and PHR, with important collaboration with governmental bodies of the respective countries. Concerning the enabling technologies, FORTH, SEF, FRAUNHOFER, DEDA and PHAST have all a consolidated experience on interoperable service oriented architectures and eHealth services, as well as on standards adoption and compliancy and standardization processes in which HL7 is among the most representative authorities. Both FRAUNHOFER and CNR have a wide expertise on Privacy issues and Security Services, while the UNISI scientists and T4ALL have extensive skills on remote sensor network and monitoring platforms. Concerning decision engineering, knowledge management and data analysis, UNICAL, FORTH and CNR are international well-known representative of the scientific community. The other main topics addressed by the project concern CLOUD-based solutions and SaaS models, that will be faced by FORTH, DEDA, CNR and FRAUNHOFER. Concerning the analysis on economic impact, UNIBG will lead and coordinate this activity with its expertise on methods for economic and human factors impact, while INNOVA will be responsible for the technology transfer and business exploitation, with the support of all the enterprises of the consortium, as the Enterprise holds a long experience in knowledge and technology transfer as well as Market analysis and Business Plans. Finally, UPMC and IASSIS as clinical partners will be responsible to setup the pilots and, therefore, to implement and validate the developed framework, with the involvement of public healthcare authorities and associations (see below). In particular, UPMC will have a specific focus on scientific aspects, while IASSIS will support the validation of the SKIPPER framework in a private clinical setting, thus strengthening the study on business exploitation models. It is evident that all the topics address by the project are well covered by complementary as well as overlapping expertise. This will guarantee from one side the successful achievement of the project results, the effectiveness of the pursued goals and the adopted solutions, and, finally, robust risk management in case of deficiency of any participant. 2.3.2.2
Research organizations and industrial participants
The Consortium is composed of both research and industrial partners in order to guarantee both the advance of the state of the art technologies that will be studied and adopted during the project lifetime, and the definition of an industrial plan for the exploitation of the results that will be achieved. In particular, 3 SMEs (INNOVA, SEF and T4ALL) and a large enterprise (DEDA) will guarantee the exploitability of the framework, being involved in the three different main branch activities of the project: technical development of the framework, pilot definition and validation of the framework, and finally market analysis and exploitation of the results. The participation of a large enterprise like DEDA represents an important strength of the Consortium, increasing the possibility to bring to the international market the SKIPPER solution. At the same time, the three SMEs could increase their opportunity acquire new market segments as providers of innovative and enabling solutions. The participation of standardization entities, such as HL7, that is a no-profit ANSI-accredited and standards developing organization, and PHAST, a no-profit standards and services development Proposal Part B
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organization, will support and strengthen the adherence of the developed framework to international standards for data representation and services interoperability, as well as the ability of the consortium to contribute to the enhancement of the standardization initiatives. Among the remaining partners, three well-known research institutions, FORTH, FRAUNHOFER and CNR, and four universities, will guarantee the scientific excellence of the industrial research carried out during the project activities as well as the dissemination of the results along the most suitable information channels and international communities, whilst INNOVA will support a successful technological transfer of the SKIPPER results to the SMEs. 2.3.2.3
Complementary in terms of countries
This partnership is composed of 6 different EU Member States: 2 from Greece, 6 from Italy, 3 from France, 1 from Germany, 1 from Belgium and 1 from UK. Additionally, pre-existing links and good previous relations already exist between most of these partners, which should provide nice affinities amongst the partnership. Moreover, several partners of SKIPPER are already involved in complementary European projects and have a long experience in carrying out R&D projects, both as participant and Coordinator, in multidisciplinary and international contests. 2.3.2.4
Complementary in terms of types of profiles and skills
Legal European entities participating in SKIPPER are composed of several profiles, which include both, for the R&D part, well-known research institutions and industries as indicated below: Institutions for research: FORTH, CNR, FRAUNHOFER, HL7 Institutions for university education: UNICAL, UNISI, UPMC, UNIBG Industries: DEDA, SEF, T4ALL, INNOVA, PHAST Hospital: IASSIS. 2.3.3
External commitments
It is worth to highlight that a number of healthcare authorities have already expressed not only their strong interest in the activities and outcomes on the SKIPPER proposal but also their availability to support the validation phases with their territorial structures as well as with their network of contacts. For this reason, these authorities have already offered to the SKIPPER consortium a signed endorsement stating their contribution if the project will be financed. In particular, the consortium received commitment letters from three Greek healthcare associations, namely the Greek Thoracic Society, the Primary Healthcare Centre of Charakas and the 7th Health Region of Crete, who will support the project by setting the Greek pilot and, hence, validating the outcomes of the project. Similarly in Italy, the Tuscany Region will support the Italian pilot with the involvement of a local healthcare structure, an association of general practitioners (GPs) and an association of patients in order to provide the possibility to validate the entire framework proposed. Finally, besides the Tuscany Region and the Greece healthcare associations, the SKIPPER project acquired the endorsement of both the Italian scientific and multi-disciplinary association for the study of respiratory diseases (AIMAR) and the French-language Society of Pneumology (SPLF). These two renowned institutions will guarantee the adequate dissemination of the achievements among the medical respiratory diseases societies and scientific communities, providing, at the same time, an important support to the exploitation activities that will follow the conclusion of the project. In Appendix A, a copy of the endorsement documents have been enclosed. Proposal Part B
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Sub-contracting
Sub-contracting costs have been kept very low since almost all the research activities will be carried out within the Consortium during the project lifetime. Nevertheless, due to the strong aspects of innovation and experimental activities, some budget has been allocated under the subcontracting cost category in order to face the necessary expenses for setting up the pilots. In particular, this budget has been allocated to DEDA and UPMC which are mainly responsible to coordinate the activities related to the pilots. Additional sub-contracting budget has been allocated to the Project Coordinator for the external advisory board that will be composed of distinguished scientist, external to the Consortium, with the goal to help the General Management Board devising the correct goals. This budget is very low, about 25.000 euros, and will be mainly used to cover the travel expenses of the board participants. Additional sub-contracting budget has been allocated for audit expenses by the Partners that are obliged to certify their costs statements. 2.3.5
Other countries
NOT APPLICABLE
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Resources to be committed
The project’s work plan has been broken down in WPs, tasks and individual work elements for each task. Each task has been time scheduled in details and each partner’s effort has been budgeted in PM per each task. The result of these efforts is a very accurate planning of the partner’s efforts needed to complete effectively and efficiently the project and achieve the objectives. The necessary resources for performing the SKIPPER project have been budgeted using a bottom-up approach. The budget shows a well-balanced project, both in terms of efforts and costs, with efficient utilisation of the resources planned in order to complete the required tasks successfully. Further to forms A3.1 illustrating the budget of each partner and form A3.2 showing the whole budget of SKIPPER, the planned budget distribution by partner and cost category for the SKIPPER project is given in Figure 12. All budgets listed in this table reflect the estimated costs expected to be incurred in carrying out the project and were calculated according to the accounting principles of the partners, which, in case their individual amount of requested funding exceeds the 375.000 Euro threshold, are also subject to compulsory financial audits. Partner
FORTH
Personnel
312.000
Travel
Durable equipment
25.000
11.500 6.500
DEDA
547.500
15.000
CNR
268.250
33.000
FRAUNHOFER
364.550
22.500
INNOVA
147.500
21.000
SEF
Other direct costs
12.200
81.000
12.000
UNICAL
222.000
16.000
UNISI
186.750
14.000
12.000
UPMC
214.650
15.000
10.650
UNIBG
87.750
10.000
PHAST
185.310
14.900
IASSIS
102.600
22.000
HL7
106.250
16.900
3.063.610
249.500
Indirect costs
15.000 8.000
18.500
237.500
Subcontracting
31.000
8.000
T4ALL
Totals
Consumables
3.000
14.000
15.000 8.500
23.000
96.150
4.000
12.000
7.000
16.500
71.000
Total costs
271.440
Requested EC contribution
650.940
529.615
113.800
697.800
360.900
182.410
499.660
377.826
288.359
696.909
527.689
101.100
269.600
205.200
149.820
399.520
302.640
64.200
171.200
130.200
142.800
380.800
288.000
127.650
340.400
258.000
144.180
399.480
302.790
63.750
170.000
130.200
120.126
320.336
242.808
90.960
249.560
190.450
73.890
197.040
152.880
1.934.485
5.443.245
3.999.198
Figure 12: SKIPPER budget distribution by partner and cost category
2.4.1
Repartition between partner categories
The SKIPPER project partners plan to mobilize an amount of 661,50 person-months for the realization of the overall project. Figure 13 shows the overall distribution of the efforts (in PM) among the partners. This figure shows a good balance of the efforts over the partners for such an industry driven research project. All budgets listed in the A3 forms reflect the estimated costs expected to be incurred in carrying out the project. All partners are informed that cost statements will have to be accompanied by audit certificates, if needed, which are registered under the management activity. In Figure 14 the budget of the whole project by cost category is shown
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Personnel costs other direct costs Indirect costs Total
Figure 13: Effort (PM) per each partner
3.063.610 437.150 1.934.485 5.435.245
56,37% 8,04% 35,59% 100,00%
Figure 14: SKIPPER whole budget distribution by cost category
Figure 15 shows the requested funding (in %) per partner and Figure 13 the requested funding (in %) per country. Funding per partner
3,82%
HL7
4,76%
IASSIS
6,07%
PHAST 3,26%
UNIBG
7,57%
UPMC 6,45%
UNISI
7,20%
UNICAL 3,26%
T4ALL
7,57%
SEF 5,13%
INNOVA
13,19%
FRAUNHOFER 9,45%
CNR
9,02%
DEDA
13,24%
FORTH
Funding per country BE; 4% GR; 18% FR; 21%
UK; 5%
DE; 13%
Figure 15: Requested funding (in %) per each partner
2.4.2
IT; 39%
Figure 16: Requested funding (in %) per each country
Repartition between RTD and Management activities
The total person month allocation shows a significant RTD work share of 624 PM and 94,5 % of the total work, which demonstrates the weight of breakthrough RTD in the project with a good balance between the Industries, the SMEs, the academic and research institutes and not-for-profit organizations. The costs for the RTD activities of the SKIPPER project are divided over the different partner types as follows: •
32,3% go to 3 technology research partners (FORTH, CNR, FRAUNHOFER), wiht 187 PP/MM;
•
24,4% go to 4 academic partners (UNISI, UNICAL, UPMC, UNIBG) with 157 PP/MM;
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•
20,5% go to 5 SME partners (INNOVA, SEF, T4ALL, IASSIS) with 131 PP/MM, so as to have the opportunity to generate knowledge and extend their portofolio;
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13,2 % go to the industry (DEDA) which will dedicate 108 PP/MM to the project.
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9,5% go to the 2 not-fot-profit organizations (PHAST, HL7), with 56 PP/MM.
The clinical domain survey with the collection and preparation of the data, the definition of evidencebased programmes, the identification of the human factors impacting in the programmes, the definition of user scenarios, and the identification of organization and management models for healthcare delivery (WP2) mobilizes 50 PP/MM of the total workforce. This work will be the input for the technical work. The technical work packages will include the architectural model driven design of the SKIPPER interoperable platform of services, the definition of the envisaged services, and the identification of the security and performance requirements (WP3), the implementation of the end-users services as clinical workflow management services, telemonitoring and telecare services, etc. (WP4), knowledge management and decision support back-end services (WP5), design and implementation of the device network infrastructure for supporting the telemonitoring and telecare services (WP6), the integration and testing of the SKIPPER services deployed into a private SaaS cloud (WP7). These technical WPs will use 393 PP/MM of the total work. The pilot runs, evaluation and validation of the system (WP8) is an important step to demonstrate the usefulness of the SKIPPER platform and its progresses beyond the state of the art. These activities will use 87 PP/MM of the total work. The SKIPPER project assigns high importance on the economic impact, through new organizational models and clear exploitation plans (WP9) and also on the dissemination activity including the significant contributions to standards which are expected as outcomes of this project (WP10). Therefore the project comprises considerable efforts on exploitation and dissemination activities, which are considered essential in order to achieve the objectives of the project, separating these actions in two WPs strictly cooperating but assuring specific focus on both activities. These activities will use 94 PP/MM of the total work involving industrial partners, SMEs and academic and research institutions.
Finally, WP1 (37,5 PM) covers all project management aspects described in detail in Section B2.1. Management and project coordination activities account for 5,7% of workforce. The budget distribution under different activity types is shown in Table 2.4.4. Total budget (eligible costs) Requested EC funding % Total budget (eligible costs) % Requested EC funding
RTD DEMO MGT Total 5.120.385 0 340.860 5.461.245 3.658.338 0 340.860 3.999.198 93,74% 0,00% 6,26% 100,00% 91,48% 0,00% 8,52% 100,00%
Figure 17: Budget distribution under different activity types
2.4.3 Repartition between budget categories As shown above, the main part of the costs will be personnel costs (approx. 56%), used to finance 661,50 person months. Travel (approx. 4,6%): Travel costs will be used to finance the following meetings: •
General project meetings (kick-off, progress meetings and review meetings)
•
An appropriate number of WP meetings as well as visits to partner sites
•
The participation of partners in selected and highly relevant conferences or events to present the project and its results.
Wherever possible, the partners will strive to make use of tele/video conferences and try to combine conference participation and meetings.
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Durable equipment and consumables (approx. 2%): several partners need to purchase sensors, mobile devices, gateways that will be used in assembling the platform and in the pilot sites. Dedicated servers for the cloud-based back-end will also be purchased. Other direct costs (approx. 0,3%): 8.500€ have been allocated to the budget of UNIBG for dissemination activities like publication fees for Internet-based journals, while 8000€ have been allocated to the budget of CNR partially as management activity (financial audit certificates) and partially as RTD (dissemination) activities (publication fees for electronic journals). Taking into account the direct costs shown above, the indirect costs amount approximately to 34% ot the total budget. Subcontracting: a. Financial audit certificates: FORTH and FRAUNHOFER have an individual amount of requested funding that exceeds the 375.000€ threshold, and will provide audit certificate costs that are accounted under the management activity (subcontracting) as this is their usual approach in EU funded projects. The total estimated costs of certificates on the financial statements amount to 9.000€. b. Reimbursement of travel and accommodation expenses for the advisory board members for the three envisaged meetings that will be held in the course of the project. These expenses will be accounted under the management activity (subcontracting) and the coordinator will execute and report them. The total estimate cost for the 5 members of the advisory boards is 25000€. c. Expenses for the external validation of the pilot sites. The Italian and the Greek pilot sites will be validated by external authorities. The expenses for such external validation have been inserted in the management activities (subcontracting) and will be 15000€ for the Italian pilot and 7000€ for the Greek pilot. d. Expenses for high-level support at international level in the clinical domains. 15000€ have been allocated to UPMC in order to involve external high-level consultants for the clinical domains in the course of the project. Resource efficiency through use of synergies The SKIPPER project will continuously follow up existing synergies with related projects. The partners will promote synergies between SKIPPER and other running EU projects as well as nationally funded projects wherever possible. The contacts between these projects will prevent redundant work and optimize the use of the SKIPPER financial resources.
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Section 3: Impact 3.1
Expected impacts listed in the work programme
3.1.1 Introduction The impact of the SKIPPER outcomes will embrace the area of the management of chronic comorbidities care, with a first application to the COPD and its comorbidities chronic disease profile, but it will also be affecting and impacting a wide range of societal, economic and technological areas. It significantly contributes to the fulfilment of the ambitious activity plans for Europe’s future and strengthens our industrial leadership in several areas, as shall be demonstrated in this section. The centre of gravity of activities will be in the ICT domain, but SKIPPER will make major impact on COPD care management, continuity of care through an effective integrated care, clinical workflows, effective models of care and policy and regulatory frameworks. Relevant regulations will not only be taken into account but will be impacted through the work on patient safety, security and privacy and health-economic framework as shaped by the emerging digital economy, named the second economy. For each expected impact point we will present also quantitative indicators or measures of success. 3.1.2 Contributions towards the expected impacts listed in the work programme Taking into account the aim of the SKIPPER project and the expected achievements in terms of technological results and evaluations of the related organizational and economic impact for the healthcare governments, potential market and business models, in the following table we summarize how the project will contribute towards several expected impacts regarding the Objective “ICT-2013.5.1: Personalised health, active ageing, and independent living” of the ICT Workprogramme: Expected Impact 1. Improved interaction between patients, their relatives and carers, facilitating more active participation of patients and relatives in care processes.
Proposal Part B
SKIPPER contributions According to the chronic care model, SKIPPER services aim at creating a space where patients will become empowered and actively involved in the management of their disease in close collaboration with relatives and carers. New ways of communication and interacting using ICTs will move beyond traditional consultation services and provide a network of relationships and interactions focused on continuous wellbeing and prevention of complications. The Master Care Plan (Master CP) and the PHR specialized services (described in detail in the WP4) are the pillars of the improved interaction between the patients (and their relatives) and the caregivers. In particular, the end-users services of the SKIPPER platform includes counselling services, with them the healthcare professionals can offer to the patient the access to PHR functionalities specialized for the COPD. The SKIPPER SaaS web application will allow ubiquitous access to PHRs and CP to the authorized users. A patient - a relative, a carer for dependent, vulnerable, disable patients - will be able to administer fine-grained access rights to her/his health data, care plans and care records to professionals, relatives, social workers and other involved actors. Conversely, all the data about patient physiology or environment that are produced by care setting, remote sensors and sources of data, that are integrated in the services
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2. Improved cooperation between the providers of health, social and informal care.
Proposal Part B
STREP proposal
SKIPPER architecture of care through the SKIPPER platform will be accessible to the patients and her/his authorized relatives and carers. The general idea is that annotations to a Care Plan, such as feedbacks to the progress of the therapy, can be posted by the patients and their representatives and are saved on the PHR (staying referenced in the CP), and are immediately accessible on-line to authorized healthcare professionals, or subscribed for offline notification, if the patient has allowed the appropriate access rights. The challenge of each care system that, like SKIPPER, puts the patient at the centre of the care system, is to reconcile the improvement of the interaction between patients (and relatives) and carers - which is necessary to improve care quality and to diminish care costs – with the guarantee of the patient privacy – which means that the patient - her/his representative - is “administrator” of fine grained visibility and access rights to her/his data. This reconciliation is obtained only by presenting to the patient (and representatives) on the SKIPPER SaaS web application powerful but very simple and easy to manipulate access right administration functionalities. In a preceding project FRAUNHOFER has developed a smart solution to this problem that will be reused and enhanced in the SKIPPER project. Measurable indicators of the patient activity and of the interaction between patients and carers will be defined and observed in the two pilots. The end-users services of the SKIPPER platform are finalized to support integration of multi-professional and multi-disciplinary approaches within the healthcare settings. This aspect will be guarantee by a fully adoption of technical and semantic interoperability services. The core artefact that allows advanced cooperation and coordination between healthcare professionals, social workers and other actors is the Master Care Plan and its related Care Record. The Master Care Plan is a continuously updated, lean and federated care plan, pursuing specific health goals with progress being measured over time, which can be accessed and updated in a controlled way and with change logs by a “virtual” care team. The first member of the care team is the patient her/himself (or her/his representative) that plays an active role (see the preceding impact point). Obviously, the care team is composed by the healthcare practitioners, from different domains and specialties, and other care setting operators. Moreover, social workers, healthcare administrators and other actors that are involved in the continuity of care are included in the care team. The “virtual” care team composition is constantly in flux: mechanisms such as foundational sharing agreements, invitations across care settings, and other will be specified and implemented. The design of the SKIPPER Continuity of Care Process, of the Master Care Plan and of the Care Record will be strongly associated to the HL7/OMG HSSP Care Coordination Service project. HL7 is partner of the project and other key partners of the SKIPPER project (FORTH, DEDA, FRAUNHOFER, SEF) are involved at different degrees in the HSSP initiative.
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Measurable indicators of the activities of the “virtual” care team activities on the care plan will be defined and observed in the SKIPPER pilots. Their correlation with indicators of the efficacy of the patient therapy and followup will be studied. 3. Strengthened evidence The SKIPPER project focus on patients with moderate and severe level of base on health chronic diseases severity and aims at: outcomes, quality of life, • preventing the advancement of the disease towards more severe care efficiency gains and stages , economic benefits from • reducing the numbers of hospitalizations and guaranteeing to the use of ICT in new patients as much as possible a regular life in their normal care models. environments, • monitoring the status of the main comorbidities, such as cardiovascular diseases and diabetes and avoiding their advancement. For addressing these objectives, the SKIPPER project will implement a set of end-users services to enhance continuity and quality of care by supporting: • early diagnosis and prevention activities, by exploiting decision support services and predictive tools • integration of multi-professional and multi-disciplinary approaches within the healthcare environments, • continuous monitoring, by exploiting devices networks infrastructure for remote telemonitoring • the personalization of care and the growing empowerment of patients. Furthermore, the SKIPPER project aims at improving the quality of life by providing patients with a user-friendly and affordable way of understanding, managing and coping with their conditions at their location. This concept provides involved patients with continuous feedback and management guidelines relevant to their health, while at the same time it offers the opportunity to interact with family members and close relatives, thus improving their social inclusion and overall life standards. The remote management of the COPD patients will reduce the number of visits to sites delivering healthcare (such as a doctor’s office, a clinic, or a hospital) and allow for the proper management of the drug regimen, thus avoiding adverse effects from drug misuse, and the possibility of subsequent costly medical interventions. The achievement of these objectives impacts on the effectiveness of the care programmes and in the efficiency of the healthcare service. At this regard the WP9 of the project is completely dedicated to : • to evaluate the economic impact of the SKIPPER solution for the health authorities and their healthcare policies • to analysis the European market at a country level and understand its barriers, trends as well as the majors competitors; t • to define the business approach and organizational models as technology or service provider; Proposal Part B
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to explore and evaluate all the business models and choose the most suitable for SKIPPER market deployment; It is worthwhile to underline that the SKIPPER solution well and completely addresses the needs of the national healthcare services to move towards more sustainable systems, by integrating primary, secondary and home care, by moving from a vertical, redundant and dispersive approach to horizontal one in order to optimize the available resources 4. Reinforced medical The COPD/Asthma medicine is migrating from intuitive to evidence-based knowledge with respect and even, for some aspects to precision medicine (use of genetic data in to efficient management some specific situations). Many aspects are yet unknown. The clinical and of comorbidities epidemiological study put in place in the Skipper project is not alone (see bibliography) but aims to accomplish a huge step in this direction whose final end is to have standardized diagnostic and guidance knowledge that can be formalized in decision support systems. In addition, the SKIPPER solution will shift COPD management from acute rescue to pro-active maintenance which will contribute to diminish the burden of comorbidities. The chronic care model and patient-centred solutions reached through the SKIPPER platform will combine delivery system redesign, clinical information systems, decision support, and selfmanagement support within a practice, linked with health care organization and community resources beyond the practice in order to reduce the occurrence of comorbidities. 5. Increased confidence in The project goal is to put in place a real-time process of integrated patient decision support systems management and follow-up that is driven by a decision support system for disease/patient based on relevant advances in the clinical and epidemiological knowledge management. about a disease that is yet in the realm of unstructured and intuitive medicine. For this reason in the framework of the SKIPPER project a work package (WP5) is completely dedicated to the development of knowledge management and decision support core tools and to their integration in the SKIPPER end-users services. The decision support and patient guidance services, proposed by the SKIPPER project, will provide a holistic and effective solution for the integrated clinical management of patients suffering from COPD. The integration of the platform through all the different care environments from the home care (patient at home), primary care (community offices and primary health care centres) and secondary care (medical doctor offices and hospitals) will guarantee the availability of the requested services at the point of need at any moment. In particular, the knowledge management and decision support core services will be able to process (both automatically and ondemand) the patient data and to provide, through a general closed-loop approach, useful information to the patients and health care givers about accurate assessment of the patient conditions and possible evolution of the disease. The SKIPPER project provides a comprehensive set of decision support services, which will help towards its acceptance by both health professionals •
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and end users alike. Easily navigable, user-friendly interfaces, secure data distribution of self-care record and clinical pathways through the Internet will be the basis provided by SKIPPER for an e-Health service that can be offered by a HealthCare provider with the support of a communication provider partner. Access to the right information at the right time is a crucial ingredient of modern life, and specifically in healthcare. Across the world there is a growing interest in information about health and health services (health e-services). Improving access to information and decentralized management of chronic patient care are important parts of the European Union’s strategy for delivering its objectives of improving health and health services. Moreover, the envisaged decision support services through the SKIPPER platform will guarantee: • The early detection of further complications effectively improving the possibility of clinical treatment of the pathology and thus reducing the probability for patients to worsen the conditions. • Better management of chronically ill patients with more autonomy and control for people and their relatives over their own disease providing a higher quality of life. • Reduction in the burden of inappropriate visits in the traditional Healthcare premises. All the above factors will stabilize or even better reduce the cost of the health delivery system and simultaneously will improve the quality and efficiency of healthcare. Knowledge management and decision support services are expected to improve multiple chronic disease management processes and, in many cases, patient outcomes. Through the clear description and quantitative indication and measurement of system design, architectural organization and end-user interfaces capabilities, local context, implementation strategy, economic costs, adverse outcomes, user satisfaction (utility and usability), safety and reliability, impact on end-user workflow, we will are able to demonstrate the effectiveness and efficiency of the SKIPPER decision support services. 6. Involvement of care The SKIPPER project aims to evaluate, through two experimentation pilots, authorities in the impact of the SKIPPER solution in terms of: development of • clinical effectiveness and economic sustainability of the possible new personalised care organizational healthcare models solutions, with increased • evolution of the eHealth market, with business models that could commitment in the exploit the SKIPPER solution. deployment of For better supporting the definition, the execution, the evaluation and the innovative services after final validation of the SKIPPER solution the proposal has asked for and got the R&D phase. the endorsement of the following public healthcare authorities and scientific associations: • Health Department of Tuscany Region (Italy); • Greek Thoracic Society; • Primary Healthcare Centre of Charakas (Greece); Proposal Part B
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SKIPPER 7th Health Region of Crete (DYPE7- Greece); Italian scientific and multi-disciplinary association for the study of respiratory diseases (AIMAR); • French-language Society of Pneumology (SPLF). The first pilot is localized in Italy and supported by the Tuscany Region (the Public Health Service is organized on a regional basis in Italy) that involves as stakeholders and users in addition to the local Health Authority, an association of general practitioners (GPs) and an association of patients. The second pilot is supported by the Greek Thoracic Society in Greece and involves the private hospital IASSIS (partner of the project), private pulmonologists and a group of patients. These institutions are very interested in the results of the project and aims towards using the outcomes and know-how gained after the end of the proposed project. In particular, Tuscany Region is adopting the chronic care model and it is very interested in verifying the impact of the SKIPPER solution for the management of this organizational model. Furthermore, the diversity of the pilots included in the SKIPPER project embracing both public healthcare structure with the support of a large Italian region and private institutions with the support of a Greek NonGovernmental Organization (NGO) of high relevance will ensure a high commitment in the deployment of the developed innovative services after the R&D phase. In general, the engagement of local authorities in support for this project demonstrate the potential interest of public organizations in the concept and the expected outcomes of the SKIPPER project and contributes to the visibility of project results and introduces awareness and knowledge about new alternative and improved services to manage COPD and its comorbidities. The public institutions and the NGOs are, in fact, interested to promote the adoption of the SKIPPER platform in other healthcare institutions in their areas of leverage (from local and regional, to national level and beyond), once the platform will be successfully validated. All the mentioned letters of support/endorsement are attached at the end of this Part B. Other care authorities are expected to be contacted, made aware and involved to a certain level during the course of the project through the members of the advisory boards, the supporting NGOs and the care authorities already endorsing the SKIPPER project Through extensive dissemination activities and close contact with local authorities, SKIPPER aims to move its services to integration in existing services. The project will also contribute to an alternative view of prevention, management and care of chronic illnesses that puts the patient as the central point in the care pathways placing important value to social and informal care. Hence, management of chronic illnesses and continuity of care becomes a social way of life with the effective integration of all levels of care. • •
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7. Increased level of education and acceptance by patients and care givers of ICT solutions for personalised care.
8. Reduced admissions and days spent in care institutions, improved disease management and treatment at the point of need, actual improvements in the daily activities of older persons through the effective use of ICT and the better coordination of care processes.
Proposal Part B
STREP proposal
SKIPPER Patient empowerment is a new approach in health care with the point of view of having patients as active participants in the health care process for the attainment of optimal outcomes. The active participation implies a higher involvement in the decision making process. An appropriate decision making can be performed only if a proper communication between patient and clinicians is assured and the patient is provided with appropriate education material and supported with the necessary information resources. An appropriate use of healthcare best practice supported by electronic processes and communication (eHealth) may enable the patient empowerment, especially in case of patients with chronic diseases, where a life-long daily disease management is required. Patient empowerment is a necessary pre-requisite of effective disease selfmanagement. Although self-management cannot substitute the acute care provided by professionals, it can help people with chronic diseases stay in the workforce and remain integral and active members of their community. Programmes on chronic disease self-management teach and support patients to identify warning symptoms, measure and evaluate vital signs, decide the most suitable treatment for them, and take medications. The SKIPPER platform will support patients in the short and long term management of COPD. Key components, specifically focused on supporting patient empowerment and self-management, of such solutions is represented by the services for the patients, which allow their interaction with the PHR, provide at any time and in any place the relevant information for them, improve their interaction with the clinicians, support education and motivation, and provide information about life-style, behaviour and emotional status. Easy user interfaces and concepts of motivational support will be adopted in order to involve patients and to increase their acceptance and their level of education, creating well health-aware end-users. Measurable indicators of the patient acceptance and improved education will be defined and evaluated in the two pilots through subjective and objective assessments. The decision support systems implementing advanced clinical and epidemiological and clinical knowledge that drives the follow-up process should improve the coordination of care processes and thus reduces COPD burden. Three major indicators would be used to assess the impact of the SKIPPER platform: 1. Real-time patient follow up process 2. Patient’s satisfaction 3. Continuity of care. The real-time patient follow-up process has to improve disease management and treatment at the point of need, reducing the need of unplanned admissions, unplanned consultations and days spent in care institutions. In addition, it will allow reducing the use of rescue medications (in the case of exacerbations) in favour of maintenance medications more appropriate to control COPD.
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SKIPPER Patient’s satisfaction that will be assessed using an appropriate questionnaire that will cover the three following areas: quality issues (i.e., is the patient satisfied with his or her medical care?), access issues (i.e., is it easy to obtain care, make an appointment or get a referral?), and interpersonal issues (i.e., are the physicians and staff caring and compassionate?). The continuity of care will be considered as an important additional criterion in the evaluation of the impact of the SKIPPER platform. Patients are increasingly seen by an array of providers in a wide variety of organisations and places, raising concerns about fragmentation of care. Policy reports and charters worldwide urge a concerted effort to enhance continuity, but efforts to describe the problem or formulate solutions are complicated by the lack of consensus on the definition of continuity. Continuity of care has to be intended as the experience of both recipients and providers that everyone involved in the care process is working together across settings and throughout the course of illness, to address the unique needs and preferences of an individual patient and family. Haggerty et al (2003) in a multidisciplinary review define three types of continuity of care: informational, management and relational. Informational continuity. The use of information about the patient’s medical condition, past treatment, and personal circumstances (including care preferences) to deliver the most appropriate care for each individual/family. The components of coordinated care are: • Families: Having information and assistance to access services as needed • Providers: Having adequate information about the medical condition and the • family, and adequate communication about all care being provided so they can • deliver the right care at the right time Management continuity. A coherent approach to the management of a health condition achieved via a consistent and flexible management plan that is accepted by all providers and the individual/family. The components are: • Families: Participating with providers in developing a shared care plan • Providers: Collaborating in care planning and delivery on a regular basis with family, clinicians and other providers within and outside their own institutions; • delivering care based on a shared care plan Relational continuity. A consistent therapeutic relationship between the individual/family and one or more providers; access at all times to a provider who “knows” the patient/family. The components are: • Families: Able to identify the person or entity “in charge” of care and know how to contact that person or entity 24/7; having a consistent
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9. Increased degree of interoperability and standardisation in the developed solutions, with secure, seamless communication of data related to health and wellbeing among all involved parties, including patients, older persons and carers.
Proposal Part B
STREP proposal
SKIPPER and reliable relationship with one or more providers • Providers: Acknowledging the role of the entity “in charge” of coordinating care; having consistent, reliable working relationships with other providers/entities serving the child and family Lastly, the access to care is also of relevance. This depends on the health system and has to be taken into account in an European project as SKIPPER. All the solutions, with no exceptions, proposed by SKIPPER project are based on international and largely accepted standards, and the compliance of the SKIPPER solution with these standards will be systematically tested. From the SKIPPER point of view interoperability in the Internet of services and things can be ensured only by effective and tested compliance with standard specifications. The presence of HL7 as a SKIPPER partner, and of key HSSP personalities in the Scientific Board, should be interpreted as a guarantee of the interoperability and standard compliance of the design and the implementation. SKIPPER service components framework is structured in three layers: (L1) Basic healthcare generic service components, (L2) Value-added healthcare generic services components, (L3) Front-end healthcare generic service components. The L1 layer, supplied by the partners as project background, implements all the HL7/OMG Healthcare Services Specification Program (HSSP) adopted or near-to-be-adopted standards (RLUS, hData, IXS, CTS2, CDSS, ServD). For basic functionalities that are uncovered by the HSSP program, such as service registry management, we will employ service components compliant with other international and European standards (IHE, ETSI, the European initiative epSOS). Security standards are the universally accepted SAML, XACML, WS-Security, WS-SecurityPolicy, XML Encryption, XML Signature… Of course, the data structures will be all HL7 V3 compliant. The L2 layer is designed and developed as project foreground and will contain three macro-components: (i) the Care Coordination Service (and its Master Care Plan) management that will be designed as an implementation of the on-going HSSP Care Coordination Service project that has started in October 2012, in which key SKIPPER partners are involved; (ii) remote mobile and fixed device handlers – all the interactions between the remote devices and the service components will be based on the basic standard services such as RLUS, hData, IXS, CTS2; (iii) decision support systems for monitoring, interactive consultation, patient guidance and clinical support, based on various inference methods and implementation technologies – all these systems will interact with the other service components through the HSSP CDSS standard. The L3 layer is based upon W3C universally accepted standards such as HTML 4.01 and the on-going work on HTML 5.0 (Recommendation scheduled for 2014), SSL and other. The service orientation adopted by the SKIPPER project facilitates openness and interoperability. The standards listed above concern service external
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10.Strengthened European industrial position in eHealth and independent living products and services by creating new business areas and relevant standardisation efforts.
Proposal Part B
STREP proposal
SKIPPER specifications (contracts), that are shared and common, not implementations that stay private and proprietary. The good news is that any entity (from care settings to devices) that has to interact with SKIPPER service components platform (whatever the level of interaction will be, from basic data retrieval to decision support system interrogation) is not obliged to change its implementation, but only to implement an adapter enabling standard service interaction. In order to make easy the access to its services and to “enrol” care settings and devices in the continuity of care, the SKIPPER platform will make available: (i) proxy and skeleton libraries for easy adapter implementation; (ii) interoperability and compliance test suites for easy testing; (iii) dedicated environments on cloud for developing and testing interactions with the platform. There is no largely accepted standard of cloud infrastructure, even if the Amazon implementation is considered by many people as a de facto standard. The European Commission sponsors the activity of ETSI on this domain. The SKIPPER project will follow very carefully this activity and adopt the resulting recommendations. Indicators resulting from the logs issued from compliance and interoperability testing campaign on the SKIPPER service framework can be considered as measures of success of this impact point. The involvement in the consortium of industrial partners (industry and SMEs) and high-profile research and academic partners ensures the SKIPPER project will have a major impact on reinforcing the eHealth industry in Europe promoting interoperable and multi-vendor solutions and thus fighting against attempts of monopoly in the market usually performed by companies selling closed and proprietary solutions. The establishment of interoperability between devices and services of different vendors in a heterogeneous environment are a precondition for market growth in the health and wellbeing sector. Health information systems are changing from more or less complex vertical applications, with significant integration costs, to horizontal solutions almost natively interoperable, based on consolidated existing standards like HL7 (messages), IHE (integration profiles) and the recent HSSP (services), in the attempt to reduce the integration costs and to minimize the delivery time. The architectural solution based on the interoperable SaaS will allow a flexible composition of services and also exploitation of separate modules/components which can be used or re-used in different, more focused or more extended contexts. More specifically DEDA, as large industry and Italian leader in the national eHealth sector, will be interested to the exploitation of the overall platform inserting it in its portfolio and thus reducing significantly the integration costs with pre-existing health information systems that nowadays have always to be taken into account in any deployment at a private or public healthcare provider.
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SKIPPER SMEs participating in the consortium will take advantage from the exploitation of interoperable modules/components compliant with relevant standards that can easily be integrated in interoperable commercial platforms. Indicators will result from the portfolio of products and services of the industrial partners and from the estimated reduction in the integration costs of the interoperable components and overall platform. Other indicators will result from the compliance with existing standards that will be assessed in the course of the project. Main standardization efforts From a standardization point of view, by managing international terminologies correctly in the pan-European space, PHAST will contribute to the ever-increasing need to have a centrally-managed terminology repository across Europe to better coordinate communication in healthcare and set an example in best practices in terminology management. The project will closely work together with the standardization bodies HL7 and IHE for the improvement of existing standards and profiles and new ones to be developed. The main standardization effort in which the SKIPPER project will be directly involved is the HL7/OMG HSSP Care Coordination Service. The Care Coordination Service is a standards development/specification effort being undertaken by HL7 to be followed by SOA specification work at the OMG. The project will be done in collaboration with the “HL7 Patient Care” and “HL7 Clinical Decision Support” work groups. “The objective is to provide SOA capabilities to support patient care coordination across the continuum. The viewpoint of these capabilities is the patient as he or she crosses care settings and interacts with care givers with different focus and specialties. The context is episodes of care spanning multiple organizations, the interactions at the boundaries of care transitions, and the subset of information necessary and sufficient to support these interactions. The CCS will support shared and coordinated care plans. The CCS will support multidisciplinary care team members to communicate changes resulting from care plan interventions and collaborate in removing barriers to care. The CCS will provide on demand synchronization of information to keep the virtual care team on the same page and prevent having the patient fall through the cracks of the silos of care. Care Team members will collaborate around these shared plans, co-authoring plan elements as the team observes. Structurally, the shared Care Plan will serve to coordinate specialty care plans, and will have the ability to seamlessly navigate to them without requiring physical centralization of data storage.” The design of the SKIPPER services architecture is concurrent with the work of the CCS project. The partners of the project will participate to the Project and will cross experiences with the other professionals involved in the standardization group. The study of a specific “storyboard” (COPD and comorbidities care) will validate more generic approaches that will be
Proposal Part B
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SKIPPER adopted for generic chronic comorbidities care. The SKIPPER service component framework will be one of the “proofs of concept” of such a standardization process. It should be noticed that for CCS project proof of concept will be particularly challenging because the services components that implement CCS must be supported by all the already standardized HSSP services (RLUS, IXS, CTS2, DSS, …), which is the case of the SKIPPER project, in which the related components (the L1 layer service components in the SKIPPER framework architecture) are in the background of the project. The involvement in the standardization project will be supported by the presence of HL7 as a partner of the project.
3.1.3 Steps necessary to bring about the impacts The organization of the SKIPPER consortium, the roles assigned to the partners, the structure of the work plan and all the project activities are been conceived, defined and proposed taking into account two main objectives: 1. the achievement of the expected results within the lifetime of the project, according to the objectives declared in our proposal 2. the building of the right basis for rapidly bring about the potential impacts, in terms of a. technological and functional perspectives of pre-existing software solutions, b. sustainable perspectives for developing and delivering innovative services architectures able to support integrated and personalize management of chronic diseases, the continuity of care across different care setting and the empowerment of patients c. integrated and new business models for delivering innovative services through new channels, such as the cloud infrastructures. In particular, the SKIPPER consortium includes very qualified research centres, universities and standardization organizations (HL7), that will guarantee innovative technological and scientific results in the several eHealth domain, such a knowledge management and decision support systems, devices network infrastructure for remote and continuous telemonitoring of patients, technical and semantic interoperability services. But it is also very important to underline that SKIPPER is a business driven proposal, where: • Dedalus is a large industry, leader in Italy of the eHealth market, that is at moment delivering in Italy and in other important countries (China, South Africa) a EHR system for supporting continuity of care between hospitals, specialists and GPs. Dedalus will provide this background to the SKIPPER project and is very interested to exploit the SKIPPER solution in order to completely cover the emerging needs of the national healthcare services in terms of seamless continuity of care, optimization of the available resources, empowerment of the patients, with the definition of sustainable healthcare organizational models. • SEF and T4ALL are very innovative SMEs respectively in the SOA domain and in the remote telemonitoring. They are very interesting to improve the interoperability and the efficacy of their solutions and to enter in the global market of the innovative healthcare service architectures. • IASSIS is a private hospital and is very interested to present the SKIPPER solution to the regional administration for evaluation, in order to incorporate it in programs aiming to help elder people in their houses, especially if they have mobility problems. • INNOVA , that during the project will identify, study and evaluate the business opportunities for the SKIPPER solution, will be interested to actual support the technology transfer and the achievement of these opportunities. • Also FORTH might be interested in exploiting the results for delivering the SKIPPER solution in the Greek Health Regions. In order to address these objectives, the work plan includes: Proposal Part B
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The WP8 for evaluating the SKIPPER solution in real healthcare settings and for providing all the information required for the social, economic and business studies related to the potential exploitability of the project results. For better supporting the definition, the activation, the evaluation and the validation of the SKIPPER solution, the project has asked for and got the endorsement of very important public healthcare authorities and scientific associations. • The WP9 for performing these studies and providing inputs for an actual exploitation of the business opportunities. During the project lifetime will be also very important the early identification of the user communities and the involvement of the different user communities (administrators, care providers, doctors, nurses, patients, relatives, insurance companies, etc.) in the requirement phase and user need definition since the very beginning of the project. Furthermore during the pilot experimentations will be useful to perform extensive validation of the platform against the user requirements through the use of questionnaire, economical comparison with the previous situation, quantitative evaluation of the significant indexes (i.e. reduction in hospitalizations, increment of early detection, etc.). The partners are confident that at the end of the project, there will be important inputs for bringing about the potential impacts. The steps after the end of the project should therefore be the following: • the partners of the consortium should support the healthcare authorities involved in the pilots in promoting the adoption of the SKIPPER platform in other healthcare institutions in their areas of leverage (from local and regional, to national level and beyond). During the lifetime of the project specific pre-commercial procurements could be defined for better addressing the objectives of the SKIPPER platform. • INNOVA should support DEDA for defining the more appropriate business models for the SKIPPER solution exploitation, taking into account also the possibility to exploit the potential international market of DEDA. • DEDA should define as soon as possible an industrial plan for the engineering of the SKIPPER solution. • According to the Consortium agreement, INNOVA should support also the necessary technology transfer of the SKIPPER results towards the SME partners. • The research centres and the universities should continue to promote the results of the SKIPPER project. In particular, the Epidemiology of Allergy and Respiratory Diseases department of UPMC should promote the SKIPPER project in the scientific events talking about the clinical and medical topics of the project. All the partners should propose the use of the SKIPPER solution in other similar research initiatives. • FRAUHOFER, in particular, will use the SKIPPER solution for enriching FOKUS’s existing portfolio of standards based platform modules which again allows FOKUS for stepping forward on innovation based on more and more sophisticated platform functionality. This will contribute to refine and consolidate the SKIPPER solution. • HL7 should promote the SKIPPER results within the international events and, in particular, in the framework of the HSSP project. How we said above, the interoperability standards will play a very important role for the exploitation of the SKIPPER results. • We have to take into account that SKIPPER is a STREP project, that involves few partners. This means that the activities above could need other support actions, in order to perform bigger trials and larger business models studies. 3.1.4 Reasons for a European approach The SKIPPER vision is based on the premise that in today’s world the right environment for the provision of effective delivery of healthcare cannot be limited and just be seen as a local or national activity. In general, for best results in care delivery to patients, especially for those suffering from chronic and in many cases debilitating diseases, there is a great need of specialised expertise from various sectors. Especially, for anybody who engages in biomedical research there is a pressing need for a communication and Proposal Part B
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computational infrastructure that provides the means for collaboration and sharing of information. In addition, progress in life sciences depends on our ability to develop common representations (ontologies, integrated vocabularies, etc.) to model and describe heterogeneous information. There are several reasons which necessitate the realisation of the proposed project by a consortium of academics, researchers and engineers at European level, including: • • • •
The sharing of international expertise and consultation; Allow for the assessment of current needs and clinical practices, compare these practices between countries and develop common guidelines based on proven and best practices; Analyse and design different protocols for different clinical or social domains in different countries with different socio-economic status and cultural differences, to see if these clinical protocols are applicable to a variety of situations; Account for regional, ethnic, economic, gender-based differences in care and while respecting diversity, establish universal principles for personal health management and clinical care.
It is therefore evident that the SKIPPER consortium has recognized the fact that the complexity of the current proposal will preclude the finding of all the needed expertise in any single European Country. Furthermore, in our view, working in multinational, multidisciplinary and cross-disciplinary environments will be the norm rather than the exception, and since in the near future the use of ICT tools and technology will be the basic enabler of future scientific work, the SKIPPER proposal will contribute towards this direction, by bringing together a critical mass of European researchers and users, supported by a state-ofthe-art computational infrastructure and services. Moreover, since the SKIPPER consortium espouses the statement that “more than ever before, partnering at European level is needed to keep pace with soaring research costs in an era of global competition, and increasingly complex and interdependent technologies”, it has brought together experts from many different countries as well as from different scientific domains. Thus, European expertise in areas dealing with: • environmental and medical sensors and their interface; • mobile computing and mobile agents; • user interfaces and web design; • heterogeneous networks for continuity of care; • clinical workflows for holistic management of chronic diseases; has been brought together, in order to provide the foundations for a truly European solution. Finally, the SKIPPER consortium, by supporting one of the main objectives of EU policy, namely, that of strengthening partnership and collaboration in ICT research in an enlarged Union, has taken concrete measures by including a number of such organizations, integrated with the remaining partners and with a real and significant part of the work assigned to them. In order to strength the European vision of the SKIPPER proposal, the consortium is already in contact or intend to activate possible collaborations with the European initiatives, related to eHealth, described in the Section 1.2.1.10. 3.1.5 Assumptions and external factors influencing the achievement of the impacts The SKIPPER consortium strongly feels that great care was taken to minimise possible hindrances and pitfalls that might be encountered in order to assure the expected impacts for the SKIPPER outcomes. The main barriers and risk factors are mainly related to the fact that relevant stakeholders might tend to still adopt a “wait and see attitude” without developing policies or adopting changes in current care models. On the other side the SKIPPER consortium has already attained a significant interest from relevant stakeholders as can be seen in a number of letter of intents or supports attached to this proposal and that make the consortium partners confident that a critical mass of stakeholders can be built before the completion of the project.
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However, evolution in technology, market and care process and delivery models will be properly monitored in the course of the project and retrofits applied to the development in order to guarantee the outcomes will be in line with the expected trends thus maximizing its impact. Furthermore, in the risk register which will be initialized at the beginning of the project, maintained and monitored for all course of the project also risks related to the attainment of the expected impact will be taken into account and proper mitigation plans will be adopted.
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Dissemination and/or exploitation of project results, and management of intellectual property
3.2.1
Dissemination activities
The dissemination of results is a key aspect for a successful research project. Such transfer begins from the first days of the project to its completion and beyond. In many cases, consortia are unaware of the interests of other stakeholders and often use very different language and concepts. At a first stage, the project will identify the potential target audience, what message we can give them and why. In this section, we show a set of activities that will be integrated in the dissemination strategy, which will be focused on identified target stakeholders. Similarly, adequate metrics will be defined to allow us monitoring and controlling if the dissemination activities are achieving goals. These aspects will be accurately defined in the Dissemination plan and strategy, to be delivered during the first year of the project lifetime. The dissemination strategy consists of policies that run through a series of actions to reach the target audience through some channels. These activities will be developed as a horizontal activity that takes place throughout the project life cycle, and will be dynamic to incorporate all the feedback we have to maximize the involvement of target interest groups. To reach the target audience, we will make use of three broadcast channels, which are structured as follows: Online channel: at the centre of diffusion we use the project website, which will include all project results and in which different stakeholders can submit their feedback. Dissemination material will be linked to this website. This channel will include online services such as mailing lists, forums, blogs and newsletters in order to become a virtual community of interested parties around the project, to enhance their participation and to create awareness of the research results. Online media, such as web newspapers, magazines, TVs and radios will be surveyed and selected for promoting the SKIPPER activities and results. Offline channel: we also use other channels to promote knowledge transfer as topic-specific articles in journals, research papers and presentations at international conferences. Interactive Channel: This channel will serve as a mechanism to interact with academia, business and the various socio-economic agents at conferences and events organized at European level and in trade fares and exhibitions. This channel will be most effective in order to create a community that maximizes the impact of the activities of dissemination and exploitation of project results. As the technical work will progress, all dissemination efforts of the project will be directed to these general objectives: Presentation of project results at international scientific forums, workshops and conferences. Presentation of the various demos and prototypes produced in the project in national and international market forums. Presentations to potential customers, users and companies that may be interested in using or commercializing SKIPPER technologies. Promotion of the news regarding the project (activities, demos, results, events etc.) though media channels. Development and maintenance of a website where people, research teams and enterprises can visualize the main features of future SKIPPER based products and solutions, including interactive demos. Proposal Part B
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Development of an open innovation framework where interest groups and individuals involved in the project can collaborate to create a virtual community around the project. Although a detailed plan for the dissemination activities of the project and the selection of target events are part of the project activities, we anticipate that the main actions to be performed in this field will be: Project website: A website dedicated to the project will be designed and developed in order to be a focal point of a virtual community around the project. All media or dissemination activities will be linked on the website to promote the project results. Knowledge management: A private area will be constructed in order to share documents and ensure smooth communication between project partners. On top of that, a project web site will be developed for the general public. The main purpose of the private area is however knowledge management ensuring appropriated, ordered and secure storage and exchange of knowledge within the project targeted at attaining the objective of SKIPPER. Newsletter: as a newspaper diffusion of project results to the interest groups signed. Scientific dissemination: The research partners within SKIPPER (universities, research centres) envisage intensive editorial activities to scientific journals and professional magazines. These activities will be carried not only within the project time scope but also after its completion. Publication activities will be related to SKIPPER but predominantly carried on behalf of respective researchers. Papers in specialized international journals and magazines, especially those ones which emphasize software engineering, testing, service platforms, distributed systems and service oriented architectures as a key subject. Presentations at international conferences and exhibitions, both scientific-technical and end user focused events. Project demos and documentation: upon completion of the project a set of documents, papers, deliverables, technical reports and presentations will be available on the website for download. Basic dissemination material: this package is envisaged to include visual identity of the project (artwork: logo, slide/document templates, etc.), project presentation, leaflets, press release templates, etc. A demo video will be developed in order to reduce the learning curve and to show the value that the project may have for each interest group. Edition of White Papers. Specific domain validation tasks: WP8 of the project is targeted at validating SKIPPER framework over two specifics pilot cases localized in Italy and Greece. Validation scenarios will be developed within the project and stakeholders will be invited. This activity will therefore reach out for non-project participant and thus disseminate information about the project and its outcome. Workshops: apart from being present at external events, conferences and workshops, SKIPPER intends to organize own specific events. In particular, the SKIPPER consortium will organize at least one workshop associated to an international conference hosted in Europe and one own international event, aiming at promoting the SKIPPER platform. Moreover the SKIPPER project will organize events associated to specific initiatives focused on the Healthcare sector. General Purpose dissemination: the consortium will identify and use the more appropriate online and offline media for promoting the most interesting news of the project through press releases, information articles, interviews, videos etc. In particular, the partners of the SKIPPER consortium that have an internal press office and/or collaborate with national and international media will use them for promoting the news concerning the project. Internal dissemination: partners will present the results internally in their organization. Proposal Part B
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Collaboration with other projects and with research & innovation community For RTD collaboration with other research projects funded under Framework Programme, participation at Future Internet Assembly and European Technology Platforms in the field of the project. Participation at EC- and FP7-related events in concentration meetings and brokerage events scheduled by the European Commission and other organisations is previewed. This will result mainly in public project reporting and summaries as well as participation in surveys targeted at FP- projects. Scientific research community working on healthcare services. Participation at standardization committees in order to maximize the use of standards and promote their creation from the project results. In particular, the SKIPPER partners will be involved in International standardization initiatives, carried out by key standardization institutions such as HL7 (which is a SKIPPER partner) and the Object Management Group. In particular the SKIPPER project will be deeply involved in the Health Services Specification Program (HSSP) Care Coordination Service (CCS) project. The SKIPPER project: •
will participate to the definition of the care coordination standard;
•
will develop some of its critical value-added service components as a CCS standard specification “proof of concept”.
Project dissemination beyond Europe: the innovative character of the project makes it subject to interest beyond the border of Europe. This way, we will expose SKIPPER to various events outside Europe in order to make our results accessible and globally known. 3.2.2
Exploitation activities
The EC is aware about the high relevance of eHealth for the actual and the future of EU countries in terms of economic competitiveness, social welfare and improvement of health services to EU citizens. Special attention has been paid to patients who suffer from multiple chronic conditions and can benefit from integrated care. The action plan for a European e-Health Area is the best illustration for the solid communitarian will to achieve the generalization of the eHealth benefits among European citizens. In fact, the EC aims, by applying the different measures included in the Action Plan to: • • • • • • • • •
Face the increase demand for health and social services for patients suffering from chronic diseases; Reinforce medical knowledge with respect to efficient management of co-morbidities; Ensure the best health services possible and reduce their access inequalities; Improve the mobility of patient and professionals, thanks to new ICT technologies; Reduce the ‘disease burden’ and respond to emerging disease risks; Limit occupational accidents and diseases; Manage better all type of information and data related to health; Limit the expenditures linked to Health, while improving their efficiency, and Exploit the huge potentialities offered by eHealth to boost investment, especially in innovative fields.
Particularly, European COPD coalition (ECC) is committed to raising awareness about Chronic Obstructive Pulmonary Diseases (COPD) and its social and economic impacts among European policy makers and stakeholders, seeking ways to reduce the burden of the disease through collective action and advocacy, developing and implementing a comprehensive EU public health policy on COPD and by being a key facilitator of COPD policy initiatives at European and country level.
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SKIPPER solution is perfectly in line with the objectives listed above and will definitely contribute to achieve them. There is therefore great potential for the commercial exploitation of SKIPPER because it is precisely capable of meeting these challenges. The development and implementation of ICT in healthcare requires willingness to invest large sums without expecting to see the economic benefits immediately. In fact, an EU project, eHealth Impact (funded project under the FP6, www.ehealth-impact.org) has demonstrated that there is at least a 4 years payback period of ICT investments in eHealth. After this period, there will be a 2:1 ratio between costs and benefits, thus illustrating the overall benefits of investing in ICT in healthcare. Most governments are adapting this view and beginning to see ICT investments as long term investments a major priority in order to ensure an efficient and cost-effective healthcare system in the future. SKIPPER will provide a viable (profitable) business case for the suppliers of healthcare technology and will support exploitation by: • • • •
Developing a suitable framework for business modelling; Identifying actors and roles and the value created in terms of health benefits for COPD patients and commercial benefit; Deriving and validating viable business cases for the COPD domains in each country; Providing sustainable business models to support exploitation of SKIPPER platforms
One of the most important factors when launching a new market initiative and in order to ensure its success and the market sustainability is the capability, in terms of technical expertise and financial situation, to implement and sustain the investment costs. Pilots activity during the project will provide an overview on how SKIPPER organises the service provision and the overall technical structure, useful for the market viability study. The SKIPPER market viability will be first ensured thanks to a well-balanced project Consortium made of a group of European organisations with complementary expertise in developing and deploying e-services, providing solutions covering the entire supply chain for SKIPPER service provision. Project partners are interested to promote SKIPPER services Europe wide as well as contributing to expand the business dimension with market strategy addressed to add new functionalities for the main target market and to conquer new market segments and therefore potential customers. SKIPPER services market viability will be first granted by the existence of a real need for assistance for people affected by COPD, common to all European countries. Epidemiologic studies examining the incidence of respiratory symptoms show that COPD is a major health problem in Europe. However, it is very difficult to have exact figures of COPD prevalence in Europe due to the heterogeneity of studied populations (general, ”targeted”, selected age groups, …), the heterogeneity of methods (symptom-based, medical diagnosis & expert opinion, spirometry-based, …), underestimation of disease severity by the patients who report their smoking with a sense of guilt. As a consequence, COPD is often under-diagnosed; the true prevalence rates and the burden of disease may be much higher than the currently available data suggest, coming from Pauwels, Wouters, Halbert studies. 3.2.2.1
Burden of illness studies of COPD and evaluation of the economic impact in SKIPPER
Burden of illness studies aim to describe the economic impact of COPD in a particular setting, usually a country. They are often used for campaigning or political purposes to highlight the importance of a particular condition. These studies aim to quantify the direct costs that result from managing a condition, such as the costs of drugs, physician time, and hospitalization. They also attempt to quantify the indirect costs to society, which for COPD are significant.
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Indirect costs represent a principal area of uncertainty in burden of illness studies and account for much of the variation in estimates of economic costs between different studies. Indirect cost estimates include the costs of lost productivity but do not usually include the costs of any social security payments or other monetary benefits paid to a patient or their caregivers as these are not considered as costs to society as a whole, but rather as transfers from taxpayers to the recipients. Indirect costs may be substantial and, in many countries, are similar to the direct cost of managing COPD. Recent data from the United Kingdom have shown that 44% of patients with COPD were under retirement age; 24% of patients reported being totally unable to work, and a further 9% were limited in their ability to work. On average, a mean of 12 d were lost per patient per year. COPD also resulted in 5% of carers missing time from work. For calculation of the costs of COPD, a number of issues arise. Analyses based on randomized control trials remain the gold standard in economic evaluations because of their high internal validity, but results should be interpreted with caution because of their low external validity. That is, it may not be possible to generalize because of aspects of the trial protocol or patient inclusion and exclusion criteria. There are a number of options to enhance external validity; of these, additional modelling and observational data based on real-world disease management are the most promising. There have also been concerns about the analysis and interpretation of cost data from published trials. Potentially misleading conclusions about the relative costs of different or new therapies have often been reported in the absence of supporting statistical evidence. Costs can be calculated by collecting data at a top level (e.g., national spending on oxygen therapy) or by collecting detailed data on individual item costs incurred in the care of specific patients. Deciding which approach to adopt depends largely on the intervention being assessed. Bottom-up or micro-costing is often more appropriate when there is a large component of staff input or overheads, significant sharing of staff or facilities between interventions or patient groups, or if the health care costing system does not routinely allocate costs to the intervention level. In the consideration of costs, the infrastructure or capital costs of buildings (such as hospitals) should not be overlooked. The costs of lost productivity can be estimated either by the human capital approach, which is based on market wage rates, or the friction cost approach, which assumes that in a society with less than full employment another worker can replace the absent worker. The choice of approach to this question can have a profound influence on the calculation of indirect costs. If a detailed bottom-up costing method is used, there may be practical and logistical problems in collecting accurate cost data for every item. In these circumstances it may be more useful to concentrate on capturing the costs of the important components rather than the often unachievable aim of capturing every cost however small. Four burden of illness studies for COPD in the EU have been published in 2007. Three used a top-down approach and one used a bottom-up approach. With the year in which they were undertaken and their design taken into account, they resulted in similar estimates of the economic burden of COPD—between euro 781 and euro 1,154 per patient per year with an overall annual cost (both direct and indirect) of between euro 800M and euro 1,500M. The breakdown of direct costs of COPD care in the EU from the most recent of these studies is shown in Figure 2. It is clear that just over half the average costs are due to hospitalization. This is also reflected in the breakdown of societal costs according to disease severity, where it is evident that patients with severe COPD account for most of the direct and indirect costs (Table below).
Table 8: Average EU societal costs of chronic obstructive pulmonary disease according to severity
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From data such as these, burden of illness studies can also help identify clinical targets or patterns of care such as hospitalization that are major drivers of health care costs. This may help when setting priorities for research or investment and can be used to compare the appropriateness of the allocation of research funding. These estimates are also often subject to reporting or classification biases that reflect local reimbursement arrangements. In addition, there are technical issues about comparing costs in different countries and whether this should be done purely on exchange rate conversions or on the basis of purchasing power within the country (known purchasing power parity). The study of the economic impact of SKIPPER on COPD will be declined into four basic approaches: •
•
•
•
3.2.2.2
Cost-Minimization Analysis. It is the simplest cost-evaluation method. It takes therapies with equal efficacy and compares their costs. Ideally, this should include all aspects of the costs of therapy, including acquisition, storage, administration, and monitoring costs. Cost-Effectiveness Analysis. It involves calculating the costs of different therapies that achieve different clinical outcomes and comparing these costs on the basis of the cost to achieve a particular outcome. The difference between therapies is often expressed as the incremental costeffectiveness ratio—that is, the additional cost to achieve a better outcome. Cost-Benefit Analysis. It calculates the cost of particular interventions and relate these to the cost savings that result from that approach. The time over which costs are spread is an important factor in such analyses. When viewed from the perspective of the whole health care budget, the cost savings can sometimes be virtual rather than real. For example, saving hospital bed days may be very important to allow other patients to be admitted, but rarely reduces overall costs to the health care system as another patient will be admitted to that bed. Nevertheless, this does allow more patients to be treated for the same expenditure and so is a more efficient use of resources. An example of cost-benefit analysis is a study of the number of patients with COPD needed to treat with a combination of budesonide and formoterol compared with formoterol alone to prevent an exacerbation, and relating this to the costs saved by preventing that exacerbation. Cost-Utility Analysis. It is becoming the most widely used form of cost evaluation for new therapies. It is essentially a subtype of cost-effectiveness analysis but uses utility to measure the effectiveness as a way of comparing therapies in different disease areas or therapies that achieve different types of outcomes within a disease (e.g., increased exercise capacity vs. reduced exacerbation rates). Business exploitation models
In order to reach viability, sustainability and scalability, the SKIPPER project will adopt an ontological perspective on the exploration of innovative service concepts and for quantifying value creation based on the analysis of economic value creation and exchange of value objects among stakeholders. The value exchange can be analysed in terms of value proposition and profitability for e.g. the “buyer” and the “seller”. By adopting the ontology consistently over the business landscape, a complete value model can be developed for the healthcare and social care ecosystem, including the values that are not monetary in nature. The business models will include and measure values created among: • • •
Primary end-users: improved quality of living and health, mobility, staying longer in the workforce, etc. Secondary end-users: improve case management, effectiveness, better resource utilisation, etc. Tertiary end-users: cost-benefit, quality of healthcare, interaction of health and social carers
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Business actors: profitability and sustainability of commercial services and supplies
The exploitation approach can be considered as a piece of the overall business strategy to exploit SKIPPER solution and in particular it aims to answer the following questions: • • •
Which business model will be used to sell SKIPPER services? Who will sell SKIPPER services? Who will organise and coordinate SKIPPER project partners to sell and run the services?
One of the main issues, relating to the organisation of the SKIPPER services, with its deployment and marketing strategy, is the definition of its primary business organisation. This entails the definition of a legal concept or framework for the to-be-defined SKIPPER entity and the partnering or shareholder models of the SKIPPER services to be marketed. From the different business and legal organisations that can be adopted by the partners to sell SKIPPER services two are considered the most suitable for deploying the services in the market: a) a decentralised model to deploy SKIPPER services recurring to responsible national/regional nodes; b) a centralised approach based on launching a new start-up; In a decentralised model, SKIPPER services deployment will be carried out on independent local “nodes”, which take care of SKIPPER market entry executing the following main functions: • • •
the identification of potential customers; marketing of SKIPPER products and services; Set up SKIPPER services for customer in coordination with the project technical partners.
Local nodes are represented first by the project partners and/or by private organisations, interested in promoting SKIPPER services that establish commercial agreements with the project partners, owners of SKIPPER platform technologies and brands. In this situation a node would be formed by means of strategic alliances between a local company, which act as promoter and, the project partners who own SKIPPER platform and technical expertise. Under this schema, some SKIPPER partners have a priori defined individual exploitation targets for bringing the SKIPPER platform and services to the market before project completion. DEDA Dedalus is a national leader in the eHealth sector and has an important role also in Hospital-Territory integration systems, with a presence in almost all the Regions implementing important projects of interoperability and cooperation among the various healthcare establishments, such as hospitals, general practitioners and local healthcare units. Dedalus is capable of consistently strengthening its position in each of these segments thanks to its innovative approach, based on the development of software aimed at ensuring interoperability and cooperation among general medicine systems and hospital systems, facilitating the optimisation of administrative management, as well as the provision of the best healthcare, thanks to a constant real time exchange of fundamental patient data, during all the stages of their life: from birth, to the growing up stage, to maturity and old age. Thanks to this approach and to its interoperability platform, Dedalus started and internationalization process, acquiring new market segments in China, East-Europe, South Africa and other countries. For this reason, Dedalus is interested in the industrialization of the SKIPPER solution, in order to strengthen its position in the national market and also advance the internationalization process. In fact, the SKIPPER solution is perfectly in line with the Dedalus product for the integration between hospital and territory, and would complete the Dedalus offer thus providing full support to patient integrated pathways, continuity of care and an improved effectiveness of the company care system. Proposal Part B
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SEF Simple Engineering France considers very carefully the opportunity to put in place As-A-Service on cloud a platform of continuity of care and of real-time patient follow-up for chronic diseases, on the basis of the SKIPPER results. The general availability of a cloud infrastructure lowers the barriers to the healthcare service provision market and put this opportunity within the reach of SMEs. T4ALL The SKIPPER project will provide T4All with new relevant opportunities to gain competitiveness into the e-health domain. The exploitation plan includes two different approaches: • •
To enhance the actual T4All solution for patient remote monitoring with data coming from wearable sensor networks rather than commercial off-the-shelf devices; To leverage the expertise in data management, taking advantages from the adoption of International standards (HL7, …) in healthcare communication
As an outcome, T4All will contribute to the market validation and deployment of the SKIPPER prototype, with main focus on the exploitation of the remote monitoring kit to be designed on a pathologybased approach and integrated into the whole SKIPPER data flow. This will represent a relevant step in terms of company competitiveness, providing the chance to expose the company skills and SKIPPER innovative solutions at European level. IASSIS Basic aim is to improve the quality of provided services. This can be achieved with the use of functional electronic devices and a solid DSS. We expect that the hospital and the associated physicians will be capable for closer monitoring of the patients’ health status with Real – Time information, thus having the ability for faster intervention. This can prove crucial for patients leaving in remote and mountainous areas. The solution will be presented to the regional administration for evaluation, in order to incorporate it in programs aiming to help elder people in their houses, especially if they have mobility problems. FRAUNHOFER As an institute for applied research Fraunhofer FOKUS core business is on innovation. Innovative solutions in healthcare always depend on the availability of platforms for sharing health data and for connecting people (and IT systems). The SKIPPER project will enrich FOKUS’s existing portfolio of standards based platform modules which again allows FOKUS for stepping forward on innovation based on more and more sophisticated platform functionality. The developed test cases and test procedures for interoperability testing and security testing will be integrated into Fraunhofer FOKUS eHealth Lab and become part of FOKUS’s regular offers to customers for testing and consulting. 3.2.2.3
SKIPPER Start-up Model
A further possibility to exploit SKIPPER platform is to develop a European Joint Venture (a new start-up) with the joint participation of potential (interested) partners. The major advantage of such a solution is related to the reduced difficulty to co-ordinate certain sensitive actions such as financing, strategy formulation and decision making. The major advantage of the launching of an SKIPPER Venture is related to a better the financial sustainability of the project in the long-run. A more centralized European start-up creates the market capillarity and visibility for SKIPPER as a provider of advanced ICT solutions. SKIPPER venture will be an independent company participated by SKIPPER partners and even by other organisation interested to invest in SKIPPER business, which will take care of deploying SKIPPER into the market. SKIPPER venture manages all business activities related to promoting and marketing SKIPPER as well as handles all the technical activities for installing SKIPPER platform or, if required, provides SKIPPER functionalities through ASP Proposal Part B
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model. SKIPPER venture will face the European market, however to better serve the national markets branches can be established locally. All possible exploitation models will be further discussed and analysed during the project, according to the in depth market analysis that will be carried out and the results of the business plan. 3.2.3
Knowledge Management and IPR
The management structure of SKIPPER includes a specific committee, the Intellectual Property Committee (IPC) for supervising the established rules in terms of knowledge management and intellectual property rights (IPR). The work will be founded on the rules described in the Consortium Agreement and, when not specifically mentioned in the Consortium Agreement, with the rules defined by the EC for projects of the 7th Framework Programme. This committee will also manage any critical issue and will take care, in case will be required by the General Management Board, of updating the rules during the course of the project with the consensus of all partners. Among the other activities the IPC will be in charge of maintaining a schedule of knowledge produced during the project (foreground knowledge) and, in conjunction with the partners involved, assessing the opportunities to apply for patents or declare copyrights. This activity will comprise the: •
Description of the innovative elements of the R&D work;
•
Review of existing patents databases and other scientific databases for similar developments;
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Reporting to the GMB about the innovation status of the project results and proposing registration of patents where appropriate.
A representative of the IPC will also take regularly part in the General Management Board reporting any relevant issue. Knowledge management There is no doubt, that SKIPPER will create new relevant knowledge. It is evident from the profile and the list of publications of academic and research partners that new knowledge is generally made available to the academic community, since the community peer-review is essential for the attainment of scientific progress. The universities and research centres in this consortium are involved with higher education, which is about formulating, disclosing and sharing knowledge for the next generations. Thus, the owner of knowledge will have to provide adequate and effective protection for knowledge that is capable of industrial or commercial application. The consortium participants may publish or disclose information on knowledge arising from the project provided this does not affect the protection of that knowledge. In case any knowledge dissemination may impact on the exploitation potential of one or more partners, the issue should be solved in the agreed within the Intellectual Property Committee and when necessary the General Management Board. As the companies in SKIPPER recognize the potential impact of this project and its relevance through market development and product sales, they will as well strive to participate in generating and publishing knowledge - the companies often chose to publish in the form of patents securing themselves intellectual property rights (IPR), but may also join the academic and research partners in scientific publications. When using knowledge, the consortium partners will make every effort to ensure confidentiality and the need to safeguard the interest of the consortium partners, especially their IPR. The process will be agreed and described in the consortium agreement and will ensure that all IPRs are properly handled both at a participant and consortium level, that patents are filed where and when necessary, and that proper and appropriate legal advice is obtained at each step along the way. General Approach The general strategy that the SKIPPER consortium will implement for managing knowledge and intellectual property will cover, without being limited to: Proposal Part B
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Management of a registry of background knowledge brought into the project by each participant and rules for its use by each partner within the scope of the project.
•
Management of a registry of knowledge generated within the project, including the identification of the partner(s) responsible for generating the knowledge, the access rights to this knowledge of other partners within the scope of the project, the exploitation rights including patents and copyrights, and eventual rules and constraints for its dissemination.
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Establishment of contractual agreements between consortium members for the individual and joint exploitation of knowledge generated within the project and, where appropriate, involving the use of background knowledge.
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Appropriate protection of any knowledge, including methodologies and technologies, resulting from the project that has identified commercial exploitation potential.
This strategy will be founded on the rules described in the Consortium Agreement and, when not specifically mentioned in the Consortium Agreement, with the rules defined by the EC for projects of the 7th Framework Programme Consortium Agreement The purpose of the Consortium Agreement is to establish a legal framework for the project in order to provide clear regulations for issues within the consortium related to responsibilities and liabilities of partners, resolution of conflicts, financial provisions, non-disclosure of information, ownership and intellectual properties (IP) of background and foreground knowledge, and access rights to background and foreground IP (including software) for the duration of the project and any other matters of the consortium’s interest. At project commencement, the SKIPPER Consortium will state the ownership of background knowledge and define the conditions related to the IP on the foreground knowledge in the Consortium Agreement which may be updated as necessary over the course of the project. In case of disputes, the General Management Board will have the final word, and any conflicts will be resolved using specific voting mechanisms defined in the Consortium Agreement. Access Rights to Background and Foreground Knowledge In order to ensure a smooth execution of the project, the project partners agree to grant each other royalty-free access rights to their Background and Foreground Knowledge for the execution of the project. Details about the access rights to Background and Foreground Knowledge, after the duration of the project, will be defined in the Consortium Agreement. IP Ownership IP on the Foreground Knowledge shall be owned by the project partner carrying out the work leading to such Foreground Knowledge. If any Foreground Knowledge is created jointly by at least two project partners and it is not possible to distinguish between the contribution of each of the project partners (final decision will be taken by the IPC), such work will be jointly owned by the contributing project partners. The same shall apply if, in the course of carrying out work on the project, an invention is made having two or more contributing parties contributing to it, and it is not possible to separate the individual contributions. Any such joint inventions and all related patent applications and patents shall be jointly owned by the contributing parties. Any details concerning the exposure to jointly owned Foreground Knowledge, joint inventions and joint patent applications will be addressed in the Consortium Agreement.
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Section 4: Ethical Issues 4.1
Legal and Ethical issues in SKIPPER
In order to fully meet its goals, SKIPPER needs to manage and elaborate sensitive patient personal data acquired by the clinicians and/or retrieved from historical biomedical and clinical databases. Under this respect, SKIPPER consortium will guarantee and respect the fundamental ethical principles reflected in the Charter of Fundamental Rights of EU. The Charter includes, inter alia, the protection of human dignity and human life, protection of personal data and privacy. More specifically, the partners will ensure that all ethical, legal, social and safety issues related to the project activities are identified and taken into account, in compliance with applicable national and international regulations related to clinical research and associated translational research on human biological samples. As such several issues need to be addressed in this regard, such as application of all ethics, codes of practices and laws related to issues of lawful grant, process and use of personal consent with regard to such (biomedical) data, protection of such personal (sensitive) data.
4.2
Possible legal and ethical issues raised by SKIPPER and its proposed activities
SKIPPER systems and services, in order to fully meet their goals, need to manage, storage and transfer sensitive patient personal data. Special attention has to be paid to data protection, as the research on human biological samples may reveal some information that requires special treatment for confidentiality. In case a problem arises with new legislation related to human biological sample collection and transfer, the SKIPPER Consortium will evaluate the situation and take appropriate action. As already mentioned, the Consortium will establish an External Advisory Board with an advisory and supervisory role. The committee will also provide external advice on ethical and legal issues related to the overall activities of SKIPPER project. In order to develop, implement and deploy the SKIPPER systems, the legal and ethical issues that will be given attention throughout include the following: •
Patient’s prior, free, express and informed consent.
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Protection of privacy of sensitive personal data and potential developed biomedical databank.
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Lawful transfer, process, transmission and storage of personal data and biomedical samples.
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Scientific legal and ethical review of the SKIPPER project.
In particular, the SKIPPER project poses ethical issues which may be classified as moderate, mainly involving the activities of WP2, WP4, WP5, WP6 and WP8. In particular, the expected pilot application (WP8) is considered important for the project validation, aiming at demonstrate the user acceptance at all levels, as well as the usefulness in producing a real field work/clinical environment for testing and assessment of project outcomes. This procedure is also important for the future market exploitation since pilot results could feed project exploitation strategy. The foreseen pilot sites will require involvement and training of medical and paramedical staff, clinicians, patients and relatives. Besides, the consortium is pledged to follow a strict protocol in data collection during the pilot application implementation. To ensure the full compliance of SKIPPER with all the relevant legal and ethical issues, the first step will be to acquire knowledge of existing legislation, at different levels: both at national, European and international levels. On the basis of this knowledge, a detailed analysis of all issues that may arise in conjunction with the activities of this project and the subjects will be carried out, in order to take necessary measures to conform to all applicable legal norms, policies and principles at all levels. Proposal Part B
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Identification of applicable regulations and guidelines from different levels
As required in each project, it is necessary to determine the technical norms applicable to the project, depending on the national, European and international legal and ethical orders likely to rule it. As the national legal and ethical requirements made differ from country to country for each participating country the requirements and procedures to be followed will be clearly established. SKIPPER is fully compliant with all the Ethic international regulations that, in the Consortium’s opinion, are relevant for the proposed research listed below: •
Charter of Fundamental Rights of the European Union (2000/C 364/01)
•
Concerning the protection of personal data: (i) Everyone has the right to the protection of personal data concerning him or her. (ii) Such data must be processed fairly for specified purposes and on the basis of the consent of the person concerned or some other legitimate basis laid down by law. (iii) Everyone has the right of access to data which has been collected, and the right to have it rectified.
•
Compliance with these rules shall be subject to control by an independent authority.
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Directive 93/42/EEC of the Council of 14 June 1993 concerning medical devices
•
In particular, SKIPPER will guarantee the tools implemented in the project will meet the requirements stated in art. 1 of the Annex I of this Directive24.
•
Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data. The SKIPPER project will guarantee the protection of any information relating to an identified or identifiable natural person, where, according to the art. 2a of the directive, “an identifiable person is one who can be identified, directly or indirectly, in particular by reference to an identification number or to one or more factors specific to his physical, physiological, mental, economic, cultural or social identity".
•
Directive 97/66/EC of the European Parliament and of the Council of 15 December 1997 concerning the processing of personal data and the protection of privacy in the telecommunications sector. In particular SKIPPER, in respect of art. 4 of this Directive, will guarantee the full protection of the data used by the system both during the project and after its conclusion. 24 Art. 1 of Annex I of the Directive 93/42/EEC “The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety”.
•
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. In particular SKIPPER will guarantee that all the activities related to the clinical testing and validation will be conducted by respecting all the rules provided by the same directive.
Apart from the EC Directives above, SKIPPER will take into account also the following provisions: • Council of Europe’s Convention 108 for the protection of individuals with regard to automatic processing of personal data of 28 January 1981. In particular, according to Art.5 of the Convention, the project will guarantee personal data are: o obtained and processed fairly and lawfully; o stored for specified and legitimate purposes and not used in a way incompatible with those purposes; Proposal Part B
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adequate, relevant and not excessive in relation to the purposes for which they are stored; accurate and, where necessary, kept up to date; preserved in a form which permits identification of the data subjects for no longer than is required for the purpose for which those data are stored.
• Council of Europe Recommendation No. R(97)5 on the protection of medical data adopted of 13 February 1997. SKIPPER will be strictly compliant to the provisions of article 4, in particular medical data will be collected and processed (…) for preventive medical purposes or for diagnostic or for therapeutic purposes. • Declaration of Helsinki Council of 1964. In accordance with this Declaration, all the research activities of SKIPPER involving human subjects will be carried out to generally improve diagnostic, therapeutic, rehabilitation and prophylactic procedures and the understanding of the aetiology and pathogenesis of disease. • International Ethical Guidelines for Biomedical Research Involving Human Subjects (International ethical guidelines for biomedical research involving human subjects”, Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO), Geneva, 1993). According with these Guidelines, SKIPPER will guarantee the full respect of three basic ethical principles: namely justice, respect for persons, and beneficence (maximizing benefits and minimizing harms and wrongs) or non-malevolence (doing no harm). • Council of Europe’s Convention on Human Rights and Biomedicine (ETS No. 164), Oviedo, April 1997, concerning biomedical research. It represents the most comprehensive multilateral treaty addressing the new human genetic technologies. According to the results of the convention, SKIPPER will guarantee the full respect of all basic ethical principles stated in the convention. • Additional Protocol to the Convention on Human Rights and Biomedicine concerning Biomedical Research, Parliamentary Assembly of te Council of Europe 25 January 2005, Strasbourg. The protocol sets standards concerning the level of risk that is acceptable for research participants, and details the information research participants should receive before giving their consent. It emphasises that no undue influence (including of a financial nature) should be put on individuals to encourage their participation in research and it also defines the duty of care owed to research participants. SKIPPER will fully compliant with the protocol.
4.4
Processing of personal data
The SKIPPER project requires to process certain sensitive personal data for its research goals. However personal data processing is subject to numerous regulations because such data are particularly sensitive and require a higher level of protection. In general, SKIPPER project will avoid the needless collection and use of personal data. To guarantee the maximum level of protection for patient’s private life, data coming from the monitoring health of the individual will be filtered automatically by the system so that only data strictly required for the monitoring activity purposes will be transferred outside of the specific environment. The data collected but not relevant for the monitoring will be periodically and automatically erased by the SKIPPER platform itself. In addition, the researchers who use the biological information and the sensitive personal data will not allowed to link them back to identifiable individuals, in order to guarantee that the privacy and dignity of patients enrolled in the project are preserved. In addition, the participating members and researchers, who will be responsible for data collection, will: •
identify the data source;
•
indicate the appropriate project documents;
•
specify the data origin.
Finally, the security of the collected and transferred data will be granted by the use of the HTTPS for the web services and other SSL based internet protocols. Proposal Part B
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Use of Human Biological samples
The main human biological samples that will be used within SKIPPER project are blood sample and sputum. Both the samples will be taken from the patients in small amount, only for the purpose to conduct biochemical and hematological analysis and collect genetic information. This will be done within the routine clinical evaluation inside hospitals, ambulatories and clinical laboratories.
4.6
Informed consent
In general, the SKIPPER project illustrates an appropriate level of ethical sensitivity and pledges to consider issues of insurance, related findings and the consequences of exiting the pilot application. In addition, the project engages in respecting the principle that each participant in SKIPPER initiative, prior to consent, should be clearly informed of its goals, that there are not possible adverse events and the possibility to refuse to enter or to retract without adverse consequences. Finally, the SKIPPER members will provide any explanation to all participants during the pilot implementation; regarding data collection and treatment under security and privacy framework. In particular, the Patient Informed Consent document will provide information on the SKIPPER project in a comprehensive form. The patients and their families (or the legal representative), that will participate in the clinical testing and evaluation of the research project, will be adequately and clearly informed, in order to obtain informed consent. In addition the document will cover the following issues: •
description of the benefits and identification of the risks (in particular on the basis of the overall pathological condition of patient) the subject may reasonable expect to encounter;
•
description of any alternatives to participating to the research project;
•
description of the procedures, equipment, clinical examinations and laboratory testing that will be carried out for the collection of relevant biomedical data;
•
description of the arrangements taken to ensure data security and confidentiality of sensitive personal data;
•
information about the possibility for patient biological material and data to be stored for research purposes. The document will state the patient’s right to give or withhold his/her consent about this aspect.
•
information on potential future/secondary research use and the right for the individual to express his/her wish regarding the future uses of material and data;
•
description will be provided about foreseeable commercial use (if any) of the material and data, including research results;
•
description of the arrangements for feedback to the subject of information generated during the research that is relevant to the patient’s health, health care and counselling.
An informed consent document will be a key element of all the research performed under SKIPPER. As much as possible, a uniform patient information sheet to use in all the participating countries will be developed. Each Clinical Partners will be responsible for the revision and adaption, if necessary, in order to fully meet the national/institutional legal and ethical requirements. Every adapted form will have to be approved by the SKIPPER Consortium, as well as by the Institutional Review Board/Ethics Committees of all the participating centres.
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ETHICAL ISSUES TABLE YES Informed Consent • Does the proposal involve children? • Does the proposal involve patients? • Does the proposal involve persons not able to give consent? • Does the proposal involve adult healthy volunteers? Biological research • Does the proposal involve human genetic material? • Does the proposal involve human biological samples? • Does the proposal involve human biological data collection? • Does the proposal involve human embryos? • Does the proposal involve human foetal tissue or cells? • Does the proposal involve human embryonic stem cells? Privacy • Does the proposal involve processing of genetic information or personal data (e.g. health, sexual lifestyle, ethnicity, political opinion, religious or philosophical conviction) • Does the proposal involve tracking the location or observation of people without their knowledge? Research on Animals • Does the proposal involve research on animals? • Are those animals transgenic small laboratory animals? • Are those animals transgenic farm animals? • Are those animals cloned farm animals? • Are those animals non-human primates? Research Involving Third Countries • Is any part of the research carried out in countries outside of the European Union and FP7 Associated states? Dual Use • Does the research have direct military application • Does the research have the potential for terrorist abuse ICT Implants • Does the proposal involve clinical trials of ICT implants? (IF NONE) I CONFIRM THAT NONE OF THE ABOVE ISSUES APPLY TO MY PROPOSAL Proposal Part B
Page Number
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X X X
Pag. 89-90 Pag. 89-90 Pag. 89-90
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Appendix A: Endorsement letters In this Section we report the endorsement letters received from health authorities and associations of public relevance that are interested in the activities of the SKIPPER project and will support the experimentation phases in order to evaluate the project achievements in relevant clinical scenarios. As described in Section 2.3.3, the Skipper Consortium has already received a formal commitment from the following entities: •
Greek Thoracic Society;
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Primary Healthcare Centre of Charakas;
•
7th Health Region of Crete (DYPE7);
•
Tuscany Region;
•
Italian scientific and multi-disciplinary association for the study of respiratory diseases (AIMAR);
•
French-language Society of Pneumology (SPLF).
In the following of this Appendix a copy of the duly signed letters has been enclosed.
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To whom it may concern Ref Num: 3380
Athens, 9th of January 2013
Recommendation letter Hellenic Thoracic Society has been informed of the intention of FORTH to submit a proposal entitled SKIPPER “Services and Knowledge based Infrastructure for defining and supporting new integrated, personalized and efficient care pathways in COPD and its comorbidities” to the FP7 call. In the proposed project IASIS Hospital in Chania will participate to host one pilot. Hellenic Thoracic Society considers as very important the goal and vision of the SKIPPER proposal to establish a platform of services for personalized care pathways and programs for patients suffering from COPD and its major comorbidities. In addition, Greek Thoracic Society has the intention to validate the results of the pilot study. Finally, Hellenic Thoracic Society strongly supports this proposal and aims towards using the outcomes and know how gained after the end of the proposed project. Yours sincerely,
Konstantinos I. Gourgoulianis Prof. of Thoracic Medicine President of the Hellenic Thoracic Society
Consiglio Direttivo Presidenti Onorari C. Grassi, Milano B. Leoncini, Pisa Past-President C.F. Donner, Borgomanero (NO)
Certificazione ISO 9001-2008 N. IT-37575
Consiglio Direttivo
Presidente F. De Benedetto, Chieti Vice Presidente/Presidente Eletto S. Nardini, Vittorio Veneto (TV)
Attention: Small or medium-scale focused research project (STREP), ICT Call 10, FP7-ICT-2013-10.
Segretario Generale - Tesoriere M. Polverino, Salerno Componenti S. Carlone, Roma M. Neri, Albizzate (VA) M. Pistolesi, Firenze S. Privitera, Giarre (CT) Direttore della Rivista C.M. Sanguinetti, Roma Coordinatore delle Attività Regionali R. Dal Negro, Verona Collegio dei Probiviri C. Grassi, Milano - Presidente A. Di Gregorio, Arco (TN) F. Iodice, Napoli
Collegio dei Revisori dei Conti C. Manni, Verbania - Presidente P. Alimonti, Roma P. Isidori, Fano (PU) P. Zamparelli, Sorrento (NA)
January 8, 2013
AIMAR (Interdisciplinary Association for Research in Lung Disease) has been informed of the intention of the Greek Institute FORTH, in collaboration with a set of European partners, that includes CNR Italy, UPMC France, to submit a proposal entitled SKIPPER “Services and Knowledge based Infrastructure for defining and supporting new integrated, Personalized and efficient care pathways in COPD and its comorbidities” to the FP7 call. AIMAR considers as very important the goal and vision of the SKIPPER proposal to establish a platform of services for personalized care pathways and programs for patients suffering from COPD and its major comorbidities. The objectives of SKIPPER are in agreement with the goals and long term vision for personalized care services of AIMAR. AIMAR strongly supports this proposal and aims towards using the outcomes and know how gained after the end of the proposed project. Yours faithfully
Dr. Fernando De Benedetto AIMAR President
Sede Legale Viale Marazza, 30 28021 Borgomanero (NO) P.I. 13408190158 L’Associazione è iscritta al Registro delle Persone Giuridiche della Prefettura di Novara con il n° 247.
Recapiti Presidente – Via N. Vernia, 20 – 66100 CHIETI – Tel.: 346-6964218 - [email protected] Segreteria – Tel.: 393-9117881 – Fax: 0871-222024 – [email protected] Casella Postale n. 42 – 28021 BORGOMANERO (NO) www.aimarnet.it
Consiglio Direttivo Presidenti Onorari C. Grassi, Milano B. Leoncini, Pisa Past-President C.F. Donner, Borgomanero (NO)
Certificazione ISO 9001-2008 N. IT-37575
Consiglio Direttivo
Presidente F. De Benedetto, Chieti Vice Presidente/Presidente Eletto S. Nardini, Vittorio Veneto (TV) Segretario Generale - Tesoriere M. Polverino, Salerno Componenti S. Carlone, Roma M. Neri, Albizzate (VA) M. Pistolesi, Firenze S. Privitera, Giarre (CT) Direttore della Rivista C.M. Sanguinetti, Roma Coordinatore delle Attività Regionali R. Dal Negro, Verona Collegio dei Probiviri C. Grassi, Milano - Presidente A. Di Gregorio, Arco (TN) F. Iodice, Napoli
Collegio dei Revisori dei Conti C. Manni, Verbania - Presidente P. Alimonti, Roma P. Isidori, Fano (PU) P. Zamparelli, Sorrento (NA)
Sede Legale Viale Marazza, 30 28021 Borgomanero (NO) P.I. 13408190158 L’Associazione è iscritta al Registro delle Persone Giuridiche della Prefettura di Novara con il n° 247.
Short description of AIMAR Since its foundation in 2003 AIMAR (Interdisciplinary Association for Research in Lung Disease) was created to help health professionals and the community improve patient care in those already diagnosed, anticipate the diagnosis in those with disease but undeclared, and prevent the diseases from developing, by gathering epidemiologic data, defining strategies to combat the diseases, and raising political and social awareness so that they become a public health priority. AIMAR is an interdisciplinary society. In fact to combat the epidemic of respiratory diseases there has to be, as with other chronic diseases, an integrated approach both in implementing preventive and treatment strategies and in the care given to individuals. Integrated action means the pooling of expertise and the willingness of professionals from different fields to “act as a team”. AIMAR (for whom interdisciplinarity is a founding principle) has promoted and continues to promote this approach both in the organization of training courses and in the selection of areas of research. AIMAR is the only scientific society in the respiratory field that has representatives from other Specialties as part of its own scientific committee. AIMAR has identified four strategic areas: 1. improve professional training, 2. explore new models of organization, 3. increase the visibility of the specialty, 4. increase the visibility of Pulmonologists as specialists at both local and regional level. Its own activities in such areas can be best implemented if there exists a network that functions as a “fan belt” between the center and periphery and viceversa. For this reason AIMAR has as part of its structure 16 regional/interregional sections. Since 2003, AIMAR has actively taken part in all the supranational initiatives in the field of respiratory medicine: European Respiratory Society (ERS), International Union Against Tuberculosis and Lung Disease (IUATLD), ERS Forum of national European Respiratory Societies (FERS). In Italy it has collaborated and continues to collaborate with the Ministry of Health and its various organs to put into practice the directives concerning respiratory diseases of the National health program and the guidelines developed by the National Agency for Regional Health Services (A.GE.NAS). AIMAR is a founding member of the Global Alliance against chronic Respiratory Diseases (GARD) of the World Health Organization (WHO). AIMAR has organized and put to conclusion several research projects, mostly of an observational type, on the epidemiology of COPD, on bone metabolism disorders in COPD, on the rhino-bronchial syndrome and so on. Currently many other research projects are in progress. AIMAR organizes also, together with the ERS, joint fellowships for individual postgraduate training in centres of excellence (Joint fellowship). AIMAR has also produced several national and international scientific events. Since 2006 AIMAR has got a scientific Journal “Multidisciplinary Respiratory Medicine”, indexed in PubMed Central, Embase, Science Citation Index Expanded, Journal Citation Reports/Science Edition, and in Scopus.
Recapiti Presidente – Via N. Vernia, 20 – 66100 CHIETI – Tel.: 346-6964218 - [email protected] Segreteria – Tel.: 393-9117881 – Fax: 0871-222024 – [email protected] Casella Postale n. 42 – 28021 BORGOMANERO (NO) www.aimarnet.it
