What the EU ehealth IoP Roadmap could bring to the Health future Michèle Thonnet French Ministry of Health

1. What the EU ehealth IoP Roadmap could bring to the Health futureMichèle ThonnetFrench Ministry of Health EU eHealth interoperability Roadmap

2. Reforming the H system : a necessity demographic changes : ageing population increased prevalence of chronic diseases citizen expectations for high Q HC increasing costs of research, equipments, examinations, treatment quicker pandemia expansion lack of staff ; shortage of HCP mobility of citizens, patients, HCP, workers mastering costs : crisis and ‘business’ model

3. ITs : Key expectations Facilitate access, continuity of HC (mobility) Improving Q of care, allowing real HC equity Enhancing coordination, continuity of care security & safety Facilitating collaboration between HCP, within/between HCPO Improving homecare and adapted delivery services at PoC Organising mutualisation and international standards usage Facilitating research, L S experimentations and deployment Decreasing the number of doubloning examinations Mastering costs through innovative model(s)

4. Multidisciplinary approach :a necessity ; from research to citizen • efficient health (disease) management • prediction / prevention of diseases • remote monitoring and care • higher patient safety and citizen empowerment • shift from hospital to personal centered system • more personalized care solution- privacy issue • higher productivity of HC and professional interoperable standardised industry solutions • adapted legal framework

5. Actors … Stakeholders Public authorities and the organized civil society • a common objective, but own missions, agendas, vocabularies and constraints • different skills, needs and access to different to eHealth expertise 5

6. Health in the EU Treaty • HEALTH is a national prerogative • subsidiarity is key • but challenges are the same in each M.S. • what could be done at EU level : • a volontarist collaboration between M.S. • supported by the E.C. • confirmed by the « eHealth action plan » • design through a dedicated organisation • declined on pragmatic priorities

7. a new era in legal and policy framework for EU Cooperation on eHealth Communication on Quality critera for a web site Communication on the eHAP Recommendation on cross-border interoperability of electronic health record systems Communication on telemedicine for the benefit of patients, healthcare systems and society eHealth Standardisation Mandate 403 ------------------------------------------------------------------------------------ Council conclusion on safe and efficient healthcare through eHealth – December 2009 Proposal for a European Directive on patients’ rights in cross-border healthcare 2002-2010 a new Era

8. other EU current initiatives • Health • Europe 2020: “Sustainable health” • Standardisation • Digital Agenda • Access • IT Standardisation • eHealth M.S. and stakeholders voluntary cooperation • epSOS • CALLIOPE 8

10. eHR Modelling: an input for collaboration(2007)

11. IOp RECOMMENDATION REVIEW • Interoperability is considered for the purpose of “integrated, connected and interoperable continuity of care for Europe”

12. Jurisdiction # 1 Use Case A Top Down Political / Legal Organisational Semantic Bottom -up Technical eHealth Interoperability Jurisdiction # 2 Political / Legal Use Case A Organisational Semantic Technical IOp Model, i2010 subgroup of eHealth; I2Health

13. A European Collaborative Initiative • How to answer to the civil society needs ? • How to balance cultural and legal norms ? • How to know and capitalise on  good practices ? • How to facilitate /accelerate pilots, adoption? • How to sustain initiatives & new models ? • How can countries coordinate efforts • And turn ideas into practice CALLIOPE Network (with the support of EC-DG INFSO)

14. The need for an Interoperability Roadmap • Each country or region is separately trying to solve the same problems. • Each country or region, organisation or division of the particular organisation lacks the resources and skills needed to boost innovation. • All countries will benefit from joint effort towards this.

15. TARGET GROUPS E-health Community Engagement through consultation

16. CALLIOPE in a nutshell (June 2008 - December 2010) To produce value for decision makers • A fully operable, open,trusted, co-operative multi-stakeholder environment • An analysis of Member States responses to the EC Interoperability Recommendation on EHR • Operational collaboration with relevant EU level projects An EU eHealth Interoperability Roadmap, “the Roadmap“ to accelerate eHealth Deployment

17. The CALLIOPE Platform 1/2 Competence Centers Health Authorities June 2008 March 2010 Malta

18. Structure The CALLIOPE co-operative working platform • Clear Governance • Efficient Supporting Structure • Outcome based management Trust must be reinforced 18

19. Governance Integrity Shared Values: openness and transparency, participation, quality, proportionality and coherence Competence though access to EU collective expertise and knowledge but also through appropriate conditions for this to be fully exploited Commitment though shared ownership of the process, content and the outcome The trilogy of Trust 19

20. WHERE? FOR WHAT PUPROSE? WHO BENEFITS? WHAT’S AT STAKE? AN EU eHEALTH INTEROPERABILITY ROADMAP

21. The Roadmap • The needs • service innovations needed to focus on existing or anticipated health care system priorities • a vision • of where we wish to go and what solutions are needed to get there • a route for achieving the vision • to select and develop the right alternatives needed to create the right services 21

22. EU Interoperability RoadmapTRUSTED? Structure Principles, platform, level of Trust Process Iterative approach, working methods Outcome Content of the Roadmap 22

23. The process Most of the necessary knowledge exists focus onidentifying, synthesizing, integrating, and diffusing this knowledge taking into account the various facets Organising this K along the value chain to reach the agreed target

24. epSOS – a highly political project • Member State obligation to deliver the best possible medical treatment – at home or when travelling • Introducing a new dimension in national healthcare systems • Goal for the epSOS eHealth Project: • “to develop a practical eHealth framework and ICT infrastructure that will enable secure access to patient health information, particularly with respect to a basic patient summary and ePrescription, between European healthcare systems” • Main political objectives: • support patient mobilitynationally and in the EU • ensure that patient safety is guaranteed • increase efficiency and cost-effectivenessin cross-border care

25. CALLIOPE and epSOS Malta 25

26. The process Roadmap versioned documents Roadmap Consolidation workshops CALLepSO workshops SDOs X-border project consultations eID,semantics 26

27. Collaborative evolving process Political priorities 1st stop Barcelona, March 2010! Agreement and validation of way of work by the Secretaries of State Stakeholder priorities Reaching agreements through continuous bench-learning loop across concerned actors 27 27

28. CALLIOPE EU eHealth IOP Roadmap : A common vision 28

29. Provisional Content High-level meeting on EU eHealth Governance-Barcelona 29

30. WHERE? FOR WHAT PUPROSE? WHO BENEFITS? WHAT’S AT STAKE? AN EU eHEALTH INTEROPERABILITY ROADMAP What: possible future actions at EU level For what: To accelerate ehealth deployment Who: Health care community How: Use Cases, alternatives, maturity and opportunities, building on what is shown to work 1st stop Barcelona validation 2nd step December 2010 A proposal for a common EU Roadmap for eHealth EU interoperability Roadmap progress 30

31. Recommendations and Outlook Political priorities propositions provide concrete input to decision making support of the eHealth high level governance process

32. Towards secure, unambiguous and portable electronic identification of EU citizens • Recommendations: • Cross border recognition of eID for healthcare purposes • A Common European Framework for eID Management is needed • One or many ID, role management … • Security, assurance levels, HP authorisation, … • European Governance for eID Management

33. Towards an internal market for eHealth services – technical interoperability • Recommendations • Establishment of European-wide standards, interoperability testing and certification and accreditation schemes for eHealth • Review of national activities on standardisation, access and use of standards, take forward the CALLIOPE Recommendations on standardisation • Use cases prioritisation and prioritization of business areas coordination for standardization based on balanced proposals by stakeholders • Sharing of experience of best practices in standards use

34. Towards a European-wide infostructure – semantic interoperability • Recommendations • Consider semantic interoperability as an area for multinational collaboration • Develop a collaborative governance framework and support coordination work • Encourage the definition of standards for electronic medical data/documents to be shared across borders. • Address the challenges of multilingual semantic mapping + All Recommendations concerning technical interoperability apply also to semantic interoperability

35. Legislation and regulation as facilitators – Legal and regulatory interoperability • Recommendations • Agree – and review national legislation - on • A realistic and appropriate level of security for electronic processing and transfer of health related information • A shared policy on patient consent to electronic processing and cross border transfer of health data • A process for continuous improvement to reflect progress in technology, harmonisation of security, quality and safety practices • Adopt an EU information governance and a permanent coordination mechanism for cross-border transfer of health data

36. Economic challenges of eHealth services Recommendations Coordinate activity and resources Support exchange of experiences with working on alternative co-operation models Invest in human resources, skills, training … Review legal and regulatory frameworks to accommodate market innovation and new models for reimbursement, funding and resource allocation for eHealth

37. Monitoring progress Recommendations Building collaboratively a substantial body of knowledge and evidence at EU level Considers the OECD model survey approach and indicators for adoption Supports specific actions and a support mechanism to help MS to effectively share lessons learnt about benefits and costs of choosing one approach over another as well as about the incentive mechanisms and reimbursement system

38. Together addressing open issues in the EU Recommendations Elaborate – at the onset of the collaboration process – a two layered EU collaborative Governance based on current EU practice and the CALLIOPE experience Consider the establishment of national multi-stakeholder platforms

39. Main observations from CALLIOPE Network • For implementing eHealth interoperability, the Network supports the Member States key proposals to • Focus on high-level governance • Value exploring the concept of EU competence network • Including benchlearning processes, best practice repositories … • Operationalise stakeholder involvement and engagement • Consider interoperability as a process and emphasize the importance of its sustainability 39

40. IoP (RM) Critical Success Factors • Relevance: that IoP activities are seen as relevant to business objectives and current activities • Openness: that the IoP process is seen as an open and inclusive one • Engagement: that all parties are able to contribute to all stages of the process • Affordability: that the results are affordable, and demonstrating a clear return on investment • Sustainability: that the framework for development of IoP is sufficiently open and flexible to allow adaption and future development

41. Adoption of a common working model Sustainable Healthcare Sharing Information and Knowledge for Better Health eHealth Governance eHealth Services Common EU priorities eHealth leadership, policy and strategy EU & National Stake-holder collaboration Electronic prescribing Community services, AAL Other national priorities Knowledge management, etc. Patient summaries Chronic Care Management Rare diseases e.g., Data analysis & aggregation Privacy, quality and safety policies National priorities Legislative and regulatory framework Foundation eHealth infostructure Clinical terminologies and classifications and codifications Data structures and value setsEHR, EMR, PHR, other Data interoperability and accessibility Patient identification and patient data discovery Fostering standards adoption Market development, new business models, and incentives HCP Authorization, authentication and rights management Consent management and access control Data and knowledge management tools Data bases and Registries Financing, Resource allocation and reimbursement models Foundation ICT infrastructure Mobile and fixed Electronic Communication Infrastructures Access to ICT Networks, equipment and facilities ICT processing and storage services ICT Professional and technical support; Training Monitoring, evaluation

43. Convergence: Contributing factors

44. Bringing EU and the national/regional activities together

45. Brussels, at EU Parliament • Crossing boundaries in eHealth: the CALLIOPE think-tank and collaborative platform November 2010 To prepare the EU eHealth High Level Governance

46. Directive on patients rights in cross border Healthcare: eHealth 1. The Union shall support and facilitate cooperation and the exchange of information among Member States working within a voluntary network connecting national authorities responsible for eHealth designated by the Member States. 2. The objectives of the eHealth network shall be to: • (a) work towards delivering sustainable economic and social benefits of European eHealth systems and services and interoperable applications, with a view to achieving a high level of trust and security, enhancing continuity of care and ensuring access to safe and quality healthcare; • (b) draw up guidelines on ▌: • (i) a non-exhaustive list of data that are to be included in patients' summaries and that can be shared between health professionals to enable continuity of care and patient safety across borders, and • (ii) effective methods for enabling the use of medical information for public health and research; • (c) support Member States in developing common identification and authentication measures to facilitate transferability of data in cross-border healthcare.

47. European eHealth Governance levels • Policy level: to set out higher level political objectives, define common priorities and policy measures • Strategic level: to agree on concrete strategies for developing and implementing integrated, value adding eHealth servicesEstablishment and maintenance of an open platform for multi-stakeholder trusted dialogue • Operational level: deeper focus in areas such as ethics, security policies and services, EU infostructure, re-engineering of the standardisation process, maintaining links to national stakeholder groups, etc.

48. A further consolidated approach is needed… • Establish a European Governance to sustain an open and transparent process involving all three levels • Reach out to the national communities, i.e. beyond what CALLIOPE was able to achieve within its life span • Establish mechanisms to support MS in their implementation of the EU Roadmap

49. Status Quo • Ministries • Competence Centers • Users • Industry • Planned project start: January 2011 • Involvement of High Level Representatives • Turning from project results (e.g. CALLIOPE RoadMap) to a MS driven aproach  the eHealth Governance Initiative

50. eHGI Main Objectives Provide to MS a consolidated approach and a strong political committment to governance at three levels (1) Policy (2) Strategy and (3) Operational Provide to the MS, the EC and other relevant stakeholders a platform and “a think tank” for current and emerging challenges which could lead to a strong consolidated Roadmap of concrete actions and the description of potential future pilot projects and partnerships Provide to the MS, the EC, the Competence Centres, the IT-Industry and to other relevant stakeholders a European eHealth Interoperability Framework Provide to the EC, EPSCO Council and to other relevant stakeholders targeted support for activities requiring broad convergence across Europe, such as future LSP eHealth projects and common interoperable service solutions at MS level