1. Washington, 16.02.2011, OECD-NSF1EU eHealth interoperability Roadmap What the EU ehealth IoP Roadmap could bring to the Health future Michèle Thonnet French Ministry of Health

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 systemsRecommendation Communication on telemedicine for the benefit of patients, healthcare systems and societyCommunication eHealth Standardisation Mandate 403Standardisation –------------------------------------------------------------------------------------ Council conclusion on safe and efficient healthcare through eHealth – December 2009 Proposal for a European Directive on patients rights in cross- border healthcareDirective 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. 11 IOp RECOMMENDATION REVIEW – Interoperability is considered for the purpose of integrated, connected and interoperable continuity of care for Europe

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

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. 14

15. 15 TARGET GROUPS E-health Community Engagement through consultation

16. (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 CALLIOPE in a nutshell

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

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 19 The trilogy of Trust

20. WHERE? FOR WHAT PUPROSE? WHO BENEFITS? WHATS AT STAKE? 20 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 Roadmap TRUSTED? 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 on identifying, 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 mobility nationally and in the EU –ensure that patient safety is guaranteed –increase efficiency and cost-effectiveness in cross-border care

25. 25 CALLIOPE and epSOS Malta

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

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

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

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

30. 30 WHERE? FOR WHAT PUPROSE? WHO BENEFITS? WHATS AT STAKE? 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 1 st stop Barcelona validation 2 nd step December 2010 December 2010 AN EU eHEALTH INTEROPERABILITY ROADMAP EU interoperability Roadmap progress A proposal for a common EU Roadmap for eHealth

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

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 32

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 33

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 34

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 35

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 36

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 37

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 38

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 40

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

42. TABLE I: IMPACTS PURSUED IMPACT OF THE CONVERGENCE PROCESS ON eHEALTH DEPLOYMENT Engagement of EU Stakeholders through stimulating broad synergies Proof of Concept: Successful unprecedented multi-stakeholder formal collaboration on developing a key policy document (vs consultation only) Facilitation of adoption of outcomes of EU collaboration projects such as the epSOS specifications and the CALLIOPE eHealth Interoperability Roadmap Acceleration of the processes involving the organisation and management of governed multi-stakeholder environments in eHealth and beyond EXPECTED IMPACT OF THE CALLIOPE OUTCOMES ON eHEALTH DEPLOYMENT Towards better alignment of EU-national level actions Acceleration of national eHealth deployment (by capitalizing on EU collaboration) Towards co-ordinated EU-national level innovation support action for eHealth deployment (though improved access and use of standards) 42

43. Convergence: Contributing factors (By Z Kolitisi)43

44. Bringing EU and the national/regional activities together 44

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 agree on concrete strategies Strategic level: to agree on concrete strategies for developing and implementing integrated, value adding eHealth services Establishment 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 48

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

51. eHGI project structure 51

52. Thank you for your time michele.thonnet@sante.gouv.fr