JA to support the ehealth Network

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1 JA to support the ehealth Network

2 ehealth Network & ehgi Directive 2011/24/EU of the European Parliament and of the Council on the application of patients` rights in cross-border healtcare

3 ehealth Network & ehgi Directive 2011/24/EU of the European Parliament and of the Council on the application of patients` rights in cross-border healtcare ehealth Network Art. 14, Directive 2011/24/EU on cross border healthcare

4 ehealth Network & ehgi Directive 2011/24/EU of the European Parliament and of the Council on the application of patients` rights in cross-border healtcare ehealth Network Art. 14, Directive 2011/24/EU on cross border healthcare Multi-Annual Work Plan ( )

5 ehealth Network & ehgi Directive 2011/24/EU of the European Parliament and of the Council on the application of patients` rights in cross-border healtcare ehealth Network Art. 14, Directive 2011/24/EU on cross border healthcare Multi-Annual Work Plan ( ) PCS ehealth Governance Initiative

6 ehealth Network & ehn-ja Directive 2011/24/EU of the European Parliament and of the Council on the application of patients` rights in cross-border healtcare

7 ehealth Network & ehn-ja Directive 2011/24/EU of the European Parliament and of the Council on the application of patients` rights in cross-border healtcare ehealth Network Art. 14, Directive 2011/24/EU on cross border healthcare

8 ehealth Network & ehn-ja Directive 2011/24/EU of the European Parliament and of the Council on the application of patients` rights in cross-border healtcare ehealth Network Art. 14, Directive 2011/24/EU on cross border healthcare Multi-Annual Work Plan ( )

9 ehealth Network & ehn-ja Directive 2011/24/EU of the European Parliament and of the Council on the application of patients` rights in cross-border healtcare ehealth Network Art. 14, Directive 2011/24/EU on cross border healthcare Multi-Annual Work Plan ( ) Joint Action to support the ehealth Network Strategic PCS

10 Multi-Annual Work Plan ( ) Multi-Annual Work Plan ( )

11 Multi-Annual Work Plan ( ) Multi-Annual Work Plan ( ) Interoperability & Standardization

12 Multi-Annual Work Plan ( ) Multi-Annual Work Plan ( ) Interoperability & Standardization Monitoring & Assessment of Implemention

13 Multi-Annual Work Plan ( ) Multi-Annual Work Plan ( ) Interoperability & Standardization Monitoring & Assessment of Implemention Exchange of Knowledge

14 Multi-Annual Work Plan ( ) Multi-Annual Work Plan ( ) Interoperability & Standardization Monitoring & Assessment of Implemention Exchange of Knowledge Global Cooperation & Positioning

15 Multi-Annual Work Plan ( ) Multi-Annual Work Plan ( ) Interoperability & Standardization Monitoring & Assessment of Implemention Exchange of Knowledge Global Cooperation & Positioning Joint Action to support the ehealth Network

16 Multi-Annual Work Plan ( ) Multi-Annual Work Plan ( ) Interoperability & Standardization Monitoring & Assessment of Implemention Exchange of Knowledge Global Cooperation & Positioning WP 5 WP 6 WP 7 WP 8 Joint Action to support the ehealth Network

17 ehn JA project structure

18 ehn JA project structure

19 Core work packages ehn-ja WP 5 Interoperability & Standardization WP 6 Monitoring & Assessment of Implementation WP 7 Exchange of Knowledge WP 8 Global Cooperation & Positioning

20 WP 5 Interoperability & Standardization Tasks T5.1 Trusted ehealth National Contact Points T5.2 Electronic Identification for ehealth T5.3 Update & revision of EU ehealth Guidelines T5.4 Alignment of standardization activities in ehealth T5.5 Semantic Interoperability T5.6 CEF operational support

21 WP 6 Monitoring & Assessment of Implementation Tasks T6.1 Implementation of ehealth guidelines T6.2 Challenges of legal interoperability in a cross-border context

22 WP 7 Exchange of Knowledge Tasks T7.1 Sharing of national ehealth strategies and action plans T7.2 Secondary use of health data T7.3 Research on added value ehealth tools T7.4 Patient access to electronic health records and health data portability

23 WP 8 Global Cooperation & Positioning Tasks T8.1 Participation, liaison and influence in global ehealth T8.2 Evaluation of global ehealth specifications

24 Draft planning (3 years)

25 Draft planning (3 years)

26 Status ehn JA starts in May Introduction at the ehn RIGA meeting Kick off at the end of May in Vienna

27 Proposal for an Organisational Framework of ehealth NCP ehn-ja D (early draft) Proposal for an Organisational Framework of ehealth NCP (ehn-ja D early draft) Open discussion at EXPAND MS Auth. & CC Workshop 21/04/15 27

28 Agenda Background Purpose Key Interoperability Layers Underlying Principles Initial Considerations Process Next Steps Proposal for an Organisational Framework of ehealth NCP (ehn-ja D early draft) Open discussion at EXPAND MS Auth. & CC Workshop 21/04/15 28

29 Background (1/2) Supporting the ehn ambitions on on sustainability policies regarding assets in the field of cross border interoperability One of main challenges is the linkage between the policy level of thinking and deciding (ehn); and the more operational level (development, deployment and maintenance of assets) Proposal for an Organisational Framework of ehealth NCP (ehn-ja D early draft) Open discussion at EXPAND MS Auth. & CC Workshop 21/04/15 29

30 Background (2/2) One of main architectural foundation for cross border interoperability relies on National Contact Point (NCP). These NCP can take distinct ways of being : Responsible Authority Technical Gateway Contact Person & Proposal for an Organisational Framework of ehealth NCP (ehn-ja D early draft) Open discussion at EXPAND MS Auth. & CC Workshop 21/04/15 30

31 Purpose (D5.1.1) Propose an organisational framework to prepare, establish and govern ehealth National Contact Points in the scope of cross border care services deployed under the CEF work plan. Proposal for an Organisational Framework of ehealth NCP (ehn-ja D early draft) Open discussion at EXPAND MS Auth. & CC Workshop 21/04/15 31

32 Key Interoperability Layers Source: Antilope project - ehealth EIF Refined Model Proposal for an Organisational Framework of ehealth NCP (ehn-ja D early draft) Open discussion at EXPAND MS Auth. & CC Workshop 21/04/15 32

33 Underlying Principles Security and Privacy trust and full compliance with the relevant regulations Transparency patients have full visibility on information collected about them Preservation of Information keep information legibility, reliability and integrity over time Openness & Reusability sharing of information and knowledge between organisations Technological Neutrality and Adaptability focus on functional needs and defer decisions on technology Proposal for an Organisational Framework of ehealth NCP (ehn-ja D early draft) Open discussion at EXPAND MS Auth. & CC Workshop 21/04/15 33

34 Initial Considerations (1/3) Experience gained and lessons learned on previous large scale health pilots at European level regarding the successes and complexities of crossborder health information exchange. E.g. epsos Final Recommendation Proposal for an Organisational Framework of ehealth NCP (ehn-ja D early draft) Open discussion at EXPAND MS Auth. & CC Workshop 21/04/15 34

35 Initial Considerations (2/3) On the EU ehealth Governance (8) Legal (19) On Data Protection and confidentiality (10) Organisational (9) On Information Security (1) Semantic (9) Technical (6) Proposal for an Organisational Framework of ehealth NCP (ehn-ja D early draft) Open discussion at EXPAND MS Auth. & CC Workshop 21/04/15 35

36 Initial Considerations (3/3) ehealth European Interoperability Framework (from Antilope 2015) Maintenance shops epsos Assets Legal & organisational Technical specifications Semantic specifications Temporary Legal Agreement PS guideline ep guideline (1) (2) I. DEFINE Document Deliverables Development Operation Open NCP component Testing (3) epsos central Service II. BUILD Components And tools Deployment D3.8.2 Deployment guideline III. SUPPORT Proposal for an Organisational Framework of ehealth NCP (ehn-ja D early draft) Open discussion at EXPAND MS Auth. & CC Workshop 21/04/15 36

37 Describe a method for Process (1/2) ensuring that trust between the ehealth NCPs can be established, maintained and reinforced, through a pre-defined set of activities and responsibilities Proposal for an Organisational Framework of ehealth NCP (ehn-ja D early draft) Open discussion at EXPAND MS Auth. & CC Workshop 21/04/15 37

38 Process (2/2) INITIATION MS Service Deployment - PLAN MS Req. and Recommend. - CHECKLIST; MS Preparation Progress - REPORT MS Service Readiness - REPORT MS Service Initial Audit REPORT OPERATION MS Service Operation - PLAN MS Service Operation Monitoring - REPORT MS Service Operation Audit REPORT MS Service Operation Evaluation REPORT Proposal for an Organisational Framework of ehealth NCP (ehn-ja D early draft) Open discussion at EXPAND MS Auth. & CC Workshop MS: Member State 21/04/15 38

39 Next Steps 1) Preparation phase for ehn JA task 5.1 members (May, June) 2) Developing the handing over process of the Organisational Framework of ehealth NCP to permanent governing body 3) Construct final deliverable for ehn November 2015 (Oct) 4) ehn decision on ehn Organizational Framework of ehealth NCP (Nov) 5) Support ehn adopting the Organisational Framework of ehealth NCP (permanent) Proposal for an Organisational Framework of ehealth NCP (ehn-ja D early draft) Open discussion at EXPAND MS Auth. & CC Workshop 21/04/15 39

40 Proposal for an SDO platform ehn-ja D (early draft) Proposal for an Organisational Framework of ehealth NCP (ehn-ja D early draft) Open discussion at EXPAND MS Auth. & CC Workshop 21/04/15 40

41 Agenda Background Objective Key Interoperability Layers Role of the SDO platform Next Steps 21/04/15 41

42 Background (1/2) In the last ehn meeting (November) the Commission proposed to have an active involvement of the Standard Developing Organisations (SDOs) and standard profiling organisations in the new Joint Action (JA2). It was concluded that: The ehealth Network will take a role in planning future EU standardisation activities for ehealth, and welcomed the involvement of CEN, as well as other standardisation organisations, in the new joint action. The option of starting a standardisation process of specific elements of the 21/04/15 42

43 Background (2/2) For the advancement of ehealth in Europe, as stimulated and ratified by the ehealth Network (ehn), standards are an essential asset for the achievement of these goals. This is true for national and regional projects within the MS, but even more essential for cross border interoperability, in order to bridge the differences between the MS. The playing field of standards in ehealth, however, is complex due to several reasons, amongst which: The building of ehealth solutions requires concerted action on several different abstractions layers. There are many different standards development organisations (SDOs), with partially overlapping areas of interest 21/04/15 43

44 Objective ehn JA (D5.4.1) The overall goal of the platform could be formulated as: Provide a one-stop shop to the ehn, where the ehn can ask questions and stimulate actions, which will be picked up in a concerted manner by all SDOs involved, with as the main outcome solutions which are strongly supported by stakeholders, have the necessary legal and formal embedding, and are free of gaps, and free of ambiguities due to overlaps. 21/04/15 44

45 Value proposition (D5.4.1) The added value of the new ehn JA SDO platform for the ehn would be: To assist the ehn in the coherent decision making process regarding ehealth (related) standards at the EU and International level, To advise and support the ehn in initiating standardisation projects and actions that would and could stimulate adoption of standards and (cross border) interoperability in the ehealth domain. To stimulate the ehn to act as the demand party regarding the development and implementation of International and European standards and to provide the possibility of influencing the development of standards (supply site) in the ehealth domain. This platform should consist all the relevant SDOs that are significantly involved and effective in providing ehealth interoperability across Europa and Internationally. 21/04/15 45

46 Starting principles The platform should enable consistent and coherent SDO support to the ehn based on the ReEIF framework; avoid gaps and overlaps. The output of the platform must be in alignment with the EU ehealth standardisation policy must aim for the objectives in the ehn MAW must provide maximum transparency in the underlying procedures and methodologies. The output of the platform should reflect the formal positions of the SDOs (i.e. the input of the them into the platform should be represent the official opinion of the SDO). 21/04/15 46

47 Starting principles It is necessary that the work of platform is based on a realistic, pragmatic and financially achievable perspective regarding developing, adopting, promoting and implementing standards and realization of interoperability. It should closely cooperate with the European Commission and Multi Stakeholder Platform regarding standardisation actions funded in the Annual Union Workplan and the Rolling Plan for ICT standardisation society-broad. The platform must strive for transparent alignment between the National, European and International SDOs and their policymaking bodies. 21/04/15 47

48 Starting principles The formal role of CEN, as one of the three formal European Standards Organisations, in the platform should further be brought to value. It should support the stakeholders in the ehn JA representing the demand site in formulating their standardisation needs for the advancement of interoperability. The platform should first act and prove its additional value in the ehn JA ( ) but must be set up in the light of a sustainable ehealth SDO platform after the duration of the ehn JA. The management of the new platform should be placed in a team formed at least by CEN and a rotating Member State Competence Centre 21/04/15 48

49 Key Interoperability Layers Source: Antilope project - ehealth EIF Refined Model 21/04/15 49

50 Key Interoperability Layers Source: Antilope project - ehealth EIF Refined Model 21/04/15 50

51 Role of the SDO platform Legal and regulatory: here we do not see any action needed from the SDO platform under ehn. Policy: this is the main area of interest for the ehn itself, which has an interest and a need for standards. Care processes: this is the place where guidelines are usually developed for health professionals on how to act in a specific care situation. In standards developing, on this abstraction layer use cases are described as the standard care process expected, on which the other standards must provide an answer. Information: This is the abstraction layer for the description of the information (structure, coding, content) needed in the specific care process / use case. This is described agnostic of implementation. 21/04/15 51

52 Role of the SDO platform Applications: this is the layer of health specific applications (EHRs, electronic prescription systems, apps, etc), which needs standards for the implementation of the information described in level 4. Especially interoperability requires much effort here: applications of totally different nature and origin (e.g. a hospital based HER and a community pharmacy based IT environment) must be brought to exchanging information in a meaningful way. IT infrastructure: this is in ReEIF the layer of not-healthcare specific technology: networks, web services, storage, etc. This is by definition not an area for development by the health sector, but the health sector has great interest in these developments as such, and for standards to be available timely and correctly for healthcare to use. 21/04/15 52

53 Next Steps Preparation phase for ehn JA task 5.4 members (May / June) Achieving a common knowledge base between the task 5.4 members Achieving a common understanding, perspective and expectation of the ehn JA task 5.4 and agreement on the task distribution and planning. Invite the SDO s for the ehn JA platform initiative (June) Organize a workshop to discuss and reflect on the proposal to initiate a (permanent) SDO platform To identify the position of the SDO s on the platform proposal, their terms of agreement and to seek broad support for the initiative. Request the invited and/or indicated SDO s to join the ehn JA SDO platform (Juli/Aug) Formally asked for their support for setting up this new platform. A letter of intent that reflect the common ambition, a solid basis for working out the governance of the platform and securing the expected output of the proposed SDO platform. 21/04/15 53

54 Next Steps Set up the governance model for the platform (Sept) To prepare the governance model of the platform. Construct final deliverable for ehn November 2015 (Okt) Prepare the final proposal for the new SDO platform (for decision). ehn decision on ehn JA SDO platform (Nov) In between Act as a platform under construction for the ehn JA (from the start) Function as a temporary platform for follow up on ehn JA actions related with this topic 21/04/15 54

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