ehealth Governance Initiative: Joint Action JA-EHGov & Thematic Network SEHGovIA DELIVERABLE Version: Date:

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1 ehealth Governance Initiative: Joint Action JA-EHGov & Thematic Network SEHGovIA DELIVERABLE TN D1.6.2 Yearly Network Plan WP1 (TN) Coordination Version: V5 Date: Project co-funded by the European Commission within the ICT Policy Support Programme and the Health Framework Programme

2 COVER PAGE Project Acronym Grant Agreement number Status* Dissemination level** Author(s) & Organization(s) Contact SEHGovIA Thematic Network Final PU Isabella Weber, ATNA Gottfried Heider, ATNA Isabella Weber: * Status: Draft / In Progress / Final ** Dissemination level: PU = Public or CO = Confidential, only for members of the consortium and the Commission Services ABSTRACT The Yearly Network Plan demonstrates an executive summary of all major events mainly influencing the work of the ehealth Governance Initiative and therewith, refers also to essential activities of the second reporting period. Page 2 of 19

3 Change History Version Date Status Author Details Review V DRAFT Gottfried Heider 1st draft V In progress Gottfried Heider adaptations V In progress Isabella Weber, Gottfried Heider comments and adaptations V Pre-Final Isabella Weber adaptations PSC Isabella Weber Gottfried Heider V Final Isabella Weber Adapt with comments received from PSC Statement of originality: This deliverable contains original unpublished work except where clearly indicated otherwise. Acknowledgement of previously published material and of the work of others has been made through appropriate citation, quotation or both. Page 3 of 19

4 ABBREVIATIONS D EC ehgi eid EU EXCO HLeHGG LPPD MS MT PC PSC RP T&A TCon WP Deliverable European Commission ehealth Governance Initiative electronic Identification European Union Executive Committee High Level ehealth Governance Group Legal and Protection of Personal Data Member States Mainstreaming Project Coordination Project Steering Committee Reporting Period Trust & Acceptability Telephone Conference Work Package LIST OF REFERENCES Name of Author CALLIOPE Steering Committee Members Isabella Weber, Gottfried Heider Reverence / Source CALLIOPE EU ehealth Interoperability Roadmap: ( D1.8.2 Deliverable Meeting/Event Summary Report Kenneth B. Ahrensberg Deliverable Evaluation Progress Report I Page 4 of 19

5 TABLE OF CONTENTS 1. Introduction Events ehealth Conference in May 2012, Copenhagen ehgi Workshop on cross-border datasharing in September 2012, Gent nd ehealth Network meeting in November 2012, Brussels ehgi Workshop on eid for ehealth in February 2013, Brussels Other activities Outlook...12 ANNEX I Conclusions of the ehealth Network meeting in May 2012, Copenhagen...13 ANNEX II Conclusions of the ehealth Network meeting in November 2012, Brussels...15 ANNEX III Agenda of ehgi Workshop in Gent (Belgium) on Cross Border Data Sharing...16 ANNEX IV Conclusions eid Workshop in February 2013, Brussels...19 Page 5 of 19

6 1. Introduction While Deliverable is dealing with regular project meetings (mainly EXCO, PSC and other committee meetings) the Yearly Network Plan focuses on a report of special events having major influence of the ongoing work of the ehgi and its activities related to the outcomes within the second reporting period (RP) 1 supported and/or operated by the Project Coordination (PC). 2. Events The following events and workshops did influence the progress of the ehgi: ehealth Conference in May 2012, Copenhagen including the 1st ehealth Network meeting 2nd ehealth Network meeting in November 2012, Brussels ehgi Workshop on cross-border data sharing on legal, regulatory and semantic interoperability aspects in September 2012, Gent ehgi Workshop on eid for ehealth in February 2013, Brussels 2.1 ehealth Conference in May 2012, Copenhagen The ehealth Conference, in May 2012 hosted by the Danish Presidency from 7th to 9th of May, is the every year s focus of ehealth and hence also of project progress and strategical stepping-forward on political high level. Based on the implementation decision referring to the establishment of the ehealth Network according to Art. 14 of the Directive 2011/24/EU the High Level ehealth Governance Group was merged into the voluntary ehealth Network. Therefore this officially established platform for the continued joint European efforts with ehealth could meet first in Copenhagen at the tenth anniversary of the high-level ministerial ehealth conferences, and during the Danish EU presidency. Preparations from PC side included several project internal meetings and Telephone Conferences (TCon) in close cooperation with the Danish partner and the EC in order 1 Second reporting period: 1st February st March 2013 Page 6 of 19

7 to align the preparatory work of the ehgi with the intentions of the Danish Presidency and further with the ehealth Network. During the ehealth Network meeting both chairs (Paola Testori-Coggi from DG SANCO and Clemens-Martin Auer, Director General Ministry of Health Austria and ehgi project coordinator) pointed out that the Network should endorse guidelines listed under Article 14(2) of the Directive 2011/24/EU. Clemens-Martin Auer presented the Conclusions on eid EU Governance for ehealth Services2 produced by the ehgi to the ehealth Network and pointed out that it shall serve with the support of political process and development of governance structures in the Member States. His presentation was followed by a fruitful discussion among its members who were asked to explain their national solutions available in this context. This in particular relates to the setting of priorities, developing strategies, recommendations and guidelines on how to initiate an interoperable ehealth system in Europe. The ehgi was requested to continue its work on eidentification. The final issue being addressed was a draft version of the meeting conclusions (see Annex I). 2.2 ehgi Workshop on cross-border datasharing in September 2012, Gent In order to complete the briefing documents for the ehealth Network meeting in November 2012 focusing on issues for the revision of the Data Protection Regulation and on semantic interoperability a profound preparation phase shall be ensured. Therefore, a joint workshop had been arranged considering also relevant external experts perspectives from the semantic healthnet project. The objective of this workshop was to expose the main issues to be addressed and collect inputs (consensus, open issues, Member States perspectives, etc.) from all parties in order to create a draft version of relevant documents. During the workshop the present competent authorities were asked to contribute to discussions aiming to clarify whether to get involved in the data protection regulation process. Based on that the aim was to find a common ground and interest in the course of a first discussion. In this context WPL of WP LPPD presented the Member States concerns regarding organizational challenges referring to: 2 The Conclusions form the Deliverable of the Joint Action WP Mainstreaming. Page 7 of 19

8 Consents acquisition, content and management Children and non-capable consent Consent storage Open questions remained towards: Which Framework should be established? Which timeframe should be given to MS in order to implement solutions setted forth by DPR? What happens with MS that have a different understanding and internal law? Which other concern should be observed by DPR? Main conclusion of the discussion referred to the agreement that the mentioned issues shall be brought to the ehealth Network in November 2012 to be further discussed. A further discussion concentrated on semantic interoperability in order to prepare for an in-depth policy discussion among the ehealth Network members in November In this context, the workshop aimed to support clarifying on the concrete topics the ehgi shall further work on as this was not that clear. WPL of WP ISM together with WPL of WP Policy and Strategy 3 presented the main results gained from the ehgi questionnaire dealing with semantic interoperability aspects. Objectives of this Questionnaire referred to: To enable ehgi to elaborate further discussions during workshop Get a clearer view of the situation of semantic interoperability Identify open issues from MS A detailed analysis of the outcomes and results gained from this questionnaire are reflected in Deliverable WPL of WP Trust and Acceptability 4 presented the results of an internal workshop dealing with the issues of Public Benefit versus Individual Rights and Legal vs. Ethical. The discussed topics referred to: Prima facie obligation of confidentiality of information given in confidence Obligation discharged when appropriate consent given for closure Regulatory penalties Justification for disclosure influenced by o Necessity 3 WP Policy Alignment and Strategy Development is part of the ehgi Joint Action. 4 WP Trust and Acceptability is part of the ehgi Joint Action. Page 8 of 19

9 o Proportionality o Risks of disclosure o Risks of serious harms to others Further goals of workshop aimed to identify political steps and political measures the ehgi should push forward in order to draw up political guidelines for the Member States. Discussions should concentrate on policy level instead of getting too technical in order to support the ehgi with the formalisation of a political policy paper to be presented to the members of the ehealth Network in November, nd ehealth Network meeting in November 2012, Brussels The ehealth Network meeting as such takes place twice a year and is organised by the EC (primarily DG SANCO) in close cooperation with the ehgi. On 7th November 2012 the ehealth Network met for the 2nd time in Brussels where all Member States were present, except one. Croatia, Norway and Switzerland participated as observers. Paola Testori-Coggi who again chaired this meeting together with Clemens-Martin Auer gave a brief overview of the EC initiatives related to ehealth: Work on eprescription under Article 11 of the Directive 2011/24 ehealth Action Plan Connecting Europe Facility (CEF) ICT multistakeholders platform on standardization EU legal study on ehealth Records in Member states Clemens-Martin Auer introduced the ehgi s discussion paper on semantic and technical interoperability 5 which outlines recommendations to handle semantic and technical interoperability in the field of ehealth in Europe. The paper refers to issues on semantic which were handled by epsos for transcoding of different catalogues. It further lays out that semantic interoperability is a precondition for exchanging information in the field of ehealth. The SemanticHealthNet project was presented by the EC. The Member States endorsed the discussion paper on semantic and technical interoperability as a first commitment at policy level and the ehgi had been requested to produce a another discussion paper which shall contain more concrete information on semantic and 5 The discussion paper forms Deliverable 8.2 of the SEHGovIA Thematic Network WP Interoperability, Standardisation and Market. Page 9 of 19

10 technical interoperability and which shall be presented at the 3rd ehealth Network meeting in May 2013in Dublin. Robert Madelin (Director General at DG CONNECT) gave an overview of the proposed eid Regulation and Article 14 of the Directive 2011/24/EU. His key statement referred to the proposal that the Member States shall be free to decide which eid means they want to notify and apply, they shall however accept all eid s of other Member States. In 2012 DG SANCO sent a questionnaire to all Member States requesting information on current existing eid solutions in the Member States and presented the results to the members of the ehealth Network. One main outcome gained was that 8 Member States have an e-card in place and 16 Member States have a cross-sector identification in use which is important for the large scale pilot esens 6. It was proposed that the ehgi shall organise a Workshop on eid for all Member States in order collect input and feedback from the Member States on the operational level first. Based on results gained the ehealth Network shall be provided with a clearer view in the field of eid and with a briefing paper containing recommendations for the Member States that shall be presented at the 3rd ehealth Network meeting in May 2013 in Dublin. 2.4 ehgi Workshop on eid for ehealth in February 2013, Brussels Based on the request of the ehealth Network the ehgi PC in close cooperation with the Joint Action WP Policy Alignment and Strategy Development organized and supported a workshop on eid for ehealth for its members and invited experts on February 11th and 12th 2013 in Brussels. The main objectives of the workshop referred to: Minimum/maximum credentials Difference between healthcare professional and patient The way of support by other European projects like epsos, STORK, etc. Cross-sectoral aspects National and international aspects Quality of authentication assurance level Minimum requirements 6 esens was launched on and is aiming at interoperability in cross-border and cross-sector aspects. Page 10 of 19

11 eid from a legal perspective cross-border aspects cross-sectoral aspects In order to meet the character of a workshop the following groups were defined and integrated as break-out sessions in the workshop: eid for citizens ehealth eid quality of authentication assurance level eid from a legal perspective In addition, participants from epsos and STORK were invited and explained how eid was handled in the relevant projects. Based on the results gained from the workshop (Annex IV Conclusions of eid workshop in February 2012, Brussels) the ehgi drafted a briefing note containing recommendations on eid for ehealth 7 to be used as background information for the 3rd ehealth Network meeting in May 2013 in Dublin. In order to trigger the political discussion among the Network s members the ehgi has additionally produced an executive summary on the basis of the background document which shall be presented to them as discussion basis. 3. Other activities The PC also supported beneficiaries in all questions related to administrative tasks, organisational issues, technical management and general coordination of project. Most issues could be discussed via or phone. As supportive instrument when sharing information, documents and other helpful documents the ehgi used the joint communication platform projectplace: Moreover, this platform is used to upload deliverables, reporting files, supportive documents for meetings, etc. in order to avoid sending huge data amounts by . For the arrangement of f2f meetings or TCons, the PC used Doodle which enables an easy handling of coordinating dates and times for upcoming meetings. 7 This documents forms Deliverable of the Joint Action WP Mainstreaming. Page 11 of 19

12 4. Outlook For the third RP two roadmap documents are foreseen to be produced by the ehgi; one focusing on eid and one on semantic and technical interoperability. Both shall be presented to the members of the ehealth Network its 5th meeting in the course of the ehealth conference in May 2014 in Greece. The work on these two roadmap documents shall further engage the active involvement of experts of the ehgi PSC and hence getting the input of the Member States which shall form an essential part of these documents. While concrete work towards the acceptability by the healthcare professionals for the usage of a minimum patient summary dataset to be exchanged across borders shall be fostered during the 3rd reporting period, also issues with regards to patient access to data and benefit of cross-border eprescription shall be tackled by the ehgi. In addition, WP Evaluation will focus on an overall impact report analysing the relationship and impact of the ehgi and the ehealth Network, while in parallel each content WP will work on a separate impact analysis being reflected in the overall evaluation report. Finally, the ehgi in close cooperation with the EC, other projects/initiatives and the ehealth Network will work on a sustainable working construct that shall enable longterm policy development in the field of ehealth which shall not be limited until June 2014 but go beyond this. Page 12 of 19

13 ANNEX I Conclusions of the ehealth Network meeting in May 2012, Copenhagen Conclusions: The ehealth Network: Adopted the Rules of Procedure and elected a Member States' co-chair Acknowledged that the following priorities shall be reflected in the Multiannual Work Programme , to be finalised in the second Network's meeting: - eldentifícation for ehealth, interoperability - particularly semantic interoperability and interoperability of data bases for medicinal products. Adopted the "Conclusions on eldentifícation EU Governance for ehealth Services", after amendment. The next meeting will take place in Brussels on 7th November 2012 and may include in its draft agenda: finalisation and adoption of the Multiannual work programme, discussion on the new proposal on data protection in view of a possible Network's common position, interoperability of data bases for medicinal products and investments, semantic interoperability. The discussions and decisions in the Network's meetings shall be prepared and conducted at strategic political level with more limited technical presentations. Some of the Network's results could be presented to the EPSCO. The ehgi is invited to further work on: The follow up of the Network's "Conclusions on eldentifícation EU Governance for ehealth Services". The follow up of the Network's request to prepare a policy paper on semantics interoperability. The Network's Secretariat (Commission) will: Draft Summary records of the meeting pursuant to article 11 and send to Network's members for comments. Reflect the Network's conclusions on priorities and adapt the draft Multiannual Work Programme in view of its finalisation and adoption the second meeting of the Network. Present a mapping of Member States practices on eld for health, on the basis Of information received. Liaise with EMA in view of the discussion on interoperability of European Page 13 of 19

14 and national data bases for medicinal products, in the second Network's meeting. Network's Members are invited to: Send short (half page maximum) written contributions regarding their system For eldentifícation for health purpose to the Network's Secretariat by 30* June 2012 Send comments to the Network's Secretariat on the drañ summary record on the 1st meeting of the ehealth Network by 30th June Send comments on the Commission working document on legal issues of telemedicine to the Commission and by 11th June 2012 (extension of deadline of 1st June 2012 given in the meeting). Page 14 of 19

15 ANNEX II Conclusions of the ehealth Network meeting in November 2012, Brussels Conclusions: The Co-Chairs recalled the rules of procedures of the Network which require summary minutes and no mention of the individual positions. They gave the preliminary information as regards the 3rd meeting of the Network: It will take place in Dublin, in the margin of the ehealth week 2013, on 13, 14 or 15 May 2013 Some draft agenda points will derive from the outcomes of this 2nd meeting and from the adopted multi annual work programme, namely: o eid for ehealth: adoption of a position paper on the Commission proposal for a regulation recognition on eid and esignature o Interoperability: adoption of a roadmap on semantic and technical interoperability o Sustainability: adoption of a Network's recommendation on the governance of the Connecting Europe Facility o First discussion on the set of data on patient's record summary Page 15 of 19

16 ANNEX III Agenda of ehgi Workshop in Gent (Belgium) on Cross Border Data Sharing AGENDA ehgi WORKSHOP on Cross-Border DATA SHARING on LEGAL, REGULATORY and SEMANTIC INTEROPERABILITY ASPECTS 4 th September, 2012: 9:00 17:00h Gent, Belgium The workshop aims at providing input which will form the basis for completing the briefing documents to be presented to the ehealth Network on 7 th November 2012 specifically referring to (i) a discussion paper on the proposed Revision of the General Regulation on Data Protection and (ii) the preliminary inputs for discussion on semantic interoperability. Time Session Objective of the Session 08:30-09:00 Registration 09:00-10:15 SESSION I Setting the Scene I.I The political background, ehealth Network and ehgi interactions: Outcomes of the first meeting Clemens Auer, Director General Ministry of Health AT I.II Working principles of the ehgi to support ehealth Network discussions and priorities: Specific Objectives of this workshop Next steps Michéle Thonnet, EU ehealth Road Map Leader The ehealth Network set up: Short feedback from the first meeting. Presentation of the objectives of the workshop, as well as the focused items and way of working during and after the workshop. I.III How to create trust and the conditions of acceptance: Setting the scene including the patient s perspective Luc Nicolas, ehgi Trust and Acceptability Lead Page 16 of 19

17 10:15-12:30 SESSION II Legal, Regulatory and Related Data Protection Issues of Cross-Border Data Sharing Moderator: Zoi Kolitsi, ehgi LPPD Lead Rapporteur: II.I Introduction to the Revision of the General Data Protection Regulation Karolina Hanslik, European Commission II.II Member States and Stakeholders perspectives on the legal and the regulatory basis, including ethical and professional codes Round Table: MS representatives; Michael Wilks, CPME DISCUSSION (Planned): II.III Learning from concrete experiences: Insights from epsos: The need for an EU level Information Governance Petra Wilson, epsos expert The objective is to focus on the main areas in the Revision of the Data Protection Regulation which effect ehealth, identify the main issues and suggest ways of addressing them within and around the framework of the Regulation. In order to best prepare the discussion, Member States Representatives are invited to provide brief responses to the attached questionnaire by August 27th latest. 12:30-13:30 LUNCH 13:30-15:30 SESSION III Semantic Aspects of Cross-Border Data Sharing III.I Discussion of key aspects with Member States Moderator: Falk Schubert, ehgi ISM Lead, Germany Rapporteur: Stephan Schug, EHTEL I.a Introduction: Suggestions from the ehgi subgroup ISM of key issues and proposals for the policy paper. Falk Schubert, ehgi ISM Lead I.b Presentation of a summary on inputs received from questionnaires completed by MS Anna Adelöf & Arturo Romero, WPL Policy & Strategy I.c DISCUSSION based on the inputs of the corresponding questionnaire on semantic interoperability and the proposals from ISM. The objective of the session is to update and specify actions profiting from discussions within the ehgi, Semantic Healthnet and other relevant initiatives. Inputs of existing strategies and development / usage in Member States have been collected by a questionnaire on semantic interoperability aspects. 15:30-15:45 COFFEE BREAK Page 17 of 19

18 15:45-17:00 III.II Semantic community & researchers point of view II.a Governance of Semantic Interoperability assets and its supporting infostructure Dipak Kalra, Semantic Healthnet Project II.b DISCUSSION towards an EU Infostructure Page 18 of 19

19 ANNEX IV Conclusions eid Workshop in February 2013, Brussels A) The Systems in place in MS on ID and Authentication, for HCP should distinguish an establish a Registers of health professionals Security of authentication for HP level 3 A review on what is existing today by a mapping exercise should be face and MS should be aware regarding the importance of this. Roles of health professionals standardization of the 5 regulated professions should be carried out in order to have a common understanding on who is entitled to have access to Clinical information. B) It would be very important for eid on Health sector to define differences between use cases on-the-spot and online services. Which of them are applicable by now. Requirements will be different for On the spot and for on line cases. A guidance agreed among MS should be faced in order to transit from the on the spot to the on line case. C) Identification of the patient a use of existing solutions and experiences has to be analyze (e.g. Notified identification schemas of citizens STORK). Issues regarding identifier have not been solved within the WS, therefore, a deeper and longer analysis should be carried out within the ehgi: one single identifier for health? federation of identifiers/mapping??? /electronic identification / and so on. D) A mapping of legal requirements and for what use cases should be addressed, as well as eauthentication of patient: is it required? In which cases? In which MS? In what situations MS require eid? E) Participants agreed the basement on a mutual recognition of access rights, as well as the need to deeply analyze matters regarding: roles, definition of consent recall and maintain consent, how to do e-consent, definition of rules for proving therapeutic relationship, registration of access. Page 19 of 19