European Health Data Space Board
1. A European Health Data Space Board (the ‘EHDS Board’) is hereby established to facilitate cooperation and the exchange of information among Member States and the Commission. The EHDS Board shall be composed of two representatives per Member State, namely one representative for primary use purposes and one for secondary use purposes, nominated by each Member State. Each Member State shall have one vote. Members of the EHDS Board shall undertake to act in the public interest and in an independent manner.
2. A representative of the Commission and one of the representatives of the Member States referred to in paragraph 1 shall co-chair the meetings of the EHDS Board.
3. Market surveillance authorities referred to in Article 43, the EDPB and the European Data Protection Supervisor, the European Medicines Agency, the European Centre for Disease Prevention and Control and the European Union Agency for Cybersecurity (ENISA) shall be invited to attend the meetings, where relevant according to the EHDS Board.
4. The EHDS Board may invite national authorities, experts and observers as well as Union institutions, bodies, offices and agencies, in addition to those referred to in paragraph 3, and research infrastructures and other similar infrastructures to attend its meetings.
5. The EHDS Board may cooperate with external experts where appropriate.
6. Depending on the functions related to the use of electronic health data, the EHDS Board may work in subgroups for certain topics, in which digital health authorities or health data access bodies shall be represented. Those subgroups shall support the EHDS Board with specific expertise and may have joint meetings, as required.
7. The EHDS Board shall adopt its rules of procedure and a code of conduct, following a proposal from the Commission. Those rules of procedure shall provide for the composition, organisation, functioning and cooperation of the subgroups referred to in paragraph 6 of this Article and the cooperation of the EHDS Board with the stakeholder forum referred to in Article 93.
The EHDS Board shall adopt decisions by consensus as far as possible. If a consensus cannot be reached, the EHDS Board shall adopt decisions by a majority of two-thirds of the Member States.
8. The EHDS Board shall cooperate with other relevant bodies, entities and experts, such as the European Data Innovation Board established by Article 29 of Regulation (EU) 2022/868, competent authorities designated in accordance with Article 37 of Regulation (EU) 2023/2854, supervisory bodies designated in accordance with Article 46b of Regulation (EU) No 910/2014, the EDPB established by Article 68 of Regulation (EU) 2016/679, cybersecurity bodies, including ENISA, and the European Open Science Cloud, with a view to reaching advanced solutions towards findable, accessible, interoperable and reusable (FAIR) data usage in research and innovation.
9. The EHDS Board shall be assisted by a secretariat provided by the Commission.
10. The EHDS Board shall publish its meeting dates and the minutes of its deliberations, and publish an activity report every two years.
11. The Commission shall, by means of implementing acts, adopt the necessary measures for the establishment and operation of the EHDS Board. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2).
Stakeholder forum
1. A stakeholder forum is hereby established for the purpose of facilitating the exchange of information and promoting cooperation among stakeholders in relation to the implementation of this Regulation.
2. The stakeholder forum shall have a balanced composition and be composed of relevant stakeholders, including representatives of patient organisations, health professionals, industry, consumer organisations, scientific researchers and academia, and shall represent their views. Where commercial interests are represented in the stakeholder forum, the representation of such interests shall be based on a balanced combination of large companies, small and medium-sized enterprises and start-ups. The tasks of the stakeholder forum shall encompass equally primary use and secondary use.
3. Members of the stakeholder forum shall be appointed by the Commission following a public call for interest and a transparent selection procedure. Members of the stakeholder forum shall make an annual declaration of interests which shall be made publicly available and updated, when relevant.
4. The stakeholder forum may establish standing or temporary subgroups, as appropriate, for the purpose of examining specific questions related to the objectives of this Regulation. The stakeholder forum shall adopt its rules of procedure.
5. The stakeholder forum shall hold regular meetings, which shall be chaired by a Commission representative.
6. The stakeholder forum shall prepare an annual report of its activities. That report shall be made publicly available.
Tasks of the EHDS Board
1. The EHDS Board shall have the following tasks relating to primary use in accordance with Chapters II and III:
(a)
assisting Member States in coordinating practices of digital health authorities;
(b)
issuing written contributions and exchanging best practices on matters related to the coordination of the implementation at Member State level, taking into account the regional and local level, of this Regulation and of the delegated and implementing acts adopted pursuant to it, in particular as regards:
(i)
the provisions set out in Chapters II and III;
(ii)
the development of online services facilitating secure access, including secure electronic identification, to electronic health data for health professionals and natural persons;
(iii)
other aspects relating to primary use;
(c)
facilitating cooperation between digital health authorities through capacity building, establishing the framework for activity-reporting referred to in Article 20 and the exchange of information;
(d)
sharing among its members information concerning risks posed by EHR systems and serious incidents as well as the handling of such risks and incidents;
(e)
facilitating the exchange of views on primary use with the stakeholder forum referred to in Article 93, as well as with regulators and policy-makers in the health sector.
2. The EHDS Board shall have the following tasks related to secondary use in accordance with Chapter IV:
(a)
assisting Member States in coordinating practices of health data access bodies in the implementation of provisions set out in Chapter IV, to ensure a consistent application of this Regulation;
(b)
issuing written contributions and exchanging best practices on matters related to the coordination of the implementation at Member State level of this Regulation and of the delegated and implementing acts adopted pursuant to it, in particular as regards:
(i)
implementation of rules for access to electronic health data;
(ii)
technical specifications or existing standards regarding the requirements set out in Chapter IV;
(iii)
incentives for promoting data quality and interoperability improvement;
(iv)
policies concerning fees to be charged by the health data access bodies and health data holders;
(v)
measures to protect the personal data of health professionals involved in the treatment of natural persons;
(vi)
other aspects of secondary use;
(c)
creating, in consultation and cooperation with relevant stakeholders, including representatives of patients, health professionals and researchers, guidelines in order to help health data users to fulfil their duties under Article 61(5), and in particular to determine whether their findings are clinically significant;
(d)
facilitating cooperation between health data access bodies through capacity building, establishing the framework for activity-reporting referred to in Article 59(1), and the exchange of information;
(e)
sharing information concerning risks and incidents related to secondary use, as well as the handling of such risks and incidents;
(f)
facilitating the exchange of views on secondary use with the stakeholder forum referred to in Article 93, as well as with health data holders, health data users, regulators and policy-makers in the health sector.
Steering groups for MyHealth@EU and HealthData@EU
1. The MyHealth@EU steering group and the HealthData@EU steering group (the ‘steering groups’) are hereby established for the cross-border infrastructures provided for in Articles 23 and 75. Each steering group shall be composed of one representative per Member State appointed from the relevant national contact points.
2. The steering groups shall take operational decisions concerning the development and operation of MyHealth@EU and HealthData@EU.
3. The steering groups shall take decisions by consensus. Where a consensus cannot be reached, a decision shall be adopted by two-thirds of the members. For the adoption of the decisions, each Member State shall have one vote.
4. The steering groups shall adopt rules of procedure, setting out their composition, organisation, functioning and cooperation.
5. Other authorised participants may be invited to exchange information and views on relevant matters related to MyHealth@EU and HealthData@EU. Where those authorised participants are invited, they shall have an observer role.
6. Stakeholders and relevant third parties, including representatives of patients, health professionals, consumers and industry, may be invited to attend the meetings of the steering groups as observers.
7. The steering groups shall elect chairs for their meetings.
8. The steering groups shall be assisted by a secretariat provided by the Commission.
Roles and responsibilities of the Commission regarding the functioning of the EHDS
1. In addition to its role in making available electronic health data held by Union institutions, bodies, offices or agencies, in accordance with Article 55, Article 56 and Article 75(2), and its tasks under Chapter III, in particular Article 40, the Commission shall develop, maintain, host and operate the infrastructures and central services required to support the functioning of the EHDS, for all relevant connected entities, by means of:
(a)
an interoperable, cross-border identification and authentication mechanism for natural persons and health professionals, in accordance with Article 16(3) and (4);
(b)
the central services and infrastructures for digital health of MyHealth@EU, in accordance with Article 23(1);
(c)
compliance checks for connecting authorised participants to MyHealth@EU, in accordance with Article 23(9);
(d)
the supplementary cross-border digital health services and infrastructures referred to in Article 24(1);
(e)
as part of HealthData@EU, a service to submit health data access applications seeking access to electronic health data held by health data holders in more than one Member State or by other authorised participants in HealthData@EU and to automatically forward the health data access applications to the relevant contact points, in accordance with Article 67(3);
(f)
the central services and infrastructures of HealthData@EU, in accordance with Article 75(7) and (8);
(g)
a secure processing environment, in accordance with Article 75(9), in which health data access bodies can decide to make data available, in accordance with Article 68(8);
(h)
compliance checks for connecting authorised participants to HealthData@EU, in accordance with Article 75(5);
(i)
a federated EU dataset catalogue connecting the national dataset catalogues, in accordance with Article 79;
(j)
a secretariat for the EHDS Board, in accordance with Article 92(9);
(k)
a secretariat for the steering groups, in accordance with Article 95(8).
2. The services referred to in paragraph 1 of this Article shall meet sufficient quality standards in terms of availability, security, capacity, interoperability, maintenance, monitoring and development to ensure the EHDS functions effectively. The Commission shall provide those services in accordance with the operational decisions of the relevant steering groups established in Article 95.
3. The Commission shall prepare a report on the infrastructures and services supporting the EHDS that it provides in accordance with paragraph 1 every two years and make it publicly available.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
