EHDS, Article 92, EU

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).

Official source

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