Data & Privacy
- Data Act
- Data Governance Act
- EHDS
- ePrivacy Directive
- GDPR
AI & Trust
- Artificial Intelligence Act
- Product Liability Directive
Cybersecurity
- Cyber Resilience Act
- Cybersecurity Act
- DORA
- NIS2
Digital Services & Media
- Digital Markets Act
- Digital Services Act
- European Media Freedom Act
European Health Data Space Regulation
- Recitals
CHAPTER I
GENERAL PROVISIONSArticles 1 — 2
CHAPTER II
PRIMARY USEArticles 3 — 24
CHAPTER III
EHR SYSTEMS AND WELLNESS APPLICATIONSArticles 25 — 49
CHAPTER IV
SECONDARY USEArticles 50 — 81
CHAPTER V
ADDITIONAL ACTIONSArticles 82 — 91
CHAPTER VI
EUROPEAN GOVERNANCE AND COORDINATIONArticles 92 — 96
CHAPTER VII
DELEGATION OF POWERS AND COMMITTEE PROCEDUREArticles 97 — 98
CHAPTER VIII
MISCELLANEOUSArticles 99 — 104
CHAPTER IX
DEFERRED APPLICATION, TRANSITIONAL AND FINAL PROVISIONSArticles 105 — 105
ANNEXES
EHDS Article 92. 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).
Relevant Recitals for this Article
In order to promote the consistent application of this Regulation, including as regards cross-border interoperability of electronic health data, a European Health Data Space Board should be set up. The Commission should participate in its activities and co-chair it. The EHDS Board should be able to issue written contributions related to the consistent application of this Regulation throughout the Union, including by helping Member States to coordinate the use of electronic health data for healthcare and certification, but also concerning secondary use, and the funding for those activities. This could also include sharing information on risks and incidents in the secure processing environments. The sharing of that kind of information does not affect obligations under other legal acts, such as data breach notifications under Regulation (EU) 2016/679. More generally, the activities of the EHDS Board are without prejudice to the powers of the supervisory authorities pursuant to Regulation (EU) 2016/679. Given that, at national level, digital health authorities dealing with primary use may be different from the health data access bodies dealing with secondary use, the functions are different and there is a need for distinct cooperation in each of those areas, the EHDS Board should be able to set up subgroups dealing with those two functions, as well as other subgroups, as needed. In order for there to be an efficient working method, the digital health authorities and health data access bodies should create networks and links at national level with other bodies and authorities, but also at Union level. Such bodies could comprise data protection authorities, cybersecurity, eID and standardisation bodies, as well as bodies and expert groups under Regulations (EU) 2022/868, (EU) 2023/2854 and (EU) 2024/1689 and Regulation (EU) 2019/881 of the European Parliament and of the Council . The EHDS Board should operate independently, in the public interest and in line with its code of conduct.
Where issues that are considered by the EHDS Board to be of specific relevance are discussed, it should be able to invite observers, for instance the EDPS, representatives of Union institutions, including of the European Parliament, and other stakeholders.