Commission Implementing Regulation (EU) 2026/771 of 7 April 2026 laying down the necessary measures for the establishment and operation of the European Health Data Space Board

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847⁽¹⁾, and in particular Article 92(11), first sentence, thereof,

Whereas:

(1) Regulation (EU) 2025/327 establishes the European Health Data Space Board (the ‘EHDS Board’) as a body responsible for promoting the consistent application of that Regulation. The EHDS Board is to serve as a forum for cooperation and exchange of information both between Member States and between them and the Commission.

(2) The EHDS Board is a key part of the governance mechanisms under the EHDS Regulation. It builds on the experience gained with the eHealth Network established under Commission Implementing Decision 2019/1765⁽²⁾ on a network of national authorities responsible for eHealth. The eHealth Network will cease to exist on 26 March 2031⁽³⁾. Until then, the EHDS Board should cooperate with the eHealth Network, as well as with the eHealth Member States Expert Group, ensuring an orderly transition to the new governance framework, including at subgroup level. As different parts of the EHDS Regulation will start to apply, for example on the exchange of the first group of priority categories, the Board will start its activities on those topics, gradually taking over from the eHealth Network.

(3) The general tasks of the EHDS Board are set out in Article 94(1) and (2) of Regulation (EU) 2025/327. While the substance of the EHDS Board’s tasks is regulated in those provisions, it is appropriate to detail the types of actions the EHDS Board may take when performing its general tasks to ensure consistent application of Regulation (EU) 2025/327. Written contributions, including in the form of non-binding guidelines issued by the EHDS Board can provide useful guidance to national authorities and other stakeholders involved in implementing the European Health Data Space (EHDS).

(4) The EHDS Board may provide written contributions in relation to technical specifications in accordance with the EHDS Regulation, supporting the access to and exchange of electronic health data, in the form of technical implementation guides and other documentation. The EHDS Board may also provide written contributions for the purpose of addressing common implementation challenges, proposing coordinated responses or joint road maps for the Member States and EHDS communication strategies. Other written contributions can provide useful information on the implementation of the EHDS, including any issues that may arise during the implementation of the EHDS Regulation. Exchanges of best practices are expected to foster mutual learning and best practice adoption among national authorities as well as the cooperation of the EHDS Board with different relevant bodies, authorities and agencies invited to attend the meetings of the EHDS Board in accordance with Article 92(3) of Regulation (EU) 2025/327.

(5) Similarly, the EHDS Board should cooperate with other fora set up to support the implementation of the EHDS, such as the Community of Practice of Health Data Access Bodies, to support cross-border interoperability of public services in general, the Interoperable Europe Board established through Regulation (EU) 2024/903 of the European Parliament and of the Council⁽⁴⁾, and with the AI Board established through Regulation (EU) 2024/1689 of the European Parliament and of the Council⁽⁵⁾.

(6) The EHDS Board should adopt, every two years, a work plan to detail the activities that it will carry out to perform its general tasks. That two-year plan may be adapted to changing circumstances. The Commission, as secretariat of the EHDS Board, should provide support to the EHDS Board’s activities, including by providing secure collaboration tools.

(7) As Regulation (EU) 2025/327 provides that the EHDS Board is to be co-chaired by a representative of the Member States and a representative of the Commission, rules on the designation of the Member State co-chair should be laid down. With the Commission providing the secretariat of the EHDS Board, the representative of the Commission on the EHDS Board should not be entitled to vote.

(8) EHDS Board members should not be remunerated by the Commission for their participation in the activities of the EHDS Board. However, the Commission should reimburse their travel and subsistence expenses incurred for participating in the EHDS Board’s activities, following the approach for other similar bodies.

(9) Given that, in the course of their work, EHDS Board members, invited experts and observers may obtain access to sensitive information, they should be subject to the obligation of professional secrecy.

(10) As the Commission provides the secretariat of the EHDS Board, documents held by the secretariat of the EHDS Board should be subject to Regulation (EC) No 1049/2001 of the European Parliament and of the Council⁽⁶⁾.

(11) The work of the EHDS Board should be transparent. For this reason, information about its membership should be publicly available, and key documents should be published on a dedicated website.

(12) The European Data Protection Supervisor was consulted in accordance with Article 42(1) of Regulation (EU) 2018/1725 of the European Parliament and of the Council⁽⁷⁾ and delivered an opinion on 23 January 2026⁽⁸⁾.

(13) The measures provided for in this Regulation are in accordance with the opinion of the committee established by Article 98(1) of Regulation (EU) 2025/327,

HAS ADOPTED THIS REGULATION: