European Health Data Space Regulation

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.