Articles of the European Health Data Space (EHDS), Article 65, Tasks of the EHDS Board, European Health Data Space (EHDS)



Article 65, Tasks of the EHDS Board, European Health Data Space (EHDS), Articles of the European Health Data Space (EHDS), (Proposal_3.5.2022)

1. The EHDS Board shall have the following tasks relating to the primary use of electronic health data in accordance with Chapters II and III:

(a) to assist Member States in coordinating practices of digital health authorities;

(b) to issue written contributions and to exchange 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) the provisions set out in Chapters II and III;

(ii) development of online services facilitating secure access, including secure electronic identification, to electronic health data for health professionals and natural persons;

(iii) other aspects of the primary use of electronic health data.

(c) to facilitate cooperation between digital health authorities through capacity-building, establishing the structure for annual activity reporting, peer-review of annual activity reports and exchange of information;

(d) to share information concerning risks posed by EHR systems and serious incidents as well as their handling;

(e) to facilitate the exchange of views on the primary use of electronic health data with the relevant stakeholders, including representatives of patients, health professionals, researchers, regulators and policy makers in the health sector.


2. The EHDS Board shall have the following tasks related to the secondary use of electronic health data in accordance with Chapter IV:

(a) to assist Member States in coordinating practices of health data access bodies in the implementation of provisions set out in Chapters IV, to ensure a consistent application of this Regulation;

(b) to issue written contributions and to exchange 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:

(xi) implementation of rules for access to electronic health data;

(xii) technical specifications or existing standards regarding the requirements set out in Chapter IV;

(xiii) incentives policy for promoting data quality and interoperability improvement;

(xiv) policies concerning fees to be charged by the health data access bodies and data holders;

(xv) the establishment and application of penalties;

(xvi) other aspects of the secondary use of electronic health data.

(c) to facilitate cooperation between health data access bodies through capacity-building, establishing the structure for annual activity reporting, peer-review of annual activity reports and exchange of information;

(d) to share information concerning risks and data protection incidents related to secondary use of electronic health data, as well as their handling;

(e) to contribute to the work of the European Data Innovation Board to be established in accordance with Article 29 of the Regulation […] [Data Governance Act COM/2020/767 final];

(f) to facilitate the exchange of views on the secondary use of electronic health data with the relevant stakeholders, including representatives of patients, health professionals, researchers, regulators and policy makers in the health sector.