Political agreement reached on European Health Data Space


On 15 March, the Council of the EU and the European Parliament reached a provisional agreement on the European Health Data Space (EHDS). The proposed regulation for the EHDS aims to improve individuals’ access to, and control over, their personal electronic health data, while also enabling certain data to be reused for public interest, policy support, and scientific research purposes.

Key points of new agreement include:

• Opt-out: Member States can allow patients to opt-out on the use of their health data being accessed, whether by a healthcare professional (primary use) or for further use (secondary use, always under strict conditions), except for purposes of public interest, policy making, statistics and research purposes in the public interest.

• Restricted information: if patients choose to restrict information, healthcare professionals will only be able to ac-cess restricted health data in situations of vital interest.

• Sensitive data: member states may put in place stricter measures governing access to certain kinds of sensitive data, such as genetic data, for research purposes.

The agreement must now be formally signed off by the Parliament and the Council. The compromise text is available at: