European Union: Adopted Council and Parliament Agreement on Regulation establishing a European Health Data Space (EHDS) including rules for portability and sharing of health data

On 15 March 2024, the Council of the EU and the European Parliament reached a provisional agreement on the Regulation on the European Health Data Space (EHDS). Firstly, the agreement introduces an opt-out mechanism, granting individuals the right to decide whether their health data, such as patient summaries, electronic prescriptions, medical imagery, and laboratory results, can be accessed by healthcare professionals, except for specific public interest purposes. Additionally, patients can restrict access to certain sensitive information, ensuring privacy protection while allowing access in vital situations. The agreement also allows for stricter governance of sensitive data types, such as genetic information, for research purposes. Moreover, member states can establish trusted data holders to facilitate secure data access, reducing administrative burdens. Finally, the agreement mandates the disclosure of clinically significant findings to relevant healthcare professionals or patients, ensuring informed decision-making. The agreement now goes to the Parliament and Council for adoption.