European Union: Passed Regulation establishing a European Health Data Space (EHDS) by European Parliament

On 24 April 2024, the Regulation on the European Health Data Space (EHDS) was passed by the European Parliament. The Regulation 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. Additionally, patients can restrict access to certain sensitive information, ensuring privacy protection while allowing access in vital situations. The Regulation 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 Regulation requires the disclosure of clinically significant findings to relevant healthcare professionals or patients, ensuring informed decision-making. The Regulation now goes to the Council for adoption.