On 21 January 2025, the Regulation on the European Health Data Space (EHDS) was adopted by the Council of the European Union. The Regulation establishes an opt-out mechanism, enabling individuals to decide whether their health data, including patient summaries, electronic prescriptions, medical images, and laboratory results, can be accessed by healthcare professionals. Patients may also restrict access to sensitive information, with exceptions for emergency situations where access is necessary to protect vital interests. The Regulation includes provisions for stricter governance of sensitive data, such as genetic information, in secondary use cases like research. Member States are permitted to designate trusted data holders to facilitate secure and efficient access to health data while minimising administrative burdens. Additionally, the Regulation mandates the disclosure of clinically significant findings to patients or healthcare professionals.
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