European Commission Launches EHDS to Transform Health Data Sharing
Brussels, Friday, 7 March 2025.
The European Commission’s EHDS initiative is revolutionizing EU healthcare by enabling secure data exchange, improving patient access, and fostering cross-border medical collaboration.
Landmark Regulation Takes Effect
The European Health Data Space (EHDS) Regulation was officially published on March 5, 2025, marking a pivotal moment in EU healthcare digitalization [1]. Set to enter into force on March 26, 2025, this comprehensive framework establishes a harmonized system for electronic health record management and cross-border data sharing [2]. The regulation, formally known as Regulation (EU) 2025/327, builds upon extensive negotiations following its initial proposal by the European Commission in March 2022 [3].
Phased Implementation and Economic Impact
The EHDS implementation follows a carefully structured timeline, with key milestones extending through 2034. Priority health data categories, including Patient Summaries and ePrescriptions, will begin cross-border exchange by March 2029 [2]. The initiative is projected to generate substantial economic benefits, with anticipated savings of €11 billion over the next decade and potential growth of 20-30% in the digital health sector [2].
Enhanced Patient Rights and Data Protection
The regulation introduces robust safeguards for patient privacy while expanding access to health information. Healthcare providers must share data within three months of access being granted by health data access bodies (HDABs), though patients retain the right to opt out [4]. For secondary use of health data, such as research and policy-making, strict processing requirements mandate secure environments with no direct downloading of personal data [2].
International Collaboration and Future Prospects
The EHDS framework extends beyond EU borders, enabling international health data applicants to request access if their countries meet compliance criteria [4]. The European Commission will release detailed guidelines on secondary data use, with consultations planned for Autumn 2025 and Spring 2026 [4]. Through the HealthData@EU infrastructure, already operational since 2022, the system facilitates secure cross-border health data exchange [4].