On March 5, the European Commission published a new “Frequently Asked Questions” document on the European Health Data Space (EHDS), clarifying this evolving framework for secure, EU-wide health data exchange and reuse.
Key highlights and timelines:
- March 2025: EHDS enters into force, initiating the transition period.
- March 2027: Deadline for the Commission to adopt key implementing acts, providing detailed technical rules.
- March 2029: Primary use of first-priority health data categories (patient summaries, ePrescriptions/eDispensations) becomes mandatory across all EU Member States. Most secondary-use rules, covering data from electronic health records, also kick in.
- March 2031: Second-priority data categories (medical images, lab results, discharge reports) come online, alongside extended secondary-use obligations (e.g. genomic data).
- March 2034: Third countries and international organisations can apply to join HealthData@EU for secondary use.
For medical device manufacturers, the EHDS introduces additional scrutiny around data interoperability, logging, and patient access rights. Notably, while the General Data Protection Regulation (UE) 2016/679 (GDPR) already safeguards personal data, the EHDS adds obligations for immediate data access and the seamless sharing of electronic health records (EHRs). If devices qualify as both medical devices and EHR systems, they must comply with both sets of regulations—meaning further testing, registration, and privacy measures on top of current medical device rules.
Have questions or need further information? Contact us at: [email protected]
