European Health Data Space (EHDS): New Regulation for Interoperability and Security of Health Data in the EU

The European Union has approved Regulation (EU) 2025/327, establishing the European Health Data Space (EHDS), an initiative aimed at improving the secure sharing of health data, digital innovation and interoperability between Member States. The regulation introduces new obligations for patients, healthcare providers and manufacturers of medical devices and wellness applications that wish to interoperate with Electronic Health Records (EHRs).

Rights of Patients and Healthcare Professionals

With the implementation of the EHDS, patients will have direct and secure access to their electronic health data and will be able to share it with healthcare professionals in any Member State. MyHealth@EU will be established, a platform that will ensure the cross-border exchange of medical information, promoting better continuity of healthcare. Healthcare professionals will also have centralised access to essential clinical records, facilitating more effective diagnoses and treatments.

Impact on Medical Device Manufacturers and Healthcare Applications

Medical devices and in vitro diagnostic devices (IVDs) that claim interoperability with EHR systems must comply with strict safety, traceability, and compliance requirements. If a product is both an EHR and a medical device, it must comply with both EHDS and European Medical Device Regulation requirements, including registration with EUDAMED. In addition, wellness applications that interact with EHRs will need to display a declaration of conformity with common EU specifications.

Implementation Deadlines and Next Steps

The regulation will enter into force 20 days after publication, with the first obligations applicable from March 2027. Until then, Member States must establish their Digital Health Authorities and ensure that national systems are compatible with the new requirements. Compliance with the EHDS will be essential for companies operating in the medical technology and digital health sector in Europe.

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