The entry into force of Regulation (EU) 2025/327 on the European Health Data Space (EHDS) marks a major shift in the digital health sector across Europe. This new regulation introduces clear rules for the interoperability of health data, promoting a more integrated, transparent, and citizen-centric healthcare ecosystem.
How is the EHDS Regulation structured, and what are its main areas of application?
The EHDS regulation distinguishes between primary use (for patient care) and secondary use (for research, innovation, and policymaking) of electronic health data. It introduces strict requirements to ensure data security, traceability, and clinical reliability.
How does the EHDS regulation enable health data exchange across Europe?
The regulation applies not only to electronic health record (EHR) system providers but also to manufacturers of medical devices, in vitro diagnostic (IVD) devices, and high-risk AI systems. These actors must demonstrate technical compliance with the new Common Specifications for interoperability.
Key requirements include:
- Adoption of interoperability standards such as HL7 FHIR
- Mandatory continuous update processes
- Compliance with MyHealth@EU (for primary use) and HealthData@EU (for secondary use)
- Alignment with the EU Artificial Intelligence Act for high-risk AI systems
These provisions directly impact device design, technical documentation, and product lifecycle management. Adapting to these new regulatory frameworks is essential to access the EU market and ensure trust from patients, healthcare professionals, and regulatory bodies.
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