The most transformative EU healthcare regulation since GDPR — primary and secondary use of health data, EHR certification, interoperability requirements, and the new patient rights framework.
The European Health Data Space Regulation (EU 2025/327), published on 5 March 2025, creates a uniform framework for accessing, sharing, and using electronic health data across the entire European Union. It distinguishes between primary use (patient care, with enhanced citizen rights and cross-border portability) and secondary use (research, public health, innovation, and regulation, through a new governance framework with Health Data Access Bodies).
For healthcare organisations, the EHDS introduces binding obligations around EHR system certification, data quality standards, interoperability requirements, and new patient rights that go beyond GDPR. For MedTech and digital health companies, it creates both compliance obligations and market opportunities through harmonised data access frameworks.
Manufacturers and operators of electronic health record systems must certify conformity with EHDS interoperability and security requirements. Self-certification with CE-like marking and EU declaration of conformity.
Healthcare organisations must ensure clinical data meets EU-defined quality standards for semantics, consistency, accuracy, and completeness. Technical specifications to be adopted by the Commission through implementing acts.
Adoption of the European electronic health record exchange format for cross-border health data portability. Machine-readable, standardised format enabling data transmission between providers across Member States.
Citizens gain the right to access, download, transmit, and restrict access to their electronic health data across any EU Member State. Organisations must implement mechanisms for cross-border patient data portability.
Penalties for non-compliance may reach EUR 20 million or 4% of annual global turnover, mirroring the GDPR sanctions regime. The Commission will adopt delegated and implementing acts to detail technical requirements throughout the implementation period.
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