European Health Data Space (EHDS) regulation: A new era for digital health in the EU
On 26 March 2025, the European Health Data Space (EHDS) Regulation officially entered into force, marking a major milestone in the EU’s strategy for digital transformation in healthcare. As one of the core pillars of the European Health Union, the EHDS establishes a comprehensive legal and technical framework to facilitate the secure sharing and reuse of electronic health data across all EU Member States.
The EHDS aims to create a unified space for the primary and secondary use of health data. It empowers individuals with better access and control over their personal health records while enabling the use of anonymized health data for research, innovation, public health planning, and policymaking. The initiative builds on existing EU digital infrastructure and introduces common standards, interoperability requirements, and a dedicated governance model.
The EHDS is designed to deliver concrete benefits to a wide range of stakeholders:
- Citizens will have free, digital access to their health data and the ability to share it securely across borders.
- Healthcare professionals will benefit from more complete patient records, supporting continuity of care and reducing administrative burden.
- Researchers and innovators will gain access to large-scale anonymised data under strict conditions, accelerating medical research and digital health solutions.
- Public authorities will be better equipped to monitor health trends and design evidence-based policy.
The regulation reinforces existing rules under the GDPR and introduces health-specific safeguards, including a full control for individuals over who can access their health data, opt-out options for secondary use, a strict requirement for secure data processing environments and certified EHR systems, the prohibition of re-identification from anonymised datasets and the oversight mechanisms at both national and EU levels to ensure compliance and transparency. This regulation is a major step toward a more integrated, transparent, and efficient health data ecosystem in Europe.
The EHDS regulation will now gradually enter into force from March 2025 to March 2034. Member States will begin the implementation phase, laying the groundwork for what is set to become a foundational infrastructure for the health systems of the future.
More information from the European Commission here
Credit: European Commission website
