On March 5, 2025, the Regulation (EU) 2025/327 establishing the European Health Data Space (EHDS) was officially published in the Official Journal of the European Union.
A major step forward for digital innovation in healthcare, the EHDS sets the framework for better access, control, and use of electronic health data across the EU.
It focuses on two main areas:
- Primary use: empowering European citizens to access, control and share their health data across borders for safe and efficient care within the EU.
- Secondary use: enabling the reuse of (de-identified) data for the purposes of scientific research, innovation, policy-making, and regulatory purposes.
About the implementation timeline:
- From March 26, 2027: entry into force of the Regulation, initiating the preparatory phase and adoption of delegated and implementing acts by the Commission.
- From 2029 to 2031: gradual application of some provisions to ensure inclusive implementation, including those related to cross-border exchange of priority categories of health data and progressive extension to other data types.
- From 2034: opening membership to the HealthData@EU network for third countries and international organizations interested in the secondary use of health data.
EHDS is not just a technological project—it’s an ethical and regulatory infrastructure built on transparency, security, and trust.
The implementation of the European Health Data Space marks profound shift in how we manage and unlock the value of data in the European healthcare landscape, laying the foundation for a secure digital ecosystem that respects fundamental rights. Its execution requires a joint commitment of healthcare professionals, companies, researchers, policymakers, and citizens to fully unlock the potential of data for public health, innovation and clinical research in Europe.
