The European Health Data Space (EHDS) is a major EU regulation that came into force on 25 March 2025, establishing a shared legal and technical framework for accessing and using electronic health data across all member states. Covering over 450 million citizens, EHDS aims to improve care, accelerate research, and support evidence-based policymaking across Europe.
By setting EU-wide standards for interoperability, data governance, and digital infrastructure—such as the MyHealth@EU platform—it enables seamless cross-border data access while protecting patient rights.
What it means in practice:
- Improved care: Clinicians can access a patient’s health data wherever care was delivered
- Empowered citizens: Individuals gain more control over how their data is accessed and shared
- Accelerated research: Access to population-level datasets enables faster, more inclusive, and more impactful studies
- Smarter policy: Aggregated data supports better public health decisions and resource allocation
- Digital innovation: High-quality data powers AI tools, clinical insights, and real-time system improvements
- Shared standards: All health systems must meet EU-wide requirements for EHR compatibility, governance, and security
Read our full summary below:
While the EHDS promises unprecedented benefits, it also brings challenges—from ensuring data privacy and building trust, to upgrading digital infrastructure and meeting tight implementation timelines. Success will depend on investment, stakeholder engagement, and a shared commitment to safe, effective, and transparent use of health data.
Find the full framework here: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=OJ:L_202500327
