The regulation on the European Health Data Space (EHDS) was adopted on 21 January 2025. It creates a secure single market for health data for citizens, professionals, researchers and public authorities. This regulation strengthens the protection of personal data while facilitating its use for healthcare, research and health management.
The COVID-19 pandemic revealed the need to improve the management of health data in Europe. It was against this backdrop that EEDS became the first common data space dedicated to a specific sector, as part of the European data strategy.
It aims to harmonise electronic medical record systems to facilitate innovation and interoperability and improve care management.
| THE PILLARS | WHAT IMPACT? |
|---|---|
| Making it easier for people to access their health data | All citizens will be able to access, consult, download and control the sharing of their health data. Simplified access to medical records will promote continuity of care, particularly when travelling within the EU. Patients will have direct control over how their data is used. |
| Increased research potential | Electronic medical records will have to comply with common technical standards in all Member States. This harmonisation will guarantee the smooth and secure exchange of data between systems and countries. It reduces disparities in the digitisation of healthcare systems. |
| Ensuring interoperability | Electronic medical records will have to comply with common technical standards in all Member States. This harmonisation guarantees the smooth and secure exchange of data between systems and countries. It reduces disparities in the digitisation of healthcare systems. |
EEDS is more than just a technical framework for interoperability: it marks an unprecedented step at European Union level, by establishing a common legal standard for accessing and re-using health data. This step forward redefines the balance between data protection, public interest and innovation. For private players, the EEDS establishes a regulatory framework that strengthens market confidence and encourages the use of health data in a way that is both secure and ethical.
The regulation came into force on 25 March 2025. It will apply progressively from March 2027. Member States will have to adapt their systems and infrastructures to meet European requirements and ensure a smooth transition to EEDS.
A bill should be tabled in October 2025 to adapt certain provisions of the EEDS to French law by April 2027.