European Health Data Space (EEDS)
On March 5, Regulation 2025/327 on the European Health Data Space
was published in the Official Journal of the European Union.
The Regulation aims to improve individuals’ access to and control over their personal electronic health data, while also enabling the reuse of certain data for health research and innovation purposes.
With the implementation of the Regulation, individuals will be able to easily and free of charge access their electronic health data, whether they are in their country of origin or in another Member State. They will also have greater control over how their data are used. Furthermore, healthcare professionals will be able to access the interoperable EU electronical medical record (EHR) of the individuals to whom they provide healthcare.
EU countries will be required to establish a digital health authority to implement the new provisions and ensure compliance. In addition, it is required that all electronic health record systems comply with the specifications of the European electronic health record exchange format to ensure interoperability at the EU level.
The European Health Data Space will also provide the research and innovation community and the health policymakers with access to health data -from both the public and private sectors- under controlled and secure conditions, anonymized or pseudonymized. This reuse of health data will allow unleash their potential to support scientific research, develop better treatments, improve patient care, boost training, and strengthen data-driven health policies.
Implementation
The Regulation will be applied progressively, starting two years after its entry into force (which will take place on March 25, 2025).
Regulation on the European Health Data Space (EHDS)
Presentation of the Regulation on the European Health Data Space
On April 28, the Commission officially launched the open-source version of the HealthData@EU platform for the implementation of Regulation 2025/327 of the European Health Data Space.
