The European Health Data Space (EHDS) seeks to improve healthcare delivery, deliver a framework for health data use, and advance a single market for digital health services and products. It was part of the European strategy for data (COM/2020/66 final) in which the new von der Leyen Commission outlined its digital and data strategy centering around several sectoral data spaces including manufacturing, agriculture, mobility, and health.
In fact, the health data space came first. The Commission proposed an initial draft of the EHDS regulation in May 2022 [link]. After a thorough and protracted negotiation involving numerous stakeholder consultations and events, the European Parliament and the Council reached a political agreement in spring 2024. The regulation was published on 5 March 2025 [link] and its provisions will successively take effect starting on 25 March 2025, with generous transition periods.
The EHDS is expected to become a powerful engine for health data interoperability and exchange across Europe, by further advancing the transfer of health data across borders, and by building an infrastructure for accessing anonymised, aggregated data for research and innovation. The regulation specifically references the European Electronic Health Record Exchange Format (EHRxF) and introduces compliance requirements for national infrastructures and for several industries. For more information on the EHDS and to stay updated on developments visit the website of the European Commission [link].