The European Health Data Space (EHDS) Regulation was officially published in the Official Journal of the European Union on 5 March 2025 and will enter into force on 26 March 2025.
The regulation enhances individual rights by granting EU citizens immediate access to their electronic health data and enabling seamless cross-border sharing. It also establishes a legal framework for secondary data use, allowing third parties such as researchers, policymakers, and innovators to access anonymized and pseudonymized information under strict privacy safeguards. To promote interoperability, the regulation mandates common standards for electronic health records (EHRs), supporting a unified digital health market. Furthermore, it introduces governance structures at both EU and national levels to oversee implementation and compliance, ensuring secure and efficient data exchange.
While the regulation takes effect in March 2025, key provisions on primary and secondary use of health data will apply from March 2029.
The regulation can be found here.
