European Health Data Space Regulation (EHDS)
European Health Data Space Regulation (EHDS)
This past March 5th, Regulation (EU) 2025/327 (hereinafter, the “Regulation”) was published in the OJEU, which establishes the regulatory framework of the European Health Data Space (hereinafter, the “EHDS”), with the aim of ensuring secure and efficient access to electronic health data in the European Union.
Entry into force
The Regulation will enter into force as from March 26th of this year. However, its applicability will be progressive: the general provisions will be applicable as of March 26, 2027, while some specific obligations will not become applicable until March 2029 and March 2031.
Objectives of the Regulation
The main objective of the Regulation is to create a common framework to enable secure, interoperable and efficient access to electronic health data across the EU, both to improve healthcare (primary use) and to foster research, innovation and data-driven policy-making (secondary use).Among its specific goals, the EHDS seeks to strengthen the control of patients’ health data, facilitating the interoperability of electronic health record (hereinafter, “EHR”) systems, and establishing quality and security standards for data processing. It also promotes the reuse of health data for scientific and social purposes, respecting fundamental rights and the protection of personal data, in line with the GDPR.
Scope of application
-
Individuals who generate electronic health data
-
Health data holders