European Health Data Space Regulation enters into force

The European Health Data Space Regulation (EHDS Regulation) entered into force on March 26, 2025.

The purpose of the Regulation is to establish a common framework for the use and exchange of electronic health data across the EU. This includes the enhancement of individuals' access to and control over their personal electronic health data, and the smooth functioning of the internal market.

The Regulation also provides for the sharing of anonymized or pseudo-anonymized health data for secondary purposes, such as scientific research or for health policy development. Unlike obligations imposed by other legislation, such as the Clinical Trials Regulation, the obligations imposed by the EHDS Regulation will apply to both companies conducting activities such as clinical trials and third parties such as hospitals.

The Regulation will enter into application in phases following adoption of related implementing acts by the European Commission by March 2027. In March 2029, the elements of the Regulation related to the "primary use" of data i.e., permitting access, control and sharing of their electronic health data by patients across borders for purposes of healthcare delivery will enter into application. In March 2031, provisions of the Regulation governing secondary use will enter into application with the possibility for third countries and international organizations to potentially benefit from secondary use entering into application in March 2034.

Useful information is available in the European Commission's Frequently Asked Questions on the European Health Data Space.