Opting Out of Scientific Research with Health Data: The Limits of the EHDS and the GDPR

Abstract In the future, the European Health Data Space ( EHDS ) Regulation will enhance the secondary use of electronic health data in the EU, including for scientific research purposes. From the data subjects’ perspective, the EHDS introduces a significant change, a new opt-out mechanism for the secondary use of data, in which data subjects shall have the right to opt out at any time without stating reasons. However, not all scientific research with health data will be covered by the opt-out rules of the EHDS . This article aims to clarify the effects of the EHDS ’ opt-out mechanism and its scope of application. It also suggests a balanced approach for Member States to implement the EHDS opt-out mechanism and reassess the implementation of the GDPR ’s right to object that remains relevant in the future in addition to the opt-out introduced by the EHDS .