Scientific research regime 2.0? Transformations of the research regime and the protection of the data subject that the proposed EHDS regulation promises to bring along

Abstract

The proposed European Health Data Space regulation (the proposed EHDS regulation) intends to facilitate the secondary use of electronic health data for scientific research purposes. The mechanism that the proposal contains will co-exist with the scientific research regime that has been established under the General Data Protection Regulation. This article examines how the proposed EHDS regulation promises to transform the EU scientific research regime and protection of a data subject in scientific research. This paper shows that a scientific research regime 2.0 is put forward, where sharing is enhanced at the cost of self-determination of the individual and without resolving many of the challenges that emerged under the GDPR.