Genomic data sharing in research across Europe: legal challenges and upcoming opportunities within the European Health Data Space.

ABSTRACT: The European Health Data Space (EHDS) will help researchers use health data across EU Member States (MS). Currently, cross-border research faces heterogeneous data access processes. Using a real-world use case, this paper analyses challenges and opportunities brought by the upcoming implementation of the EHDS, assessing the situation before and after the regulation comes into force. The use case focused on metastatic colorectal cancer, analysing the relations between mutational signatures and clinical trajectories while addressing data access procedures across MS. The regulatory landscape and the challenges that need to be addressed for the EHDS to enable the secondary use of health data, particularly genomic data, are complex and heterogeneous across MS. We describe the pathway from data

SUBMITTER: Royo R 

PROVIDER: S-EPMC12420906 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature