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

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 application to access to pseudonymized data in secure processing environments, emphasizing the legal requirements, including the role of ethics committees. Finally, we analyse the success factors for achieving access to the data and the reasons for access denial to support shaping the upcoming EHDS implementation. Several challenges remain unaddressed for cross-border data use, especially in the context of genomic data, where the complexity and heterogeneity of informed consent can impact or even impede data-sharing efforts. While EHDS can simplify processes across MS, it is crucial to ensure that additional safeguards do not negatively impact or block access to health data and that EHDS infrastructure is ready for effective and affordable processing of large volumes of genomic and other data.