The European Health Data Space (EHDS) and its significance for the German healthcare system: A summary and critical reflection on its potential

Background As part of the EU data strategy, a common European data space aims to create a domestic data market. For the healthcare sector, the regulation for a European Health Data Space (EHDS) has been politically agreed on in spring 2024. Objective The EHDS is expected to facilitate the cross-border exchange and access to health data within the EU and to create a trustworthy environment for data-driven innovations. This overview article summarizes relevant aspects of the EHDS and contextualizes the demands and criticisms of relevant stakeholders regarding the German healthcare system. Results The empowerment of citizens to take control of their electronic health data and the cross-border exchange of these data in the areas of primary and secondary use are prioritized. Initial assessments of the creation of a common European Health Data Space show positive feedback from stakeholders in the German healthcare system. Conclusion The EHDS has the potential to realize significant advantages for European healthcare systems, particularly through the secondary use of electronic health data. However, it is necessary to harmonize legal, ethical, and social frameworks within the EU through supranational cooperation and to integrate new solutions into existing systems. In Germany, extensive prerequisites have already been established through the national Health Data Lab (Forschungsdatenzentrum (FDZ) Gesundheit) and various legislative initiatives.