Medical registries are a central component of modern, data-driven health research and healthcare management. They collect structured data on diagnoses, treatments, and disease progression from real-world clinical practice, thereby providing valuable insights for quality assurance, health research, and the further development of medical care. Under current law, this potential for utilizing and linking data from medical registries is not being fully realized, given the heterogeneous registry landscape - which includes more than 350 medical registries not governed by specialized legislation.

The MRG-RefE seeks to bring about a paradigm shift from previous legislation on specific health registries, with the goal of creating a coherent legal and organizational framework for cross-registry data processing. It aligns with European and national efforts to strengthen the use of health data and promote the digitization of the healthcare system. The Regulation on the European Health Data Space (EHDS Regulation) serves as the normative starting point for the legislatively intended consolidation and linking of electronic health data (sets) within the context of secondary use (see Art. 78(3)(f) of the EHDS Regulation). In this context, the present draft bill acts as a link between the EHDS Regulation and the announced legislative process for implementing the EHDS by establishing Germany’s legal and (infra)structural integration into the European Health Area with regard to medical registries.

The enactment of a Medical Registry Act will make a significant contribution to breaking down data silos and, as a result, improving data exchange, quality, usability, and security in the primary and secondary use of electronic health data. This is fully in line with the European, sector-specific data strategy aimed at providing a coherent, secure, reliable, and efficient framework for the use of health data in healthcare and scientific and medical research. In its practical implementation, however, the draft bill contains numerous inconsistencies and inaccuracies that are likely to create significant legal uncertainty for those applying the law. There is an urgent need to amend the draft bill accordingly.