The federal cabinet has adopted a new Medical Registries Act aimed at improving the use of registry data for patient care, research, and the assessment of medical innovations, the Federal Ministry of Health announced on Wednesday.
According to the Act, a unified legal framework and clear quality requirements will enhance the comparability and overall quality of registry data. A central coordination centre at the Federal Institute for Drugs and Medical Devices will be established to coordinate and support the use of registries.
Health Minister Nina Warken (CDU) said that medical registries provide valuable insights into diseases and treatments, and that the new rules will particularly benefit population groups that have been underrepresented in clinical trials. “So that this valuable data can be used safely in the future, we are, for the first time, creating uniform rules along with reliable quality and safety standards with the Medical Registries Act” she added.
The legislation provisions form a centre for medical registries that will carry out coordination and advisory duties. A central registry directory will give a systematic overview of existing registries. Registries can also seek voluntary qualifications to gain extended data‑processing authorisations. Clear statutory powers for data processing will facilitate research and quality assurance while maintaining high data‑protection standards.
