The federal cabinet has approved a new law on medical registries, aiming to enhance the use of registry data for patient care, scientific research and the assessment of medical innovations. The health ministry announced the decision on Wednesday.
Under the new framework, all registries will operate under a single legal structure and be subject to clear quality criteria. This should make registry data more comparable and improve overall data quality. A new coordinating office will be set up at the Federal Institute for Drugs and Medical Devices (BfArM) to oversee and support registry activities.
Health Minister Nina Warken (CDU) highlighted that registries provide valuable insights into diseases and treatments, especially for population groups that have historically been underrepresented in clinical trials. She said, “By establishing consistent rules and reliable quality and safety standards for the first time with the medical registry law, we ensure that these vital data can be used safely in the future”.
Key provisions of the legislation include:
” Creation of a Center for Medical Registries, responsible for coordination and advisory functions.
” Maintenance of a central registry directory that offers a systematic overview of existing registries.
” Option for registries to qualify voluntarily, thereby gaining access to expanded data‑processing powers.
” Explicit legal authority for data processing that will ease research and quality‑control activities while upholding stringent data‑protection standards.
The law therefore seeks to foster a well‑regulated, high‑quality, and privacy‑conscious registry ecosystem that benefits patients, researchers and health‑care innovation alike.