Medical Register Act to ensure uncomplicated data access

The Federal Ministry of Health (BMG) wants to significantly simplify the use of medical register data in Germany. A draft for a law to strengthen medical registers and improve the use of medical register data (“Medical Register Act”), which has now been submitted, is intended to create a uniform legal framework for previously unregulated registers for the first time and, at the same time, a basis for the European Health Data Space (EHDS) in the area of medical registers. The law is intended to clarify existing legal uncertainties and strengthen research and quality assurance.

According to the draft, the establishment of a Center for Medical Registers (ZMR) at the Federal Institute for Drugs and Medical Devices (BfArM) is planned, which will maintain and coordinate a central directory for more than 350 medical registers. Registers that have successfully completed the ZMR's qualification process, are established by federal law, or are financed in whole or in part by the federal government or statutory health insurance must register. This includes registers such as the implant register, the hemophilia register, and various cancer registers.

Similarly, qualified registers will receive data more easily instead of classic consent via data releases. This is intended to facilitate cooperation with other register operators. Data should be easier to link from different sources and made available pseudonymized or anonymized for research and quality assurance. This is intended to create an interoperable data basis for care, research, and public health in the long term.

Pseudonym and opt-out solution

For particularly qualified registers, data collection with an opt-out solution is also planned. The unchangeable part of the health insurance number (KVNR) is also intended to create a cross-register pseudonym that facilitates data linking, although according to the draft, patient identity is not to be disclosed. According to the draft, “personal data must be deleted no later than 100 years after its collection,” which also links to the storage period of the Health Research Data Center at BfArM and is intended to enable long-term studies.

The ministry expects an annual relief of approximately 3 million euros. Citizens will also be spared bureaucratic efforts, as participation in a medical register regularly required detailed informed consent—sometimes multiple times, for example, for register changes. In the future, a single data release will suffice.

(mack)