Overview
- On 11 March, the federal cabinet approved the draft Medizinregistergesetz, sending the government bill into the next stage of lawmaking.
- The proposal would create a single legal framework with uniform quality and security standards for medical registers not otherwise regulated in Germany, where more than 350 exist.
- The Health Ministry says the reform will improve comparability and data quality and provide a clear legal basis for collecting and using register data.
- Health Minister Nina Warken said registers reveal what works in everyday care and are vital for groups underrepresented in clinical trials, including older people and women.
- The plan establishes a coordination office at BfArM and patient consent rules with opt‑out in defined cases, and the draft now goes to the Bundesrat before Bundestag debate.