German Data Protection Commissioner Weighs in on Healthcare Digital Innovation Law
The Federal Commissioner for Data Protection and Freedom of Information (BfDI) issued a statement on Germany's draft law implementing EU Regulation (EU) 2025/327 (EHDS Regulation) for healthcare data and digital innovation. The statement generally endorses the government's draft while providing detailed technical feedback on proposed amendments concerning access logging, document-level access controls in electronic patient records, research data linkability, and consent-based data processing authorization requirements. Healthcare organizations and health insurers operating in Germany should monitor this legislation closely as it will materially affect data governance obligations under both national law (SGB V, GDNG-E) and the EHDS framework.

