In the current interconnected health research ecosystem, comprehensive and secure access to health data is key to accelerate drug discovery and improve patient outcomes. On 9 October 2025, Germany launched a public health research data centre, known as Health Data Lab or FDZ Health (Forschungsdatenzentrum Gesundheit), which aims to provide a central infrastructure granting broad access to health data for (secondary) use in specified research projects. FDZ Health sits within BfArM, the German drug approval authority.
FDZ Health holds fully pseudonymised datasets of all persons with statutory health insurance, which is about 90% of the German population, collected between 2009 and 2023. FDZ Health is expected to provide researchers access to electronic patient records starting in October 2026, unless the insured individuals object to it. Over time, FDZ Health aims to interconnect with additional health datasets, including cancer registries, offering researchers a broad and diverse range of valuable health data (FDZ Data).
For data security reasons, FDZ Data is pseudonymised or anonymised. FDZ Health employs a secure‑by‑design access model with strict purpose limitations. Each access requires a formal application and is limited to projects that demonstrably serve the improvement of healthcare, such as scientific research on health-related issues or the development of drugs, medical devices, or digital health applications. Eligible applicants include public and private researchers. Analysis of FDZ Data may only be conducted within a virtual and access‑controlled environment. Research projects approved by FDZ Health are listed in a publicly accessible register.
The FDZ Health operating model is closely aligned with the upcoming European Health Data Space (EHDS) regime, which sets a common EU framework for the secondary use of health data via designated data access bodies, standardised permits, and secure processing mechanisms. FDZ Health will allow Germany to plug into EHDS once that platform has become fully operational, which is currently contemplated for 2031. In the meantime, FDZ Health provides a local health data space that presents huge opportunities for researchers on the German market.