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Health Data Lab

Who are we?

The Health Data Lab (HDL) at the Federal Institute for Drugs and Medical Devices (BfArM) aims to promote medical research in order to improve healthcare for citizens. Research generates new insights that ultimately help to further develop medical treatments more quickly and in a more targeted manner.

The HDL is an evolution of the former data processing unit, which was based at the former German Institute for Medical Documentation and Information (DIMDI) since 2013 and enabled the analysis of claims data for research purposes. In 2019, DIMDI was dissolved, and with the enactment of the Digital Healthcare Act, the establishment of the HDL was initiated. The HDL takes over all tasks of the former data processing unit and fully replaces it. The legislator has enacted the Data Transparency Regulation (DaTraV) and the Health Data Use Act (GDNG) to specify the legal framework. Although the HDL is located at BfArM, it operates independently and autonomously. The center is currently still being established and will begin accepting the first applications for data use starting in early 2025.

Analyses based on HDL data result in a wide range of scientific publications that help to improve the medical care people receive.
The data is transmitted in pseudonymised form to the HDL. In such a case, the data can no longer be assigned to a specific person without the addition of further information.
Only authorised institutions will have access to HDL data. These include, e.g. healthcare research institutions and key federal organisations for the representation of patients' interests (cf. Section 303e SGB V).
New methods such as machine learning or the use of artificial intelligence are also gaining ground in the medical field to the benefit of patients. The HDL also plays a crucial role in this development.

New HDL currently being established

The new Health Data Lab is currently in the process of being established which will take place in phases. Unfortunately, no applications can be submitted at this time. First, the legal, technical personnel and organisational measures of the new HDL must be defined and implemented. It is expected that applications can be submitted online in the first half of 2025.