Health Data Lab launches with expanded responsibilities.

On October 9, the Health Data Lab (Forschungsdatenzentrum Gesundheit – FDZ Gesundheit) officially began operations in its new form. A central element of this restructuring is the facilitated access to routine data from the statutory health insurance system. This development establishes the foundations for Germany to make health data securely and efficiently usable for research, healthcare delivery, and policy-making – a key component for the implementation of the European Health Data Space (EHDS).

EHDS as a driving force

The FDZ Gesundheit is a direct outcome of the EHDS initiative. With the EHDS regulations that entered into force in March 2025, the EU aims to simplify and promote the cross-border exchange of health data. In addition to improving primary data use – that is, access to electronic health data for patient care – the focus lies especially on secondary data use, meaning the utilization of electronic health data for research, innovation, public health, and policy-making.

Germany is thus taking an early and active role in implementing the EHDS – both in primary and secondary data use. The Health Data Use Act (Gesundheitsdatennutzungsgesetz) of March 26, 2024, laid the foundation by establishing a robust framework for the reuse of health data.

The Health Data Lab

As part of the restructuring, the FDZ Gesundheit – based at the Federal Institute for Drugs and Medical Devices (BfArM) – has been significantly expanded and now takes on additional responsibilities related to health data use. One of its key future goals is integration with the EHDS. Applications for the use of health data can now be submitted directly to the FDZ Gesundheit.

At the core of this reform is improved access to routine data from statutory health insurance. The National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) provides the FDZ Gesundheit with pseudonymized billing data from all statutory health insurers. These datasets include information on diagnoses, prescribed medications and hospital stays. In the future, data from electronic patient records (ePA) will also be integrated. This creates a centralized, data-protection-compliant infrastructure for scientific analyses – with great potential for healthcare delivery and research.

In parallel, several legal and organizational adjustments have been made: the range of eligible institutions and permissible purposes for data use has been significantly broadened. As a result, many more researchers – including representatives from industry – will be able to apply for access to health data, provided that their research serves to improve healthcare.

The legal framework for these processes has been defined by the Federal Ministry of Health (BMG) in the “Regulation on the Health Data Lab” of January 29, 2025. This ordinance regulates, among other things, the scope of data, the application procedures, data provision, and the associated costs.

Data protection as top priority

Special emphasis is placed on the protection of sensitive health data. These data are not released to researchers but made available only within secure, access-controlled analysis environments – so-called secure processing environments. Access is granted solely after approval of an application. Researchers can only access anonymized or pseudonymized datasets and never obtain the raw data themselves. At no point is it possible to trace information back to individual persons.

The FDZ Gesundheit follows the principle of data minimization: researchers receive only the data necessary to answer their specific research question. Only the final results may leave the secure processing environment. All approved research projects are documented in a publicly accessible application register.

Data Access and Coordination Office

European integration is also being prepared: the Data Access and Coordination Office (DACO), currently being established, is closely linked to the FDZ Gesundheit’s area of work. It will also be located at BfArM and will serve as Germany’s national access and coordination point for the EHDS. Through DACO, applications for secondary use of health data from other EU countries will be received and coordinated. DACO will thus become Germany’s central interface and a technical hub in the European network for secondary data use (HealthData@EU).

A foundation for data-driven healthcare

The launch of the FDZ Gesundheit marks an important milestone for the electronic exchange of health data. Germany is thereby making a key contribution to the data-driven advancement of healthcare systems – both nationally and across Europe. This benefits patients, health insurers, researchers, and ultimately, healthcare provision throughout Europe.