Germany’s new Health Data Use Act promises researchers access to nationwide insurance claims data, but the application process has strict eligibility rules, takes months to complete, and requires working in a controlled environment. Here’s what actually qualifies and when commercial alternatives make more sense.
Key Takeaways
- The GDNG (Health Data Use Act), effective March 26, 2024, opened a structured pathway for researchers to access nationwide German statutory health insurance (SHI) claims data through the FDZ Gesundheit at BfArM.
- Access is application-based – researchers work inside a secure analytical environment and never receive raw data copies.
- Eligibility hinges on research purpose, not just organization type; projects oriented toward market research or commercial product development are excluded, though some commercially funded research that demonstrably serves public health goals may still qualify.
- The process takes weeks to months from submission to access – early planning is essential, and some steps (like fee structures and scheduling) are best verified directly with FDZ documentation.
- When timelines, flexibility, or commercial objectives matter, commercial claims data providers may be the more practical route – a comparison worth assessing before committing to either path.
Germany’s Health Data Use Act has changed the landscape for health data research in Europe. Access to this data is not automatic or straightforward. Here is exactly what researchers and HEOR professionals need to know before starting the process.
GDNG Opens Nationwide SHI Claims Data – But Access Has Real Conditions
The Gesundheitsdatennutzungsgesetz (GDNG), which came into force on March 26, 2024, was designed to make German health data more accessible for research that serves the public interest. At the center of this effort is the FDZ Gesundheit (Forschungsdatenzentrum Gesundheit), housed at the Federal Institute for Drugs and Medical Devices (BfArM), which now functions as the central national access point for pseudonymized statutory health insurance claims data.
The opportunity is significant. Germany’s SHI system covers the vast majority of the population, making this one of the most far-reaching routine healthcare datasets in Europe. Still, the GDNG does not open a free-for-all. It establishes a formal governance model with eligibility rules, defined research purposes, and a controlled analytical environment. Researchers who go in without understanding these conditions are likely to face delays – or outright rejections.
For a deeper look at how German health data providers compare under the new framework, MEDDDICAL’s overview of German health data providers and claims data under the GDNG is a useful starting point. The rest of this article focuses on what the FDZ actually provides, who qualifies, and how the application process unfolds in practice.
These national developments also need to be viewed in the context of the emerging European Health Data Space (EHDS).
What the FDZ Gesundheit Actually Provides
Pseudonymized SHI Data From All German Insurers
The FDZ Gesundheit consolidates pseudonymized claims data from all German statutory health insurers – not just a subset. This nationwide scope is one of the key advantages over commercial alternatives, which typically draw from a smaller pool of participating insurers and may not offer the same population coverage.
The data reflects routine healthcare utilization: diagnoses, procedures, prescriptions, hospitalizations, and more – structured as administrative claims rather than clinical records. The GDNG also sets out how electronic patient record (ePA) data may eventually flow into research channels; direct researcher access via the FDZ Gesundheit is expected to begin in October 2026.
Secure Analysis Environment, Not Data Copies
Approved researchers do not receive a copy of the data. Analyses are conducted within a secure, server-based analytical environment (Analyseraum) controlled by BfArM. This design allows broad data access while preventing re-identification or unauthorized extraction of patient-level records. Every output released from the environment goes through a review step before it reaches the researcher.
Researchers should also understand what information is available within the FDZ dataset, including the increased granularity provided by Data Model 3 from 2019 onwards.
Who Is Eligible to Apply
Eligibility Is Driven by Research Purpose, Not Organization Type – With an EU/EEA Note
One of the more important clarifications in the GDNG framework: eligibility is not limited to academic institutions. Public health authorities and commercial organizations can also apply – provided the project demonstrably serves the public interest and aligns with the legally permitted research purposes defined under the legislation.
There is a geographic boundary to be aware of. Access is available only to organizations based within the EU or EEA. Applicants outside this boundary should verify their eligibility directly with the FDZ before proceeding.
Applicant institutions must also complete a formal registration process before any project-level application can be submitted. Eligibility is not assumed – it has to be established and documented.
Advertising and Marketing Projects Are Excluded – But Some Commercial Research May Qualify
The legislation is explicit about what does not qualify. Projects oriented toward market research, product development as a purely commercial objective, or improving healthcare provision for commercial gain are excluded from the permitted purposes. This rules out many typical pharma or medtech commercial evidence activities.
That said, some commercially funded organizations – particularly those conducting outcomes research, epidemiological studies, or development of drugs, medical devices, or digital health applications that genuinely serve a broader public health goal – may find their projects do meet the criteria. The distinction is not always obvious, and careful assessment before submission is strongly recommended.
The Application Process, Step by Step
Institutional Registration
Before any research proposal can be submitted, the applicant institution must be formally registered with the FDZ. This involves verifying organizational identity, confirming EU/EEA status, and establishing the institutional account through which all subsequent applications will be filed. Researchers at eligible institutions should confirm whether their organization is already registered before starting.
Research Proposal Submission and Assessment
Once registered, applicants submit a detailed research proposal. This document needs to clearly articulate the scientific question, the specific data required, and – critically – which of the legally permitted purposes the project satisfies. The FDZ evaluates submissions against these statutory criteria. Vague or poorly scoped proposals are likely to face delays or be returned for revision.
A key principle underlying the entire process is data economy: only the minimum data necessary for the approved research question will be made available. Variables not specified in the proposal may not be accessible later, and adding them could require a new application entirely. Getting the study design right before submission is essential.
Note: The FDZ application portal is currently available only in German, though English-language applications are accepted. An English version of the portal is expected in 2026. Non-German-speaking applicants should factor in translation support when planning.
Analytical Environment Allocation and Scheduled Access
Once a proposal is approved, the FDZ prepares a dataset matching the approved specification and allocates a scheduled access window within the secure environment. Researchers do not get open-ended access – analytical time is structured and pre-allocated. Project timelines need to account not just for application processing, but also for access scheduling on the FDZ side.
Working Inside the FDZ Environment
Scripting and Analysis Tools Are Supported – Confirm Approved Software With FDZ Directly
Inside the Analyseraum, researchers can work with standard analytical software. R, Python, and SQL are commonly referenced in the context of secure research environments, but the specific toolset available through the FDZ Gesundheit should be confirmed directly with FDZ before designing analytical workflows around any particular platform. Researchers cannot freely import external scripts or export results without staff review.
Output Review Before Release
All analytical outputs – tables, figures, summary statistics – go through a formal review process before they are released to the researcher. This step ensures that no output risks re-identifying individual patients, even indirectly. Released outputs are also subject to predefined limits on granularity. Planning analyses with this constraint in mind will reduce friction at the output review stage.
Time, Cost, and Planning Realities
Preliminary Review Takes Weeks to Months – Verify Access Scheduling With FDZ Documentation
The complete journey from initial submission to first analysis can span several months. Processing queues, assessment timelines, dataset preparation, and access scheduling all add time. Fees are structured around several components – including base charges, the number of reporting years requested, analytical environment allocation, and optional services or training. Applicants are expected to estimate costs using the published fee schedule under the Data Transparency Fee Ordinance (DaTraGebV); whether individual quotations are available should be confirmed directly with the FDZ. Certain public institutions may qualify for reduced fees under this ordinance – applicants should verify this with FDZ documentation.
The FDZ offers support resources – including a Helpdesk, consultation services, and online webinars – which can help applicants work through both cost estimation and the application process. Using these resources early is advisable.
When Commercial Claims Data Is the Better Fit
Not every project belongs in the FDZ pathway. Commercial claims data providers may be the more practical choice when a project requires faster initiation, iterative study design, repeat analyses, commercially oriented evidence, or more predictable timelines. The tradeoff is typically narrower population coverage compared to the FDZ’s nationwide SHI dataset – but for many RWE, HEOR, and market access studies, operational flexibility outweighs breadth.
Before committing to either route, it is worth honestly assessing whether the project’s purpose, timeline, and organizational setup are genuinely suited to the statutory access model. For projects that sit in a gray area on eligibility, approaching the FDZ Helpdesk for a preliminary consultation before submitting a full application can save significant time.
FDZ Access Suits Public-Interest Research – Verify Eligibility Before You Start
The GDNG has created a real and meaningful opportunity to work with one of Europe’s most far-reaching health datasets. For eligible public-interest research, the FDZ Gesundheit route offers strong population coverage and a robust governance framework that supports credible, publishable findings.
The process demands preparation: confirmed institutional eligibility, a tightly scoped study design, realistic timeline planning, and a clear alignment between the project’s purpose and the GDNG’s permitted categories. Skipping any of these steps early almost always costs more time later.
If a project does not fit the FDZ’s requirements, or requires greater flexibility, it is worth comparing the two access models directly in FDZ Gesundheit vs Commercial Claims Data Providers.
For organizations working through German health data options – statutory or commercial – MEDDDICAL provides expert guidance on real-world evidence and health data access across the German market. Feel free to reach out to us to discuss your objectives.
