Germany's Federal Health Research Data Centre (FDZ Gesundheit) has approved just eight of the 108 research applications it has received since opening, leaving the Federal Health Ministry's target of 300 approved projects by October 2026 looking increasingly remote. The figures, disclosed at a specialist conference in Bonn this week, reveal an approval rate of 7.4% and a backlog of 100 applications still under review.
A centre built for volume, running at a trickle
The FDZ Gesundheit, operated by the Federal Institute for Drugs and Medical Devices (BfArM), was designed to become the primary gateway for researchers seeking access to routine health data. Its legal mandate stems from the Health Data Use Act (Gesundheitsdatennutzungsgesetz), which came into force in 2024 with the explicit aim of unlocking the analytical value of claims data, clinical registries and, eventually, the electronic patient record (ePA). Dr Steffen Heß, who heads the centre, told the Bonn conference that the eight approved projects represent the first completed procedures under the new framework.
The gap between expectation and reality is stark. When the Health Data Use Act was debated, the ministry cited international benchmarks suggesting that a mature research data infrastructure should handle hundreds of projects annually. The 300-project target for the first full operational year was set as a political milestone, not a statutory requirement, but it has become the measure by which the centre's launch is being judged.
Why the pipeline is blocked
Several factors explain the bottleneck. The centre must conduct a multi-stage review for each application: legal admissibility, data protection compliance, scientific merit and technical feasibility of data provision. Each step involves coordination between BfArM, the Federal Commissioner for Data Protection and Freedom of Information, and the data-holding institutions, primarily statutory health insurance funds. The centre also lacks a fully automated data-provisioning pipeline; most approved projects still require manual data extraction and pseudonymisation.
Compounding the delay, the technical architecture for the new 'data rooms', secure virtual environments where researchers analyse data without downloading it, is still being rolled out. The first production-ready data room went live only in June 2026. Until the full fleet is operational, the centre cannot parallelise data preparation at the scale the ministry envisioned.
The ePA factor
The ministry's optimism rests heavily on the electronic patient record. Dr Nick Schneider, deputy head of digitalisation at the Federal Health Ministry, described ePA data as 'the central cornerstone of our data agenda' at the same conference. The nationwide ePA rollout began in January 2025 for all statutory insurees, with an opt-out model that has so far seen uptake above 95%. In theory, this creates a longitudinal dataset covering 73 million people, a resource of unprecedented depth for epidemiological and health-services research.
In practice, ePA data cannot yet flow to FDZ Gesundheit. The technical specifications for pseudonymised secondary use are still under negotiation between the gematik (the national agency for telematics applications), the data protection authority and the BfArM. A pilot involving three university hospitals and two sickness funds is scheduled for the fourth quarter of 2026. Until that pipeline is validated, the centre's primary data source remains claims data from the statutory health insurance system, valuable, but limited to billing codes and lacking clinical detail such as laboratory values, diagnoses from outpatient notes or medication adherence.
Private insurance blind spot
A further structural gap concerns the roughly 10% of the population covered by private health insurance (PKV). Their claims data are not subject to the same mandatory submission requirements as the statutory funds. The Health Data Use Act contains a provision for voluntary participation, but as of September 2026 no private insurer has signed a data delivery agreement with FDZ Gesundheit. Industry representatives cite unresolved liability questions and the absence of a standardised technical interface. The ministry has signalled it may amend the law to compel participation if voluntary uptake remains negligible by early 2027.
European deadline looms
The European Health Data Space (EHDS) regulation, which entered into force in March 2026, sets a two-year transition period for member states to establish national health data access bodies capable of handling cross-border requests. FDZ Gesundheit is Germany's designated body. By March 2028 it must be able to process applications from researchers in other EU countries under harmonised rules. The current throughput of eight approvals in roughly eight months suggests the centre would need to accelerate by a factor of 30 to meet both the domestic October target and the EU readiness deadline.
The European Commission's first implementation report on EHDS, due in early 2027, will benchmark national bodies against key performance indicators including median processing time, approval rates and data catalogue completeness. Germany's figures will be visible alongside those of Finland's Findata, France's Health Data Hub and Denmark's Health Data Authority, all of which approve dozens of projects per quarter.
Research community reaction
Academic researchers contacted for this article described a mixture of frustration and realism. A senior epidemiologist at Charité Berlin, who asked not to be named because her institute has applications pending, said: 'We knew the first year would be slow. The problem is not the review standards, they are appropriate, but the lack of parallel processing capacity. Every application is still treated as a bespoke legal negotiation.' A representative of the German Association of Research-Based Pharmaceutical Companies (vfa) noted that industry-sponsored studies face additional contractual hurdles with data holders, adding months to the timeline.
The ZMDT conference also heard from patient advocacy groups, who warned against rushing approvals at the expense of transparency. The German Patients' Association (Deutsche Patientenliga) has called for a public dashboard showing the status of every application, the legal basis for each decision, and the intended commercial or non-commercial use. The ministry has committed to publishing aggregate statistics quarterly but has resisted project-level disclosure, citing trade-secret protections for industry applicants.
What happens next
The ministry has instructed BfArM to present an acceleration plan by the end of September. Options under discussion include: hiring additional legal reviewers on fixed-term contracts; introducing a fast-track procedure for low-risk projects using only aggregated claims data; and mandating standardised data delivery APIs for all sickness funds by January 2027. The ePA pilot results, expected in December, will determine whether the 2027 pipeline can include clinical data at scale. Meanwhile, the 100 pending applications will continue through the queue, at current throughput, the last of them would not be decided until mid-2027.
People mentioned
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Dr Steffen Heß
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Dr Nick Schneider
Organisations
Bundesinstitut für Arzneimittel und Medizinprodukte · Bundesgesundheitsministerium · Zentrum für Medizinische Datennutzbarkeit und Translation
