Germany just unlocked access to decades of statutory health insurance data covering most of its population, but there’s a catch: navigating the dual-layer system of national and EU regulations requires understanding which data you can actually access and how to get it legally.
Key Takeaways
- Germany’s Health Data Use Act (GDNG), in force since March 2024, creates a centralized access point – the FDZ Gesundheit – making statutory health insurance data more accessible for legitimate research.
- The European Health Data Space (EHDS) regulation entered into force in March 2025 and adds a second regulatory layer that complements, not replaces, Germany’s national framework – creating a dual-layer policy environment with real implications for cross-border data use.
- Life sciences companies stand to benefit from increasingly granular, longitudinal German claims data, but formal governance requirements remain firmly in place.
- Data Model 3 and anticipated ePA (electronic patient record) access – with research availability expected from 2025 onward – are set to expand what researchers can do with this data.
Germany has long maintained some of the strictest health data protections in Europe – which made it both a gold standard for patient privacy and a frustrating bottleneck for researchers. That balance is shifting. Two major policy developments, one national and one European, are converging to open up German health data for secondary research use in ways that simply were not possible before.
Germany Just Opened Its Health Data Doors
The Health Data Use Act (Gesundheitsdatennutzungsgesetz, or GDNG) came into force in March 2024. Its core purpose: make it meaningfully easier for researchers, public health bodies, and life sciences organizations to access pseudonymized routine health data collected by Germany’s statutory health insurers. For years, that data sat in silos – technically available, practically inaccessible. The GDNG is designed to change that by centralizing access and reducing administrative friction.
At the same time, the European Health Data Space (EHDS) – an EU-wide initiative – entered into force in March 2025 and is now in a staged transition toward full application, with key provisions becoming applicable from March 2027 onward. Together, these two frameworks are creating what analysts describe as a dual-layer policy transformation: national reform reinforced by European architecture.
For life sciences companies working on real-world evidence (RWE) generation in Germany, understanding both layers is no longer optional. MEDDDICAL’s overview of German health data providers and claims data under the GDNG offers a practical starting point for organizations mapping out their access strategy.
Two Policies, One Shift
GDNG: Germany’s National Reform
The GDNG formally mandates the FDZ Gesundheit (Research Data Centre for Health) as the single, centralized access point for statutory health insurance data in Germany. Before this, researchers often had to negotiate separately with individual insurance funds – a slow, fragmented process that discouraged investment in German RWE studies. The GDNG simplifies the application pathway and broadens the scope of eligible research purposes, explicitly including pharmaceutical research, health technology assessment, and disease surveillance.
The GDNG also enshrines the concept of secondary use – data originally collected for billing and care coordination can now be legitimately repurposed for research and innovation, within a defined governance framework. This is a meaningful legal shift, not just a procedural one.
EHDS: The European Layer
The EHDS operates at a different level. Published on March 5, 2025 and in force from March 26, 2025, it establishes consistent rules for health data exchange across all Member States, with implementation occurring in stages through 2031. Its secondary use provisions allow researchers and life sciences companies to apply for access to cross-border health datasets through national access bodies, with harmonized data standards and governance requirements across the EU.
For Germany specifically, the EHDS does not override the GDNG. It is designed to work alongside it – aligning national infrastructure with European expectations rather than replacing what Germany has already built. The practical effect is a more interoperable system over time, where German claims data can eventually be analyzed alongside datasets from other EU countries.
The EHDS does not exist in isolation from Germany’s national framework. To understand the German pathway that is already in place, see How to Access German Claims Data under the GDNG.
FDZ Gesundheit: The Central Access Point
The FDZ Gesundheit is the institutional backbone of Germany’s secondary data access system. It provides researchers with access to pseudonymized routine data from statutory health insurance funds – covering the vast majority of the German population – through secure, server-based analytical environments. Outputs are reviewed before release, and access is granted only for defined, legally permitted research purposes.
What Data Is Actually Available
Ambulatory Diagnoses, Procedures and Prescriptions (ICD-10, OPS, ATC)
The FDZ dataset includes ambulatory diagnoses coded in ICD-10, medical procedures under the OPS classification, and pharmaceutical prescriptions coded by ATC. This combination gives researchers a structured view of outpatient care, treatment patterns, and medication use across a nationally representative population – without relying on survey data or hospital records alone.
Sociodemographic Variables and Longitudinal Coverage
Data is available with longitudinal coverage from 2009 onwards, enabling cohort studies, disease progression analyses, and long-term outcomes research. Sociodemographic variables – including age, sex, and insurance status – allow for meaningful stratification and subgroup analyses. This time depth is particularly valuable for chronic disease research and HEOR work that requires multi-year patient trajectories.
ePA Data: Research Access Expected From 2025
One of the most anticipated developments is the planned integration of ePA (elektronische Patientenakte) data into the research access pathway. Germany’s electronic patient record rollout is underway, and data from electronic health records is expected to be shared with the Health Data Lab for research starting from 2025, with researcher access via the ePA system also anticipated from that point. The specific timeline for full research access continues to develop as the rollout progresses. When available at scale, ePA data is expected to substantially deepen the clinical picture that researchers can build from claims alone.
Data Model 3 and Growing Granularity
Data Model 3 represents the FDZ’s most recent advancement in data standardization and granularity. It structures available statutory health insurance data in a more consistent and analytically accessible format – reducing the preprocessing burden for researchers and enabling more complex, multi-variable study designs. As the FDZ continues to refine this model, the practical utility of the dataset for sophisticated RWE analysis continues to grow.
This broader development can already be seen in the increasing granularity of FDZ data through Data Model 3.
What This Means for Real-World Evidence
The combination of GDNG-enabled access, longitudinal claims data, and increasing granularity through Data Model 3 supports a broader range of RWE study types than Germany has historically accommodated at scale.
Research Areas Now Supported
- Epidemiology and disease burden – population-level incidence, prevalence, and distribution analyses
- Healthcare resource utilization (HCRU) – understanding how patients move through the German healthcare system
- Treatment pathway analysis – what sequences of therapy are used, and in what patient profiles
- Comparative effectiveness research – head-to-head comparisons across treatment groups in routine practice
- Health economics and outcomes research (HEOR) – cost and outcome modeling for market access submissions
Academic, Quality and Safety Research
Beyond commercial applications, FDZ data supports academic institutions and healthcare quality bodies in analyzing outcomes, benchmarking care quality, and identifying care gaps across the German statutory insurance population.
Drug and Medical Device Surveillance
For life sciences companies with post-market obligations, German claims data provides a nationally representative, longitudinal signal source for pharmacovigilance and device surveillance – supporting regulatory requirements without the cost and timelines of primary data collection.
Disease-Specific Analyses: Long COVID and Beyond
The longitudinal depth and coding detail in FDZ data make it well-suited for tracking emerging conditions. Long COVID has been a prominent example – researchers have used claims data to study symptom persistence, healthcare utilization patterns, and associated diagnoses over extended follow-up periods, precisely the kind of analysis that requires years of linked patient records.
Governance Has Not Gone Away
Greater access does not mean simpler access in the administrative sense. The governance architecture around German health data remains robust, and that is intentional.
Formal Access Requirements Still Apply
Researchers and organizations accessing data through the FDZ must submit formal applications, specify a legally permitted research purpose, conduct analysis within secure environments, and undergo output disclosure review before results are released. These steps exist regardless of GDNG or EHDS status – they are structural features of the access model, not temporary obstacles.
Timelines should be planned accordingly. Projects that underestimate the application and onboarding process risk delays that compress analytical timelines significantly.
EHDS Complements, Not Replaces, National Law
A common misconception is that EHDS implementation will simplify or supersede national access procedures. It will not – at least not directly. The EHDS is designed to harmonize standards and enable cross-border access, but German national law governs German data. The GDNG and FDZ governance framework will remain the primary mechanism for accessing German claims data. EHDS adds interoperability and cross-border dimensions; it does not remove the compliance layer that already exists.
Life Sciences Companies: Strategic Implications
For pharmaceutical companies, medical device manufacturers, and health technology developers, the evolving German data landscape carries several practical implications worth building into strategic planning now.
- Earlier engagement pays off. The FDZ application process requires clearly defined research questions and regulatory-ready study protocols. Organizations that begin scoping studies before a regulatory deadline are far better positioned than those reacting to it.
- Data Model 3 changes what’s feasible. Research designs that were analytically impractical on earlier data structures are increasingly viable. Study design teams should be aware of current FDZ data capabilities – not what was available two years ago.
- Commercial and statutory access are complementary. The FDZ provides access to nationally representative data for eligible research, but commercial claims data providers offer faster initiation, flexible design, and iterative analysis – capabilities that serve different research needs. Knowing when to use which pathway is a strategic skill in itself.
- ePA integration is a developing asset. Research access to ePA data is expected from 2025 onward, with the scope and depth of available data growing as the rollout matures. Studies designed today should account for current availability while positioning to incorporate richer ePA data as it becomes accessible.
Evolution, Not Revolution – Plan Accordingly
Germany’s health data transformation is real, but it is incremental. The GDNG establishes infrastructure and legal clarity. The EHDS adds a European dimension. The FDZ continues to expand the data it holds and improve how it is structured. None of these changes happened overnight, and their full effects will continue to develop over the coming years.
For life sciences companies, the right posture is neither to wait for the system to fully mature nor to overestimate how much has already changed. The opportunities for high-quality RWE generation in Germany are meaningfully larger than they were three years ago – and they will be larger still as ePA data becomes more accessible and EHDS provisions come into application. Organizations that build their data access capabilities now, understand the governance requirements, and maintain realistic timelines will be best placed to capitalize on what is coming.
To find out how Germany’s evolving health data infrastructure fits into a broader RWE or market access strategy, simply reach out to us. We provide expert guidance on German and European claims data environments.
