Unchaining RWE in Germany: First Look Into the Potential of a Nationwide German Health Data Lab for Outcomes Research and Data-Driven Market Access Strategies

OBJECTIVES: To foster the utilization of real-world data, the German Health Data Lab (HDL) is currently being set up at the Federal Institute for Drugs and Medical Devices (BfArM). As a nation-wide data platform, it includes claims data of about 74 million individuals insured by the statutory health insurance (SHI) who represent approx. 90% of the German population. Our work gives an overview of the current planning for the HDL.

METHODS: We describe the administrative framework of the HDL such as access regulations, application procedures, and technical requirements for data processing. Furthermore, we will provide an insight into the data structure and potential analyses.

RESULTS: The launch of the HDL is scheduled for early 2025. Access to the data is governed by an application process that verifies a legitimate study purpose. Legitimate purposes are defined in German law. Applications must adequately explain the study objectives, the planned analyses, and the data needed for their conduct. Anyone, including companies, can submit applications. After acceptance, the analyses are performed in a secure digital environment using either R or Python. Patient-level data sets will be available for the years from 2009 onwards. These data sets will be enriched over time, perspectively including links to other data sources (e.g, registries). The non-identifiable data includes demographics of the insured persons, claimed outpatient and inpatient services including ICD-10 codes as well as drug prescriptions. Patient-centered analyses will be possible across care sectors and over time, which allows for epidemiological, patient pathways, and comparative (e.g. matched cohorts) research on a nation-wide scale.

CONCLUSIONS: The HDL creates a unique source of real-world data from the German SHI system that is available to all stakeholders. Thus, for organizations that can handle the application process and the analyses, it will bring public health outcomes research and data-driven market access strategies to a new level.