Pharmacoepidemiological research is predominantly conducted on the basis of large routine data (secondary data). These data facilitate the investigation of the utilization and safety of drugs, including vaccines, in real-world healthcare settings and the investigation of rare or delayed adverse events. In so-called PAS studies (Post-Approval Safety Studies), these databases are used to investigate the utilization and safety of newly approved drugs. They also provide an important basis for research on other healthcare services. Since 2004, BIPS has been working on the utilization of claims data (GePaRD). GePaRD contains information based on claims data from four statutory health insurance (SHI) providers in Germany. This information relates to approximately 25 million persons who have been insured with one of the participating providers since 2004 or later. In addition to demographic data, GePaRD contains information on drug dispensations as well as outpatient (i.e., from general practitioners and specialists) and inpatient services and diagnoses. Per data year, there is information on approximately 20% of the general population and all geographical regions of Germany are represented.

Utilization in research projects

Access to the claims data is granted only to BIPS employees within the framework of officially approved research projects. Project approval is based on the authorization by the SHI providers and the respective governing authorities (e.g., the Federal Office for Social Security for national SHI providers). For this purpose, BIPS applies for project-specific permits from the SHI providers. Upon approval, the SHI provider requests official project approval from the governing authority. This may be issued in accordance with Section 75 of the German Social Code (SGB) X if the public interest in the research significantly outweighs the interest in personal privacy of those affected. The process of approval by the SHI providers and the respective governing authorities may take several months.

We would like to thank the statutory health insurance providers AOK Bremen/Bremerhaven, Techniker Krankenkasse (TK), DAK-Gesundheit, and hkk Krankenkasse for their many years of support for the research based on health claims data at BIPS.