Medical Research: Apply for Health Data Centrally

As part of the MII, funded by the Federal Ministry of Education and Research, data integration centers have been established at over 30 university medical locations throughout Germany. These facilities make patient data and biosamples from routine care available for medical research in compliance with data protection regulations. "The FDPG offers a central point of contact for accessing and requesting the available data from the healthcare documentation of all German university hospitals. This is an enormous advantage for research and the healthcare system in Germany," says Sebastian C. Semler, Managing Director of the TMF - Technology and Methods Platform for Networked Medical Research and Head of the MII Coordination Office, which is operated jointly with the Association of Medical Faculties and the Association of University Hospitals. The portal is being developed jointly by all partners in the MII and operated by the TMF.

Better Data for Medical Research

Data based on the MII core dataset can be queried via the FDPG. This includes basic demographic characteristics as well as a wide range of clinical and care-relevant characteristics, which are bundled together in modules. The following modules of the core data set can currently be queried: Person, Diagnosis, Procedure, Laboratory Findings, Medication, Consent, and Biospecimen Data. At the moment, for example, several million data records are available in the personal module, which contains information on age and gender, among other things.

The data is standardized in FHIR format. Nevertheless, the heterogeneity of the data sources presents challenges when evaluating and using the data. The MII, therefore, continues to work with data users and providers to improve the standardization and availability of the data in the sense of a learning system.

How Can Data Be Requested?

Therefore, the portal is initially available in a pilot operation, as the data request and the associated data infrastructure are being tested and continuously improved based on initial usage projects. The connection of the university medical sites to the MII data query will be successively completed as part of the pilot operation. With a feasibility request, researchers can find out how many cases for their search criteria are available in the data integration centers nationwide and can be requested for medical research purposes.

In order to apply for data for a research project, researchers must submit a positive ethics vote from their institution. The Use and Access Committees (UACs) at each requested university hospital decide on the application for data use. This means that data sovereignty remains with the individual sites. If they approve the use of data for the research project, the pseudonymized data is made available to the researcher centrally via the portal. Researchers applying for data must allow sufficient time for the necessary steps up to the conclusion of the contract with the sites providing the data. It is currently recommended that research projects should allow at least five months to receive the data.

Transparent Presentation of Research Projects

The portal creates transparency by publishing all research projects approved as part of the MII and their results in a project register. Patients can use the website and a newsletter to determine which projects are being carried out with patient data. To date, twelve research projects have been approved and published.

Background

The Medical Informatics Initiative (MII) aims to digitally network routine patient care data across Germany and make it available for medical research to treat diseases faster and more effectively in the future. All German university medicine institutions are working on this with other research institutions, companies, health insurance companies, and patient representatives in the four consortia DIFUTURE, HiGHmed, MIRACUM, and SMITH. Data protection and security have the highest priority here.

The focus of the expansion and extension phase (2023-2026) is on extended collaboration between the university hospitals and their cooperation with new partners in healthcare and research, particularly on expanding the use of data across locations in terms of data types and data sources.

The Federal Ministry of Education and Research (BMBF) is funding the MII with a total of over 400 million euros up to and including 2026.

A coordination office operated by the Technology and Methods Platform for Networked Medical Research (TMF), the Association of German Medical Faculties (MFT), and the Association of German University Hospitals (VUD) in Berlin is responsible for the national vote on the MII.

Press Contact

Sophie Haderer
Phone: 030 − 22 00 24 732
Mobile: 0173 4054214
E-mail: presse@medizininformatik-initiative.de