Research Data Act: Ministry of Health wants public statements
The Federal Ministry of Research (BMBF) wants to obtain opinions on the planned research data law and has now started the consultation. In addition to the Health Data Utilization Act and Digital Act announced by the Federal Ministry of Health, the Research Data Act is intended to give science better access to data. For the upcoming decentralized research data infrastructure, the framework conditions for the transfer, storage and backup of the data are to be clarified.
The background is that the amount of data is growing exponentially and at the same time research is being carried out in ever larger and more complex projects and associations. Among other things, the data should help to develop AI language models or to optimize a decentralized energy supply. New services such as digital medical twins for prognosis models can also be tested and genome data can be obtained for research and medical care in order to be able to better evaluate certain therapy options.
Statements to the Ministry of Health
The Federal Ministry of Research invites you to a public consultation. It wants to determine whether the planned regulations can be implemented legally and practically. Comments can be submitted until April 11th. At the same time, the BMBF is working with the Medical Informatics Initiative (MII) to make the medical care data of all German university hospitals available to researchers. The expansion has been funded with 200 million euros since the beginning of 2023 and should be completed in 2026.
Researchers should be able to apply for the use of this recorded care data via the newly established health research data portal. By the end of 2026, the Federal Ministry of Health wants to have carried out or initiated at least 300 research projects using data from the Research Data Center (FDZ). However, it has not yet been clarified how the legally prescribed pseudonymisation procedure is to be implemented in the FDZ – a research project is currently underway.
(mack)
