Gesundheitsdatennutzungsgesetz und Digital-Gesetz unter der Lupe

On 14 December 2023, the German Bundestag passed two bills that will be of considerable importance for health care as well as research on health care in the upcoming years: the Act for the Improved Use of Health Data (Health Data Usage Act—GDNG) and the Act on Accelerating the Digitalization of the Healthcare System (Digital Law—DigiG). The laws came into effect on 26 March 2024. According to a statement from the responsible Federal Ministry of Health, the laws are intended, among other things, to make health data for research (GDNG) available and promote the exchange and use of health data (DigiG).

In this article, we want to examine the two laws with regard to their importance for research with routine practice data. The laws are analyzed in light of existing regulations on the admissibility of data storage and processing and compared with other models of data use in health services research.

The laws will have considerable potential for research. This applies in particular to the possibility of linking cancer registry and claims data as well as research of health facilities with their own data in a network.

Whether the potential of the new legislation is exploited, now depends on its implementation, on the establishment of the necessary structures and on the data protection authorities’ conduct.