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Germany: GDNG enters into effect

On March 25, 2024, the Federal Ministry of Health (BMG) announced that the Health Data Use Act (GDNG) is effective from March 26, 2024. In particular, the GDNG is intended to make health data accessible for research and set up a decentralized health data infrastructure with a central data access and coordination point for the use of health data. More specifically, the BMG has issued frequently asked questions (FAQs) on the GDNG as well as a press release highlighting important points of the GDNG.

According to the BMG, the lead data protection supervision for transnational research projects will be expanded to include all health data. Additionally, the data protection supervision for cross-state research projects in the health care sector will be coordinated by a state data protection officer (DPO). Importantly, the BMG stated, among other things, that data is not released at the Health Research Data Center (FDZ), but researchers are given access to the data in secure, virtual processing rooms. Data is transmitted to applicants depending on the data in anonymized and aggregated or pseudonymized form. Attempting to re-identify insured persons or service providers is, in any case, punishable by up to one year of imprisonment.

You can read the GDNG here, its legislative history here, the FAQs here, and the important points of the GDNG here, all only available in German.