Germany: Entry into force with grace period of Health Data Utilisation Act including data use regulation

On 26 March 2024, the Health Data Utilisation Act (BGBl. 2024 I Nr. 102) entered into force one day after its publication in the Federal Gazette. The Act states that health institutions that process data are allowed to do so and continuously use the data if necessary to increase the safety of the patient, for research purposes, or statistical purposes. The Act notes the necessity of pseudonymisation and eventual anonymisation of personal data for quality assurance and research. The Act enables entities from the private sector to request access to health data and use it for research purposes. The use of health data for commercial purposes, such as advertising or market research, is prohibited.