Germany: Adopted Health Data Utilisation Act including data use regulation

On 2 February 2024, the Health Data Utilisation Act, including data use regulation, was adopted by the Federal Council. The Act regulates the use and processing of health data for research and healthcare system development. 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.