Regulatorische Maßnahmen für künstliche Intelligenz in Europa und Deutschland: Rahmenbedingungen, Implementierung und Perspektiven

The integration of artificial intelligence (AI) into the German healthcare system has made significant progress in recent years. The application of AI promises not only to optimize patient care, but also to significantly increase efficiency in the healthcare system. In oncology in particular, the use of AI has the potential to have a transformative effect on cancer diagnosis and treatment. Regulatory measures are being taken at the European level to promote the ethical and responsible use and development of AI and to create the necessary data basis for this. The European Artificial Intelligence Act sets uniform rules for the development, use and monitoring of AI systems, especially for high-risk applications. The regulation establishing the European Health Data Space enables and facilitates access to health data, thereby supporting the development and training of AI systems. In line with the European projects, Germany is striving to improve the availability and use of health data through national legislation such as the Health Data Use Act (26.03.24), the future Regulation and Strengthening of Medical Registries Act, and the Consolidation of Cancer Registry Data Act (18 August 2021). In the future, this data could also form the basis for the practical use of AI in the German healthcare system. In addition, the Federal Government is funding a number of medical research projects that demonstrate innovative approaches in this area and can therefore provide guidance for upcoming projects such as legislation, new therapies, and new research questions.