Regulierung intelligenter Medizinprodukte

Medicine is achieving considerable success with medical devices based on artificial intelligence (AI). In contrast to traditional medical devices, these are characterized by special system architecture and programming. This work comprehensively examines whether the existing legal framework is sufficient to address specific features of AI-based intelligent medical devices and to what extent additional AI regulation is needed. The focus is on central requirements of the MPVO and DSGVO that must be complied with in the development and use of intelligent medical technology. The work thus has immense practical relevance. The work was awarded the Scientific Prize for Medical Product Law by the University of Augsburg.