Résumé
For several years, Artificial Intelligence (AI) has played a major role in many aspects of our lives. The health sector is no exception to this new technology, which is itself a source of a considerable amount of data. Various AI solutions are in common use in the hospital sector where it is already finding a particular place in the cancer and radiology field for its diagnostic assistance. This phenomenon is expected to increase with the improvement of computer technologies and the unlimited applicability. However, this rapid progress reveals limits in the European regulation, which is experiencing difficulties in regulating it. These limits represent the keystone of many regulatory challenges. An improvement in the legislative framework therefore seems essential to continue to keep up with the state of the art and its development. In this thesis, I would like to highlight the limits of the regulation surrounding AI in the European Union based on 3 major themes: the registration of AI as a Medical Device, the management of health data according to the GDPR, and the distribution of responsibilities in case of damage.