Regulation of Artificial Intelligence in Healthcare within the European Union

The use of artificial intelligence (AI) is spreading rapidly in healthcare. AI systems have no regulation of their own in the European Union, but are subject to a growing set of overlapping regulations that are difficult to identify and systematize. This paper provides an orderly analysis of all these regulations at the European level in order to clarify the cardinal points of the regulation of AI systems in healthcare, as it is not homogeneous, but depends on the specific use of the system. The new EU’s Regulation on AI and the Regulation on Medical Devices are the two key points that should complement each other. However, they are insufficient as the AI Regulation is too generic and the Medical Devices Regulation is outdated. Therefore, a specific regulation is needed to regulate the use of AI in healthcare.