The integration of artificial intelligence (AI) technologies in healthcare promises safer, more efficient, and more personalized care. Typical applications of such systems include personalized diagnosis, early disease detection, hospitalization risk prediction, and pattern discovery. These technologies process vast amounts of data, can learn from experience and self-improve their performance, which challenges the applicability of existing medical device regulations that were not designed for progressive and adaptive AI. The automated processing of data that will evaluate, analyze, and predict health-related outcomes may also affect not only data protection regulations but also the safety of the individual. In this respect, this panel explores the suitability of the existing legal framework for the increasing development and use of AI in healthcare. The panelists will give concrete examples of AI applications, identify specific problems, and will discuss with the audience potential solutions.