Artificial Intelligence and Medical Devices: Do We Need New Regulation?

Abstract

The article deals with the legal aspects of the use of artificial intelligence in health care, with a focus on clinical decision support systems and surgical robots. Emphasis is placed on the regulation of medical devices and product liability. The author analyses how the current European legislation affects the use of the above technologies in health care and examines its shortcomings. She then uses these findings to evaluate whether new comprehensive legislation is needed or whether it would be sufficient to adjust the current legislation to the specific features of artificial intelligence.