Regulatory Science on AI-based Medical Devices and Systems

AI-based medical and healthcare devices and systems have unique characteristics including 1) plasticity causing changes in system performance through learning, and need of creating new concepts about the timing of learning and assignment of responsibilities for risk management; 2) unpredictability of system behavior in response to unknown inputs due to the black box characteristics precluding deductive output prediction; and 3) need of assuring the characteristics of datasets to be used for learning and evaluation. The Subcommittee on Arti cial Intelligence and its Applications in Medical Field of the Science Board, the Pharmaceuticals and Medical Devices Agency (PMDA), Tokyo, Japan, examined “new elements speci c to AI” not included in conventional technologies, thereby clarifying the characteristics and risks of AI-based technologies. This paper summarizes the characteristics and clinical positioning of AI medical systems and their applications from the viewpoint of regulatory science, and presents the issues related to the characteristics and reliability of data sets in machine learning.