Regulatory Aspects on AI-based Medical Devices and Systems

Abstract

Recent advances in artificial intelligence (AI) are propelling the development of AI-based medical and healthcare devices and systems. AI-based medical systems have new characteristics to be considered by developers and reviewers, namely, plasticity causing changes in system performance through learning, unpredictability of system behavior due to the black box nature of the AI process, and impact of advanced autonomy of AI-based medical systems on the relationship between patients and doctors. New research-and-development and medical-device-reviewing platforms need to be urgently discussed to prepare for up-coming new AI-based medical systems by considering aforementioned characteristics.