Supervision System of AI-based Software as a Medical Device

Abstract

A scientific supervision system enhances vigorous and standardized development of emerging products. Artificial intelligence-based software as a medical device (AI-based SaMD) is an important class of products in the healthcare industry. As AI develops, its unique black-box algorithm and independent learning ability pose major supervision challenges. AI-based SaMD supervision must keep pace. Therefore, a more scientific supervision strategy is urgently needed to minimize the risk of adverse events associated with AI-based SaMDs. This article summarizes the current status of supervision systems and supporting resources of AI-based SaMD resources in China and abroad, considering the difficulties in algorithm change management, quality control, and safety traceability. In addition, we explore the problems and challenges associated with AI-based SaMDs in China. We recommend that AI-based SaMD supervision and support systems should be improved in China to avoid the disadvantages of post-market supervision.