Supervision System of AI-based Software as a Medical Device

Abstract

A scientific supervision system enhances vigorous and standardized development of emerging things. Artificial intelligencebased software as a medical device (AI-Based SaMD) is an important product in the health field enabled by artificial intelligence (AI). As AI develops further, its unique black box algorithm and independent learning ability have posed major supervision challenges. AIBased SaMD supervision needs to keep pace with the times and a more scientific supervision strategy is urgently required to minimize the adverse events of AI-Based SaMD and their risk impact. This article summarizes the current status of supervision systems and supporting resources of AI-Based SaMD in China and abroad considering the difficulties in algorithm change management, quality control, and safety traceability. In addition, we explore the problems and challenges of AI-Based SaMD in China. Furthermore, we suggest that the AI-Based SaMD supervision and support systems should be improved in China to overcome the disadvantages of postmarket supervision.

Keywords

• software as a medical device (SaMD)，artificial intelligence (AI)，supervision science