Subcommittee on Software as a Medical Device Utilizing AI and Machine Learning

Background

Along with the advancement of artificial intelligence (AI) technology, there is great promise for the implementation of medical devices which change in performance by post-marketing use with machine learning (ML).
The subcommittee reviews the trends of domestic and international regulations and safety standardization activities for AI-based Software as a Medical Device (SaMD), and discusses bias in ML, reuse of test data in post-marketing learning, construction of training data using physical model simulation, and development of medical information databases, etc., as a part of the scope, including analysis of medical imaging, electrocardiograms, and other physiological data.
 

Member List

Member List of the Subcommittee on Software as a Medical Device Utilizing AI and Machine Learning