Statistical Review of Regulatory Requirements for AI Diagnosis
Naoki Ishizuka · 2024
We will discuss how to implement AI Diagnosis into practice. Many research of AI application for healthcare have been reported. However, in order to use these techniques in practice it is necessary to get regulatory approval from the authority in each country according to the regulation or the act at first. We will review the latest status so called SaMD: Software as Medical Device in regulation for AI diagnosis with Gastrointestinal endoscopy in Japan as an example. In addition to some the results of clinical research which were not included in the data package for regulatory submission to get approval as SaMD will be introduced. The category of medical device, i.e. from I to IV, and some regulation would affect the design of how to evaluate of performance and utility for SaMD.