Next-generation Medical Device Evaluation Index Created Business: Evaluation Index for Judgement of AI-based Medical Devices by Working Group

Abstract

Artificial intelligence (AI)-based medical devices are currently being marketed as a tool of supporting diagnosis for medical doctors. However, there are some problems in AI to be taken into consideration in judgement of approval as a medical devices. Japanese government has initiated a working group which consists of members recommended by Academia, PMDA as well as Ministry of Health, Labor and Welfare. The mission is to make an evaluation index for AI-based medical devices. The main problems are ①unknown algorithm through the whole processing by using AI and ②change of original function of the AI-based medical devices equipped with automatic classification learning function after commercialization compared to that of the initial application. ③The data resources as well as ④data quality in the learning processing of the AI software are also very serious problems. How to deal with the problems and what are the conditions to be approved as a medical devices are being discussed in the working group. The final responsibility to use the AI-based medical devices are owed by medical doctors. Manufactures should report at the time of application about the data resources and the range of functions of the devices such as rate of accuracy or false positive rate. It is recommended that both users and manufactures better pay more attention to the risk management for usage of the AI-based medical devices.