Utilization of Medical Information in Developing Medical Devices

Abstract

Recently, the development of SaMD (Software as a medical device) has been actively carried out along with the progress of AI utilization. On the other hand, the use of medical information which is essential for the development of SaMD requires measures based on various laws and guidelines. The need for measures to facilitate utilization medical information is indicated in “The implementation plan for regulatory reform”. This paper outlines the challenges and initiatives related to medical data utilization in Japan to date.