KAHSI Project: Supporting SaMD and application development

Recently software as a medical device (SaMD) has received a great deal of attention. SaMD is a blanket term for software programs that run on medical devices, for treating illnesses, managing medicine intake and supporting health. SaMD products cannot be distributed in Japan except with approval and certification under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices “the Pharmaceuticals and Medical Devices Law”); moreover, only a handful of companies are permitted to submit applications for approval. This state of affairs creates a number of problems, such as SaMD products circulated without approval and many excellent programs that are never commercialized because the approval process is too troublesome.

Kyoto Advanced Health Software Initiatives (KAHSI) aims to address these problems. The members of this project, which include Kyoto University faculty, possess a wealth of knowledge and experience as well as extensive professional networks. Drawing on these resources, KAHSI presents seminars to deepen understanding of SaMD, advises on whether a given software program qualifies as SaMD and supports the commercialization of health management software.