2023 Volume 13 Issue 3 Pages 221-230
A sub-forum was held on February 6, 2023 as a study session of the SaMD Forum. The themes were “Issues Related to Medical Reimbursement in SaMD” and “Issues Related to the Utilization of Medical Data”. This paper provides an extensive review of the two topics, not limiting itself to the discussions that took place on the day of the forum. In the former discussion, industry made recommendations for evaluation based on issues specific to SaMD. The latter discussion focused on current issues regarding specific methods of providing medical data with appropriate protection of personal information. Based on these discussions, specific evaluation methods for SaMD are currently being discussed at the Central Social Insurance Medical Council (Chuikyo) of the Ministry of Health, Labour and Welfare (MHLW). In addition, a research group of the MHLW is preparing guidelines on appropriate methods of providing medical data. It is hoped that discussions on how to balance innovation and regulation will continue in the future.
