Considering the experience of COVID-19 and anticipating the 2040 Problem from the post-coronavirus perspective: Insights into Digital Applications

Abstract

In the second-term Basic Plan for Medical Devices, approved in May 2022, digital applications have garnered significant attention. In the regulatory context of our country, these digital applications are referred to as Software as a Medical Device (SaMD). As of 2023, there are 486 approved SaMD items, with a predominant focus on areas such as CT image analysis, provision of physiological signal parameters, and support for treatment planning. 　Promotion policies for SaMD encompass development, regulatory affairs, and reimbursement considerations. While efforts in development and regulatory aspects are noticeable, challenges persist in the realm of reimbursement. 　Against the backdrop of reforms in the working practices of healthcare professionals, the Medical Device Basic Plan places particular emphasis on medical devices that contribute to the efficiency and reduction of burdens in the tasks of healthcare professionals. However, evaluating these devices is challenging within the current framework of the medical reimbursement system. 　As we approach the 2040 Problem, the societal implementation of digital applications holds promise. Discussions regarding the assessment of medical reimbursements are expected to progress further in the coming years.