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.

View full abstract

The COVID-19 pandemic has dramatically changed healthcare systems worldwide, underscoring the need for more efficient and innovative emergency medical services. We discuss the evolution of home-based acute care, particularly focusing on models such as Hospital at Home (HaH) or emergency home visit services, which have gained prominence abroad and are informed by pandemic experience. Strengthening HaH or emergency home visit services in Japan may improve the emergency care system, reduce the workload of medical staff, and build an effective care system during health crises. However, the successful integration of the HaH and the conventional emergency system in Japan requires evaluation of their economic viability and outcomes. ＊1

View full abstract

　The “digital health technologies,” including telemedicine, has been anticipated as a means to address the seemingly contradictory challenges: “improving healthcare quality” and “containing healthcare costs.” 　Since the onset of the COVID-19 pandemic in 2020, telemedicine has rapidly proliferated as a powerful measure for infection control. 　However, as the current situation indicates a gradual stabilization in the pandemic, it is crucial to reconsider the significance of online healthcare beyond the scope of infection control. 　In the context of Japan, facing a declining population, the optimization of healthcare becomes indispensable, and the utilization of telemedicine stands out as a powerful candidate as a means to achieve efficiency in healthcare. 　The development of medical devices, including Software as a Medical Device (SaMD), that can be utilized in telemedicine is also progressing, with expectations that the digitization of healthcare will accelerate in the future. 　On the other hand, to promote the digital transformation of healthcare, it is imperative not only to focus on technological development but also to urgently enhance the digital literacy of both healthcare providers and patients.

View full abstract

Japan's healthcare system faces a pressing challenge: escalating national healthcare expenditures and social insurance premiums. While the complexity of the healthcare insurance system is undeniable, structural issues undoubtedly exist. 　Addressing healthcare cost optimization necessitates a nuanced approach beyond mere innovation. Meticulous efforts are required within the existing framework, focusing on healthcare delivery systems, payment methods, and the design of medical fee schedule. 　Discussions on healthcare cost optimization sometimes center around six categories of unnecessary services, services delivered inefficiently, prices that are too high, excess administrative costs, missed prevention opportunities, and fraud. The government's plan for optimizing healthcare expenditure encourages deliberations and planning among stakeholders, including healthcare professionals and insurers, concerning these categories. 　Crucially, identifying specific areas for optimization and promoting data visualization using the National Database which contains almost all healthcare claims data throughout Japan and other data are key to bolstering the plan's effectiveness. 　Healthcare cost optimization is a collective responsibility of all stakeholders to ensure the sustainability of Japan's healthcare system. Concerted efforts are essential, focusing on incremental improvements within the existing framework.

View full abstract