The Current State and Framework of Digital Health in Japan9 Comparative Perspectives and Future OutlookFurthermore, in November 2020, the Japanese government launched the “Program Medical Device Practical Application Promotion Package (DASH for SaMD),” aiming to streamline the traditionally stringent review process for medical devices and expedite regulatory approval. Going forward, fostering a government-led, unified digital health infrastructure and strengthening collaboration among healthcare facilities, insurers, and industry stakeholders are anticipated to drive wider adoption of digital healthcare. Such measures could simultaneously reduce healthcare costs and enhance patients’ quality of life.A comparative assessment from June 2021 suggests that, relative to Europe as a whole and the United States, the number of approvals in Japan remains comparatively low, highlighting the country’s nascent stage in terms of product approvals and widespread adoption of digital medical solutions. Looking ahead, Japan can benefit by drawing on the successes and lessons from Germany and other markets, such as the United States, to accelerate the refinement of its legal and technological infrastructure. Strengthening collaboration among healthcare providers, insurers, and private enterprises will be instrumental in elevating the quality and efficiency of digital healthcare and developing a new delivery model. If these endeavors become more advanced and comprehensive, Japan too could emerge as a global leader in the evolving field of digital healthcare.population aging, an increasing prevalence of chronic illnesses, and a shortage of healthcare professionals, all of which underline the urgency of reducing clinical workloads while improving quality of care. In this environment, the introduction of software-based medical devices (SaMD)—in addition to electronic medical records and telemedicine—has attracted considerable attention. SaMD refers to software products designed to diagnose, treat, or prevent diseases, representing a novel therapeutic modality distinct from conventional medical devices. CureApp SC exemplifies such innovation in Japan. As the first therapeutic app in Asia to be approved by the Ministry of Health, Labor and Welfare, CureApp SC supports smoking cessation by providing personalized treatment plans via smartphone. Patients follow these plans remotely, while physicians can monitor real-time data and collaborate closely with face-to-face consultations to optimize treatment efficancy.drawn significant attention as digital health solutions addressing systemic healthcare challenges. Germany’s environment, shaped by the DVG and DiGA Fast-Track approval pathways, has streamlined insurance reimbursement and accelerated regulatory procedures, creating an ecosystem conducive to innovation from startups. Meanwhile, Japan has targeted the introduction of SaMD as a strategy to cope with an aging society, promoting more efficient market entry through initiatives such as DASH for SaMD. Nevertheless, data from September 2022 show that while Germany has approved dozens of digital therapeutic products for reimbursement, Japan has only a handful (see figure below). Additionally, Germany’s reimbursement price ranges are broader, and coverage extends to a wider variety of disease areas. By contrast, Japan faces pressing issues such as rapid Both Germany’s DiGA and Japan’s SaMD initiatives have
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