JAPAN Trends and Developments Contributed by: Satoshi Ogawa, Yuto Noro, Hitoshi Fujimaki and Yuka Hirata, TMI Associates
utilisation rate. This policy is designed to incen- tivise the adoption of digital infrastructure within the healthcare system and to accelerate broader use of the My Number Card nationwide. Remote clinical trials “Remote clinical trials” have been gaining trac- tion in Japan. These trials allow patients to participate in drug or medical device studies remotely, such as from home, rather than visit- ing study sites. While previously slow to develop due to cost-effectiveness concerns, the COV- ID-19 pandemic highlighted the need for such trials as more people stayed home. Using smartphone apps, participants can con- duct parts of the trial at nearby clinics or at home, saving travel time. For pharmaceutical companies, remote trials offer potential cost and time savings, enhancing the efficacy of drug development. The MHLW released guidelines in Spring 2020 on conducting clinical trials during the pandem- ic, followed by a March 2023 notice permitting electronic methods for informed consent for both clinical and post-marketing trials. In September 2024, an additional notice addressed the evaluation of the safety and efficacy of data collected remotely, helping to establish the legal framework necessary to sup- port wider adoption of remote clinical trials in Japan. Medical AI In recent years, the use of artificial intelligence in Japan’s healthcare sector has contributed to greater efficacy, improved data collection and utilisation, reduced patient burden, and improved access to medical information. To date, AI in healthcare has primarily been used for
structuring diagnostic interview information and analysing medical images. Over 20 medical AI- powered medical devices have been approved by the MHLW, most of which focus on image analysis. Under a MHLW notice in 2018, AI medical devic- es must be used under physician oversight. Phy- sicians must lead the diagnostic process and make all final treatment decisions. As such, AI serves only as a tool to support, not replace, clinical decision-making. To facilitate the use of adaptive AI, which con- tinuously learns and improves in real-world set- tings, the Pharmaceuticals and Medical Devices Agency (PMDA) plans to expand its IDATEN (Immediate Deployment and Acceleration of Technologies for the Nation) system. This sys- tem allows pre-approved improvement plans for AI-based SaMD, eliminating the need for regula- tory re-approval with each update. This reduces the cost and administrative burden associated with approval of AI-driven devices that evolve over time. In April 2024, the Ministry of Internal Affairs and Communications and the Ministry of Economy, Trade and Industry released the “AI Guidelines for Business”, consolidating earlier AI guidelines into a unified framework. The guidelines call for stakeholders to identify risks throughout the AI life cycle, take voluntary risk-mitigation meas- ures, and align with international trends, while promoting innovation. These guidelines apply broadly, including to public organisations, and are expected to guide developers, providers, and users of medical AI in Japan. Metaverse Companies across various industries are increasingly exploring the use of metaverse
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