16What Happens if Japan’s Challenges Remain Unresolved?How Can Japan Overcome the Barriers?outcomes, worsen clinicians’ workloads, weaken industrial compet it iveness, and place Japan at a disadvantage in international medical cooperation.A look at nations where medical AI is advancing shows that, although they face challenges similar to Japan’s, each has found its own breakthrough. In the United States, collaboration among private insurers, hospitals, and IT companies allows implementation and reimbursement to move forward in parallel. The digital pathology platform introduced at the Mayo Clinic is a prime example: AI analyzes pathology images in minutes, and insurers, recognizing lower diagnostic costs and faster turnaround, are moving to cover the service.The European Union took a different path with the 2024 EU AI Act, designating medical AI as “high-risk” and imposing strict safety requirements. At the same time, the Act created regulatory sandboxes that let developers test and submit applications while using real clinical data. This framework, which blends rigor with speed, illustrates a “protect yet progress” approach—an area where Japan has struggled.China is pushing ahead through state-led data consolidation and large-scale pilot projects. The government has built nationwide health-data infrastructure and set up programs in which universities and tech companies jointly train AI “doctors.” As a result, highly accurate diagnostic systems are rolling out in remarkably short time frames. Discussion of personal-data protection is limited, but the combination of market size and strong policy support accelerates deployment at a rapid pace.Together, these cases reveal three distinct ways of overcoming barriers: market-insurance synergy in the United States, a balance of safety and sandbox testing in Europe, and centralized, government-driven expansion in China. Unless Japan maintains its cautious review standards while simultaneously creating venues for data sharing and real-world validation, it will be difficult to close the gap in AI adoption and narrow the healthcare disparities that follow.To accelerate medical AI in Japan, the country must lower four barriers at the same time: reimbursement policy, data utilization, hospital infrastructure, and human resources. Regarding reimbursement, it is effective to supplement the rigorous full-review process with a time-limited “conditional early listing” once safety has been confirmed. This approach, similar to the EU’s regulatory sandbox, allows real-world data to be gathered while an application is already in use, balancing speed with careful evaluation.The key to solving the data problem is nationwide circulation of anonymized information. If a designated organization manages usage purposes and supplies researchers and companies with traceable data, hospitals can share information with confidence, and highly accurate domestic models can be trained. In parallel, public subsidies should support the replacement of aging electronic medical-record systems and image servers, so that even regional and mid-sized hospitals have an adequate foundation on which AI can run.On the talent front, it is urgent to establish systematic training programs for professionals who understand both medical IT and clinical practice and can link developers with physicians inside hospitals. In addition, creating “regional AI test beds” where hospitals, universities, companies, and government collaborate would provide a small-scale environment for easy real-world trials, making results and challenges visible at an early stage. As successful examples multiply, psychological resistance in the field falls, and the speed at which technology reaches patients increases.By upgrading systems and infrastructure step by step in this way, Japan can present the world with its own model of “Japan-style medical AI,” one that emphasizes both high accuracy and safety instead of merely following overseas trends. Whether the country chooses to act now or retreats from the challenge will determine the direction of the next decade.
元のページ ../index.html#17