通过梳理日本数字疗法的应用现状、医保支付路径及标准,发现日本数字疗法的准入在传统医疗器械框架下进行,得益于独立的分类管理和监管策略,以及产学研数据共享和数字疗法的快速发展。但较为有限的卫生技术评估基础导致数字疗法评估维度不全面,伦理审查和社会影响有潜在隐患。基于此提出未来我国可探索以真实世界证据为准绳,尝试快速审查与支付的地区试点,确保多方利益和伦理考量,定期进行影响评估以保障数字疗法健康发展。
Abstract
By combing the application status, paths and standards of health insurance payment of digital therapeutics (DTx) in Japan, it is found that the access to DTx in Japan is carried out under the framework of traditional medical devices, benefiting from independent classification management and regulatory strategies, data sharing between industry, academia and research institutes, and rapid development of DTx. However, limited basis of health technology assessment has led to an incomplete evaluation dimension of DTx, and there are potential pitfalls in terms of ethical review and social impacts. In the future, China can explore regional pilots that use real-world evidence as the criterion, try to quickly review and pay, ensure the interests of multiple parties and ethical considerations, and regularly conduct impact assessments to ensure the healthy development of DTx.
关键词
数字疗法 /
政策保障 /
医疗保险 /
日本
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Key words
digital therapeutics /
policy guarantee /
health insurance /
Japan
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