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韩国数字医疗产品的法律规制及其对我国的启示OA

Legal regulation of digital medical products in South Korea and its implications for China

中文摘要英文摘要

数字技术正快速重塑包括医疗健康在内的各行各业,越来越多的国家和地区对数字医疗予以法律规制,其中,韩国制定了世界首部数字医疗产品专门立法——《数字医疗产品法》.在加快发展新质生产力的当下,强化数字医疗法治化建设也是我国面临的关键问题.文章深入解析韩国数字医疗产品立法内容及经验,剖析我国数字医疗产品法律规制的现状与困境,并提出从探索制定数字医疗单行法、统一数字医疗产品的概念、明确政府支持数字医疗产品发展的职责、健全数字医疗产品制度内容等方面逐步推进数字医疗产品法治化建设的建议,以保障我国数字医疗行业的健康发展.

Digital technology is rapidly reshaping various industries,including healthcare.An increasing number of countries and regions are imposing legal regulations on digital health.Among them,South Korea has formulated the world's first dedicated legislation for digital medical products,the"Digital Medical Product Act".As we accelerate the development of new productive forces,strengthening the legalization of digital health is also a key issue facing China.This article delves into the content of South Korea's digital medical product legislation,analyzes the current situation and dilemmas of legal regulation on digital medical products in China,and proposes suggestions for gradually advancing the legalization of digital medical products from aspects such as exploring the formulation of a separate law for digital health,unifying the concept of digital medical products,clarifying the responsibilities of the government in supporting the development of digital medical products,and improving the content of the digital medical product system,in order to ensure the healthy development of China's digital health industry.

赵越;刘兰秋

首都医科大学附属北京友谊医院,北京 100050首都医科大学,北京 100069

医药卫生

韩国数字医疗产品法律规制

South Koreadigital medical productlegal regulation

《健康发展与政策研究》 2026 (4)

665-672,8

国家社会科学基金(24SGC106)

10.12458/HDPR.202505037

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