智慧医疗时代个人健康信息保护立法路径研究  

Research on the Legislative Path of Personal Health Information Protection in the Era of Smart Medicine

作　　者：陈硕 Chen Shuo(Law School,Fuzhou University,Fuzhou 350108,China)

机构地区：[1]福州大学法学院,福建福州350108

出　　处：《锦州医科大学学报(社会科学版)》2025年第2期12-19,共8页Journal of Jinzhou Medical University(Social Science Edition)

摘　　要：随着医疗领域与人工智能的深度结合,智慧医疗技术依托“数据+算法”快速发展,但个人健康信息保护问题也随之而来。个人健康信息具有“高敏感性+社会公共性+主体弱控制性+高价值性”特征,存在告知同意规制难以适用、信息安全泄露、数据合规风险以及新技术应用安全风险。我国虽已初步形成医疗信息数据保护制度体系框架,但仍面临一系列的困境。鉴于此,需要探寻智慧医疗个人健康信息立法保护路径,秉持合法收集、目的限制、安全保障的基本原则,通过构建基本法与专门法的双层法律体系、建立公法与私法协同的双重规制体系、确立硬法与软法并重的二元法律治理模式来完善保护框架。在此基础上,细化个人健康信息处理的规范性规则,为智慧医疗时代的健康信息保护实践提供可操作的指南,保障个人健康信息安全。With the deep integration of the medical field and artificial intelligence,intelligent medical technology is developing rapidly based on“data+algorithm”,but the problem of personal medical protection has also arisen.Medical personal information has the characteristics of“high sensitivity+social publicity+weak control of the subject+high value”,and there are difficulties in the application of informed consent regulation,information security leakage,data compliance risk and security risk of the application of new technologies,which makes it necessary to protect it.Although China has initially formed the framework of medical information data protection system,there are still a series of dilemmas.In view of this,there is a need to explore the path of legislative protection of personal information for intelligent medical care,upholding the basic principles of lawful collection,purpose limitation,and security,and improving the protection framework by constructing a two-tiered legal system of basic law and specialized law,establishing a dual regulatory system of synergy between public and private law,and establishing a binary legal governance model that places equal emphasis on both hard law and soft law.On this basis,the normative rules for the handling of personal health information are refined to provide actionable guidelines for the practice of health information protection in the era of smart healthcare and to safeguard the security of personal health information.

关 键 词：智慧医疗 个人健康信息 立法保护 

分 类 号：R197.1[医药卫生—卫生事业管理]