医疗数据利用的“领域法”规制路径  

Regulatory Path of the “Domain Law” for Medical Data Utilization

作　　者：任颖[1] REN Ying

机构地区：[1]广东外语外贸大学法学院,广东广州510420

出　　处：《中南民族大学学报（人文社会科学版）》2023年第8期105-113,185,共10页Journal of South-Central Minzu University (Humanities and Social Sciences)

基　　金：中国法学会部级法学研究课题“智能医疗新技术新业态的叠加型风险防控及融合型立法路径研究”CLS(2021)D47;广州市哲学社科规划课题“广州健康医疗大数据发展的法律保障研究”(2021GZGJ231);广东法治研究院及广东省地方立法研究评估与咨询服务基地招标课题。

摘　　要：医疗数据与人类生命健康保障紧密相连,分立的部门法律规制难以对医疗数据利用中复杂的矛盾和冲突进行调整,无法满足公共卫生信息利益平衡要求。应重视以医患利益平衡原则、生命健康权优先原则、个案审查原则为基础,确立医疗数据利用的“领域法”规制路径:通过医疗数据公法秩序与私法秩序的一体多维建构,以及医疗数据权利冲突实体平衡与程序预防的有机结合,应对医疗数据利用中患者个人信息与公共卫生信息的利益协调问题;通过医疗数据影响评估制度建设和特别法授权性规范设置,解决医疗数据利用中一般法审查规制较难应对个案差异化需求的困难,以及医疗数据本地化义务中一般禁止式调整方式难以满足跨境疫情防控要求的现实困境,为人民生命健康保障提供数据法治支持。Medical data is closely linked to human life and health security.The regulation of medical data utiliza-tion by separate sectoral laws is insufficient to address the complex contradictions and conflicts in medical data utilization and cannot meet the requirements for balancing public health information interests.It is necessary to establish a"domain law"regulatory path for medical data utilization based on the principles of balancing the interests of medical practitioners and patients,prioritizing the right to life and health,and conducting case-by-case review.This path involves the multi-dimensional construction of the public law order and private law order of medical data,as well as the organic combina-tion of substantive balance of medical data rights conflicts and procedural preventive measures,to address the issue of coordinating the interests of individual patient information and public health information in medical data utilization.It al-so includes the establishment of a medical data impact assessment system and the authorization of specific legislation to address the difficulties faced by general legal scrutiny in responding to differentiated case-specific demands in medical data utilization,as well as the challenges of meeting the requirements of cross-border epidemic prevention and control with the general prohibition-style adjustment approach in medical data localization obligations.This regulatory path pro-vides data rule of law support for safeguarding people's lives and health.

关 键 词：医疗数据 领域法 公共卫生信息 患者信息 数据法治 

分 类 号：D912.16[政治法律—宪法学与行政法学]