健康医疗数据行政法规制及其构建之思考  

Reflections on Administrative Law Regulation and Construction of Healthcare Data

作　　者：邢昕 XING Xin(Zhengzhou University,Zhengzhou,Henan 450001,China)

机构地区：[1]郑州大学,河南郑州450001

出　　处：《医学与法学》2024年第5期85-90,共6页Medicine and Jurisprudence

基　　金：国家社科基金重大项目“突发重大公共卫生事件防控的法治体系研究”(项目编号:20&ZD188);四川医事卫生法治研究中心资助项目“公共卫生二元化立法路径国际比较研究”(项目编号:YF21-Q06)的阶段性成果。

摘　　要：健康医疗数据之传统“知情-同意”私法保护模式已面临难以应对大规模社会性侵权、无法监督行政行为以及隐匿国家生物安全风险这三大困境,将其保护纳入行政法规制,便能有效应对新时代健康医疗数据保护的规制目标变迁、规制对象调整、规制时机优化等三重变化。而相应的行政法规制应坚持体系构造和规范构造的双轨思路:一方面建立“事前审批—事中监管—事后救济”的全流程规制框架体系,并依据不同的主体优势,形成由外到内的“行政强制性规制+行业软性标准规制+内部自我监督问责规制”三阶层级;另一方面针对健康医疗数据本身的高度敏感性、商用价值突出等特点,在界定其规范含义的基础上制定特定的“原则+规则”规范体系。The traditional"informed consent"private law protection mode of healthcare data has been faced with difficulties in cop⁃ing with large-scale social infringement,supervising administrative actions,concealing national biosecurity risks.If its protection is in⁃corporated into administrative law regulation,it can effectively cope with regulation target change,regulation object adjustment and regulation timing optimization of healthcare data protection in the new era.The corresponding administrative law regulation should ad⁃here to system construction and norm construction:on one hand,the whole process regulation framework system of"pre-approval-inprocess supervision-post-relief"should be established,and according to different main body advantages,a three-level system of"ad⁃ministrative mandatory regulation+industry soft standard regulation+internal self-supervision and accountability regulation"should be formed from the outside to the inside;on the other hand,according to the characteristics of high sensitivity and outstanding commer⁃cial value of healthcare data itself,a specific"principle+rule"normative system should be formulated on the basis of defining its nor⁃mative meaning.

关 键 词：健康医疗数据 行政法规制 法律构造 

分 类 号：D922.1[政治法律—宪法学与行政法学] R-05[政治法律—法学]