医疗数据使用权的私法保障与边界厘定被引量：9

Private Law Protection of the Right to Use Medical Data

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摘要医疗数据使用权配置是激活医疗数据要素作用的关键所在。医疗数据使用行为受到法律规制,但片面强调行为规制,无法满足医疗数据流通激励的现实需求。医疗数据使用权配置亟待完成。在具体的权利配置过程中,分散化、多点源的数据权利配置方式,不利于医疗数据公益保障,应当采用集中配置方法,以医疗机构为核心完成医疗数据私法赋权。医疗机构享有法定医疗数据使用权,并可对商业主体进行意定授权、向管理机构传输特定范围内的医疗数据。医疗机构对商业主体的意定授权,原则上以非个人数据为限,并需遵循许可方式限定的要求。管理机构调取和使用医疗数据,需要说明理由、保证效率、及时补偿。在紧急情况下,管理机构基于公益目的有权调取和使用医疗机构控制的医疗数据;在常态情形下,管理机构调取医疗数据需要经过卫生健康主管部门审核和授权。医疗数据使用权的实现以分层义务的履行为前提,具体包括一般义务、附随义务、特别义务三个层次。 The configuration of medical data usage rights is the key to activating the role of medical data elements.The use of medical data is regulated by law,but one-sided emphasis on behavioral regulation cannot meet the actual needs of incentives for medical data circulation.The configuration of medical data usage rights needs to be completed.In the specific rights allocation process,decentralized and multi-point source data rights allocation methods are not conducive to the public interest protection of medical data,and centralized allocation methods should be adopted to complete the private law empowerment of medical data with medical institutions as the core.Medical institutions enjoy the statutory right to use medical data,and may authorize commercial entities to transmit medical data within a specific scope to management bodies.In principle,the intended authorization of medical institutions to commercial entities is limited to non-personal data,and must comply with the requirements limited by the licensing method.The management agency collecting and using medical data needs to explain the reasons,ensure efficiency,and compensate in a timely manner.In an emergency,the management agency has the right to access and use medical data controlled by medical institutions for public welfare purposes;Under normal circumstances,the collection of medical data by the management agency needs to be reviewed and authorized by the health authorities.The realization of the right to use medical data is premised on the performance of layered obligations,which specifically include three levels:general obligations,ancillary obligations,and special obligations.

作者任颖 Ren Ying(Law School of Guangdong University of Foreign Studies,Guangzhou Guangdong 510420)

机构地区广东外语外贸大学法学院

出处《政法论丛》 CSSCI 北大核心 2023年第6期99-110,共12页 Journal of Political Science and Law

基金 2022年度教育部哲学社会科学研究重大课题攻关项目“公共卫生法治体系研究”(22JZD016)的阶段性研究成果。

关键词医疗数据使用权私法赋权有限排他使用 right to use medical data private law empowerment limited exclusive use

分类号 DF521 [政治法律—民商法学]

作者简介任颖(1984-),女,河南巩义人,法学博士,广东外语外贸大学法学院教授,研究方向为卫生法学、法学理论。