摘要
伴随着大数据时代的快速发展,临床研究也逐渐成为其应用的重要阵地。然而临床研究者们在具体实践中发现,在现阶段分散的、修补式的法律体系下,临床研究大数据的权属问题尚不明确,尤其是对于去标识化的数据,其保护和规制的范围十分有限。虽有一些行业内的软法规范,但不成体系且缺乏统一的标准。临床研究大数据作为随科技进步而产生的新事物,其保护与规制也需要进行相应的法律规制。本文从去标识化的临床研究大数据的角度,以机构和国家层面的规制为切入点,探讨其在流动与共享的过程中遇到的困境,并提出在法律规范的制定和软法治理两方面的建议和展望。
With the rapid development of the era of big data, clinical research has gradually become an important field for its application. However, clinical researchers have found in practice that, under the current decentralized and mending legal system, the ownership of big data in clinical research is still unclear, especially for the de-identified data, the scope of protection and regulation is very limited. Although there are some soft regulations in the industry, they are not systematic and lack uniform standards. As a new thing emerges with the progress of science and technology, the protection and regulation of big data in clinical research naturally need corresponding legal regulation. In this paper, from the perspective of big data in clinical research that has been de-identified, regulation at the institutional and national levels is taken as the entry point to discuss the difficulties encountered in the process of flow and sharing, and suggestions and prospects on the formulation of legal norms and soft law governance are put forward.
作者
贺宁
胡汝为
HE Ning;HU Ru-wei(School of Public Health,Sun Yat-sen University,Guangzhou 510000,China)
出处
《科技与法律》
CSSCI
2019年第6期49-58,共10页
Science Technology and Law
基金
国家重点研发计划“基于数据安全的重大慢病临床研究数据利用的法律与伦理遵循标准研究”（2018YFC1315403）
中国行为法学会软法研究会和北大软法研究中心资助一般课题“全球健康治理与软法”（201505）
关键词
临床研究大数据
数据权属
法律规制
立法
软法
clinical research big data
data ownership
legal regulation
legislation
soft law
作者简介
贺宁(1996—),女,陕西汉中人,硕士研究生,研究方向:卫生法学;通讯作者:胡汝为(1980—),女,广东顺德人,副教授,博士生导师,研究方向:卫生法学、政府管制,通讯方式E-mail:huru⁃wei@mail.sysu.edu.cn。
