中美医学研究对象健康信息处理法律规制的比较研究

Comparative Research on the Legal Regulation of Health Information Processing for Chinese and American Medical Research Objects

随着大数据技术的发展,越来越多的个人健康信息用于研究目的,带来了研究对象健康隐私信息保护的新挑战。文章对美国和我国目前医学研究对象健康信息处理原则和条件、合理使用情形予以梳理和比较分析,我国和美国均以知情同意作为个人健康信息处理的合法性条件,并允许未经信息主体同意处理去标识化的个人健康信息,但美国相关法律规定了删除个人健康信息的18个标识符等更具体地去标识化要求,并制定了以研究为目的处理个人健康信息合理使用情形相关规定。文章提出明确个人健康信息去标识化的范围和方法、制定更灵活、更具体的豁免同意使用制度、鼓励消费者驱动的数据共享模式的建议。

With the development of big data technology,more and more personal health information is used for research,which brings new challenges to the protection of health privacy information of research subjects.The relevant terms,principles and proper use of dealing with personal health information aiming at research between China and America were comparatively analyzed.Both in China and America,the informed consent was taken as the legal requirement of dealing with personal health information,and dealing with de-identified personal health information without the agreement from information subjects was permitted.While there were some more specific de-identified requirements like 18 identifiers to delete personal health information in America,which also established some regulations on the proper use situation of dealing with personal health information aiming at study.Some suggestions were put forward on determining the scope and methods of de-identification,formulating more flexible and specific use system of consenting to exemption,and encouraging the establishment of consumer-driven data sharing.