医疗科研中的生物医疗数据“匿名化”问题研究

Study on the Anonymization of Biomedical Data in Medical Research

生物医疗数据具有较强的人格属性、财产属性和公益属性;其“脱敏”处理,在我国《数据安全法》和《个人信息保护法》的法律框架下主要依据“去标识化”和“匿名化”制度来操作。而为保留“匿名化”处理后的生物医疗数据的科研价值,有必要调适“去标识化”的技术规范,其具体措施包括在特殊情境下降低“匿名化”标准、基于直接标识与间接标识的区分建立“去标识化”分级制度、制定患者“泛知情同意”的特别规定;同时要建立伦理审查制度,对数据使用的全过程做审查、跟踪和监管,以平衡生物医疗数据在医疗科研中的公共价值和对个体利益的保护这两个价值目标。

Biomedical data has strong personality attribute,property attribute and public benefit attribute.Under the legal framework of Data Security Law and Personal Information Protection Law,personal information is desensi⁃tized mainly through de-identification and anonymity systems.In order to retain the value of biomedical data appli⁃cable to scientific research after anonymization,our technical specifications of de-identification should be adjusted,and its specific measures include reducing the anonymization standard in special situations,establishing a de identification classification system based on the distinction between direct identification and indirect identification,and formulating special provisions for patients’general informed consent.Meanwhile,an ethical review system should be established to review,track and supervise the whole process of data use,so as to balance the two value goals of the public value of biomedical data in medical research and the protection of individual interests.