数据治理法制化背景下我国临床研究数据收集和应用新考量

New consideration for data collection and application of clinical research under the back-ground of ligalization of data administration in China

在临床研究过程中处理分析的医疗数据包含大量患者个人信息,因此,临床研究人员在临床研究中应做好医疗数据安全管理工作。2021年9月1日和11月1日相继正式实施的《中华人民共和国数据安全法》和《中华人民共和国个人信息保护法》为我国数据安全和个人信息保护提供了法律依据,为医疗数据的安全使用指明方向,这标志着数据治理进入“强监管时代”。在临床研究的医疗数据收集及应用过程中尊重保护患者隐私安全,保障医疗数据质量,安全管理医疗数据并开展高质量临床研究,将是在新的法律背景下临床科研数据收集和应用的重要考量。

The medical data processed and analyzed in clinical research often contain a large number of personal information.Therefore,researchers should pay attention to the safety management of medical data during clinical research.The Data Security Law of People's Republic of China and the Personal Information Protection Law of People's Republic of China implemented on 1st September and 1st November 2021 respectively establish legal basis for data security and personal information protection and point out the direction for medical data security,which indicate that data governance has entered the'strong regulatory era'.In the process of medical data collection and application of clinical research,respecting and protecting the privacy and safety of patients,ensuring the quality of medical data,safely managing medical data and carrying out high-quality clinical research will be an important test for the collection and application of clinical scientific research data under the new legal background.