宏基因组二代测序技术临床应用中的数据合规性研究与实践

Research and Practice of data Compliance in Clinical Applications of Metage-nomic Second-generation Sequencing Technology

数据已经成为重要的生产要素,宏基因组测序标本采集涉及面广,宏基因组二代测序技术数据是医疗健康领域重要的基础性战略资源。结合《网络安全法》和《个人信息安全规范》《数据安全法》《个人信息保护法(草案)》等相关规定,提出宏基因组二代测序数据合规性框架和数据合规要点,为医疗机构在利用宏基因组二代测序数据开展医疗诊治活动的同时,切实保证测序机构不出现数据合规风险或法律纠纷,并建议强化内部管理,兼顾社会效益,承担相应的社会责任,积极开展数据合规培训和教育。

Data has become an important factor of production.The collection of metagenome sequencing specimens involves a wide range of specimen.Metagenome second-generation sequencing technology data is an important basic strategic resource in the field of medical and health.Combined with the relevant provisions of the network security law,personal information security code,data security law and personal information protection law(Draft),this paper tentatively puts forward the compliance framework and key points of metagenome second-generation sequencing data,so as to provide a reference for medical institutions to carry out medical diagnosis and treatment activities while using metagenome second-generation sequencing data,It is suggested to strengthen internal management,give consideration to social benefits,assume corresponding social responsibilities,and actively carry out data compliance training and education.