摘要
临床真实世界数据研究是通过利用临床医疗信息、健康行为监测等实际应用过程所产生的健康数据作为研究的信息基础。其数据应用过程,防止隐私信息泄露,在充分利用数据的同时保障数据安全与信息安全成为不可忽略的重要问题。对真实世界数据的应用应以明确数据权益为前提,在充分知情同意的情况下,依据法律法规和技术标准的相关要求,完善数据安全等级划分和分级安全保护策略,从物理安全、数据安全、应用安全各角度构建完整的信息安全保护体系,促进充分的数据利用。
Real-world study uses health information data generated from clinical care,health behavior monitoring and other applications as the information basis for research.In data applications,protecting the privacy information and ensuring the data security and information security,while making full use of data have become important issues.The application of real-world data should be based on clear ownership with informed consent,and follow the relevant requirements of laws,regulations and technical standards.The investigators should improve data security classification and hierarchical security protection strategy to build a complete information security protection system,including physical security,data security and application security,and promote data utilization.
作者
李雪迎
王熙诚
沙若琪
尚美霞
姚晨
LI Xue-ying;WANG Xi-cheng;SHA Ruo-qi;SHANG Mei-xia;YAO Chen(Department of Biostatistics,Peking University First Hospital;School of Management,University College London;China Construction Bank Fintech;Peking University Clinical Research Institute;Hainan Institute of Real World Data)
出处
《中国食品药品监管》
2022年第10期46-53,共8页
China Food & Drug Administration Magazine
基金
国家科技重大专项(2018ZX09206003-005)
国家重点研发计划(2020YFC2006400)。
关键词
真实世界数据
数据安全
信息安全
隐私保护
权益
real-world data
data security
information security
privacy protection
rights and interests
