医学实验室数据应用:伦理学现况与未来探索  

Application of medical laboratory big data:current ethical status and future exploration

作　　者：赵秀英[1] Zhao Xiuying(Department of Clinical Laboratory,Beijing Tsinghua Changgung Hospital,School of Clinical Medicine,Tsinghua University,Beijing 102218,China)

机构地区：[1]清华大学附属北京清华长庚医院检验医学科、清华大学临床医学院,北京102218

出　　处：《中华检验医学杂志》2025年第2期179-185,共7页Chinese Journal of Laboratory Medicine

基　　金：北京市卫生系统高层次公共卫生技术人才建设项目(学科带头人-03-03)。

摘　　要：医学实验室数据与临床诊疗背景交互,在现代临床医学的决策、支持系统中发挥巨大作用。当信息技术与现代化数智分析技术结合,医学实验室的海量数据升华为医疗"大数据"的一部分,在积累与流动过程中,其所发挥的直接作用与二次应用价值都备受瞩目。然而,医学实验室数据涉及大量个人敏感信息及隐私,研究者从研究设计、数据收集、分析处理及成果应用等方面需提供隐私保护方案,以避免数据泄密和违背伦理学的应用。各级伦理委员会在医学实验室数据合规应用中可以发挥关键作用,但也需要探索适合大数据研究和应用的伦理学评审方案。大数据的研究及应用既是时代需要,也关乎国家战略和全民大健康的需要,国家立法与行业规范的实施,以及探索新的知情同意和数据应用的实施方案有助于推进个人隐私保护和大数据的科学应用。Medical laboratory data interacts with clinical practice and therapeutic contexts,playing a significant role in up-to-date clinical decision-making and support systems.With the integration of information technology and modern analytical techniques such as artificial intelligence,the vast amounts of data produced by medical laboratory are sublimated into medical"big data",attracting significant attention for its direct impact and secondary application value in the process of accumulation and data streaming.However,laboratory data involves a large amount of sensitive personal information.Researchers must provide robust privacy protection methods throughout research design,data collection,analysis,processing,and application of consolidated results to prevent data leakage,misuse,and unethical applications.Ethics committees or institution review board at all levels should play a pivotal role in the compliant application of medical laboratory data,while developing ethical review protocols suitable for big data research and applications.The research and applications of big data are also related to the needs of national strategies and public health.The implementation of national legislation,expert consensus and industry standards,as well as innovative approaches to informed consent and data application strategies,would promote the protection of individual privacy and the scientific application of big data.

关 键 词：实验室 数据 伦理学 隐私权 数据安全 

分 类 号：TP311.13[自动化与计算机技术—计算机软件与理论] R-052[自动化与计算机技术—计算机科学与技术]