医院医学临床研究中健康医疗数据出境现状研究  

Study on the current situation of health medical data export in medical clinical research of hospitals

作　　者：李静 卓柳俊 闫文光 崔倩 LI Jing;ZHUO Liujun;YAN Wenguang;CUI Qian(Beijing Municipal Health Big Data and Policy Research Center,Beijing 101160,China;Beijing Shu'anxin Information Technology Research Institute;RenMin University of China Law School;University of Chinese Academy of Social Sciences)

机构地区：[1]北京市卫生健康大数据与政策研究中心,北京101160 [2]北京数安信信息科技研究院 [3]中国人民大学法学院 [4]中国社会科学院大学

出　　处：《中国数字医学》2024年第8期108-112,共5页China Digital Medicine

基　　金：2023年度北京市卫生健康大数据与政策研究中心自主研究项目。

摘　　要：在全球医疗创新和数字化高度发展背景下,医学临床研究中健康医疗数据跨境需求日益增多。健康医疗数据的跨境流动对医学研究的全球协作大有裨益,主要体现在降低行医诊疗中的不确定性、推进观察性医学研究以及降低新药物审批成本等方面。目前北京地区尚无针对医院医学临床研究涉及的健康医疗数据出境需求、现状的专门研究。文章调研了北京地区部分三级医院医学临床研究中健康医疗数据的出境需求、信息化支撑现状及存在问题,并对卫生健康领域数据跨境工作相关政策及管理提出建议。In the context of global medical innovation and highly developed digitalization,the cross-border demand for health and medical data in medical clinical research is increasing.The cross-border flow of health and medical data is of great benefit to global collaboration in medical research,mainly in terms of reducing uncertainty in medical practice,promoting observational medical research,and reducing the cost of new drug approval.At present,there is no specialized research on the outbound demand and current situation of health and medical data related to hospital clinical research in Beijing.This paper investigates the outbound demand,current situation and existing problems of health care data support in clinical research of some tertiary hospitals in Beijing,and provides policy and management suggestions for cross-border data management in health care industry.

关 键 词：医学临床研究 数据出境 安全合规 

分 类 号：R319[医药卫生—基础医学] R197.3