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三级医院临床研究去标识化系统开发经验

Experience of de-identification system development for clinical research in tertiary hospital.

作者信息

Shin Soo-Yong, Lyu Yongman, Shin Yongdon, Choi Hyo Joung, Park Jihyun, Kim Woo-Sung, Lee Jae Ho

机构信息

Department of Biomedical Informatics, Asan Medical Center, Seoul, Korea.

出版信息

Stud Health Technol Inform. 2013;192:1044.

Abstract

To protect patients' privacy and to improve the convenience of research, Asan Medical Center (AMC) has been developing a de-identification system for biomedical research, which mainly consists of three components: de-identification tool, search tool, and chart review tool. The de-identification tool can substitute a randomly assigned research ID for a hospital patient ID, remove the identifiers in the structured format, and mask them in the unstructured format, i.e., texts. The search tool can find the number of patients which satisfies given criteria. The chart review tool can provide de-identified patient's clinical data for review. We found that clinical data warehouse was essential for successful implementation of de-identification system, and this system should be tightly linked to an electronic institutional review board system for easy operation of honest brokers.

摘要

为保护患者隐私并提高研究便利性,峨山医学中心(AMC)一直在开发一种用于生物医学研究的去识别系统,该系统主要由三个部分组成:去识别工具、搜索工具和图表审查工具。去识别工具可以用随机分配的研究ID替代医院患者ID,去除结构化格式中的标识符,并在非结构化格式(即文本)中对其进行屏蔽。搜索工具可以查找符合给定标准的患者数量。图表审查工具可以提供去识别后的患者临床数据以供审查。我们发现临床数据仓库对于去识别系统的成功实施至关重要,并且该系统应与电子机构审查委员会系统紧密相连,以便诚实中介机构轻松操作。

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