结构化电子知情同意书平台建设与应用  

Construction and application of structured electronic informed consent platform

作　　者：冯艳 郑林 李强[1] FENG Yan;ZHENG Lin;LI Qiang(Department of Information Management,Beijing Tsinghua Changgung Hospital Affiliated to Tsinghua University,School of 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信息管理部,清华大学临床医学院,北京102218

出　　处：《中国数字医学》2023年第8期62-66,共5页China Digital Medicine

摘　　要：目的:推进知情同意书无纸化建设,实现知情同意书管理模式从传统的纸质管理模式向无纸化、智能化管理模式转变。方法:引入第三方认证机构的电子认证服务,实现患者电子签名。利用结构化数据标识和存储方式,对签名人信息及签署内容等数据进行抽取和再利用,使之成为病历内涵质控和终末质控的依据。结果:北京某三级甲等综合医院2022年第四季度住院患者知情同意书,患者电子签名率为92.8%(25019/26961),智能质控率为100.0%(25019/25019),智能筛查出缺陷问题4303项。结论:该平台的应用,将9类知情同意书纳入病历质控管理,实现知情同意书缺陷筛查覆盖面达100.0%,极大提升了知情同意书质控效率和质量。Objective To promote the construction of paperless informed consent and to realize the transformation of the management mode of informed consent from the traditional paper-based management mode to the paperless and intelligent management mode.Methods The Electronic Authentication Service of the third-party authentication organization was introduced to realize the electronic signatures of patients.Structured data identification and storage methods were used,and data such as signer information and signed content were extracted and reused,which becomes the basis of internal quality control and final quality control of medical records.Results In the fourth quarter of 2022 in a Grade-A Tertiary hospital,the e-signature rate of patients'informed consent reached 92.8%(25,019/26,961),and the intelligent quality control rate was 100.0%(25,019/25,019),and the intelligent screen found 4,303 defects.Conclusion The application of this platform has incorporated 9 kinds of informed consent forms into the quality control management of medical records,achieving 100.0%coverage of defects screening in informed consent and greatly improving the efficiency of informed consent quality control.

关 键 词：知情同意书 电子签名 内涵质控 终末质控 

分 类 号：R197.3[医药卫生—卫生事业管理] R319[医药卫生—公共卫生与预防医学]