在大型大学医院开发可信赖的第三方:设计和实施研究
Eric Wündisch1, Peter Hufnagl2, Peter Brunecker3
1Core Unit THS, Berlin Institute of Health at Charité - Universitätsmedizin Berlin, Berlin, Germany.
JMIR medical informatics
|April 18, 2024
概括
本研究介绍了一个用户友好的可信第三方 (TTP) 系统,用于安全的医疗研究数据管理. 该TTP简化了假名化和同意流程,减少了运营工作,提高了研究项目的数据安全性.
科学领域:
- 医疗信息学 医疗信息学
- 数据安全 数据安全
- 卫生研究管理管理 卫生研究管理
背景情况:
- 伪名化对于医疗研究中安全管理患者和研究参与者的身份至关重要.
- 值得信赖的第三方 (TTP) 经常处理假名化,但它们的实施可能会增加工作流的复杂性.
- 管理复杂的假名化和数据共享流程需要适当的工具支持.
研究的目的:
- 解决大型大学医院缺乏关于TTP架构和工具的公开信息的问题.
- 描述为柏林Charité - Universitätsmedizin的TTP开发的软件架构和工具集.
- 为其他寻求建立高效和有效的TTP的机构提供榜样.
主要方法:
- 设计了一个模块化的TTP基础设施,维护要求低,使用MOSAIC工具进行基本功能.
- 开发了一个集成层与统一的REST API,以实现跨越患者注册,伪名生成和同意收集的复杂工作流.
- 实现了统一的图形用户界面 (GUI),并使用Keycloak进行统一的角色和权利管理.
主要成果:
- 自2019年12月以来,TTP已经支持了10多个研究项目,管理了3000多个身份,并产生了3万多个假名.
- 150多名个人定期使用该平台,提交的同意表超过1500份.
- 集成层和统一的GUI显著减少了TTP的操作工作量,使研究项目人员能够独立使用.
结论:
- 开发的TTP架构为支持医学研究项目提供了一个用户友好和合规的环境.
- 从这一TTP实施中获得的见解可以指导其他机构建立类似的结构.
- 高效和有效的TTP对于现代,安全的医学研究数据管理至关重要.
关键词:
欧洲人权理事会 欧洲人权理事会申请申请表 申请表 申请表建筑 建筑学 建筑学 建筑学同意同意同意同意同意同意同意同意数据管理数据管理数据隐私 隐私数据 隐私数据电子健康记录 电子健康记录卫生平台 卫生平台医疗记录 医疗记录识别数据可以识别数据.实施实施实施实施实施.基础设施基础设施基础设施的基础设施.这是一个模块化的模块化系统.伪名化 伪名化伪名化 伪名化可扩展性可扩展性.安全的安全的安全的安全的安全.软件 软件 软件 软件 软件值得信赖的第三方.用户界面用户界面更多相关视频
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