将可信赖的第三方软件集成到数据保护的EDC系统中 - 符合身份管理,同意管理和医学研究研究中的假名化
Johannes Wagner1, Hauke Schneiderheinze1, Marcus Wurlitzer2
1Trusted Third Party of the University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Studies in health technology and informatics
|September 5, 2024
概括
使用新型集成系统安全管理敏感医疗数据. 该解决方案将电子数据捕获与可信赖的第三方结合起来,用于伪名化,增强参与者的隐私和数据完整性.
科学领域:
- 医疗信息学 医疗信息学
- 数据安全 数据安全
- 临床研究 临床研究
背景情况:
- 医学研究需要在电子数据捕获期间安全管理敏感的参与者数据.
- 保护参与者身份需要强大的伪名化和识别信息的管理.
研究的目的:
- 为安全的电子数据捕获和参与者身份管理开发综合解决方案.
- 将REDCap与可信的第三方软件相结合,实现统一的工作流.
主要方法:
- 开发了一个基于网络的解决方案,将REDCap (电子数据捕获) 与格莱夫斯瓦尔德大学医学院可信的第三方工具集成在一起.
- 创建了一个单一的用户界面,用于临床数据输入和身份,假名和知情同意的管理.
主要成果:
- 实现了参与者注册,数据输入和伪名生成的无工作流.
- 在独立管理的系统中保持医疗和识别数据的严格分离.
- 实现了高效的数据输入,并最大限度地减少了手动假名传输中的错误.
结论:
- 综合解决方案通过限制识别信息的可见性来增强数据保护.
- 为研究人员提供了一种节省时间的工作流程.
- 显著提高数据安全性,减少数据泄露的可能性.
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