符合OHDSI标准:一组文档模板,用于实现和运行软件堆,以便在现实世界中生成证据
Felix N Wirth1, Hammam Abu Attieh1, Fabian Prasser1
1Berlin Institute of Health at Charité - Universitätsmedizin Berlin, Center of Health Data Science, Berlin, Germany.
Frontiers in medicine
|May 31, 2024
概括
本研究介绍了OHDSI-Compliance,这是一套文档模板,旨在简化观察健康数据科学和信息学 (OHDSI) 设施的监管合规性. 这些资源有助于为现实世界证据网络提供数据保护和信息安全文件.
科学领域:
- 医疗信息学 医疗信息学
- 数据科学数据科学数据科学
- 监管合规性 监管合规性
背景情况:
- 观察健康数据科学和信息学 (OHDSI) 平台对于现实世界的证据网络至关重要.
- 集装箱技术简化了OHDSI的部署,但监管合规仍然是一个重大挑战.
- 简化数据保护和信息安全的文档对于OHDSI安装设置和运行至关重要.
研究的目的:
- 为OHDSI装置开发一套全面的文档模板.
- 简化监管合规流程,特别是在数据保护和信息安全方面.
- 提供公开可用的资源,以促进OHDSI平台的建立.
主要方法:
- 分析法律要求,重点关注"一般数据保护条例" (GDPR).
- 检查典型的OHDSI软件架构以将组件映射到文档需求.
- 基于OHDSI原型安装 (Broadsea包) 和德国指导方针,创建和通用化文档模板.
主要成果:
- 提出了四个关键文档模板:处理活动记录,信息安全概念,授权概念和操作概念.
- 这些文件旨在涵盖维护OHDSI堆的技术和监管方面.
- 开发的文档模板在许可许可许可证下公开提供.
结论:
- OHDSI-Compliance为简化OHDSI部署的监管文件提供了一个全新的,全面的起点.
- 提供的模板解决了OHDSI合规性公共资源的缺口.
- 用户必须以当地具体情况补充这些模板,并根据不同的国际法律要求进行调整.
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