走向欧洲健康数据空间:IMPACT-Data是基于电子健康记录的精准医学研究的安全基础设施
Silvia Rodríguez-Mejías1, Sara Degli-Esposti2, Sara González-García1
1Computational Health Informatics Group, Institute of Biomedicine of Seville, IBiS/Virgen del Rocio University Hospital/CSIC/University of Seville, Avenue Manuel Siurot S/N, Seville, 41013, Spain.
Journal of biomedical informatics
|June 16, 2024
概括
欧洲健康数据空间 (EHDS) 要求对电子健康数据交换采取具体的安全措施. 在IMPaCT-Data项目中,确定了节点的关键安全措施,以确保GDPR的合规性和对二次数据使用的公共利益.
科学领域:
- 医疗信息学 医疗信息学
- 数据安全 数据安全
- 欧洲卫生政策 欧洲卫生政策
背景情况:
- 欧洲卫生数据空间 (EHDS) 条例的第50条规定了电子健康数据访问的安全处理环境.
- 确保技术,组织,安全和互操作性要求对于健康数据交换至关重要.
研究的目的:
- 为健康数据空间中的节点确定特定的安全措施.
- 为了利用IMPaCT-Data项目的发现,在精准医学研究中对电子健康记录 (EHR) 的二次使用.
- 确保遵守"一般数据保护条例" (GDPR).
主要方法:
- 分析了来自西班牙国家安全计划 (ENS) 的72项安全措施中的24项.
- 在IMPaCT-Data项目中,联邦数据基础设施成员采取的措施的评估.
主要成果:
- 澄清参与EHDS的实体的角色和责任.
- 识别和解释数据空间守门员,启用者和前者最相关的安全措施.
- 展示技术系统概念如何与EHDS环境中的法律术语保持一致.
结论:
- 欧洲卫生健康系统的可行性取决于公共卫生当局保持其信托照顾义务.
- 个人健康数据的二次使用必须符合公共利益或保护数据主体的重要利益.
- 为了实现EHDS的目标,所有参与节点都必须采取适当的组织和技术安全措施.
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