数据保护,互操作性和治理评估工具:概念验证调查结果
Concetta Tania Di Iorio1, Elettra Ronchi2, Ivan Pristas3
1Serectrix Srls, Pescara, Italy.
Frontiers in digital health
|November 12, 2025
概括
一个新的工具,数据保护,互操作性和治理评估 (DIGA),帮助健康数据控制者和持有者导航复杂的法规. 它评估了欧洲健康数据空间 (EHDS) 的合规性和准备性,显示了数据治理的有希望的结果.
科学领域:
- 医疗信息学 医疗信息学
- 数据治理数据治理
- 监管合规性 监管合规性
背景情况:
- 协作健康信息欧洲框架 (CHIEF) 旨在标准化护理质量监测,并为欧洲健康数据空间 (EHDS) 做好准备.
- 对健康数据治理的复杂法律和道德标准进行导航对数据控制者和数据持有者来说是一个重大挑战.
- 需要实际的解决方案来确保合规性,并促进健康数据的二次使用.
研究的目的:
- 定义,开发和应用一个实用的工具来评估数据保护,互操作性和健康信息系统的治理.
- 帮助数据控制者和数据持有者理解和适应健康数据的不断变化的法律条件.
- 评估该工具在衡量机构遵守和为EHDS做好准备方面的有效性.
主要方法:
- 设计和应用了一个模块化问卷,数据保护,互操作性和治理评估 (DIGA).
- 该DIGA工具使用定量和定性分析来衡量遵守欧盟数据保护法律,治理标准和EHDS法规.
- 进行了测试调查,以评估该工具的适用性和可用性.
主要成果:
- 该DIGA工具有效地捕捉了现实世界的实践,并确定了数据治理的优势和缺陷.
- 调查参与者表现出了坚实的数据保护基础,以及对二次健康数据使用的中等至高能力.
- 用户反证实了该工具的相关性和可用性,表明了对EHDS法规的准备.
结论:
- 该DIGA工具是疾病登记册和健康信息系统的战略资源,支持自我评估和监管准备.
- 该工具为实施国家和欧盟一级健康数据政策提供了洞察力.
- 为了大规模实施和加强其在EHDS准备中的作用,需要进一步验证和完善.
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