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同意管理2.0:在医学研究和护理中赋予患者意志权
Sebastian Stäubert1, Angela Merzweiler2, Jörg Römhild3
1Institute of Medical Informatics, Statistics and Epidemiology, Leipzig University, Germany.
Studies in health technology and informatics
|September 3, 2025
概括
修订后的HL7 FHIR同意管理2.0标准现在支持选择/选择退出同意,撤回和反对. 这增强了医疗研究中的合法健康数据处理和患者自主权.
科学领域:
- 医疗信息学
- 数字健康
- 符合法规要求
背景情况:
- 管理患者的同意和异议对于医疗研究中的合法健康数据处理至关重要.
- 现有的标准主要集中在选择同意,需要更广泛的选择退出,撤回和反对的解决方案.
- 不断变化的法律环境需要在数字健康领域进行全面的同意管理.
研究的目的:
- 系统地修订HL7FHIR同意管理标准,以解决处理不同同意场景的局限性.
- 加强管理患者同意的标准,包括选择参与,选择退出,撤回和反对.
- 提高健康数据的法律稳定性和互操作性.
主要方法:
- 根据三年的实践经验,对2021年的标准进行了批判性评估.
- 评估健康数据同意管理的新兴监管要求.
- 通过HL7投票程序进行了反和修订.
主要成果:
- 增加了对不同类型的文件的支持:同意,撤回,拒绝和反对.
- 制定精细的技术规范,将问卷答复自动转换为机器可读的同意资源.
- 增加了一个新的"结果类型"类别,用于特定用例的同意信息汇总,简化处理并减少模两可.
- 在实施指南中定义了统一的FHIR搜索参数,并整合了全面的示例.
结论:
- 扩展的HL7FHIR同意管理2.0标准显著提高了互操作性和法律稳定性.
- 促进患者在数字健康数据的再利用方面获得更好的自主权和信任.
- 通过早期实际实施和2025年4月成功的HL7投票证明了实用性.
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