将CEN ISO/TS 82304-2纳入加泰罗尼亚卫生应用评估框架:比较案例研究
Berta Llebot Casajuana1, Petra Hoogendoorn2, Maria Villalobos-Quesada2
1Fundació TIC Salut Social, Ministry of Health, Government of Catalonia, Aragó 330-332, Barcelona, 08009, Spain, 34 667162080.
JMIR mHealth and uHealth
|June 4, 2025
概括
加泰罗尼亚的TIC Salut社会基金会 (FTSS) 框架将整合CEN ISO/TS 82304-2 (82304-2) 健康应用评估标准. 这种协调旨在提高整个欧盟的健康应用程序评估的质量和可靠性.
科学领域:
- 数字健康数字健康
- 医疗信息学 医疗信息学
- 卫生技术评估 卫生技术评估
背景情况:
- 越来越多的人使用健康应用程序,需要客观的质量评估,而不仅仅是基本的监管标志.
- 缺乏标准化的质量信息会给用户带来风险.
- 健康应用程序评估框架正在出现,以应对这些挑战.
研究的目的:
- 进行FTSS评估框架和CEN ISO/TS 82304-2 (82304-2) 标准之间的比较分析.
- 探索将82304-2集成到加泰罗尼亚的健康应用评估中的可行性和方法.
- 为其他考虑类似框架整合的卫生当局提供一个模型.
主要方法:
- 一种混合方法的方法,结合了定性案例研究和定量分析.
- 质量评估两个框架的理由,特征,治理,工作流程和质量方面.
- 定量分析涉及将要求转化为概念/子概念和评分系统以识别匹配.
主要成果:
- CEN ISO/TS 82304-2 (82304-2) 标准根据证据和使用情况评估应用程序,与FTSS框架的基于使用的方法不同.
- 发现了显著的重叠,其中48%的子概念是两个框架共同的.
- FTSS决定整合所有74 82304-2要求,采用和调整它们,将5个FTSS特定要求纳入Label2Enable 82304-2手册.
结论:
- 这项比较分析促使FTSS决定全面整合82304-2质量要求,并采用Label2Enable 82304-2手册.
- 预计这种整合将促进加泰罗尼亚和潜在的其他地区协调和强大的健康应用程序评估.
- FTSS建议其他卫生当局进行类似的评估,以考虑采用或调整82304-2.
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