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对CEN ISO/TS 82304-2健康应用程序质量评估的测试和代改进:试点间隔器可靠性研究

Anna-Lena Frey¹, Diana Matei¹, Ben Phillips¹

¹Organisation for the Review of Care and Health Apps (ORCHA), Daresbury, United Kingdom.

JMIR formative research

|March 10, 2025

概括

这项研究测试了国际组织的CEN ISO/TS 82304-2健康应用程序评估框架. 结果显示了有希望的interrater可靠性和清晰度,支持其发展为一致的全球健康应用程序评估.

科学领域:

数字健康数字健康
医疗信息学医疗信息学
软件工程软件工程软件工程

背景情况:

越来越多的人使用健康应用程序,需要强大的质量评估框架.
现有的框架面临着可扩展性问题,缺乏国际标准化.
CEN ISO/TS 82304-2倡议的目标是实现统一的全球健康应用程序评估.

研究的目的:

完善和验证CEN ISO/TS 82304-2评估手册和开发人员指南草案.
测试框架在各种国际组织中的适用性.

主要方法:

参与了5个国际评估组织,对24个健康应用程序进行了3轮评估.
评估了组织之间的互评测可靠性,并收集了开发者/评估者的时间和清晰度反.
根据收集的数据,代地改进了手册和指南.

主要成果:

在整个评估轮中,评价者之间的可靠性得到了改善,在第3轮评估问题上达成80%的一致意见.
开发人员的平均准备时间为8小时59分钟;评估人员的平均评估时间为8小时46分钟.
开发人员和评估人员都认为指导方针和手册草案很明确.

结论:

这项研究是首次在国际上评估健康应用程序评估的跨组织一致性.
有希望的早期结果对层间的可靠性和清晰性支持CEN ISO/TS 82304-2的持续发展.
该框架有可能减少重复工作,促进市场准入,并增强用户对健康应用程序的信任.

关键词:

评估框架的评估框架.数字健康数字健康健康应用程序健康应用程序评价者之间的可靠性.移动健康的移动健康质量评价质量评估质量评价

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