健康应用程序的质量标准和原则 - - 综合性审查
Jona Schnepel1, Annabelle Mielitz1, Urs-Vito Albrecht1
1Department of Digital Medicine, Medical School OWL, Bielefeld University, Bielefeld, Germany.
Studies in health technology and informatics
|April 9, 2025
概括
标准化质量标准对于数字健康应用至关重要. 本次审查确定了关键的质量领域,强调用户体验和健康信息质量,以进行可靠的健康应用程序评估.
科学领域:
- 数字健康数字健康
- 医疗信息学 医疗信息学
- 软件质量保证 软件质量保证
背景情况:
- 数字健康应用程序提供治疗潜力,但由于质量变化而带来风险.
- 需要标准化的质量标准来确保健康应用程序的安全性和有效性.
- 现有的健康应用程序评估框架缺乏统一性.
研究的目的:
- 审查评估健康应用程序质量的现有方法.
- 确定用于健康应用程序评估的关键质量领域和标准.
- 突出不同框架的评估方法之间的差异.
主要方法:
- 对18项关于健康应用程序质量评估的研究进行系统审查.
- 对一般和专业评估框架的分析,包括移动应用评分得分 (MARS).
- 识别和分类关键的质量领域和经常引用的标准.
主要成果:
- 确定了六个关键的质量领域:技术特征,用户体验,一般特征,健康信息质量,道德/法律合规性和数据安全性.
- "用户体验"和"健康信息质量"是跨框架最常引用的标准.
- 尽管标准重叠,但评估方法存在显著差异.
结论:
- 建立数字健康应用程序的标准化质量标准至关重要.
- 利益相关者之间的合作是必要的,以确保一致和可靠的健康应用程序质量评估.
- 未来的努力应集中在协调评估方法,以提高健康应用程序的质量和安全性.
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