开发数字健康软件产品的基于证据的评估框架
Jennifer C Goldsack1, Colby Holliday1, Yashoda Sharma1
1The Digital Medicine Society, Inc. (DiMe), 90 Canal St 4th Fl, Boston, MA, 02114, USA.
Scientific reports
|November 1, 2025
概括
一个新的评估框架 (EF) 解决了分散的数字健康软件产品 (DHSP) 标准. 它综合了专家的意见和现有研究,以评估DHSP的质量和可信度.
科学领域:
- 医疗信息学 医疗信息学
- 软件工程 软件工程 软件工程
- 公共卫生政策 公共卫生政策
背景情况:
- 现有的数字健康软件产品 (DHSP) 评估框架是分散的.
- 当前的标准可能无法捕捉DHSP评估的所有利益相关者的优先事项.
- 需要一种统一的,基于证据的方法来评估DHSP的质量和可信度.
研究的目的:
- 为数字健康软件产品 (DHSP) 开发一个基于证据的,开放的评估框架 (EF).
- 确定用于评估DHSP质量和可信度的关键组件和领域.
- 协调最佳实践,促进采用高质量的DHSP.
主要方法:
- 混合方法研究涉及对173名主题专家 (中小企业) 进行需求评估,通过采访,焦点小组和调查.
- 1053篇论文的叙述性审查和160个相关框架,指南和标准的景观分析.
- 通过58次额外的中小企业访谈验证开发的EF.
主要成果:
- 开发的EF包括高级主题 (领域),评估标准和DHSP评估的基准.
- 评估整体DHSP质量的顶级领域包括证据,可用性,隐私和安全.
- 公平性在所有评估领域中都成为一个跨领域的主题.
结论:
- 新的EF巩固了DHSP在多个信任和价值领域的最佳实践.
- 该框架支持有效采用高质量,可靠的数字健康软件.
- EF为DHSP评估提供了一种协调,基于证据的方法.
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