在使用数字健康评估方法的数字健康干预中改进安全声明
Stuart Harrison1, Carsten Maple1, Gregory Epiphaniou1
1Institute of Digital Healthcare, Warwick Manufacturing Group (WMG), University of Warwick, Coventry, UK.
Digital health
|July 29, 2024
概括
本研究介绍了数字健康干预 (DHI) 的标准化危险识别方法,改进了安全主张的证明和卫生系统挑战调整. 该方法增强了监管合规的证据表达.
科学领域:
- 医疗信息学 医疗信息学
- 系统安全工程 系统安全工程
- 数字健康数字健康
背景情况:
- 数字健康干预 (DHI) 在医疗保健系统中提出了独特的挑战.
- 建立强大的DHIs安全声明对于监管合规和有效实施至关重要.
- 现有的危险评估方法可能无法充分解决 DHI 的复杂性.
研究的目的:
- 建立数字健康干预 (DHI) 和卫生系统挑战 (HSC) 之间的关系.
- 通过使用共同的术语和本体学来标准化 DHI 的危险评估.
- 改进对 DHI 的安全性声明的证明和阐述.
主要方法:
- 一项定性危险识别 (HazID) 研究用于危险分类和分析.
- 该方法将DHI的预期使用简单性与多学科团队 (技术人员,医疗信息专家) 的投入相结合.
- 分析的重点是确定了危险和相关的失败,以提高安全要求的质量.
主要成果:
- 应用的方法促进了危险评估,并产生了保证案例.
- 安全理由得到了改进,增加了对安全声明的信心.
- 确定对危害的控制有助于应对已定义的卫生系统挑战.
结论:
- 拟议的危险评估和分析方法,利用DHI和HSC本体学,增强了安全主张的合理性.
- 这种方法改善了支持DHI安全的证据的表达.
- 标准化方法为健康战略和监管合规性提供了指导.
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