评估数字疗法 (DTX) 的潜在风险:DTX风险评估帆布
Kerstin Denecke1, Richard May2, Elia Gabarron3,4
1Department Engineering and Computer Science, Institute Patient-Centered Digital Health, Bern University of Applied Sciences, 3012 Bern, Switzerland.
Journal of personalized medicine
|October 27, 2023
概括
数字疗法 (DTX) 需要风险监测. DTX风险评估帆布帮助研究人员和开发人员识别与DTX相关的潜在负面影响和患者安全风险.
科学领域:
- 数字健康数字健康
- 医疗信息学 医疗信息学
- 患者安全 患者安全
背景情况:
- 数字疗法 (DTX) 的处方越来越多,需要监测其风险和不良事件的方法.
- 目前对DTX潜在的负面影响和必要的监测方面的理解是有限的.
- 随着数字卫生干预措施的日益使用,患者安全问题也出现了.
研究的目的:
- 开发一个新的工具,DTX风险评估帆布,用于评估DTX的负面影响.
- 为研究人员,开发人员和从业人员促进参与过程,以评估DTX风险.
- 提供一个结构化的方法来识别和减轻数字治疗的潜在危害.
主要方法:
- 调整了商业模式帆布框架,以确定DTX.的相关风险评估方面.
- 通过审查ISO/TS 82304-2,科学文献和现有的DTX不良影响来定义方面.
- 通过六位健康信息学家和心理健康专家的反来验证和完善画布.
主要成果:
- DTX风险评估帆布包括15个主题块,分为三个组:DTX,用户和影响.
- 每个块包括指导性问题,以促进对潜在的DTX风险和负面后果的反思.
- 该帆布为解释DTX风险提供了一个全面的框架.
结论:
- DTX风险评估帆布是思考和识别DTX风险的一个有价值的工具.
- 在DTX设计和开发过程中早期应用可以帮助实施缓解策略.
- 该工具支持主动措施,以确保患者安全,并监测数字治疗中的不良事件.
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