数字干预及其意想不到的结果 - 现在是数字警的时候了吗?
Guillermo Lopez-Campos1, Elia Gabarron2,3, Fernando Martin-Sanchez4
1Wellcome-Wolfson Institute for Experimental Medicine, Queen's University Belfast, Belfast, UK.
Studies in health technology and informatics
|January 25, 2024
概括
数字健康干预措施需要对患者安全进行市场后监测. 这篇论文倡导一个新的领域,数字监控,以系统地监测临床试验中的不良事件.
科学领域:
- 数字健康干预措施 数字健康干预措施
- 软件作为医疗器械 (SaMD)
- 医疗保健技术法规 医疗保健技术法规
背景情况:
- 医疗保健中的数字干预越来越多地被开发为软件作为医疗设备 (SaMD).
- 现有的医疗器械法规要求对市场后监测进行不良事件评估.
- 确保正确的使用和患者安全需要对数字健康干预措施进行适当的标签.
研究的目的:
- 提高研究界对数字健康干预挑战的认识.
- 为了突出当前文献中数字健康干预措施的意想不到后果的忽视.
- 建议采取主动措施,以确保数字卫生技术的患者安全.
主要方法:
- 数字健康干预和不良事件报告的文献综述和概念分析.
- 识别当前研究中关于意外后果的空白.
- 制定未来研究和监测的框架.
主要成果:
- 数字健康干预措施的意想不到的后果往往被忽视或没有记录.
- 需要对不良事件进行系统的评估和监测至关重要.
- 目前的做法并不能充分解决数字健康干预所带来的独特挑战.
结论:
- 为了应对这些挑战,提出了一个新的研究领域 - - 数字监控.
- 对不良事件的系统评估和监测应纳入临床试验.
- 报告不良事件和元分析对于推动数字健康安全至关重要.
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