与FDA医疗器械报告相关的人工智能相关的安全问题
Jessica L Handley1, Seth A Krevat1,2, Allan Fong3
1MedStar Health National Center for Human Factors in Healthcare, Washington, DC, USA.
NPJ digital medicine
|December 3, 2024
概括
分析人工智能 (AI) 和机器学习 (ML) 医疗设备的患者安全报告揭示了一些挑战. 许多报告缺乏足够的细节,表明需要改善人工智能安全倡议的数据收集.
科学领域:
- 医疗器械安全 医疗器械安全
- 医疗保健中的人工智能
- 医疗信息学 医疗信息学
背景情况:
- 拜登2023年行政命令要求制定一个人工智能患者安全计划.
- 患者安全报告是识别AI/ML设备问题的潜在数据来源.
- 了解AI/ML在医疗器械不良事件中的贡献至关重要.
研究的目的:
- 评估使用现有的患者安全报告来识别AI/ML支持的医疗器械问题的可行性.
- 确定可以明确与AI/ML技术联系的报告的比例.
主要方法:
- 对429份患者安全报告的审查.
- 分析以识别与人工智能 (AI) 和机器学习 (ML) 医疗设备相关的报告.
- 报告的分类基于确定AI/ML贡献的能力.
主要成果:
- 在429份报告中,108份报告 (25.2%) 可能与AI/ML医疗设备有关.
- 148份报告 (34.5%) 没有足够的信息来确定任何AI/ML参与.
- 很大一部分报告无法确定与AI/ML技术的联系.
结论:
- 当前的患者安全报告系统可能无法充分捕捉AI/ML设备相关事件.
- 需要一个更全面的战略,以有效监测AI/ML支持的医疗器械的安全性.
- 增强的数据收集和报告标准对于AI患者安全计划是必要的.
更多相关视频
相关概念视频
Issues And Trends In Healthcare Delivery System
5.6K
The issues and trends in healthcare delivery are constantly changing. The COVID-19 pandemic is one recent issue that wreaked havoc on healthcare systems, causing a shortage of healthcare workers, high demand for medicines and supplies, and increased medical expenditure due to a lack of insurance. Other issues include rising healthcare costs and care fragmentation.
Cost Containment
Payment for healthcare services has historically promoted adoption of costly and often unnecessary or inefficient...
Cost Containment
Payment for healthcare services has historically promoted adoption of costly and often unnecessary or inefficient...
5.6K
Bacterial Signaling
31.5K
Bacterial signaling can occur within bacteria (intracellular) or between bacteria (intercellular). At times, a group of bacteria behaves like a community. To achieve this, they engage in quorum sensing, the perception of higher cell density that causes changes in gene expression. Quorum sensing involves both extracellular and intracellular signaling. The signaling cascade starts with a molecule called an autoinducer (AI). Individual bacteria produce AIs that move out of the bacterial cell...
31.5K
Types of Reports II: Incident or Occurrence Report
800
An Incident or Occurrence Report in a healthcare setting is a crucial document used to record any unexpected occurrence that may or may not have affected a patient, employee, or visitor. Such reports are critical to improving patient safety and include all details leading up to and including the event.
Purposes:
In the healthcare industry, reports play a crucial role in documenting incidents within an agency. The primary objective of these reports is to ensure patient safety, uphold the...
Purposes:
In the healthcare industry, reports play a crucial role in documenting incidents within an agency. The primary objective of these reports is to ensure patient safety, uphold the...
800
Types of Reports III: Telephone and Verbal Reports
720
Telephone and Verbal Reports in healthcare settings are two communication methods for conveying therapeutic instructions from healthcare providers to nurses or other healthcare staff.
Here's an overview of each type:
Telephone Orders
Here's an overview of each type:
Telephone Orders
720


