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经FDA批准的神经放射学机器学习算法:对目前批准的证据进行系统审查

Alexander G Yearley¹, Caroline M W Goedmakers², Armon Panahi³

¹Harvard Medical School, 25 Shattuck St, Boston, MA 02115, USA; Computational Neuroscience Outcomes Center (CNOC), Department of Neurosurgery, Brigham and Women's Hospital, Harvard Medical School, 75 Francis St, Boston, MA 02115, USA.

Artificial intelligence in medicine

|September 6, 2023

概括

食品和药物管理局 (FDA) 对中枢神经系统 (CNS) 人工智能 (AI) 算法的批准可能无法保证临床使用,因为神经算法的证据往往有限. 需要改善监管框架,以弥合人工智能批准和现实应用之间的差距.

科学领域:

医疗人工智能医疗人工智能
神经科学是一个神经科学.
监管科学监管科学

背景情况:

机器学习 (ML) 和人工智能 (AI) 越来越多地用于医学,需要对患者安全进行监管监督.
美国食品和药物管理局 (FDA) 监管人工智能算法作为医疗设备,包括用于中枢神经系统 (CNS) 应用的神经算法.
人工智能医疗器械的FDA审批流程是否足够存在担忧.

结论:

在FDA批准ML算法和其实际临床实施之间存在很大的差距.
建议包括要求对预期性能提供有力的证据,最小样本大小,标准化指标和预审批临床实用性评估.
这项研究为未来关于全球医疗保健中人工智能最佳监管框架的研究提供了基础.

关键词:

在这里,我们可以看到AIAIAI.美国食品和药物管理局 (FDA) 批准机器学习机器学习神经算法的神经算法神经辐射学神经辐射学

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