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Not all AI health tools with regulatory authorization are clinically validated
Nature Medicine ( IF 58.7 ) Pub Date : 2024-08-26 , DOI: 10.1038/s41591-024-03203-3 Sammy Chouffani El Fassi 1, 2 , Adonis Abdullah 1 , Ying Fang 1, 3 , Sarabesh Natarajan 4, 5 , Awab Bin Masroor 6 , Naya Kayali 1, 7 , Simran Prakash 8 , Gail E Henderson 9
Nature Medicine ( IF 58.7 ) Pub Date : 2024-08-26 , DOI: 10.1038/s41591-024-03203-3 Sammy Chouffani El Fassi 1, 2 , Adonis Abdullah 1 , Ying Fang 1, 3 , Sarabesh Natarajan 4, 5 , Awab Bin Masroor 6 , Naya Kayali 1, 7 , Simran Prakash 8 , Gail E Henderson 9
Affiliation
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Devices that lack adequate clinical validation pose risks for patient care. A new validation standard is proposed to evaluate FDA authorization as an indication of clinical effectiveness in medical AI.
中文翻译：
并非所有获得监管授权的 AI 健康工具都经过临床验证
缺乏充分临床验证的设备会给患者护理带来风险。提出了一个新的验证标准来评估 FDA 授权作为医疗 AI 临床有效性的指标。
更新日期：2024-08-26
中文翻译：
并非所有获得监管授权的 AI 健康工具都经过临床验证
缺乏充分临床验证的设备会给患者护理带来风险。提出了一个新的验证标准来评估 FDA 授权作为医疗 AI 临床有效性的指标。
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