Matthew C. Diamond

AI, Health, and Health Care Today and Tomorrow

Derek C. Angus, Rohan Khera, Tracy A. Lieu, Vincent Liu et autres

Importance: Artificial intelligence (AI) is changing health and health care on an unprecedented scale. Though the potential benefits are massive, so are the risks. The JAMA Summit on AI discussed how health and health care AI should be developed, evaluated, regulated, disseminated, …

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Artificial intelligence and real-world data for drug and food safety – A regulatory science perspective

Shraddha Thakkar, William Slikker, Frank Yiannas, Primal Silva et autres

In 2013, the Global Coalition for Regulatory Science Research (GCRSR) was established with members from over ten countries (www.gcrsr.net). One of the main objectives of GCRSR is to facilitate communication among global regulators on the rise of new technologies with regulatory applications …

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Landscape Analysis of the Application of Artificial Intelligence and Machine Learning in Regulatory Submissions for Drug Development From 2016 to 2021

Qi Liu, Ruihao Huang, Julie Hsieh, Hao Zhu et autres

An analysis of regulatory submissions of drug and biological products to the US Food and Drug Administration from 2016 to 2021 demonstrated an increasing number of submissions that included artificial intelligence/machine learning (AI/ML).AI/ML was used to perform a variety of tasks, such …

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A quality assessment tool for artificial intelligence-centered diagnostic test accuracy studies: QUADAS-AI

Viknesh Sounderajah, Hutan Ashrafian, Sherri Rose, Nigam H. Shah et autres

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