The ability of algorithm to provide accurate assessments will drift if left untended, often in unpredictable, and sometimes dangerous ways.
Robert M. Califf
U.S. Food and Drug Administration commissioner, 2022–2025.
In 2024 prepared remarks, FDA Commissioner Robert M. Califf said untended health algorithms can drift in unpredictable and sometimes dangerous ways.
Commissioner of the U.S. Food and Drug AdministrationMarch 5, 2024U.S. Food and Drug Administration
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First, we need to monitor the algorithm and test its operating characteristics over time. The ability of algorithm to provide accurate assessments will drift if left untended, often in unpredictable, and sometimes dangerous ways. With traditional medical products in general, this responsibility primarily rests with the manufacturer of the product with the FDA overseeing the process.
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