MIT researchers call for FDA oversight of unregulated AI tools used in US hospitals
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MIT researchers published a viewpoint in The Lancet Digital Health highlighting that many AI tools used in clinical decision-making across US hospitals operate without FDA oversight. These algorithms, embedded in electronic health records and used by nearly two-thirds of hospitals for tasks like sepsis detection and cancer screening, have never been reviewed by regulators. The researchers argue for updated regulatory frameworks to ensure patient safety and accountability as AI becomes increasingly central to healthcare delivery.
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· 3 pulledAn algorithm flags a patient as high risk for sepsis; a risk score informs whether a woman receives additional cancer screening; a deterioration model triggers an alert that sends a care team to a bedside.
These tools are embedded in the workflows of nearly two-thirds of US hospitals, integrated into the electronic health record systems clinicians rely on daily.
But many have never been reviewed by the FDA.
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