AI tools shaping patient care are operating outside regulatory oversight. Researchers say it's time to change that

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Every day, across thousands of American hospitals, artificial intelligence quietly shapes decisions that determine patient outcomes. An 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 U.S. 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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