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

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.