FDA’s Final AI SaMD Guidance: Where Medical Ethics, Policy, and Patient Experience Converge

FDA’s Final AI SaMD Guidance: Where Medical Ethics, Policy, and Patient Experience Converge

A single log entry could spell the difference between trust and trepidation in AI-driven care. As STAT’s “AI Prognosis” newsletter recently canvassed over ninety experts predicting mandatory audit trails and real-world performance monitoring by year’s end, health systems and patients prepare for the Food and Drug Administration to codify these requirements in its final guidance for artificial intelligence and machine-learning software as a medic…