Federal regulators misunderstand the value of transparency rules for clinical AI. Together, these requirements were the closest that the United States had come to a model-card mandate—a requirement that all AI developers publish a standardized “nutrition label” describing how a model was trained, tested, and intended to be used, for clinical AI. The second trend is that much of the clinical AI now entering hospital workflows is not regulated by FDA at all. Non-device clinical decision support tools, internally developed models, and generative AI assistants frequently fall outside the agency’s jurisdiction. It also acknowledges what the past three years of deployment have demonstrated: Clinical AI may not fail at the moment of regulatory clearance, but it may fail quietly, over months, as populations shift and models drift.