Evaluating Translational AI: A Two-Way Moving Target Problem.

ABSTRACT: Predictive artificial intelligence models are being deployed across health systems with dangerously inconsistent oversight, creating two critical gaps: a compliance gap, where clinical tools that likely qualify as software as a medical device are implemented without seeking U.S. Food and Drug Administration authorization; and a regulatory gap, where administrative and operational models are deployed without any external review despite their potential to influence care and widen disparities. Given that comprehensive U.S. Food and Drug Administration oversight of all such models is infeasible, the de facto onus of ensuring their safety and efficacy falls on the implementing institutions. However, this imperative for self-governance is undermined by a fundamental and previously unarticulated

SUBMITTER: Leuchter RK 

PROVIDER: S-EPMC12851562 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature