Lessons for local oversight of AI in medicine from the regulation of clinical laboratory testing

Abstract

Current regulatory frameworks for artificial intelligence-based clinical decision support (AICDS) are insufficient to ensure safety, effectiveness, and equity at the bedside. The oversight of clinical laboratory testing, which requires federal- and hospital-level involvement, offers many instructive lessons for how to balance safety and innovation and warnings regarding the fragility of this balance. We propose an AICDS oversight framework, modeled after clinical laboratory regulation, that is deliberative, inclusive, and collaborative.