Federal health technology regulators have launched a month-long sprint with outside experts to forge shared standards for evaluating clinical AI tools. The initiative, announced July 23, is led by the White House Office of Science and Technology Policy, the FDA, and the Office of the National Coordinator for Health IT.
The effort uses a two-phase structure with a written submission period followed by discussion sessions, according to an invitation reviewed by STAT News. Participants aim to produce a consensus framework for how clinical AI systems should be benchmarked and assessed before entering patient care.
The sprint arrives as Washington doubles down on AI in medicine. The Department of Health and Human Services recently committed to the White House’s $5 billion Genesis Mission, with the NIH targeting a 50% reduction in the time from scientific discovery to patient access. The FDA has also been advancing AI policy, including new draft guidance on lifecycle management for AI-enabled medical device software.
The initiative draws together stakeholders from device makers, health systems, academic research, and patient advocacy. The push for standard benchmarks reflects growing unease that current clinical AI evaluation methods vary widely across institutions, leaving health systems without consistent ways to compare safety and effectiveness across different AI products.
Standardized evaluation frameworks are seen as essential to building trust in clinical AI as the technology moves from pilot programs into routine patient care. The sprint aims to produce deliverables that could inform future FDA policy and guidance on AI device clearance and post-market monitoring.
