01/14/2026
The FDA recently emphasized the importance of ongoing performance monitoring for AI tools used in healthcare, signaling a shift from one-time approvals to continuous oversight. As AI becomes more embedded in clinical, billing, and operational workflows, regulators want assurance that these tools remain accurate, unbiased, and compliant over time—not just at launch.
For healthcare organizations, this highlights a growing need for governance, documentation, and regular validation of AI-driven systems. Transparency, accountability, and strong internal processes will be critical as oversight increases.
Staying ahead of regulatory expectations now can help practices avoid compliance risks later. Read More: https://www.healthcaredive.com/news/fda-comments-ai-performance-monitoring/808120/
Medtech industry groups said the FDA should use existing regulatory and quality tools to monitor performance, while medical groups said device manufacturers should be responsible for monitoring AI.