MobiHealth News September 12, 2025
Dr. Erik Langhoff, chief medical officer and consultant for the Bronx Regional Health Information Organization, discusses how the agency is addressing safety and efficacy in AI.
According to the Food and Drug Administration (FDA), the traditional paradigm of medical device regulation was not designed for adaptive artificial intelligence and machine learning technologies. As a result, changes to AI- and ML-driven devices may need premarket review.
In January, the FDA published the Draft Guidance: Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations, which proposes lifecycle considerations and specific recommendations to support marketing submissions for AI-enabled medical devices.
In April, bipartisan senators introduced the Health Tech Investment Act (S. 1399), which would establish a Medicare reimbursement pathway for...
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