An Incidental Standard for Medical AI

Document Type

Article

Publication Date

2026

Abstract

Medical AI is poised to make a major difference in the provision of health. It brings major challenges, though: how can developers and implementers ensure that it will work safely and effectively—especially within the context of complex and highly variable health-care systems? Standards provide one key tool, potentially providing guidelines for everything from privacy to accuracy to how AI interacts with human clinicians. This Essay considers the last of these, describing a powerful quasi-standard from a surprising source: an FDA guidance document that tells developers when certain AI systems are not considered medical devices, and are therefore not regulated by FDA. In defining this negative regulatory space, FDA provides considerable detail about one influential vision of how humans and AI should interact in medical practice.

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