FDA Releases Digital Health and AI Glossary as an Educational Resource

The U.S. Food and Drug Administration (FDA) has introduced a digital health and AI glossary, compiling definitions for essential terms in AI, digital health, and machine learning. Developed as a general educational tool, the glossary draws from public documents, consensus standards, and academic literature to provide clear definitions of frequently used terminology in the field.

The glossary, which is acknowledged by the FDA as a work in progress, currently omits terms like “Digital Therapeutics” and “AI Agent” among others, highlighting the agency’s ongoing efforts to adapt as new concepts emerge in healthcare technology. While it is not an official policy document and does not establish legally enforceable requirements, the glossary serves as a foundational reference to support clearer, more informed discussions around digital health and AI.