Comment from Retinex, Inc.
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Summary: Retinex, Inc., an AI-native electronic medical record system company, supports the pilot program while suggesting specific improvements to its framework. They argue that the Agency should recognize electronic health record systems as a distinct participant category and expand the infrastructure requirements to include upstream data production at clinical sites.
Please find attached Retinex's response to questions A.3 and A.4.b of Docket No. FDA-2026-N-4390, AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program. Retinex, Inc. is an ONC-certified, AI-native electronic medical record system headquartered in Bellaire, Texas.