Comment from Medical Information Technology Inc (MEDITECH)
AnonymousOpposeBusiness
Summary: MEDITECH, a medical information technology company, opposes the proposed guidance because it classifies foundational EHR functions as regulated medical devices. They argue that this creates an excessive regulatory burden that could lead to alert fatigue, increase documentation requirements, and hinder the operational efficiency of healthcare delivery.
Comments submitted from MEDITECH on Guidance for Industry and Food and Drug Administration Staff Document issued on January 29, 2026.