
Oct 22, 2026
8 popular AI scribes may need medical device regulation: TGA
The Therapeutic Goods Administration (TGA) has identified that eight out of twelve AI-powered digital scribes may require regulation as medical devices, despite suppliers not classifying them as such.This review, published on October 16, underscores a significant gap in the awareness of medical device regulations among suppliers as AI scribes evolve from simple documentation tools to systems that can influence patient care through recommendations. The TGA has issued guidance to clarify the regul







