FDA Steps In as AI Scribes Shape Clinical Records

Dr. Sina Bari shares why generative AI scribes now face FDA oversight. These tools do more than transcribe—they interpret and shape clinical notes that impact patient care. Errors can lead to clinical risks, moving them into the FDA’s regulatory scope. With no LLM-based ambient scribe cleared yet, developers should now prepare for De Novo classification and gather validation data. As trust and safety become priorities, the shift toward regulated AI scribes will define how these tools can reduce burnout while protecting patient outcomes. Continue reading...

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