Sina Bari MD: Generative AI Scribes
Face New FDA Reality
Dr Sina Bari explains why ambient AI scribes are now under FDA focus as they move beyond transcription to interpreting and summarizing patient visits, shaping records that impact care These tools can introduce clinical risks if errors occur, bringing them under regulatory oversight. Since no large language model-based scribe has FDA clearance, developers should prepare for the De Novo pathway. With over 100 scribe tools in use and none cleared, the shift toward regulation is here, making trust and validation essential for safe clinical integration Read more