The Therapeutic Goods Administration (TGA) of Australia has published its report titled “Clarifying and strengthening the regulation of Medical Device Software including Artificial Intelligence (AI)” which sets outs findings in relation to a consultation aimed at identifying areas for improvement in the legislative framework to mitigate future risks and leverage opportunities associated with the use of AI within the therapeutic goods sector, including software as a medical device. Notably, the report looks at “digital scribes” and has recommended a further review to determine whether digital scribes are “medical devices” under the TGA. The report has not provided a definitive position to this question yet.
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