The regulator is moving from education to compliance action after identifying scope creep, inadequate monitoring and a lack of transparency in some AI-powered scribes.
The Therapeutic Goods Administration will begin compliance action against suppliers of some artificial intelligence-powered clinical scribes after finding evidence of regulatory non-compliance during a year-long review of the rapidly growing technology.
Speaking at the Australian Institute of Digital Health’s HIC2026 conference in Sydney on Monday, the TGA’s product quality division head Tracey Duffy said the regulator had completed 12 months of engagement with vendors and was now shifting its focus to enforcement.
“When it comes to digital scribes, this review has moved into compliance action,” Ms Duffy said.
“We’ve had 12 months of reviewing and discussing with various companies around Australia, but we are now moving into compliance for those organisations who have deployed a scribe that’s operated as a medical device and have not sought medical device regulatory approval.”
Ms Duffy said the review had identified several areas of concern.
“We’ve identified scope creep, inclusion of AI that’s influencing decisions of clinicians, and a general lack of transparency and post-market feedback into a lifecycle approach about how they’re managing their AI out in the field,” she said.
“The team has also identified that there is a lack of monitoring controls in place, including foreseeable risks and how they’ve mitigated those foreseeable risks.”
“So you could see some action going out in the next 12 months on this one.”
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Ms Duffy said the TGA planned to publish the outcomes of its review of digital scribes “in the coming weeks”, along with updated guidance for developers.
She said the regulator’s broader review of AI regulation had concluded that Australia’s existing legislative framework remained fit for purpose, with refinements rather than new laws required.
“We don’t intend to put any new regulations or legislation in place. We found that the existing regulations were fit for purpose and flexible enough to allow us to make some refinements,” Ms Duffy told the conference panel discussion.
She said any move towards streamlining regulatory approval for AI products would depend on stronger post-market monitoring systems being established.
“If we were to lower that [regulatory hurdle], at the moment those mechanisms aren’t in place,” Ms Duffy said.
“There needs to be some … feedback through to the developer to make sure that it can be validated as working as intended.”
The AIDH HIC2026 conference was held in Sydney on 3-4 August.
