The MSIA has defended the Administration's decision not to identify eight digital scribes potentially subject to medical device regulation, warning that naming developers before assessing safety or performance could be prejudicial.
The peak body representing Australia’s medical software industry has backed the Therapeutic Goods Administration’s handling of its review of AI-powered digital scribes, arguing that publicly identifying products potentially subject to medical device regulation would serve no practical purpose.
The TGA last week released the outcomes of a preliminary review of 12 digital scribe products, finding that eight were likely to meet the definition of a medical device.
However, the regulator did not identify the products or their developers, and stressed that its review did not assess their safety, quality or performance.
Medical Software Industry Association president Emma Hossack said criticism of the TGA’s decision was misplaced.
“The TGA has attracted criticism for their actions in releasing a transparent report about what scribes they have reviewed and the parameters. This is unfair, and illogical,” she told The Medical Republic.
“TGA make it crystal clear that they are not making an assessment of safety or performance.”
Ms Hossack described the exercise as a preliminary market scan that would inform future regulatory decisions, rather than an assessment of individual products.
“Naming companies now has no practical value because the TGA clearly states the review does not cover safety or performance,” she said.
“Consequently, effectively ‘naming and possibly blaming or shaming’ companies would have no value to a clinician genuinely wanting to assure themselves of safety and performance at this time.”
She warned that identifying developers could imply safety risks that had not been established.
“The TGA approach is fair and appropriate, giving industry an opportunity to respond. If there is a safety issue, clearly other TGA powers would be triggered.”
The review has raised questions about which AI scribes fall within the medical device regulatory framework, particularly as products move beyond transcribing consultations and summarising clinical notes into generating clinical recommendations.
Ms Hossack said the MSIA represented many, although not all, digital scribe providers, with membership growing as existing software developers built their own AI tools or integrated third-party products.
She said the industry welcomed the TGA’s willingness to work collaboratively with developers, drawing parallels with its approach to software as a medical device regulation in 2021.
“The TGA has once again shown a willingness to work with industry to understand the risks and benefits and find the right balance,” she said.
“This preliminary process was appropriate.”
Purchasers urged to exercise caution
Ms Hossack said the TGA’s report should not be mistaken for a consumer comparison of digital scribe products.
“This was a market scan; it shouldn’t be treated like a Choice Magazine review for consumers,” she said.
“While in theory uncertainty can delay purchasing decisions, we all know the fundamental rules of Software as Medical Device and if purchasers have doubt – they should hold back until they are confident.”
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She also cautioned against assuming that a digital scribe was operating unlawfully simply because it did not appear on the Australian Register of Therapeutic Goods.
“Absence from the Australian Register of Therapeutic Goods does not itself establish non-compliance: some products fall outside TGA regulation, while exempt medical devices remain subject to regulatory obligations,” she said.
The MSIA and Medical Technology Association of Australia have developed a voluntary governance code for unregulated software to help address issues outside the medical device framework.
Industry wants clearer rules
Despite defending the regulator, Ms Hossack acknowledged that developers needed greater clarity about which AI functions would trigger medical device requirements.
“Sure we need more specificity around boundaries; it is a complex area,” she said.
“That is why we are meeting with TGA to work through the requirements.”
The MSIA wants practical examples of borderline functions and greater certainty about eligibility for exemptions applying to clinical decision support software.
It is also seeking clearer expectations for validation, clinician oversight and explanations of AI-generated recommendations, along with consistent ways for suppliers to communicate their regulatory status.
The association has called for predictable compliance processes and realistic remediation timeframes, where legally available and safe, for Australian and overseas suppliers.
“Transparency will help clinicians assess evidence, limitations and appropriate use, while protecting legitimate intellectual property and avoiding misleading comparisons between reviewed and unreviewed products,” Ms Hossack said.
The MSIA will meet with the TGA at a roundtable on 26 October to discuss the findings and potential regulatory responses.
Ms Hossack said the discussions would consider further guidance, education, regulatory extensions or exemptions, and proportionate compliance measures that would not unnecessarily disrupt clinical care.
“That engagement will translate into practical settings that strengthen patient safety, support innovation and give clinicians and developers confidence,” she said.
