Feedback provided to the TGA suggests two-thirds of people feel certain digital mental health tools should no longer be excluded from regulation.
More mental health apps could soon find themselves subjected to the TGA’s regulatory requirements.
Tracey Duffy, first assistant secretary of the medical devices and product quality division, told the AIDH’s AI Care conference in Melbourne today how the TGA viewed the association between AI and software as a medical device.
The federal government introduced legislation in February 2021 that carved out, or excluded, digital mental health products from TGA regulation that is based on established clinical practice guidelines that are referred and displayed in a way that allows the user to review them, regardless of whether it meets criteria of what a medical device is.
“When a product is excluded, there’s generally another oversight mechanism in place, or they’re very low risk [and therefore do not require oversight],” said Ms Duffy.
“For example, the oversight of general health and wellness apps are provided by the ACCC or state and territory government consumer protection laws.”
As an example, if a CBT app that helps manage severe anxiety references clinical practice guidelines from the RANZCP it would not be regulated by the TGA.
Instead, the oversight of certain CBT tools like this falls under the voluntary accreditation framework set out by the Australian Commission on Safety and Quality in Healthcare.
However, rapid developments and improvements in the technology available in this space were causing headaches, according to Ms Duffy.
“There have been some emerging concerns since we introduced these carve-outs, and that’s generally been because of the rapid change in the risks associated with some of these products.”
In particular, if a product has been upgraded to incorporate large language models to take on increased complexity and functionality, they may have moved away from their intended design purpose.
Ms Duffy went on to detail some of the recent work the TGA has done in this space, which has involved running large workshops with key stakeholders and completing a public consultation regarding the review of the agency’s legislative regulations and software framework.
The TGA is currently finalising the report of its findings, which will be submitted before the end of the year.
Although this feedback process revealed that the TGA’s existing regulatory framework broadly aligned with the federal government’s proposed guardrails around the use of AI in healthcare, the process identified certain areas where amendments would be required moving forward.
“Sixty-two percent of people felt that the digital mental health tool exclusion was not appropriate anymore,” Ms Duffy said.
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But bringing mental health apps under the purview of the TGA won’t mean future updates and changes to these apps will automatically fall into line.
It is the responsibility of the manufacturer, not the TGA, to seek reapproval of their product or software if there are extensive changes.
Ms Duffy said it was currently a mixed bag with respect to manufacturers actually fulfilling this responsibility: some self-reported changes, others were dobbed in by external sources, and others simply ignored this requirement.
The TGA is technology agnostic when it comes to viewing digital technology as a medical device. This means that it doesn’t matter what the technology is – an online chatbot or a mobile app, for example – but rather its intended purpose, or what it does and how it does it.
The TGA views software as a medical device if it is intended to be used for (a) diagnosis, prevention, monitoring, prediction, prognosis or treatment of a disease, injury or disability, (b) alleviation of or compensation for an injury or disability, (c) investigation of the anatomy or of a physiological process, or (d) control or support of conception.
AI.Care 2024 was held in Melbourne on 27 and 28 November.
