Consultation: Clarifying and strengthening the regulation of artificial intelligence
This consultation paper seeks feedback on proposals identified for mitigating risks and leveraging opportunities associated with the use of AI models.
- The report on the public consultation for Clarifying and strengthening the regulation of Medical Device Software including Artificial Intelligence (AI) has been published. The report provides a detailed overview of the AI review process, outcomes, and key findings.
- The consultation was open from 12 September 2024 to 20 October 2024 through an online survey hosted on the TGA Consultation Hub.
- Through the consultation, we sought to identify areas for improvement in the existing 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.
About this consultation
In the 2024-25 Federal Budget, the Australian Government provided $39.9 million over 5 years for the development of policy and capability to address the increasing use of AI models and systems across the Australian economy.
Several government agencies, including the Department of Health, Disability and Ageing (the Department), are working to address priority areas including consumer and copyright law, and the use of AI in health and care.
As part of this work, we conducted a review of our legislative framework to clarify and strengthen regulation relating to AI.
This consultation paper aimed to identify 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.
Outcome of the consultation
We engaged with over 600 stakeholders from across the therapeutic goods sector through 23 workshops and webinar sessions.
Fifty-three (53) formal responses were received from stakeholders from across the therapeutic goods sector.
Our report on the review has now been published: Clarifying and strengthening the regulation of Medical Device Software including Artificial Intelligence (AI).
We have also published a summary of responses to our public consultation on the TGA Consultation Hub with consent received from each respondent.
The Department has published the final report from their overarching review of the use of AI in health and care settings on their website: Safe and Responsible Artificial Intelligence in Health Care - Legislation and Regulation Review: Final Report.
Next steps
In January 2025 we received Government approval to undertake further work in response to the 14 key findings of our report.
Enquiries
For any enquiries relating to this consultation or next steps, contact emergingtechnology@health.gov.au.