Consultation: Clarifying and strengthening the regulation of Artificial Intelligence (AI)

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 and Aged Care (DoHAC), 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, the Therapeutic Goods Administration (TGA) 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

A total of fifty-three (53) formal responses were received from stakeholders from across the therapeutic goods sector.

We have published a summary of responses on the TGA Consultation Hub - external site with consent received from each respondent.

Next steps

The feedback will be used to inform the TGA’s report to government. This report aims to inform the Australian Government of the specific considerations and concerns facing the therapeutic goods sector relating to the safe and responsible use of AI. This report will help inform a forward program of work to further clarify and strengthen the TGA’s existing framework.

Enquiries

For any enquiries relating to this consultation or next steps, please contact emergingtechnology@health.gov.au.