Clarifying and strengthening the regulation of Artificial Intelligence (AI)

In the 2024-25 federal budget, the Australian Government provided $39.9 million over 5 years for the development of policy and capability across government to support the adoption and use of AI technology in a safe and responsible manner. The Department of Industry, Science and Resources (DISR) is leading the whole-of-government Safe and Responsible Use of AI agenda. One proposal is to establish “guardrails” for the development and deployment of AI systems in high-risk settings, while allowing AI use in low-risk settings within the bounds of existing laws. For full details regarding the whole-of government review, please consult the full consultation paper.

The TGA has issued this consultation paper as part of the review of priority areas in the health and aged care sector which intends to ensure our existing legislative framework aligns with the guardrails proposed by DISR.

This in-principle consultation paper is seeking your feedback on identified areas for potential reform or refinement to address the risks and leverage the opportunities associated with the increasing use of AI models and systems in our sector. Your responses help inform our report to the Australian government which aims to:

• Identify areas of our legislative and regulatory framework where strengths currently exist and where potential changes could be considered to strengthen the mitigation of risks associated with AI models and systems.
• Raise matters for consideration that are broader than the TGA’s responsibilities, legislation that is interconnected with AI in therapeutic goods and requires cross-agency consideration such as privacy, data security, and cybersecurity.
• Emphasise the importance of international harmonisation being maintained as much as possible to assist access to products and export opportunities.