Safe and Responsible Artificial Intelligence in Health Care – Legislation and Regulation Review

Overview

Artificial Intelligence (AI) can help solve urgent and emerging challenges in our health care system and support the health care workforce dedicate more time to delivering care. However, along with the potential opportunities of AI in health care, there is community concern about the safety and risks of AI. There are concerns that current legislative and regulatory frameworks do not adequately mitigate potential for harm.

There are high-risk use cases for AI in health care. With the rapid rollout and fast pace of innovation of AI, new settings may be required to ensure the safe adoption of AI. The right regulatory settings for AI-powered systems are critical.

In 2023 and 2024, the Australian Government has followed a whole of economy approach on AI, including the Department of Industry, Science and Resources (DISR) consultation on AI in 2023 and publishing a response paper in 2024, as well as a range of AI initiatives across other parts of the economy.  The 2024-25 Budget included funding for priority reviews of consumer, privacy and heath care laws. As part of this, the Department of Health and Aged Care (the department) is now consulting to clarify and strengthen legislation and regulation for AI in Australia’s health care settings.

With the Safe and Responsible Artificial Intelligence in Health Care Legislation and Regulation Review (the Review), the department will consider the range of legislation that we administer. In doing so, we are considering three critical questions related to the safe and responsible use of AI in Australia's health and care.

• What about AI are we trying to regulate?
• Who is affected by AI and related regulation?
• How could we regulate to prevent AI harms and to enable benefits of AI?

We are taking a balanced approach to the Review. In the public consultation, we ask that submissions consider the benefits and risks of AI and potential regulatory changes across Australia’s health care system.

You are welcome to answer as many or as few of the consultation questions as you wish, and to raise any additional matters relating to this subject.

The department welcomes all feedback, including additional measures or proposals to address the content outlined in this paper.

If you wish to submit a response in a non-written format, such as a voice recording, please email us at digitalfutures@health.gov.au

Webinars to outline the scope and approach to the consultation will be held on:

• Tuesday 24 September 12-12:45pm
• Friday 27 September 11-11:45am
• Tuesday 8 October 12-12:45pm

To attend a webinar, please register here https://events.humanitix.com/public-consultation-on-safe-and-responsible-ai-in-healthcare