Clarifying and strengthening the regulation of Artificial Intelligence (AI)
Overview
Artificial Intelligence (AI) has already made a difference to many lives, providing the potential to solve problems faster, and opening up opportunities to get things done in smarter and better ways. If safely deployed, its development and adoption can improve wellbeing, quality of life and economic growth. At the same time, caution is needed as AI presents a potential to create or amplify harms to individuals, organisations, communities and social cohesion through risks associated with its use including inherent bias, accuracy and data quality. These harms may disproportionally affect vulnerable and marginalised groups including people with cognitive disability, displaced workers, older people, culturally and linguistically diverse communities, regional communities, women, girls, gender diverse people and people who are mentally or physically unwell.
Due to the number of unknowns around how AI works in the general public, there is low public trust that AI systems are being designed, developed, deployed and used safely and responsibly, particularly in high-risk settings. People are concerned about personal privacy, the impact of bias and errors, and a near future where people can’t tell real from fake.
Through the 2024-2025 Budget measure for Safe and Responsible AI, the Australian Government is acting to ensure the design, development and deployment of AI systems in Australia in legitimate but high-risk settings, is safe and can be relied upon, while ensuring the use of AI in low-risk settings can continue to flourish largely unimpeded.
As part of the Australian Government’s Department of Health and Aged Care, the Therapeutic Goods Administration (TGA) regulates therapeutic goods, including AI models and systems when they meet the definition of a medical device under Section 41BD of the Therapeutic Goods Act 1989. The TGA has issued this consultation paper as part of the review of priority areas in the health and aged care sector.
Why your views matter
This consultation seeks feedback on proposals identified for mitigating risks and leveraging opportunities associated with the use of AI models and systems across our regulated environment, and aligns with the Department’s broader review. Your feedback will help shape the Australian Government's approach to clarifying and strengthening the regulation of AI within the therapeutic goods sector.
Give us your views
Events
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Webinar registrations open - TGA AI review - Clarifying and strengthening the regulation of AI
From 26 Sep 2024 at 09:30 to 26 Sep 2024 at 11:30This webinar will provide an overview of the consultation paper and an opportunity for stakeholders to ask questions.
To register, please copy the following link into your browser:
https://events.teams.microsoft.com/event/1c1989dd-5225-4653-ae85-a09539e7e570@34a3929c-73cf-4954-abfe-147dc3517892 -
Webinar registrations open - TGA AI review - Clarifying and strengthening the regulation of AI
From 1 Oct 2024 at 13:00 to 1 Oct 2024 at 15:00This webinar will provide an overview of the consultation paper and an opportunity for stakeholders to ask questions.
To register, please copy the following link into your browser: https://events.teams.microsoft.com/event/67af7a9f-3dc4-435b-9a64-dc3a7ae96185@34a3929c-73cf-4954-abfe-147dc3517892
Audiences
- Anyone from any background
Interests
- Hospitals
- e-Health
- Health technology
- Legislation
- Rural health services
- Home Care
- Mental health
- Prescription drugs
- Dental health
- Non-prescription medicines
- Strategic Policy
- Policy Development
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