Luke Hawthorne
New TGA guidance on the regulation of AI-based software medical devices
17 February 2026
Opportunities for the application of AI in health and life sciences continue to grow.
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Creators first? No text and data mining for Australia
30 October 2025
The Albanese Government has commenced consultations on updates to Australia’s copyright laws in light of emerging challenges presented by Artificial Intelligence (AI), while explicitly ruling out introducing a broad Text and Data Mining (TDM) exception.
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It’s alive — and growing! Updates from the TGA’s 2025 AI review
5 August 2025
The rapid evolution of artificial intelligence and the expansion of the use of software in the delivery of healthcare is transforming the medtech landscape, offering unprecedented opportunities for innovation in patient care.
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Expert evidence blows up detonator patent litigation
25 July 2025
In a long, but intricately reasoned first instance judgment, Australia’s Federal Court has ruled on the validity and infringement of patents relating to wireless detonators.
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Not child’s play! What you need to know about the Children’s Online Privacy Code
18 June 2025
On 12 June 2025, the Office of the Australian Information Commissioner (OAIC) announced the release of its Issues Paper on the forthcoming Children’s Online Privacy Code (the Code).
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Regulatory spotlight on telehealth
3 June 2025
Health Minister Mark Butler has requested that the Therapeutic Goods Administration consider ‘options to improve standards of telehealth’ in online prescribing.
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Iconic? Making a song and dance about AI transparency
20 May 2025
In an open letter addressed to Prime Minister Keir Starmer, more than 400 of the UK’s most celebrated artists and creative leaders, including Elton John, Coldplay, Dua Lipa, Paul McCartney, and Shakespeare’s Globe, urged the UK Parliament to protect copyright, ‘the lifeblood of the creative industries.’ The icons expressed their support for an amendment to the Data (Use and Access) Bill that could have reshaped the relationship between the creative industries and AI developers by requiring AI companies to disclose which copyrighted works have been used to train their models.
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One year on: the Treaty, WIPO, Traditional Knowledge, and patents
15 May 2025
Imagine an organisation obtaining patent protection over a formulation derived from Kakadu plum, while the First Nations community whose Knowledge guided the discovery receives neither recognition nor benefit.
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It’s alive! Safe and responsible AI in therapeutic goods
3 December 2024
Imagine a future where medical devices, powered by artificial intelligence, are seamlessly integrated into our lives.
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