NEWS - eHealthNews.nz editor Rebecca McBeth

New proposals for regulating therapeutic uses of artificial intelligence (AI) and software as a medical device will be presented to Cabinet by the end of November 2024.

The Therapeutic Products Act (TPA), passed in 2023, introduced a new regulator and market authorisation regime for medical devices, including software as a medical device (SaMD), but did not mention AI.

The new coalition Government promised to repeal the Act and has had its first reading of a bill to do so, with consultation on replacement legislation taking place this year.

Cabinet minutes relating to the repeal of the TPA say associate health minister Casey Costello intends to return to Cabinet by the end of November, “with policy proposals for modern, risk proportionate regulation for medicines and medical devices, including therapeutic uses of artificial intelligence and software as a medical device”.

Aisling Weir, special counsel, Buddle Findlay, says it will be interesting to see how far the new medicines and medical device legislation goes in terms of regulating digital therapies and devices.

“The TPA covered software as a medical device, but it did not expressly mention AI, so it is possible that the new legislation will go further than the TPA did,” she says.

“We may even see the new legislation use approaches from the FDA or TGA playbook when it comes to regulating therapeutic AI".

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