Govt to regulate therapeutic use of AI

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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eHealthNews previously reported that digital health suppliers were concerned about the unintended consequences of the Therapeutic Products Act, which they believed could stifle investment and innovation in the sector.

However, while they felt the repeal was a positive move for digital health innovation, it also left a regulatory hole for SaMD.

Costello says repealing the TPA shows the Government is listening to the concerns of industry and consumers.

The TPA was not due to take effect until September 2026 and the regulatory regime required to support it, including the creation of a new regulatory agency and IT systems, had still to be developed.

Costello says repealing the Act now means that industry and practitioners will not have to change their businesses or the way they operate, and there will be no disruption to consumers or the health system.

“There is no question that the current Medicines Act is outdated, and we are already working on a modern, fit-for-purpose regulatory system for medicines and medical devices and what will be a separate system for natural health products,” Costello says.

“We can replace the TPA with legislation that protects consumers without creating unnecessary red tape for industry and I will take proposals to cabinet later this year.”

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