AI and the TGA: ‘Our role is not to throw sand in the gears’
Professor Tony Lawler said the TGA was successfully dealing with AI software with its existing approach to medical devices.
The fact that drugs rarely transform if left to their own devices has been useful for regulators.
Even software usually requires a human hand to change — a process dubbed ‘feature creep’ when it happens without a regulator’s knowledge.
AI is different. It is taking medical regulators into a new world.
“It defies regulation under the same paradigm as previous therapeutic goods,” TGA boss Professor Tony Lawler told AusDoc.
