Doctors are already using AI-enhanced decision-support tools — but aren’t they a medical device?
There is a major question being asked with significant financial consequences — are clinical evidence AI tools medical devices?
There is a billion-dollar market looming over the creation of AI-enhanced decision-support tools.
In recent months, there has been a flurry of media releases and marketing campaigns promising a revolution for Australian doctors, with the promise they will help build confidence in their clinical decision-making.
That is a powerful argument given the complexity and legal risks of modern medicine should things go wrong.
But there is a major question being asked — are clinical evidence AI tools medical devices, no different from, say, pacemakers, drug-eluting stents and diagnostic imaging machines?
