How are AI models approved for use in health care?

Before a new healthcare intervention can be brought to market, it must first undergo a rigorous approval process with the Therapeutic Goods Administration (TGA). For a medicine, this often means presenting evidence from clinical trials, to prove it alleviates symptoms, or treats a health condition, with minimal risk. But what about AI models for use in health care? Hospital + Healthcare speaks with the TGA to find out.

From apps that diagnose melanoma, to chatbots that suggest treatments, the sector is not short of AI solutions.

But who decides which are safe, and by which criteria…