Macquarie University researchers have published a world first review into the safety of artificial intelligence (AI) enabled medical devices approved for use by the United States Food and Drug Administration (FDA). They reviewed AI systems used for the diagnosis, management, or prevention of disease).

The research was published in the Journal of the American Medical Informatics Association (JAMIA) –

Led by Dr David Lyell and Professor Farah Magrabi from the Australian Institute of Health Innovation at Macquarie University, Sydney, Australia, the research found a number of safety concerns when AI enabled medical devices are used in real world settings.

Of the 266 safety reports reviewed, 16% were associated with patient harm, while 66% were hazards with the potential to harm. 4% were near-miss events where users recognised the potential for harm to occur and intervened.

“Reports about safety events show the need for a whole of system approach to ensure AI enabled medical devices are safe, and that means also understanding how patients and health professionals interact with the systems.”

This report was featured in an article in the Sydney Morning Herald on Saturday 29 April under the title: A new breed of AI is changing healthcare. But it comes with a warning. Click here for the full article. The report was also published in Croakey Health Media on Wednesday 3 May under the title Artificial Intelligence in healthcare must focus on diversity and equity. Click here for the full article.