It took me a long time to understand what artificial intelligence (AI) actually encompasses. Initially, I assumed that most technology applications fit broadly within the definition of AI. However, AI is characterised by unique features such as autonomy, data dependency and opacity. 

These features present particular challenges when applied in the context of medical devices. Together, these challenges pose the question: is the existing medical devices regulatory framework flexible enough to accommodate AI medical devices?

Colleagues and I discuss this question in full in this article: