Clearly, a system whose behaviour is impossible to guarantee seems unsatisfactory from a safety or regulatory perspective. To appreciate why components that incorporate artificial intelligence (AI), and specifically, machine learning, might even be considered, it is helpful to gain a little bit of insight into how modern AI systems are being built, and why they are changing the way in which complex software systems are being engineered. The purpose of this white paper is to provide a very brief overview of where AI is being used in healthcare, and why it might be increasingly seen in medical devices. We also consider what specific additional requirements this might place on regulatory requirements in the near future.
