Introduction

In medicine, artificial intelligence (AI) research is becoming increasingly focused on applying machine learning (ML) techniques to complex problems, and so allowing computers to make predictions from large amounts of patient data, by learning their own associations.1 Estimates of the impact of AI on the wider economy globally vary wildly, with a recent report suggesting a 14% effect on global gross domestic product by 2030, half of which coming from productivity improvements.2 These predictions create political appetite for the rapid development of the AI industry,3 and healthcare is a priority area where this technology has yet to be exploited.2 3 The digital health revolution described by Duggal et al 4 is already in full swing with the potential to ‘disrupt’ healthcare. Health AI research has demonstrated some impressive results,5–10 but its clinical value has not yet been realised, hindered partly by a lack of a clear understanding of how to quantify benefit or ensure patient safety, and increasing concerns about the ethical and medico-legal impact.11

This analysis is written with the dual aim of helping clinical safety professionals to critically appraise current medical AI research from a quality and safety perspective, and supporting research and development in AI by highlighting some of the clinical safety questions that must be considered if medical application of these exciting technologies is to be successful.