Detecting Algorithmic Errors and Patient Harms for AI-Enabled Medical Devices in Randomized Controlled Trials: Protocol for a Systematic Review

Aditya U Kale   ^{1, 2, 3, 4} , MBChB ;   Henry David Jeffry Hogg   ⁵ , PhD ;   Russell Pearson   ⁶ , PhD ;   Ben Glocker   ^{7, 8} , PhD ;   Su Golder   ⁹ , PhD ;   April Coombe   ¹⁰ , MSc ;   Justin Waring   ¹¹ , PhD ;   Xiaoxuan Liu   ^{1, 2, 3, 4} , PhD ;   David J Moore   ¹⁰ , PhD ;   Alastair K Denniston   ^{1, 2, 3, 4} , PhD

¹ Institute of Inflammation and Ageing, University of Birmingham, Birmingham, United Kingdom

² University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom

³ NIHR Birmingham Biomedical Research Centre, Birmingham, United Kingdom

⁴ NIHR Incubator for AI and Digital Health Research, Birmingham, United Kingdom

⁵ Population Health Science Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom

⁶ Medicines and Healthcare Products Regulatory Agency, London, United Kingdom

⁷ Kheiron Medical Technologies, London, United Kingdom

⁸ Department of Computing, Imperial College London, London, United Kingdom

⁹ Department of Health Sciences, University of York, York, United Kingdom

¹⁰ Institute of Applied Health Research, University of Birmingham, Birmingham, United Kingdom

¹¹ Health Services Management Centre, University of Birmingham, Birmingham, United Kingdom