AI as a Medical Device Adverse Event Reporting in Regulatory Databases: Protocol for a Systematic Review

Aditya U Kale   ^{1, 2, 3, 4} , MBChB ;   Riya Dattani   ⁵ , BSc ;   Ashley Tabansi   ⁶ , MPharm ;   Henry David Jeffry Hogg   ⁷ , PhD ;   Russell Pearson   ⁸ , PhD ;   Ben Glocker   ^{9, 10} , PhD ;   Su Golder   ¹¹ , PhD ;   Justin Waring   ¹² , PhD ;   Xiaoxuan Liu   ^{1, 2, 3, 4} , PhD ;   David J Moore   ¹³ , PhD ;   Alastair K Denniston   ^{1, 2, 3, 4} , PhD

¹ Institute of Inflammation and Ageing, College of Medical and Dental Sciences, 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 Springer Nature Group, London, United Kingdom

⁶ School of Chemistry, Food and Pharmacy, University of Reading, Reading, United Kingdom

⁷ Population Health Science Institute, Faculty of Medical Science, Newcastle University, Newcastle, United Kingdom

⁸ Medicines and Healthcare Products Regulatory Agency, London, United Kingdom

⁹ Kheiron Medical Technologies, London, United Kingdom

¹⁰ Department of Computing, Imperial College London, London, United Kingdom

¹¹ Department of Health Sciences, University of York, York, United Kingdom

¹² Health Services Management Centre, University of Birmingham, Birmingham, United Kingdom

¹³ Institute of Applied Health Research, University of Birmingham, Birmingham, United Kingdom