Independent and openly reported head-to-head comparative validation studies of AI medical devices: a necessary step towards safe and responsible clinical AI deployment.

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Title: Independent and openly reported head-to-head comparative validation studies of AI medical devices: a necessary step towards safe and responsible clinical AI deployment.
Authors: Cleland CR; International Centre for Eye Health, London School of Hygiene and Tropical Medicine, London WC1E 7HT, UK; Eye Department, Kilimanjaro Christian Medical Centre, Moshi, Tanzania. Electronic address: charles.cleland@lshtm.ac.uk., Tufail A; National Institute for Health and Care Research (NIHR) Biomedical Research Centre (BRC) for Ophthalmology, Moorfields Hospital London NHS Foundation Trust, and Institute of Ophthalmology, University College London, London, UK., Egan C; National Institute for Health and Care Research (NIHR) Biomedical Research Centre (BRC) for Ophthalmology, Moorfields Hospital London NHS Foundation Trust, and Institute of Ophthalmology, University College London, London, UK., Liu X; University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK; National Institute for Health and Care Research (NIHR) Birmingham Biomedical Research Centre, Birmingham, UK., Denniston AK; University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK; National Institute for Health and Care Research (NIHR) Birmingham Biomedical Research Centre, Birmingham, UK., Rudnicka A; Population Health Research Institute, City St George's, University of London, London, UK., Owen CG; Population Health Research Institute, City St George's, University of London, London, UK., Bascaran C; International Centre for Eye Health, London School of Hygiene and Tropical Medicine, London WC1E 7HT, UK., Burton MJ; International Centre for Eye Health, London School of Hygiene and Tropical Medicine, London WC1E 7HT, UK; National Institute for Health and Care Research (NIHR) Biomedical Research Centre (BRC) for Ophthalmology, Moorfields Hospital London NHS Foundation Trust, and Institute of Ophthalmology, University College London, London, UK.
Source: The Lancet. Digital health [Lancet Digit Health] 2025 Nov; Vol. 7 (11), pp. 100915. Date of Electronic Publication: 2025 Dec 10.
Publication Type: Journal Article
Journal Info: Publisher: Elsevier Ltd Country of Publication: England NLM ID: 101751302 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2589-7500 (Electronic) Linking ISSN: 25897500 NLM ISO Abbreviation: Lancet Digit Health Subsets: MEDLINE; In Process
Database: MEDLINE Ultimate
Description
ISSN:2589-7500
DOI:10.1016/j.landig.2025.100915