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

Saved in:
Bibliographic Details
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
FullText Text:
  Availability: 0
Header DbId: mdl
DbLabel: MEDLINE Ultimate
An: 41381300
AccessLevel: 2
PubType: Academic Journal
PubTypeId: academicJournal
PreciseRelevancyScore: 0
IllustrationInfo
Items – Name: Title
  Label: Title
  Group: Ti
  Data: Independent and openly reported head-to-head comparative validation studies of AI medical devices: a necessary step towards safe and responsible clinical AI deployment.
– Name: Author
  Label: Authors
  Group: Au
  Data: <searchLink fieldCode="AU" term="%22Cleland+CR%22">Cleland CR</searchLink>; 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.<br /><searchLink fieldCode="AU" term="%22Tufail+A%22">Tufail A</searchLink>; 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.<br /><searchLink fieldCode="AU" term="%22Egan+C%22">Egan C</searchLink>; 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.<br /><searchLink fieldCode="AU" term="%22Liu+X%22">Liu X</searchLink>; University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK; National Institute for Health and Care Research (NIHR) Birmingham Biomedical Research Centre, Birmingham, UK.<br /><searchLink fieldCode="AU" term="%22Denniston+AK%22">Denniston AK</searchLink>; University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK; National Institute for Health and Care Research (NIHR) Birmingham Biomedical Research Centre, Birmingham, UK.<br /><searchLink fieldCode="AU" term="%22Rudnicka+A%22">Rudnicka A</searchLink>; Population Health Research Institute, City St George's, University of London, London, UK.<br /><searchLink fieldCode="AU" term="%22Owen+CG%22">Owen CG</searchLink>; Population Health Research Institute, City St George's, University of London, London, UK.<br /><searchLink fieldCode="AU" term="%22Bascaran+C%22">Bascaran C</searchLink>; International Centre for Eye Health, London School of Hygiene and Tropical Medicine, London WC1E 7HT, UK.<br /><searchLink fieldCode="AU" term="%22Burton+MJ%22">Burton MJ</searchLink>; 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.
– Name: TitleSource
  Label: Source
  Group: Src
  Data: <searchLink fieldCode="JN" term="%22101751302%22">The Lancet. Digital health</searchLink> [Lancet Digit Health] 2025 Nov; Vol. 7 (11), pp. 100915. <i>Date of Electronic Publication: </i>2025 Dec 10.
– Name: TypePub
  Label: Publication Type
  Group: TypPub
  Data: Journal Article
– Name: TitleSource
  Label: Journal Info
  Group: Src
  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Elsevier+Ltd%22">Elsevier Ltd </searchLink><i>Country of Publication: </i>England <i>NLM ID: </i>101751302 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>2589-7500 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2225897500%22">25897500 </searchLink><i>NLM ISO Abbreviation: </i>Lancet Digit Health <i>Subsets: </i>MEDLINE; In Process
PLink https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=mdl&AN=41381300
RecordInfo BibRecord:
  BibEntity:
    Identifiers:
      – Type: doi
        Value: 10.1016/j.landig.2025.100915
    Languages:
      – Code: eng
        Text: English
    PhysicalDescription:
      Pagination:
        StartPage: 100915
    Titles:
      – TitleFull: Independent and openly reported head-to-head comparative validation studies of AI medical devices: a necessary step towards safe and responsible clinical AI deployment.
        Type: main
  BibRelationships:
    HasContributorRelationships:
      – PersonEntity:
          Name:
            NameFull: Cleland CR
      – PersonEntity:
          Name:
            NameFull: Tufail A
      – PersonEntity:
          Name:
            NameFull: Egan C
      – PersonEntity:
          Name:
            NameFull: Liu X
      – PersonEntity:
          Name:
            NameFull: Denniston AK
      – PersonEntity:
          Name:
            NameFull: Rudnicka A
      – PersonEntity:
          Name:
            NameFull: Owen CG
      – PersonEntity:
          Name:
            NameFull: Bascaran C
      – PersonEntity:
          Name:
            NameFull: Burton MJ
    IsPartOfRelationships:
      – BibEntity:
          Dates:
            – D: 01
              M: 11
              Text: 2025 Nov
              Type: published
              Y: 2025
          Identifiers:
            – Type: issn-electronic
              Value: 2589-7500
          Numbering:
            – Type: volume
              Value: 7
            – Type: issue
              Value: 11
          Titles:
            – TitleFull: The Lancet. Digital health
              Type: main
ResultId 1