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

Charles R Cleland; Adnan Tufail; Catherine Egan; Xiaoxuan Liu; Alastair K Denniston; Alicja Rudnicka; Christopher G Owen; Covadonga Bascaran; Matthew J. Burton

doi:10.1016/j.landig.2025.100915

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

Charles R Cleland^*
, Adnan Tufail
, Catherine Egan
, Xiaoxuan Liu
, Alastair K Denniston
, Alicja Rudnicka
, Christopher G Owen
, Covadonga Bascaran
, Matthew J. Burton

^*Corresponding author for this work

Applied Health Sciences

Research output: Contribution to journal › Comment/debate › peer-review

3 Downloads (Pure)

Original language	English
Article number	100915
Number of pages	3
Journal	The Lancet. Digital health
Volume	7
Issue number	11
Early online date	10 Dec 2025
DOIs	https://doi.org/10.1016/j.landig.2025.100915
Publication status	Published - 16 Dec 2025

ASJC Scopus subject areas

Medicine (miscellaneous)
Health Informatics
Decision Sciences (miscellaneous)
Health Information Management

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10.1016/j.landig.2025.100915Licence: Creative Commons: Attribution (CC BY)

ClelandCR2025IndependentFinal published version, 146 KBLicence: Creative Commons: Attribution (CC BY)

Cite this

Cleland, C. R., Tufail, A., Egan, C., Liu, X., Denniston, A. K., Rudnicka, A., Owen, C. G., Bascaran, C., & Burton, M. J. (2025). Independent and openly reported head-to-head comparative validation studies of AI medical devices: a necessary step towards safe and responsible clinical AI deployment. The Lancet. Digital health, 7(11), Article 100915. https://doi.org/10.1016/j.landig.2025.100915

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author = "Cleland, \{Charles R\} and Adnan Tufail and Catherine Egan and Xiaoxuan Liu and Denniston, \{Alastair K\} and Alicja Rudnicka and Owen, \{Christopher G\} and Covadonga Bascaran and Burton, \{Matthew J.\}",

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Cleland, CR, Tufail, A, Egan, C, Liu, X , Denniston, AK, Rudnicka, A, Owen, CG, Bascaran, C & Burton, MJ 2025, 'Independent and openly reported head-to-head comparative validation studies of AI medical devices: a necessary step towards safe and responsible clinical AI deployment', The Lancet. Digital health, vol. 7, no. 11, 100915. https://doi.org/10.1016/j.landig.2025.100915

Independent and openly reported head-to-head comparative validation studies of AI medical devices: a necessary step towards safe and responsible clinical AI deployment. / Cleland, Charles R; Tufail, Adnan; Egan, Catherine et al.
In: The Lancet. Digital health, Vol. 7, No. 11, 100915, 16.12.2025.

Research output: Contribution to journal › Comment/debate › peer-review

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AU - Cleland, Charles R

AU - Tufail, Adnan

AU - Egan, Catherine

AU - Liu, Xiaoxuan

AU - Denniston, Alastair K

AU - Rudnicka, Alicja

AU - Owen, Christopher G

AU - Bascaran, Covadonga

AU - Burton, Matthew J.

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SN - 2589-7500

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JO - The Lancet. Digital health

JF - The Lancet. Digital health

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