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Peer-Reviewed Publication
Comput Biol Med2025;192(Pt B):110237.June 1, 2025Journal Article

A deployment safety case for AI-assisted prostate cancer diagnosis.

Yan Jia1, Clare Verrill2, Kieron White3, Monica Dolton4, Margaret Horton5, Mufaddal Jafferji6, Ibrahim Habli7
1Department of Computer Science, University of York, York, YO10 5GH, UK. Electronic address: yan.jia@york.ac.uk.
2Department of Cellular Pathology, Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital, Headley Way, Oxford, OX3 9DU, UK; Nuffield Department of Surgical Sciences, University of Oxford, John Radcliffe Hospital, Headley Way, Oxford, OX3 9DU, UK; NIHR Oxford Biomedical Research Centre, Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital, Headley Way, Oxford, OX3 9DU, UK. Electronic address: Clare.Verrill@ouh.nhs.uk.
3Department of Cellular Pathology, Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital, Headley Way, Oxford, OX3 9DU, UK. Electronic address: Kieron.White@ouh.nhs.uk.
4Nuffield Department of Surgical Sciences, University of Oxford, John Radcliffe Hospital, Headley Way, Oxford, OX3 9DU, UK. Electronic address: monica.dolton@nds.ox.ac.uk.
5Paige, 11 Times Sq, Fl 37, New York, NY 10036, USA. Electronic address: margaret.horton@paige.ai.
6Paige, 11 Times Sq, Fl 37, New York, NY 10036, USA. Electronic address: mufaddal.jafferji@paige.ai.
7Department of Computer Science, University of York, York, YO10 5GH, UK. Electronic address: Ibrahim.Habli@york.ac.uk.
PubMed PMC DOI PDF

Abstract

Deep learning (DL) has the potential to deliver significant clinical benefits. In recent years, an increasing number of DL-based systems have been approved by the relevant regulators, e.g. FDA. Although obtaining regulatory approvals is a prerequisite to deploy such systems for real world use, it may not be sufficient. Regulatory approvals give confidence in the development process for such system…

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