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A guide for the deployment, validation, and accreditation of clinical digital pathology tools

Research Highlight PN A guide for the deployment, validation, and accreditation of clinical digital pathology tools

The following abstract is drawn from a recently published paper in Journal of Pathology Informatics | ScienceDirect.com by Elsevier. We invite you to read the full paper and join the conversation, become a member of the Pathology News community to share your thoughts, ask questions, and engage with others around this work.

Authors: Andrew Janowczyka,b,c,f, Johan Ferraric,f, Nicolas Brandtc, Laura Padayachyc, Aurélie Bornandc, Suzanne Chartierc, Thomas Malletc, Nicolas Roduitd, Paul Seedd, Medya Tekes  Mizraklic, Julien Massonnetc,e, Petros Liakopoulosb, Vincent Braunersreutherc, Mario Kreutzfeldtc,e, Laura Rubbia-Brandtc,e,g, Doron Merklerc,e,g

Abstract

Digital pathology (DP) has become an integral part of modern diagnostic practice, enabling efficient workflows, reproducible assessments, and the integration of computational tools. Whereas many institutions are transitioning toward digital diagnostics, deployment, validation, and routine usage of DP tools in clinical settings remains a major challenge. Existing recommendations often remain high-level, leaving labs without detailed, practical guidance on how to structure and document validation processes in real-world settings. To address this gap, we present a framework derived from the experience of Geneva University Hospitals (HUG), which since 2019 has operated a fully digital primary diagnostic workflow processing more than 230,000 slides annually. Drawing on this implementation, we outline best practices and lessons learned for the development, deployment, validation, and accreditation of DP tools. Document templates are also provided, which may serve as adaptable blueprints for other labs. This practical guide is intended to support reproducible, transparent, and audit-ready validation processes, helping institutions bridge the gap between general recommendations and operational deployment of DP tools in accredited diagnostic environments.
aDepartment of Biomedical Engineering, Emory University and Georgia Institute of Technology, Atlanta, GA, USA
bDivision of Precision Oncology, Geneva University Hospitals, Geneva, Switzerland
cDivision of Clinical Pathology, Geneva University Hospitals, Geneva, Switzerland
dDigital Transformation and Augmented Intelligence Department, Geneva University Hospitals, Geneva, Switzerland
eDepartment of Pathology and Immunology, University of Geneva, Geneva, Switzerland
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