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The use of artificial intelligence will likely transform clinical practice over the next decade and the early impact of this will likely be the integration of image analysis and machine learning into routine histopathology. In the UK and around the world, a digital revolution is transforming the reporting practice of diagnostic histopathology and this has sparked a proliferation of image analysis software tools. While this is an exciting development that could discover novel predictive clinical information and potentially address international pathology work-force shortages, there is a clear need for a robust and evidence-based framework in which to develop these new tools in a collaborative manner that meets regulatory approval. With these issues in mind, the NCRI Cellular Molecular Pathology (CM-Path) initiative and the British In Vitro Diagnostics Association (BIVDA) has set out a roadmap to help academia, industry and clinicians develop new software tools to the point of approved clinical use. This article is protected by copyright. All rights reserved.

Original publication




Journal article


J Pathol

Publication Date



analysis, artificial, digital, evidence-based, image, intelligence, pathology