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Computational pathology definitions,best practices,and recommendations for regulatory guidance: a white paper from the Digital Pathology Association
Authors:Esther Abels  Liron Pantanowitz  Famke Aeffner  Mark D Zarella  Jeroen van der Laak  Marilyn M Bui  Venkata NP Vemuri  Anil V Parwani  Jeff Gibbs  Emmanuel Agosto-Arroyo  Andrew H Beck  Cleopatra Kozlowski
Affiliation:1. Regulatory and Clinical Affairs, PathAI, Boston, MA, USA;2. Department of Pathology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA;3. Amgen Research, Comparative Biology and Safety Sciences, Amgen Inc., South San Francisco, CA, USA;4. Department of Pathology and Laboratory Medicine, Drexel University College of Medicine, Philadelphia, PA, USA;5. Department of Pathology, Radboud University Medical Center, Nijmegen, The Netherlands

Center for Medical Image Science and Visualization, Linköping University, Linköping, Sweden;6. Department of Pathology, Moffitt Cancer Center, Tampa, FL, USA;7. Data Science Department, Chan Zuckerberg Biohub, San Francisco, CA, USA;8. Department of Pathology, The Ohio State University, Columbus, OH, USA;9. Hyman, Phelps & McNamara, P.C, Washington, DC, USA;10. PathAI, Boston, MA, USA;11. Department of Development Sciences, Genentech Inc., South San Francisco, CA, USA

Abstract:In this white paper, experts from the Digital Pathology Association (DPA) define terminology and concepts in the emerging field of computational pathology, with a focus on its application to histology images analyzed together with their associated patient data to extract information. This review offers a historical perspective and describes the potential clinical benefits from research and applications in this field, as well as significant obstacles to adoption. Best practices for implementing computational pathology workflows are presented. These include infrastructure considerations, acquisition of training data, quality assessments, as well as regulatory, ethical, and cyber-security concerns. Recommendations are provided for regulators, vendors, and computational pathology practitioners in order to facilitate progress in the field. © 2019 The Authors. The Journal of Pathology published by John Wiley & Sons Ltd on behalf of Pathological Society of Great Britain and Ireland.
Keywords:artificial intelligence  computational pathology  convolutional neural networks  digital pathology  deep learning  image analysis  machine learning
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