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Computational pathology definitions, best practices, and recommendations for regulatory guidance: a white paper from the Digital Pathology Association
The Journal of Pathology ( IF 7.3 ) Pub Date : 2019-09-03 , DOI: 10.1002/path.5331
Esther Abels 1 , Liron Pantanowitz 2 , Famke Aeffner 3 , Mark D Zarella 4 , Jeroen Laak 5, 6 , Marilyn M Bui 7 , Venkata NP Vemuri 8 , Anil V Parwani 9 , Jeff Gibbs 10 , Emmanuel Agosto‐Arroyo 7 , Andrew H Beck 11 , Cleopatra Kozlowski 12
Affiliation  

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.

中文翻译:

计算病理学定义,最佳实践和法规指导建议:数字病理学协会的白皮书

在本白皮书中,来自数字病理学协会(DPA)的专家定义了新兴的计算病理学领域中的术语和概念,重点是将其应用于分析的组织学图像及其相关的患者数据以提取信息。这篇综述提供了历史的观点,并描述了该领域研究和应用带来的潜在临床益处,以及采用方面的重大障碍。介绍了实现计算病理学工作流程的最佳实践。其中包括基础设施方面的考虑,培训数据的获取,质量评估以及监管,道德和网络安全方面的问题。为监管者,供应商和计算病理学从业人员提供了建议,以促进该领域的进步。该病理学杂志代表英国和爱尔兰的病理学学会出版由John Wiley父子有限公司。
更新日期:2019-09-03
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