Implementation of Digital Pathology and Artificial Intelligence in Routine Pathology Practice

Abstract

The advent of affordable technology has significantly influenced the practice of digital pathology, leading to its growing adoption within the pathology community. This review article aims to outline the latest developments in digital pathology, the cutting-edge advancements in artificial intelligence (AI) applications within this field, and the pertinent U.S. regulatory frameworks. The content is based on a thorough analysis of original research articles and official U.S. federal guidelines. Findings from our review indicate that several FDA-approved digital scanners and image management systems are establishing a solid foundation for the seamless integration of advanced technologies into everyday pathology workflows, which may reduce device and operational costs in the future. AI is particularly transforming the way morphological diagnoses are automated, notably in cancers like prostate and colorectal, within screening initiatives, albeit challenges such as data privacy issues and algorithmic biases remain. The regulatory environment, shaped by standards from the FDA, CMS/CLIA, and CAP, is evolving to accommodate these innovations while ensuring safety and reliability. CMS/CLIA have issued policies to allow pathologists to review and render diagnoses using digital pathology remotely. Moreover, the introduction of new digital pathology CPT codes designed to complement existing pathology CPT codes is facilitating reimbursement processes. Overall, these advancements are heralding a new era in pathology that promises enhanced diagnostic precision and efficiency through digital and AI technologies, potentially improving patient care as well as bolstering educational and research activities.