K. Yao and Z. Li proposed a lifecycle framework for implementing and sustaining digital pathology programs in the United States in an article published on June 27, 2026, in the Journal of Clinical and Translational Pathology. The article, titled "A Lifecycle Framework for Digital Pathology Implementation: Integrating Infrastructure, Workflow, Regulatory Compliance, and AI Readiness for Sustainable Adoption," emphasizes defining and operationalizing institutional artificial intelligence readiness.

Digital pathology is transitioning from an adjunct technology to an enterprise diagnostic platform in the United States. Many laboratories face barriers to adoption including high capital and operating costs, workflow disruption, interoperability challenges, and a complex regulatory and reimbursement environment. The framework aims to facilitate safe and sustainable adoption of digital pathology.

The review describes an institution-level artificial intelligence readiness model that can be assessed across data quality, integration, validation, monitoring, governance, and workforce capabilities. The article distinguishes device authorization from laboratory validation and operational quality management.

Key implementation domains span foundational infrastructure, workflow redesign, validation and quality management, regulatory compliance and accreditation, cost capture, interoperability strategy, cybersecurity and access control, education and change management, and long-term governance. Foundational infrastructure includes scanners, storage and networking, and integrated image management platforms. Workflow redesign spans pre-analytic, analytic, and post-analytic phases.

The review was informed by searches of PubMed/MEDLINE and Google Scholar for English-language publications from January 1, 2014, through December 31, 2025. Core search concepts included digital pathology, whole slide imaging, image management and viewing systems, laboratory information system integration, validation, reimbursement, U.S. Food and Drug Administration clearance, Clinical Laboratory Improvement Amendments oversight, College of American Pathologists accreditation, interoperability standards, cybersecurity, and artificial intelligence. The database searches were supplemented by reference screening and a review of primary guidance and public databases from regulatory and professional organizations in the United States.