A new study outlines a lifecycle-oriented approach to help laboratories navigate costs, regulatory compliance, and artificial intelligence readiness.
Digital pathology is transitioning from an adjunct technology to an enterprise diagnostic platform in the US, but many laboratories face persistent barriers to adoption. A new narrative review published in the Journal of Clinical and Translational Pathology proposes a lifecycle framework to help institutions implement and sustain these programs.
While clinical adoption is accelerating, laboratories often struggle with high capital and operating costs, workflow disruption, and interoperability challenges. The review also notes that a complex regulatory and reimbursement environment remains a significant hurdle for many facilities.
Key Implementation Domains
The framework identifies several domains necessary for successful implementation, ranging from foundational infrastructure to long-term governance. These include:
- Foundational infrastructure, such as scanners, storage, and integrated image management platforms
- Workflow redesign across pre-analytic, analytic, and post-analytic phases
- Validation and quality management
- Regulatory compliance and accreditation
- Interoperability strategy, cybersecurity, and access control
- Education, change management, and institutional governance
The study emphasizes the importance of explicitly distinguishing device authorization from laboratory validation and operational quality management. By addressing these domains proactively, pathology departments can better realize clinical and operational benefits, according to the study.
Artificial Intelligence Readiness
The review also introduces an institution-level artificial intelligence (AI) readiness model. This model is designed to support safe clinical AI deployment by assessing data quality, integration, validation, and monitoring. It also evaluates institutional governance and workforce capabilities.
To develop the framework, researchers performed a review of literature from 2014 through 2025. The search covered whole slide imaging, laboratory information system integration, and oversight from the Food and Drug Administration. They also reviewed standards from the Clinical Laboratory Improvement Amendments and the College of American Pathologists.
“Durable success requires a comprehensive, lifecycle-oriented framework integrating infrastructure, workflow redesign, validation, interoperability, AI readiness, security, education, performance monitoring, and institutional governance,” the study authors conclude in a release.
The authors suggest that this approach allows laboratories to position themselves for continued innovation in an increasingly data-driven diagnostic landscape.
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