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Implementation of Digital Pathology and Artificial Intelligence in Routine Pathology Practice.
David Y Zhang1, Arsha Venkat2, Hamdi Khasawneh3
1Department of Computation, NovinoAI, Fort Lauderdale, Florida; Department of Veterans Affairs New York Harbor Healthcare System, New York, New York.
Summary
Digital pathology and artificial intelligence (AI) are revolutionizing diagnostics, improving efficiency and patient care. Regulatory frameworks are adapting to support these advancements in pathology.
Area of Science:
- Digital Pathology
- Artificial Intelligence in Pathology
- Regulatory Science
Background:
- Affordable technology drives digital pathology adoption.
- Artificial intelligence (AI) offers transformative potential in diagnostic automation.
- Evolving regulatory landscapes impact digital pathology implementation.
Purpose of the Study:
- Review latest developments in digital pathology.
- Outline AI applications in digital pathology.
- Examine US regulatory frameworks for digital pathology.
Main Methods:
- Analysis of original research articles.
- Review of official United States Federal guidelines.
- Synthesis of information on regulatory standards and policies.
Main Results:
- FDA-approved systems support digital pathology integration.
- AI automates diagnoses for cancers like prostate and colorectal.
- Regulatory bodies (FDA, CMS/CLIA, CAP) are adapting standards.
- CMS/CLIA policies enable remote digital pathology diagnostics.
- New CPT codes facilitate digital pathology reimbursement.
Conclusions:
- Digital and AI technologies promise enhanced diagnostic precision and efficiency.
- Advancements improve patient care, education, and research.
- Addressing challenges like data privacy and bias is crucial for AI integration.
