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Published on: October 3, 2016
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Patient safety in AI-powered diagnostic pathology
Massimo Rugge1, Matteo Fraschini2, Enrico Orvieto3
1DIMED, Università degli Studi di Padova, Padova, Italy massimo.rugge@unipd.it.
Journal of Clinical Pathology
|November 6, 2025
Summary
Artificial intelligence (AI) enhances diagnostic pathology accuracy but cannot replace human oversight. Implementing AI requires clear application domains and robust safety measures for patient well-being.
Area of Science:
- Pathology
- Medical Informatics
- Artificial Intelligence
Background:
- Diagnostic pathology integrates traditional histology with artificial intelligence (AI) for enhanced accuracy.
- AI in pathology involves digital image generation, algorithm training, dataset construction, validation, and output monitoring.
- Current evidence indicates AI complements, but does not autonomously replace, human diagnostic capabilities.
Purpose of the Study:
- To critically review current AI applications in diagnostic pathology.
- To emphasize patient-centered safety considerations in AI implementation.
- To highlight the need for collaborative regulatory measures for AI in pathology.
Main Methods:
- Review of current scientific evidence on AI in diagnostic pathology.
- Analysis of key steps in AI-powered diagnostic pathology workflow.
- Examination of international healthcare recommendations for AI implementation.
Main Results:
- AI can improve diagnostic accuracy but requires human supervision.
- Generative intelligence presents new opportunities in pathology.
- Clear definition of application domains and safety monitoring are crucial for clinical AI use.
Conclusions:
- Patient safety is paramount in AI-powered diagnostic pathology.
- Collaborative efforts are essential for developing safety-oriented regulatory measures.
- International cooperation among stakeholders is necessary for responsible AI deployment in pathology.

