Harmonizing Artificial Intelligence Governance; A Model for Regulating a High-risk Categories and Applications in Clinical Pathology: The Evidence and some Concerns

The Canadian healthcare system, grappling with issues like systemic and intelligently established structural anti-black racism, including indigenous nations; even within Pathology and Laboratory Medicine Communities: and deteriorating outcomes, sees potential in AI to address challenges, though concerns exist regarding exacerbating discriminatory practices. In clinical pathology, AI demonstrates superior diagnostic accuracy compared to pathologists in a study, emphasizing its potential to improve healthcare. However, AI governance is crucial to navigating ethical, legal, and societal concerns. The Royal College of Physicians of Canada acknowledges the transformative impact of AI in healthcare but stresses the need for responsible AI tools co-developed by diverse teams. Despite positive attitudes towards AI in healthcare, concerns about patient safety, privacy, and autonomy highlight the necessity for comprehensive education, engagement, and collaboration. Legal concerns, including liability and regulation, pose challenges, emphasizing the need for a robust regulatory framework. AI application in healthcare is categorized as high-risk, demanding stringent regulation to ensure safety, efficacy, and fairness. A parallel is drawn to drug regulation processes, suggesting a similar approach for AI. The lack of transparency in AI-based decision-making raises ethical questions, necessitating measures to address biases and ensure patient privacy. Social accountability is crucial to prevent AI from exacerbating health disparities and harming marginalized communities. In conclusion, while AI offers potential benefits in clinical pathology, a cautious approach with comprehensive governance measures is essential to mitigate risks and ensure ethical AI integration into healthcare.