Objective:

To address the lack of a coherent governance framework for clinical AI tools in healthcare, focusing on validation, monitoring, and accountability.

Key Findings:

• AI tools are being deployed without proper validation and monitoring, leading to potential risks.
• Current governance frameworks for AI are unclear and inconsistent, resulting in gaps in oversight.
• Pathologists and laboratory professionals have the expertise to establish necessary oversight structures, ensuring patient safety.

Interpretation:

The deployment of AI in healthcare is outpacing the establishment of necessary governance, posing significant risks to patient safety and care quality that must be urgently addressed.

Limitations:

• The regulatory framework for AI in medicine is still developing, which complicates oversight.
• Many health systems lack established quality control programs for AI tools, leading to inconsistent practices.

Conclusion:

To ensure the safe and effective use of AI in clinical settings, a robust governance framework modeled after laboratory practices is essential.