The College has submitted a response to the Medicines and Healthcare products Regulatory Agency’s (MHRA) call for evidence to help shape the work of the new National Commission on the Regulation of AI in Healthcare. 

As a technology‑driven specialty, pathology is well positioned to harness AI to improve diagnostic accuracy and efficiency, ease system bottlenecks, and enhance patient outcomes. The response emphasises that robust, effective regulation is crucial to realising this potential – ensuring innovation progresses safely and responsibly – and offers recommendations on how such regulation should be designed and implemented. To support delivery of AI effectively in pathology, the profession needs to have direct influence in the regulation of AI.  

Read the full response here:

Key areas identified in the response include the need for: 

• Robust, transparent and pathology‑relevant evidence standards including clear, accessible information about the evidence supporting each AI product 
• Clear, pathology‑specific regulatory pathways that recognise the unique validation needs of digital diagnostics, including requirements for demonstrating performance across diverse laboratory settings, instruments and population groups 
• Strong post‑market surveillance and ongoing monitoring including continuous oversight of AI systems in real‑world use, national reference datasets, shared monitoring tools and clearer reporting to comparatively test algorithms 
• Clear allocation of responsibilities and liability across manufacturers, providers, and clinicians with transparent documentation and clearly identified roles for pathologists in evaluation, interpretation and oversight.  

While there has been a significant investment in digitisation, pathology labs have some way to go before all are fully equipped to support AI.  

Pathologists remain fundamental to safe laboratory practice. AI can enhance efficiency and diagnostic quality, but it does not replace clinical expertise. Improving infrastructure, addressing workforce shortages and investing in training and protected time is essential to enable pathologists to adopt AI safely and responsibly within routine diagnostic workflows 

The College will continue to engage with the National Commission on the Regulation of AI in Healthcare. In addition to the written submission, College representatives will attend a consultation engagement exercise with the Commission in February 2026.