I want to start with something that tends to get lost in the political conversation about artificial intelligence and healthcare: AI tools for clinical use are not hypothetical. They exist. Some of them are very good. Several have demonstrated, in peer-reviewed clinical trials, sensitivity and specificity for cancer detection that is comparable to, or in specific tasks exceeds, the performance of specialist clinicians. These are not marketing claims. They are published findings in leading medical journals, with independent validation in multiple patient populations.
I know this because I spent several years building one of them.
At an AI diagnostics company, I led the development of machine learning tools for oncology pathology. The technology analyses digital images of tissue samples to detect cancer cells, flagging cases for pathologist review and prioritising those most likely to require urgent attention. The work required deep engagement with clinical validation methodology, with the FDA's regulatory framework for software as a medical device, and with the very specific challenge of demonstrating that a system trained on one population will generalise to others. We achieved FDA clearance. The product works in clinical use in the United States.
The NHS picture is different. NHS radiology departments face a shortage of roughly 30 percent of the radiologists needed to meet current demand, according to the Royal College of Radiologists. The diagnostic backlog is real, is measurable, and is contributing to worse outcomes for patients whose conditions are caught later than they should be. AI tools that can triage imaging studies, flag urgent findings for immediate review, and handle routine cases with lower levels of supervision represent a genuine opportunity to address that backlog. The technology is not the constraint.
The constraint is governance, and the current governance framework for AI in the NHS is neither rigorous enough to protect patients nor flexible enough to enable the adoption of tools that are demonstrably safe and effective.
On the rigour side: the MHRA's framework for regulating software as a medical device has improved but still lacks the depth of engagement with AI-specific validation challenges that the FDA has developed over the past five years. Issues such as performance degradation over time as clinical practice and patient populations change, the need for ongoing real-world monitoring of deployed systems, and the appropriate handling of edge cases where the AI's confidence is low and human review is essential: these are not adequately addressed by the current regulatory framework.
On the flexibility side: the NHS's internal processes for adopting AI tools are fragmented across trusts, slow, and commercially unattractive for companies trying to build a viable business. A tool that has achieved MHRA clearance and NICE endorsement can still face trust-level procurement decisions that are effectively independent evaluations, each requiring its own evidence submission, pilot programme, and commercial negotiation.
What good governance looks like in practice is not complicated in principle, though it is hard to deliver. It means a regulatory pathway that engages with AI companies early, sets clear validation requirements, and provides a credible approval that the NHS as a whole respects rather than relitigating locally. It means a mandatory post-market surveillance requirement for AI tools in clinical use, with standardised metrics and reporting. And it means a national procurement framework for AI diagnostics that allows trusts to adopt approved tools through a single commercial route, rather than reinventing the wheel in every commissioning area.
The political conversation about AI tends to oscillate between those who want to claim that it will transform everything and those who regard it with blanket suspicion. Both positions are unhelpful. The honest position is that these tools are ready, that the governance infrastructure to use them safely at scale is not, and that building that infrastructure is exactly the kind of thing that a serious government should be prioritising.