techUK's response to the National Commission’s Findings on AI Regulation in Health

Last week, the MHRA published the findings of the National Commission into the Regulation of AI in Healthcare's Call for Evidence, the most substantial assessment yet of how the UK should regulate AI in health and care. The Commission is the independent advisory group convened by the MHRA to recommend a new regulatory framework for AI in healthcare. It is chaired by Professor Alastair Denniston and draws on working groups led by MHRA Chief Executive Lawrence Tallon, both of whom techUK has engaged closely over the past year. Its findings rest on 761 responses from patients and the public, clinicians, providers, academics and industry, and techUK's own submission.

For techUK members, this is an important milestone to see the growing the alignment and cooperation between the MHRA and industry, as the priorities techUK advocated for via our response and engagement sessions are strongly featured into the Commission’s publication.

Where techUK and the Commission align

The closest test of impact is to set the two documents side by side. The Commission identified ten key findings; the following six map directly onto positions techUK proactively put forward in its submission.

1. A proportionate, risk-based approach across the full lifecycle

techUK called for "a pragmatic calibration of regulation by risk and use" and a "dual-path" offering "a low-risk fast track and a higher-risk full route."

The Commission found (Key Finding 1): "There is a clear call for a proportionate, lifecycle-based approach to regulation," with stakeholders seeking an approach that is "risk-based" and "addresses existing duplication and fragmented oversight."

2. Significant reform, not a complete overhaul

techUK called for a framework that "requires significant reform, centred on proportionate regulation, reusability of assurance, and clearer coordination."

The Commission found (Key Finding 2): "There is strong consensus for significant regulatory reform," with most respondents saying the framework "needed 'significant reform' but did not need a 'complete overhaul'."

3. Post-market surveillance built for adaptive AI

techUK called for the MHRA to "define post-market surveillance expectations that are aligned with dynamic AI tools (drift monitoring, improper use, escalation triggers)."

The Commission found (Key Finding 3): "broad consensus that AI systems will increasingly require continuous post-market surveillance and monitoring," with upgraded approaches needed to "manage performance drift, validate performance in real world settings, and track changes in performance over time." Key Finding 9 adds support for "a national reporting system for AI incidents."

4. Clearer liability and genuinely shared responsibility

techUK called for the MHRA to "improve consistency and clarity of guidance, especially on liability," warning that "fragmented liability fosters a pervasive fear environment."

The Commission found (Key Finding 4): "Responsibility should be shared across the system, with each individual and institution understanding their essential role and responsibilities," alongside "a consistent emphasis on the need for greater clarity and consistency in how liability is allocated." The findings even echo our framing, cautioning that liability must not create "excessive fear among clinicians or provider organisations."

5. Clearer device classification, and curbing "shadow AI"

techUK called for the MHRA to "clarify medical device classification for AI low-risk scenarios to reduce unintended capture of 'shadow or general' AI," flagging "over-classification of AI as 'medical device' and blurred boundaries with general-purpose AI."

The Commission found (in response to how the framework should be improved): respondents called for "clearer guidance on classifications and safety standards for AI systems" to "help the healthcare sector better understand which AI systems are regulated as medical devices."

6. An end to NHS duplication: reuse, coordination and a single front door

techUK called for "a more centralised 'once-assessed unlock-access' reuse mechanism, like the Innovator Passport, to tackle NHS duplication," and to "align parallel regulatory regimes and develop a simplified 'front door'," citing "duplicative assurance and procurement burdens across the NHS."

The Commission found (Key Finding 1 and the framework-improvement responses): the proportionate approach must "address existing duplication and fragmented oversight," with respondents calling for "better coordination between regulators and improvements to be made to NHS procurement processes."

What this means, and what comes next

These findings are a descriptive account of the evidence base, not yet the Commission's recommendations. Those recommendations are due in the summer and will directly inform the new regulatory framework committed to under the 10 Year Health Plan and the Life Sciences Sector Plan. But the direction of travel is unmistakable, and industry's priorities, as articulated through techUK, are well represented in the evidence that will shape it.

techUK will continue to engage with the MHRA and the National Commission through to publication, and to feed the sector's expertise into the framework as it takes shape. To get involved in our response to the Commission's recommendations this summer, contribute to future submissions, or join the Health and Social Care programme's policy discussions, please contact the techUK team.


Robert Walker

Robert Walker

Head of Health & Social Care, techUK

Rachel Kennedy

Rachel Kennedy

Programme Manager Health and Social Care, techUK

Lewis Stewart

Lewis Stewart

Programme Manager ‑ Health and Social Care, techUK

Viola Pastorino

Viola Pastorino

Junior Programme Manager, Health and Care Team, techUK

Health and Social Care Programme activities

techUK is helping its members navigate the complex space of digital health in the UK to ensure our NHS and social care sector is prepared for the challenges of the future. We help validate new ideas and build impactful strategies, ultimately ensuring that members are market-ready. Visit the programme page here.

 

Upcoming events

Latest news and insights 

Learn more and get involved

 

Health and Social Care updates

Sign-up to get the latest updates and opportunities from our Health and Social Care programme.

 

 

Here are the five reasons to join the Health and Social Care Programme

Download

Join techUK groups

techUK members can get involved in our work by joining our groups, and stay up to date with the latest meetings and opportunities in the programme.

Learn more

Become a techUK member

Our members develop strong networks, build meaningful partnerships and grow their businesses as we all work together to create a thriving environment where industry, government and stakeholders come together to realise the positive outcomes tech can deliver.

Learn more