Research and innovation support for NHS and industry:
01
Education and Knowledge Transfer
Recognising the urgent need for leaders of AI implementation across the healthcare workforce, we created the AI Implementation (Healthcare) MSc, the UK’s first taught programme focused on equipping clinical, technical and operational leaders with the expertise to advance responsible and impactful AI innovations. In parallel, online seminars and CPD courses have been developed to accelerate shared understanding across clinicians, digital
02
Hardian Regulatory Intelligence Platform (HaRi) – Regulatory Intelligence
Delivered by Hardian Health, this project has established a tool that standardises the availability of information about medical devices. HaRi displays registration data from the UK, EU and USA as well as peer reviewed evidence and adverse event data from the UK and UK. Designed for regulators, providers, innovators, procurement teams, and patients, it enables faster, safer adoption through its free-to-use site for public users and additional functionality for commercial users. We’re exploring how further enhanced functionality for the MHRA could support global intelligence including advanced early signal detection of safety.

03
AI Readiness Assurance Framework and the AI Readiness Checklist for NHS providers
Funded by the Health Foundation, this practical self-assessment tool will help UK healthcare organisations prepare for safe, effective, and equitable AI adoption. It evaluates readiness across key domains including data and digital infrastructure, governance, workforce capability, ethics, and organisational strategy. The team in Birmingham’s Responsible Innovation Group for Health and Technology (Bright) developed this tool through desk research, expert interviews, and stakeholder consultation. The checklist is now open for public consultation and is being piloted with NHS trusts.

04
Borderline Manual (Software as a Medical Device/AI as a Medical Device)
The Borderline Manual for SaMD and AIaMD provides practical UK guidance on classifying AI health technologies as medical devices. Developed by the University of Birmingham and Hardian Health, it clarifies regulatory status, risk classification and compliance pathways to support safe, accelerated innovation. We’ve worked closely with the regulator, MHRA, to support consistent borderline classification decisions. Our aim is to reduce regulatory ambiguity for innovators and accelerate safe adoption.
05
Optimising Secure Data Environments (SDEs)
Funded by NHS England’s Data for R&D Programme and the Office for Life Science, this project explored how SDEs can be made secure, innovation-ready, and trusted. Covering governance, data access, evaluation, disclosure risk, and sustainable operating models for pre- and post-market AI testing, we published an analysis of model egress and disclosure risk, recommendations, a report and insights from patients and the public. Our vision is a future-ready SDE ecosystem that balances security with functionality, enabling access to NHS data for AI innovation, robust governance, and transparent engagement with the public.
Solving novel regulatory and safety problems
01
Health Chatbot Users’ Guide
An international team of academics, health professionals and technologists, led by Dr Joe Alderman, began to build a global effort on safety guidelines for the public when using AI health chatbots by building The Health Chatbot Users’ Guide in February 2026
03
Model stress testing using causal generative AI
This Imperial College London project in collaboration with the EPSRC Causality in Healthcare AI Hub uses causal generative AI to stress test medical imaging models with realistic synthetic data. It identifies performance weaknesses across populations and conditions, supporting safer clinical deployment and informing MHRA guidance on AI evaluation.
05
LLMs – Qualification & Risk Classification as Medical Devices
This project is focused on clarifying when large language models (LLMs) should qualify as medical devices in healthcare. Led by the University of Birmingham and UHB, and supported by the Health Foundation, the project identified common healthcare use cases for LLMs, developed intended-use statements, and applied regulatory principles to determine whether those uses fall within the definition of a medical device. Through identifying characteristics that influence risk classification, we have produced policy recommendations for UK regulators (MHRA, NICE, CQC) and international bodies. It also aims to guide the future regulatory landscape by clarifying how LLM-based medical use cases should be assessed and governed, outlining what an optimal future approach to regulating these technologies should entail, and ultimately creating clarity on how LLMs fit within medical device regulation what that means for their safe and effective use.
Convening and coordination of partners and stakeholders
01
Health AI Global Governance Forum Workshop
We delivered a workshop at the Health AI Global Governance Forum in Nairobi in December 2025. The session explored our framework for responding when Health AI fails, based on the OODA Loop (Observe, Orientate, Decide, Act), supporting rapid, structured decision-making for clinical AI solutions.
02
Davos 2026 - From Pilots to Impact Contribution
Alastair Denniston, Director of CERSI-AI, was on the Davos 2026 programme for the Roundtable: From Pilots to Impact – Collaborative Pathways for Responsible AI in Health. Alastair spoke of the importance of the “value intersect”: the point where priority clinical need, technological capability, and system readiness align. Strengthening regulatory clarity and preparedness is a critical part of that readiness, and a central focus of the National Commission’s work.











