Key insight from CERSI-AI’s Impact and Sustainability Workshop
28th August 2025
On 18th June 2025, we hosted our CERSI-AI Impact and Sustainability Workshop. Led by Alastair Denniston and Peter Bannister, the workshop brought together regulators, clinicians, SME manufacturers, approved bodies, and patients to address a critical challenge: how we can build regulatory frameworks that both protect patients and enable breakthrough innovations to reach those who need them.
Highlights included:
- Stakeholder prioritisation sessions revealing critical regulatory needs which CERSI-AI can address.
- A showcase of HaRi – Hardian Health‘s Regulatory Intelligence database for AI-enabled medical device transparency.
- International insights from Joseph Ross (Yale University/Mayo Clinic CERSI).
The discussions reinforced that sustainable AI regulation requires collaboration across the entire healthcare ecosystem. Over the coming weeks, we’ll be sharing key insights and recommendations from these important conversations. A huge thank you to all speakers, facilitators, and attendees for your energy, ideas, and commitment. We look forward to continuing the journey together.
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Professor Alastair Denniston filmed with The Lancet Group
28th August 2025
Recording will be available in October.
CERSI-AI Director Professor Alastair Denniston has been filming with The Lancet Group, discussing how AI and machine learning are already transforming healthcare and research.
It’s a fascinating conversation about where we are now, and what’s next. We can’t wait to share the full recording with you this September!
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How do we ensure safe, effective implementation of AI for diabetic eye screening in the NHS?
28th August 2025
Earlier this summer, we brought together a group of experts for a focused workshop on evidence for ARIAS (Automated Retinal Image Analysis Software) in the English NHS Diabetic Eye Screening Programme (DESP).
Co-hosted by the ARIAS Research Group, the NIHR Incubator for AI and Digital Healthcare
- Current evidence on human grader QA standards
- Results from a recent head-to-head evaluation of multiple ARIAS tools
- Key requirements to support safe, evidence-informed implementation in the NHS
Our goal was to share insights on performance, safety, and regulatory needs, and to collaboratively shape early recommendations for implementation pathways.
Thank you to everyone who contributed to such a constructive and impactful discussion, we’re excited about the next steps!
Images and LinkedIn post here: https://www.linkedin.com/posts/cersi-uk_aiinhealthcare-nhsinnovation-diabeticeyescreening-activity-7357041126198894594-LYpK?utm_source=share&utm_medium=member_desktop&rcm=ACoAAFRfVxcBHqGcyb7Pe-QXQWWRVZ1T7jiZA-U
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When does a large language model (LLM) become a medical device?
28th August 2025
When does a large language model (LLM) become a medical device?That critical question shaped a series of insightful discussions at our recent expert workshop, part of the Qualification and Risk Classification of LLMs project led by the AI & Digital Health Group at the University of Birmingham.
Funded by The Health Foundation and supported by CERSI-AI, we brought together regulatory experts from the Medicines and Healthcare products Regulatory Agency, notified bodies, and AI verification specialists to explore one of digital health’s most urgent challenges.
Together, we analysed real-world LLM use cases across healthcare, mapped regulatory pathways, and assessed device classifications and risk levels under existing frameworks. The conversations highlighted both the practical hurdles and exciting opportunities facing innovators and regulators alike. A huge thank you to everyone who attended and contributed to the discussions, and to our brilliant team for helping to shape such a thought-provoking and productive day.
This work reflects our commitment to enabling smarter, more adaptive regulation that supports safe and effective innovation in digital health – a commitment we’ll continue advancing through our ongoing collaborative workshops.
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What does it take for NHS organisations to be truly AI ready?
28th August 2025
On 11th July 2025 at the Wellcome Trust in London, CERSI-AI was proud to support a high-energy, expert-led workshop exploring exactly that. We welcomed policy makers, clinicians, public representatives, and digital leaders to define what “AI readiness” looks like in practice.
Hosted by the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust‘s AI and Digital Health Research & Policy group, with support from NHS England and The Health Foundation, the workshop focused on four core aims:
- Characterise the organisational risks and opportunities of AI adoption
- Develop a readiness framework grounded in real-world NHS contexts
- Co-design practical tools to help provider organisations assess and build readiness
- Signpost existing tools, frameworks and evidence that can support NHS organisations on their AI journey
The day included implementation case studies, collaborative risk-mapping, and lively group discussions on what success should look like, all rooted in NHS realities and future ambitions.
A huge thank you to our Chairs Jeff Hogg and Alastair Denniston, our brilliant speakers Robin Carpenter, Andy Mayne and Kevin Percival who shared valuable lessons from across the system, and to everyone who contributed their time, insight and expertise.
This work is a vital step toward supporting safe, responsible and scalable AI adoption in the NHS. We’re looking forward to sharing the project’s outputs as they develop.
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CERSI-AI announced by Lord Vallance, Science Minister
28th August 2025
CERSI-AI was announced today by Lord Vallance, Science Minister and formerly Chief Scientific Adviser to the UK Government. Lord Vallance noted “New technologies are transforming our economy at rapid pace.
“The system of regulation must keep up with that, so that we can quickly and safely seize the economic and social benefits that new innovations could unlock…that is why we are launching CERSIs. They will make a valuable contribution to regulatory innovation – and will complement wider efforts to make the UK’s regulation fit for the future…”
Prof Denniston, Executive Director of CERSI-AI, said “Working across the health and technology ecosystem, the Centre will identify and address current and future needs and opportunities in the regulation of AI and digital healthcare products and services … Key to the Centre’s role will be balancing the needs of innovators, such as speed and market certainty, with those of the end-users, such as cost-effectiveness, safety, equity and sustainability, to ensure resulting technologies are able to truly improve people’s lives.”
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New national Centre of Excellence in AI and digital health awarded to Birmingham
28th August 2025
On 28 January 2025, the University of Birmingham was selected to host the Centre of Excellence for Regulatory Science and Innovation in AI & Digital Health Technologies (CERSI-AI), backed by a £1 million award to drive safe and effective innovation in digital healthcare University of BirminghamUK Research and Innovation.
CERSI-AI brings together a distinguished consortium of founding partners—including the University of York; industry innovators Hardian Health, Newton’s Tree, Romilly Life Sciences, and the Association of British HealthTech Industries; and NHS organisations like University Hospitals Birmingham NHS Foundation Trust and NHS Greater Glasgow and Clyde University of Birmingham, newtonstree.ai & birminghamhealthpartners.co.uk.
Guided by Executive Director Professor Alastair Denniston, the Centre aims to balance the pace of innovation with rigorous regulatory science—ensuring technologies are safe, effective, equitable, and sustainable, while supporting innovators with rapid development and regulatory clarity University of BirminghamUK Research and Innovation.
Part of a wider UK initiative, CERSI-AI is one of seven new CERSIs funded through a collaborative effort led by Innovate UK, the MHRA, the Office for Life Sciences, and the Medical Research Council. Collectively, they will generate tools, frameworks, and guidance to streamline the pathway for medical innovation in areas ranging from advanced therapies to digital health UK Research and Innovation University of Birmingham.
Full article here: New national Centre of Excellence in AI and digital health awarded to Birmingham – University of Birmingham











