Cersi- AI Patients & Public - NF
WHAT WE DO FOR HEALTHCARE
"We work with innovators, regulators, patients and the NHS to optimise the regulation of AI and Digital Healthcare so as to accelerate innovation that will improve people’s lives."
Protect patient safety in real-world use (not just “lab performance”)
Healthcare AI can fail through data drift, workflow misuse, poor integration, or unexpected edge cases. Regulation-focused authorities help define what “safe enough” means across the product lifecycle and support post-market monitoring approaches fit for AI.
Build public trust and legitimacy through transparency and explainability
Trust depends on people understanding what an AI is doing, why, and what happens when it’s wrong. Public/patient involvement has been explicitly linked to the need for explainability and transparency of AI decisions—especially where decisions affect care pathways.
Reduce bias and improve equity (so benefits aren’t unevenly distributed)
AI can embed or amplify health inequalities if trained on unrepresentative data or deployed unevenly. Regulation authorities can require stronger evidence on subgroup performance and support standards that foreground equity—where public engagement is repeatedly cited as part of bias-reduction approaches.
Enable responsible innovation and faster access to beneficial tools
Good regulation isn’t only restrictive—it can accelerate safe adoption by giving innovators and the NHS clearer pathways, evidence requirements, and confidence. CERSI-AI’s stated mission is to optimise regulation to accelerate innovation that improves lives.
Ensure policy and guidance reflect lived experience and societal values
Patient/public engagement helps surface what “good” looks like beyond accuracy: consent expectations, acceptable trade-offs, communication needs, and impacts on staff/patients. In the UK, the MHRA’s National Commission on AI regulation explicitly includes UK-wide engagement—public deliberation and targeted outreach—so those voices shape recommendations.
Clear Accountability!
Quisque sit amet nunc sit amet enim aliquet rhoncus. Aenean faucibus erat a sapien tincidunt, non faucibus velit interdum. Aenean ultrices maximus metus sit amet consectetur. Nullam sed lobortis nulla. Suspendisse commodo erat nec sapien viverra fringilla. Sed ut augue nulla. Etiam euismod, velit vitae pharetra luctus, quam ante rhoncus sem, eget eleifend risus mi at nisl. Nulla id ex id leo vestibulum rutrum. Suspendisse dapibus elit vitae eleifend euismod.
18+
Major projects ranging from Legislation Checklists to Automated AI Diagnosis
4130+
Website visitor engagements since August 2025
100%
National and Internation project success rate for Cersi-AI
320+
Project support enquiries for AI legislation guidance and implementation
“Ensuring today’s patients can benefit from tomorrow’s technologies.”
Cersi- AI Impact
The Impact of Cersi-AI
Smarter Regulation for Better Innovation
WHAT WE DO FOR HEALTHCARE
"We work with innovators, regulators, patients and the NHS to optimise the regulation of AI and Digital Healthcare so as to accelerate innovation that will improve people’s lives."
18+
Major projects ranging from Legislation Checklists to Automated AI Diagnosis
4130+
Website visitor engagements since August 2025
100%
National and Internation project success rate for Cersi-AI
320+
Project support enquiries for AI legislation guidance and implementation
About Us
At CERSI-AI, we work across the health and tech ecosystem to identify and address current and future needs and opportunities in the regulation of AI & Digital Healthcare products and services, using scientific methodology, community engagement and whole system impact. Our vision is to make the UK a global leader in the regulation of AI and digital healthcare, being recognised as the best place for innovators to develop, evaluate and market new products and services, and the best place for patients and health staff to benefit from AI and digitally-enabled healthcare.
Projects that are DELIVERING RESULTS already
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Nullam urna mauris, venenatis quis magna eget, sodales laoreet augue. Etiam nibh ligula, aliquet congue augue sed, venenatis aliquam justo. Phasellus tempor tincidunt cursus. Suspendisse auctor sapien eleifend venenatis gravida. Fusce hendrerit vulputate posuere. Nulla tincidunt metus non lectus mollis placerat. Donec eleifend diam mi, non convallis arcu commodo nec. Donec sit amet dictum nibh, consequat elementum leo. Sed iaculis tortor eget dapibus dapibus. Etiam efficitur lacus sed urna malesuada auctor.
Real GOVERNMENT ENGAGEMENT for change
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Keeping theUNITED KINGDOM centre stage
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Nullam urna mauris, venenatis quis magna eget, sodales laoreet augue. Etiam nibh ligula, aliquet congue augue sed, venenatis aliquam justo. Phasellus tempor tincidunt cursus. Suspendisse auctor sapien eleifend venenatis gravida. Fusce hendrerit vulputate posuere. Nulla tincidunt metus non lectus mollis placerat. Donec eleifend diam mi, non convallis arcu commodo nec. Donec sit amet dictum nibh, consequat elementum leo. Sed iaculis tortor eget dapibus dapibus. Etiam efficitur lacus sed urna malesuada auctor.
It’s not just about ‘what’ we do, it is also about ‘how’ we do it.
Partners
The founding partners and wider community of CERSI-AI bring together the knowledge and skills of the UK’s Universities, the NHS, regulators and industry.
People
Our leadership and wider community represent the UK’s exceptional expertise in regulatory science and the policy and practice of regulation and innovation.
Collaborate
It’s not just about ‘what’ we do, it is also about ‘how’ we do it. We are clear about our destination and how we want to get there. And we’d love you to get involved…
“Ensuring today’s patients can benefit from tomorrow’s technologies.”
Cersi- AI Patients & Public
Working with Patients and the Public
Smarter Regulation for Better Innovation
WHAT WE DO FOR HEALTHCARE
"We work with innovators, regulators, patients and the NHS to optimise the regulation of AI and Digital Healthcare so as to accelerate innovation that will improve people’s lives."
Protect patient safety in real-world use (not just “lab performance”)
Healthcare AI can fail through data drift, workflow misuse, poor integration, or unexpected edge cases. Regulation-focused authorities help define what “safe enough” means across the product lifecycle and support post-market monitoring approaches fit for AI.
Build public trust and legitimacy through transparency and explainability
Trust depends on people understanding what an AI is doing, why, and what happens when it’s wrong. Public/patient involvement has been explicitly linked to the need for explainability and transparency of AI decisions—especially where decisions affect care pathways.
Reduce bias and improve equity (so benefits aren’t unevenly distributed)
AI can embed or amplify health inequalities if trained on unrepresentative data or deployed unevenly. Regulation authorities can require stronger evidence on subgroup performance and support standards that foreground equity—where public engagement is repeatedly cited as part of bias-reduction approaches.
Enable responsible innovation and faster access to beneficial tools
Good regulation isn’t only restrictive—it can accelerate safe adoption by giving innovators and the NHS clearer pathways, evidence requirements, and confidence. CERSI-AI’s stated mission is to optimise regulation to accelerate innovation that improves lives.
Ensure policy and guidance reflect lived experience and societal values
Patient/public engagement helps surface what “good” looks like beyond accuracy: consent expectations, acceptable trade-offs, communication needs, and impacts on staff/patients. In the UK, the MHRA’s National Commission on AI regulation explicitly includes UK-wide engagement—public deliberation and targeted outreach—so those voices shape recommendations.
Enable responsible innovation and faster access to beneficial tools
Good regulation isn’t only restrictive—it can accelerate safe adoption by giving innovators and the NHS clearer pathways, evidence requirements, and confidence. CERSI-AI’s stated mission is to optimise regulation to accelerate innovation that improves lives.
What CERSI-AI does to ENGAGE PATIENTS & THE PUBLIC (practically)
Convening and co-design: bringing patients/public into workshops, forums, and lifecycle governance discussions (including ethics-by-design approaches).
Supporting regulators’ engagement programmes: feeding evidence and methods into wider national consultation and deliberation activity.
Turning engagement into guidance: translating public priorities (transparency, fairness, accountability) into usable standards, evaluation methods, and education resources for innovators and the NHS.
Nullam urna mauris, venenatis quis magna eget, sodales laoreet augue. Etiam nibh ligula, aliquet congue augue sed, venenatis aliquam justo. Phasellus tempor tincidunt cursus. Suspendisse auctor sapien eleifend venenatis gravida.
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Maecenas ac erat augue. Praesent vel vulputate metus. Aenean eu est sit amet nulla facilisis tempor eget efficitur ex. Nullam iaculis sem purus, eget feugiat lectus fermentum at. Suspendisse a pretium nisi, et placerat urna. In ultrices, mi in vehicula consectetur, massa orci ultrices tellus, ut consequat sem nunc eu sem. Ut ac eros id enim bibendum bibendum. Ut dui risus, tincidunt a ante eu, iaculis blandit diam. Sed fringilla molestie vestibulum.
Nullam urna mauris, venenatis quis magna eget, sodales laoreet augue. Etiam nibh ligula, aliquet congue augue sed, venenatis aliquam justo. Phasellus tempor tincidunt cursus. Suspendisse auctor sapien eleifend venenatis gravida.
18+
Major projects ranging from Legislation Checklists to Automated AI Diagnosis
4130+
Website visitor engagements since August 2025
100%
National and Internation project success rate for Cersi-AI
320+
Project support enquiries for AI legislation guidance and implementation
“Ensuring today’s patients can benefit from tomorrow’s technologies.”
Cersi-AI Research & Development Projects
Research Projects
Smarter Regulation for Better Innovation
WHAT WE FOCUS ON IN OUR SPECIALIST RESEARCH
Our research spans today’s most pressing challenges and tomorrow’s emerging opportunities in AI and digital health. Some of these technologies are already transforming care, while others are still being developed. Across all our work, we aim to ensure that AI is safe, effective, equitable and inclusive, sustainable, technically robust, and affordable for health systems.
Research Projects
These key projects form the backbone of CERSI-AI’s implementation phase and represent our most critical areas of delivery and focus. Developed in collaboration with our UK-wide network of partners, they tackle the priority challenges identified by innovators, regulators, and health systems, ensuring that AI and digital health technologies are safe, effective, and trusted.
From building transparency through AI medical device databases and post-market surveillance, to addressing algorithmic bias and secure data environments, these projects are designed to deliver real-world impact and position the UK as a global leader in regulatory science and innovation.
Explore the projects below and see how we’re driving smarter regulation for better innovation.
Optimising SDEs for AI Health Technologies
This project explores how Secure Data Environments can be optimised to support AI health technology development. Led by UHB and the University of Birmingham, it balances innovation, privacy and governance, proposing technical and policy improvements to enable safe, trusted NHS data access.
Qualification and Classification of Large Language Models
This project clarifies when large language models should qualify as medical devices in healthcare. Led by the University of Birmingham and UHB, it defines LLM use cases, risk classification and regulatory guidance to support safe, accountable adoption and inform UK and international regulation.
The AI Readiness Checklist
The AI Readiness Checklist is a practical self-assessment tool helping UK healthcare organisations prepare for safe, effective and equitable AI adoption. Funded by NHS England and the Health Foundation, it evaluates data, governance, workforce and ethics readiness to support deployment.
Hardian Regulatory Intelligence Platform (HaRi)
The Hardian Regulatory Intelligence Platform (HaRi) brings together global medical device regulatory and safety data into one connected system. Developed by Hardian Health, it supports faster, safer, and more transparent decision-making for regulators, healthcare professionals, researchers, and patients worldwide.
Borderline Manual for Software as a Medical Device (SaMD)/ AI as a Medical Device (AIaMD)
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.
Projects Funded by Cersi-AI
These projects are funded through the CERSI-AI Project Support Fund and reviewed by our Project Prioritisation Committee. Delivered by our CERSI-AI network partners, they represent our shared commitment to smarter regulation for better innovation, ensuring the UK leads in safe, effective, and equitable adoption of AI and digital health technologies.
Each project tackles key priorities such as AI-enabled medical device regulation, large language model qualification, post-market surveillance, and algorithmic performance and bias.
Learn more about each project below.
Qualifying Large Language Models for Oversight in Patient Safety Governance
This University of York project evaluates how large language models can support NHS patient safety governance. It compares LLM reviews with expert oversight, identifies risks, and develops qualification frameworks to inform safe, transparent and scalable regulatory use in non-diagnostic settings.
Model stress testing using causal generative AI
This Imperial College London project 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.
ARIES GenAI tool producing radiology-style reports in 3 imaging modalities
ARIES-MED evaluates a generative AI tool producing radiology-style reports across CT trauma, CT head and chest X-ray imaging. Led by the University of Glasgow, the project assesses clinical accuracy, safety and acceptability to support safe NHS adoption and regulatory guidance.
Autonomous Reporting of Chest X-Rays- side by side comparison of two CXR tools in Glasgow
This project evaluates two AI tools—qXR and Annalise Enterprise CXR—using 110,000 chest X-rays from NHS Greater Glasgow and Clyde. It assesses whether these tools can accurately identify normal scans without missing clinically important findings, potentially reducing reporting delays caused by radiologist shortages.
CLIO – extension to current Newton’s Tree UK project monitoring the risk of ambient scribes
To implement and evaluate a federated monitoring platform for AI scribe tools across NHS outpatient settings, enabling monitoring of input quality, AI output drift, and clinician over-reliance.
Collaborate with us …
If you have a project where you would like CERSI-AI endorsement or support
Primary Research Objectives
Identification of Need
We help Innovators know what to build, by helping the NHS ‘demand signal’, saying what patients and the NHS needs and are willing to pay for.
Project Design
We help Innovators know how to design their products to meet the needs of patients, health professionals and the wider NHS.
Technical Development
We help regulators address technical aspects of AI development, and help them ensure their processes balance the unique opportunities and risks.
Pre-market Evaluation
We work with innovators and regulators to design efficient but robust systems of evaluation to check the product is ready for routine use.
Post-market Surveillance
We design ways to assess that a product is continuing to work safely.
Updates & Withdrawals
We help innovators and the NHS decide when to replace a product, and how to do so safely.
“Ensuring today’s patients can benefit from tomorrow’s technologies.”
CERSI-AI Events
The Latest Events from Cersi AI
Smarter Regulation for Better Innovation
WHAT WE DO FOR HEALTHCARE
"We work with innovators, regulators, patients and the NHS to optimise the regulation of AI and Digital Healthcare so as to accelerate innovation that will improve people’s lives."
Future Events
Past Events
Nothing found.
“Getting today’s regulatory system ready for tomorrow’s technologies.”
Our People - Back Up
Our People
Smarter Regulation for Better Innovation
OUR LEADERSHIP & DEVELOPMENT TEAM
"CERSI-AI is led by an experienced team representing leaders in regulatory science and innovation in AI and Digital Health from across the UK, working with national partners and an international network of experts."
Meet the Team
We are the UK’s national Centre of Excellence for Regulatory Science and Innovation in AI and Digital Health. We work with innovators, regulators, patients and the NHS to optimise the regulation of AI and Digital Healthcare so as to accelerate innovation that will improve people’s lives.
Professor Alastair Denniston
Professor Alastair Denniston is Professor of Regulatory Science and Innovation at the University of Birmingham and Honorary Consultant Ophthalmologist at University Hospitals Birmingham NHSFT. He is a leader in the field of Artificial Intelligence (AI) and Digital Health Technologies.
Ms Charlotte Radovanovic
Charlotte Radovanovic is the Programme Manager at University Hospitals Birmingham NHS Foundation Trust, leading the operational delivery and strategic coordination of CERSI-AI.
Mr Mark Slater (PhD)
Mark Slater is a dedicated Patient and Public Partner for CERSI-AI, where he brings the public perspective to the forefront of AI research and policy in healthcare.
Professor Peter Bannister
Peter Bannister is Managing Director of Romilly Life Sciences and leads on activities related to CERSI AI’s commercial strategy.
Dr Hugh Harvey
Hugh is an ex-consultant radiologist, academic and entrepreneur, currently managing director at Hardian Health. He has helped bring to market dozens of SaMD including artificial intelligence systems, and is widely published and renowned for his insight into the healthtech landscape.
Mr Haris Shuaib
Haris Shuaib is the Founder and CEO of Newton’s Tree, a pioneering startup focused on AI transformation at scale within health and care. He also directs the Fellowships in Clinical Artificial Intelligence.
Professor Ibrahim Habli
Professor Ibrahim Habli is Professor of Safety-Critical Systems at the University of York, specialising in the design and assurance of software-intensive systems, with a strong focus on AI and autonomy.
Mr Andrew Davies
Andrew Davies is Executive Director of Digital Health at the Association of British HealthTech Industries (ABHI), where he works closely with system partners to ensure the UK fully leverages its unique NHS infrastructure to drive both citizen health and economic value through data-driven healthcare.
Mr Robin Carpenter
Robin Carpenter is Head of AI Governance and Policy at Newton’s Tree and an active contributor to CERSI AI’s strategic work.
Dr Joe Antoun
Joe brings a research-led and regulatory-aware perspective to the CERSI AI programme, contributing to our shared work on streamlining the adoption of safe, effective technologies.
Professor David Lowe
Professor David Lowe is an Emergency Medicine Consultant at NHS Greater Glasgow and Clyde, and a Professor at the University of Glasgow. He leads the Digital Health Validation Lab (dhvl.org) within the Living Lab supporting the creation of evidence from concept to clinic for healthtech with a focus on AI and devices.
Danica Baluyot
Danica is a Project Support Officer at University Hospitals Birmingham NHS Foundation Trust. She provides operational and administrative support across projects and events, helping the team ensure that AI in healthcare is safe, effective, and equitable.
Ms Ellen Coughlan
Ellen is Programmes & Partnerships Manager having worked at the Health Foundation delivering funding programmes and developing research to advance analytical capability in healthcare.
AI & Digital Health
Steering Group, Global Opportunities Group & National Council
Our Steering Group brings together leading experts from all sectors and stakeholder groups from across the UK.
Our Global Opportunities Group is chaired by Laura Adams, Senior Adviser to the National Academy of Medicine, USA, and represents experts from around the world. Our National Council represents the senior leadership of the UK’s Health and Life Sciences Ecosystem, including national regulators, government, industry and the NHS.
Patients and the public will be represented in all three groups.
We are currently in the process of appointing and on-boarding to these groups… so please check back later for more information.
Global Opportunities Group Overview and Purpose:
The CERSI-AI Global Opportunities Group (GOG) is a dedicated forum that focuses on identifying, developing, and strengthening international collaborations and opportunities in regulatory science and innovation for AI and digital health. A worldwide collaborative platform, this group connects global experts, innovators, and regulators to explore emerging opportunities, foster partnerships, and drive progress in AI-driven healthcare innovation on an international scale.
The three major functions of the CERSI-AI GOG are to:
- Advise CERSI-AI (as represented by the Executive Director and the Senior Leadership Team) on all CERSI-AI activities, bringing a global perspective to current projects and future proposals.
- Identify and access opportunities for CERSI-AI in a global context, to contribute to relevant initiatives around the world in the regulation and innovation of AI and digital health.
- Horizon scan, identifying at a global level where advances in regulatory approaches to AI are occurring, and helping CERSI-AI learn from these and supporting CERSI-AI in sharing best practice from around the world, wherever it may be found.
Meet the Global Opportunities Group
Ms Laura Adams
Laura L. Adams is a Senior Advisor at the National Academy of Medicine, where she leads initiatives in digital health and evidence mobilisation.
Dr Bilal Mateen
Bilal Mateen, is the inaugural Chief AI Officer at PATH, where he leads the organisation’s AI strategy and oversees programs developing innovative AI solutions to tackle major healthcare challenges, including strengthening regulatory systems for emerging technologies.
Dr Melissa McCradden
Melissa McCradden is the Artificial Intelligence Director and Deputy Research Director at the Women's and Children's Health Network, and a Fellow at the Australian Institute for Machine Learning.
Mr Marc Lamoureux
Marc Lamoureux is the Head of the Digital Health Division at Health Canada. Since 2011, Marc has worked at Health Canada specializing in the technical assessment of medical software, diagnostic imaging devices, and radiotherapy equipment.
Professor Stephen Gilbert
Stephen Gilbert is a leading expert in medical device regulatory science at the Else Kröner Fresenius Center for Digital Health, Technische Universität Dresden, where he leads interdisciplinary research on regulatory frameworks for digital and AI-enabled medical technologies.
Dr Peiling Yap
Peiling Yap is a pharmacist and infectious-diseases epidemiologist with over 15 years of experience in global and public health.
Adjunct Associate Professor Raymond Chua Swee Boon
Raymond Chua Swee Boon is a public health-trained physician and presently the Deputy Director-General of Health (Health Regulation) at Singapore’s Ministry of Health (MoH) and the Chief Executive Officer of the Health Sciences Authority (HSA), overseeing the regulations of healthcare services, information and health products respectively.
Mr Ran Milman
Ran Milman is Head of AI Policy at the Israeli Ministry of Health and a key contributor to HealthAI, where he plays a central role in shaping global strategies for responsible AI in healthcare.
Mr Russel Pearson
Russell Pearson is the AI Regulatory Policy and Projects Lead at the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), where he leads national efforts to ensure the safe and effective integration of artificial intelligence in healthcare.
Mr Pat Baird
Pat Baird is the Head of Global Software Standards at Philips, where he leads international efforts to develop regulatory frameworks and standards for software and artificial intelligence in healthcare.
Anindita (Annie) Saha
Annie Saha is the Assistant Director for the Digital Health Center of Excellence (DHCoE) at the FDA’s Center for Devices and Radiological Health (CDRH). She leads efforts in regulatory science, partnerships, and operations to support digital health innovation and equity.
Jessica Paulsen
Jessica Paulsen is the Deputy Director of AI and Software at the UK Medicines and Healthcare products Regulatory Agency (MHRA), where she leads the development of regulatory approaches for digital health, medical device software, and AI‑enabled technologies.
Dr Camilla Fleetcroft
Camilla Fleetcroft is the Deputy Director of AI Regulatory Policy at PATH, where she leads global initiatives on AI regulation, including regulatory sandboxes, AI‑enabled medical devices, and international collaboration to strengthen health systems.
CERSI-AI National Council
The CERSI-AI National Council (NC) is an advisory group that provides strategic direction, fosters national and international collaboration, and drives regulatory innovation to support the safe and effective adoption of AI in healthcare. The Council aims to:
- Provide strategic guidance to help CERSI-AI align to areas of national priority and international opportunity where CERSI-AI may have the greatest positive impact, to support the health and wealth of the UK.
- Provide strategic guidance to help CERSI-AI work effectively with other actors within the wider regulatory and innovation landscape to help optimise the UK’s regulatory ecosystem for the innovation and adoption of AI in healthcare.
- Strengthen national and international collaboration between regulatory agencies, relevant arms length bodies, industry leaders, and research institutions within the area of AI health technologies.
- Advocate for evidence-based policy and regulatory development to enable AI innovation while ensuring patient safety.
- To receive advance intelligence from CERSI-AI regarding new discoveries, challenges and opportunities in relation to AI health technologies, that may be relevant to Council Members and their institutions.
AI & Digital Health
Community of Practice
If you are interested in the regulation and safe implementation of AI and advanced digital technologies into healthcare, then this is the community for you. If you are already working in this field – whether researcher, innovator, health professional, regulator or through lived experience – we would like to hear about your work, connect you to others in the community, and explore ways we can work together. If you just want to find out more, then you’re welcome! We will be hosting a wide range of community events from educational seminars, to research updates, and online resources.
We are currently in the process of appointing and on-boarding to these groups… so please check back later for more information.
“Creating the regulatory system of the future for AI and digital health technologies.”
CERSI-AI News
The Latest News from the CERSI-AI Network
Smarter Regulation for Better Innovation
WHAT WE DO FOR HEALTHCARE
"We work with innovators, regulators, patients and the NHS to optimise the regulation of AI and Digital Healthcare so as to accelerate innovation that will improve people’s lives."
Latest News
“Getting today’s regulatory system ready for tomorrow’s technologies.”
Our People
Our People
Smarter Regulation for Better Innovation
OUR LEADERSHIP & DEVELOPMENT TEAM
"CERSI-AI is led by an experienced team representing leaders in regulatory science and innovation in AI and Digital Health from across the UK, working with national partners and an international network of experts."
Meet the Team
Professor Alastair Denniston
Professor Alastair Denniston is Professor of Regulatory Science and Innovation at the University of Birmingham and Honorary Consultant Ophthalmologist at…
Ms Charlotte Radovanovic
Charlotte Radovanovic is the Programme Manager at University Hospitals Birmingham NHS Foundation Trust, leading the operational delivery and strategic…
Ms Ellen Coughlan
Ellen is Programmes & Partnerships Manager having worked at the Health Foundation delivering funding programmes and developing research to advance analytical…
Mr Mark Slater (PhD)
Mark Slater is a dedicated Patient and Public Partner for CERSI-AI, where he brings the public perspective to the forefront of AI research and policy in…
Professor Peter Bannister
Peter Bannister is Managing Director of Romilly Life Sciences and leads on activities related to CERSI AI’s commercial strategy.
Dr Hugh Harvey
Hugh is an ex-consultant radiologist, academic and entrepreneur, currently managing director at Hardian Health. He has helped bring to market dozens of SaMD…
Mr Haris Shuaib
Haris Shuaib is the Founder and CEO of Newton’s Tree, a pioneering startup focused on AI transformation at scale within health and care. He also directs the…
Professor Ibrahim Habli
Professor Ibrahim Habli is Professor of Safety-Critical Systems at the University of York, specialising in the design and assurance of software-intensive…
Mr Andrew Davies
Andrew Davies is Executive Director of Digital Health at the Association of British HealthTech Industries (ABHI), where he works closely with system partners…
Mr Robin Carpenter
Robin Carpenter is Head of AI Governance and Policy at Newton’s Tree and an active contributor to CERSI AI’s strategic work.
Dr Joe Antoun
Joe brings a research-led and regulatory-aware perspective to the CERSI AI programme, contributing to our shared work on streamlining the adoption of safe,…
Professor David Lowe
Professor David Lowe is an Emergency Medicine Consultant at NHS Greater Glasgow and Clyde, and a Professor at the University of Glasgow. He leads the Digital…
Danica Baluyot
Danica is a Project Support Officer at University Hospitals Birmingham NHS Foundation Trust. She provides operational and administrative support across…
AI & Digital Health
Steering Group, Global Opportunities Group & National Council
Our Steering Group brings together leading experts from all sectors and stakeholder groups from across the UK.
Our Global Opportunities Group is chaired by Laura Adams, Senior Adviser to the National Academy of Medicine, USA, and represents experts from around the world. Our National Council represents the senior leadership of the UK’s Health and Life Sciences Ecosystem, including national regulators, government, industry and the NHS.
Patients and the public will be represented in all three groups.
We are currently in the process of appointing and on-boarding to these groups… so please check back later for more information.
Global Opportunities Group Overview and Purpose:
The CERSI-AI Global Opportunities Group (GOG) is a dedicated forum that focuses on identifying, developing, and strengthening international collaborations and opportunities in regulatory science and innovation for AI and digital health. A worldwide collaborative platform, this group connects global experts, innovators, and regulators to explore emerging opportunities, foster partnerships, and drive progress in AI-driven healthcare innovation on an international scale.
The three major functions of the CERSI-AI GOG are to:
- Advise CERSI-AI (as represented by the Executive Director and the Senior Leadership Team) on all CERSI-AI activities, bringing a global perspective to current projects and future proposals.
- Identify and access opportunities for CERSI-AI in a global context, to contribute to relevant initiatives around the world in the regulation and innovation of AI and digital health.
- Horizon scan, identifying at a global level where advances in regulatory approaches to AI are occurring, and helping CERSI-AI learn from these and supporting CERSI-AI in sharing best practice from around the world, wherever it may be found.
Meet the Global Opportunities Group
Ms Laura Adams
Laura L. Adams is a Senior Advisor at the National Academy of Medicine, where she leads initiatives in digital health and evidence mobilisation.
Dr Bilal Mateen
Bilal Mateen, is the inaugural Chief AI Officer at PATH, where he leads the organisation’s AI strategy and oversees programs developing innovative AI solutions to tackle major healthcare challenges, including strengthening regulatory systems for emerging technologies.
Dr Melissa McCradden
Melissa McCradden is the Artificial Intelligence Director and Deputy Research Director at the Women's and Children's Health Network, and a Fellow at the Australian Institute for Machine Learning.
Mr Marc Lamoureux
Marc Lamoureux is the Head of the Digital Health Division at Health Canada. Since 2011, Marc has worked at Health Canada specializing in the technical assessment of medical software, diagnostic imaging devices, and radiotherapy equipment.
Professor Stephen Gilbert
Stephen Gilbert is a leading expert in medical device regulatory science at the Else Kröner Fresenius Center for Digital Health, Technische Universität Dresden, where he leads interdisciplinary research on regulatory frameworks for digital and AI-enabled medical technologies.
Dr Peiling Yap
Peiling Yap is a pharmacist and infectious-diseases epidemiologist with over 15 years of experience in global and public health.
Adjunct Associate Professor Raymond Chua Swee Boon
Raymond Chua Swee Boon is a public health-trained physician and presently the Deputy Director-General of Health (Health Regulation) at Singapore’s Ministry of Health (MoH) and the Chief Executive Officer of the Health Sciences Authority (HSA), overseeing the regulations of healthcare services, information and health products respectively.
Mr Ran Milman
Ran Milman is Head of AI Policy at the Israeli Ministry of Health and a key contributor to HealthAI, where he plays a central role in shaping global strategies for responsible AI in healthcare.
Mr Russel Pearson
Russell Pearson is the AI Regulatory Policy and Projects Lead at the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), where he leads national efforts to ensure the safe and effective integration of artificial intelligence in healthcare.
Mr Pat Baird
Pat Baird is the Head of Global Software Standards at Philips, where he leads international efforts to develop regulatory frameworks and standards for software and artificial intelligence in healthcare.
Anindita (Annie) Saha
Annie Saha is the Assistant Director for the Digital Health Center of Excellence (DHCoE) at the FDA’s Center for Devices and Radiological Health (CDRH). She leads efforts in regulatory science, partnerships, and operations to support digital health innovation and equity.
Jessica Paulsen
Jessica Paulsen is the Deputy Director of AI and Software at the UK Medicines and Healthcare products Regulatory Agency (MHRA), where she leads the development of regulatory approaches for digital health, medical device software, and AI‑enabled technologies.
Dr Camilla Fleetcroft
Camilla Fleetcroft is the Deputy Director of AI Regulatory Policy at PATH, where she leads global initiatives on AI regulation, including regulatory sandboxes, AI‑enabled medical devices, and international collaboration to strengthen health systems.
CERSI-AI National Council
The CERSI-AI National Council (NC) is an advisory group that provides strategic direction, fosters national and international collaboration, and drives regulatory innovation to support the safe and effective adoption of AI in healthcare. The Council aims to:
- Provide strategic guidance to help CERSI-AI align to areas of national priority and international opportunity where CERSI-AI may have the greatest positive impact, to support the health and wealth of the UK.
- Provide strategic guidance to help CERSI-AI work effectively with other actors within the wider regulatory and innovation landscape to help optimise the UK’s regulatory ecosystem for the innovation and adoption of AI in healthcare.
- Strengthen national and international collaboration between regulatory agencies, relevant arms length bodies, industry leaders, and research institutions within the area of AI health technologies.
- Advocate for evidence-based policy and regulatory development to enable AI innovation while ensuring patient safety.
- To receive advance intelligence from CERSI-AI regarding new discoveries, challenges and opportunities in relation to AI health technologies, that may be relevant to Council Members and their institutions.
AI & Digital Health
Community of Practice
If you are interested in the regulation and safe implementation of AI and advanced digital technologies into healthcare, then this is the community for you. If you are already working in this field – whether researcher, innovator, health professional, regulator or through lived experience – we would like to hear about your work, connect you to others in the community, and explore ways we can work together. If you just want to find out more, then you’re welcome! We will be hosting a wide range of community events from educational seminars, to research updates, and online resources.
We are currently in the process of appointing and on-boarding to these groups… so please check back later for more information.
“Creating the regulatory system of the future for AI and digital health technologies.”
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Smarter Regulation for Better Innovation
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