Digital health products, from smartphone apps to AI-enhanced diagnostic devices, are increasingly beneficial for patients and healthcare professionals alike – and the UK is a global pioneer in this sector. However, the rapid evolution of artificial intelligence and medical technologies presents complex regulatory challenges that must be addressed to ensure innovation thrives while safeguarding patients and users.
To tackle this issue, a new Centre of Excellence in Regulatory Science and Innovation (CERSI) in Transformative Digital Health and AI will be established, with £1 million funding from the UK’s Innovate UK, the Medical Research Council, the Medicines and Healthcare products Regulatory Agency, and the Office for Life Sciences – announced today.
RADIANT is the interdisciplinary consortium behind this CERSI. Led by Dr Gabriella Spinelli, Reader at Brunel University London’s Design School, the CERSI involves three other world-leading universities based in the capital: King’s College London, University College London and the University of Westminster. The universities will be joined by Imperial College NHS Trust and three key business collaborators: the consortium’s co-lead Helix Data Innovation, plus venture builder Zinc and global knowledge provider BMJ Group. The Health Innovation Network of South London will also work with the Consortium.
The CERSI represents a strategic initiative by the regulator to establish trusted research groups capable of influencing policy, guiding innovation, and supporting transformative digital health and AI solutions. RADIANT will address the critical need for a regulatory framework that is proportionate, evidence-based, and supportive of businesses and innovators, while ensuring that digital health products are safe, secure, inclusive, trusted, and sustainable.
RADIANT’s work will be guided by the needs of six key stakeholder groups – patients, clinicians, innovators, regulators and policymakers, service providers, and academia – ensuring that its outputs are inclusive and actionable. The team will apply implementation science to translate research into policy action. The team is supported by a strong Advisory Board, including the Association of British HealthTech Industries, the National Institute for Health and Care Excellence, the National Institute for Health and Care Research’s Healthtech Research Centres and a patient advisory group.
The Centre’s co-leadership by Helix Data Innovation, alongside Brunel University of London, highlights the unique collaboration between academic and industrial leaders in healthcare innovation. “The combined expertise at the intersection of design engineering, computer science, and health will drive impactful regulatory science to empower innovators and safeguard users,” said Dr Spinelli, who is also the Director of Innovation and Digital Health in Brunel Partners Academic Centre for Health Sciences. “We will work closely with other funded CERSIs to develop a complementary offer to the whole UK healthcare innovation ecosystem.”
Dr Lucie Burgess, Founder and Director of Helix Data Innovation, added: “With the strategically important digital health sector forecast to be worth $188 billion globally by 2030, it’s essential that the UK’s strength is underpinned by a regulatory environment that gives consumers and companies the confidence that digital healthcare solutions provide transformative benefits while being safe and trusted.”
Prof Hua Zhao, Brunel’s Pro Vice-Chancellor for Research, said: “Brunel and its consortium partners want to produce science that can become guidance for regulation. The strategic investment by Innovate UK, the Medical Research Council, the MHRA and the Office for Life Sciences is fundamental to improve patient care and to boost the UK economy.”
Launching in February for an initial year, the Centre will focus on:
- Building a collaborative network: Growing institutional and individual memberships and initiating community-led pilot projects.
- Advancing regulatory support for innovation: Developing novel tools to support innovators through their regulatory journey, assessing AI risk frameworks, and creating tailored resources for SMEs.
- Upskilling the sector: Delivering targeted training programmes for innovators, healthcare leaders, and regulators to navigate the evolving landscape.
- Driving global insights and solutions: Collaborating with an international working group and creating a Digital Health and AI Observatory to identify future challenges and co-design regulatory solutions.
- Sustainability and long-term impact: Evaluating outcomes and ensuring the Centre’s work extends beyond its initial year for lasting contributions to the healthcare sector.
RADIANT, the Brunel-led CERSI in Transformative Digital Health and AI, is one of seven national CERSIs established in Human Health and it is set to position the UK as a global trailblazer in health regulatory science and innovation.
Reported by:
Joe Buchanunn,
Media Relations
+44 (0)1895 268821
joe.buchanunn@brunel.ac.uk