Centre of Excellence for Regulatory Science and Innovation in AI & Digital Health Technologies (CERSI-AI)
Lead Research Organisation:
University of Birmingham
Department Name: Not supplied
Abstract
The UK has a unique opportunity to lead the way in the rapidly growing fields of artificial intelligence (Al) and digital healthcare. To consolidate its position as a global leader in this field, the UK needs to ensure regulation is optimised to accelerate innovation ('pro-innovation') whilst also ensuring these technologies are safe, cost-effective, equitable, and sustainable ('responsible innovation').
Regulatory science utilises scientific methodology to support this optimisation process, but most regulators currently lack this expertise 'in-house', especially for novel and advanced technologies. Ensuring regulators strike this balance will be the remit of the UK Centre of Excellence for Regulatory Science and Innovation
(CERSI) for Al and Digital HealthTech. Our CERSI will bring together experts working in different sectors to enhance the efficiency, effectiveness, safety, fairness, and sustainability of regulation and innovation. It will do so by connecting experts and supporting their ability to work together on pressing scientific questions which have the capability to streamline regulatory assessments and policy, facilitating a faster translation of these technologies from concept to consumer whilst upholding and enhancing principles around safety and equity. "
Regulatory science utilises scientific methodology to support this optimisation process, but most regulators currently lack this expertise 'in-house', especially for novel and advanced technologies. Ensuring regulators strike this balance will be the remit of the UK Centre of Excellence for Regulatory Science and Innovation
(CERSI) for Al and Digital HealthTech. Our CERSI will bring together experts working in different sectors to enhance the efficiency, effectiveness, safety, fairness, and sustainability of regulation and innovation. It will do so by connecting experts and supporting their ability to work together on pressing scientific questions which have the capability to streamline regulatory assessments and policy, facilitating a faster translation of these technologies from concept to consumer whilst upholding and enhancing principles around safety and equity. "
Technical Summary
We will create a world-leading, network-based Centre of Excellence for Regulatory Science and Innovation (CERSI) in Artificial Intelligence (Al) and Digital Health Technologies, centred on Al/software as a medical device (AlaMD/SaMD). The UK is uniquely placed to benefit from this accelerating market, safely, equitably and rapidly enhancing the health and wealth of the nation. This CERSI will accelerate Al/Digital innovation by providing evidence, tools, and processes that optimise the regulatory system for these technologies, from those that are established but under-leveraged (e.g. Al-enabled decision support tools), to emerging technologies (e.g. autonomous Al diagnostics, Al-enabled therapeutics, wearables) and frontier technologies (e.g. Medical large language models and Foundation models).
Having undertaken prioritisation exercises to map the needs of innovators and regulators in the Discovery Phase, we will now deliver solutions in the Implementation Phase. This will leverage the network's capability to address the needs of innovators (speed and market certainty) alongside those of the consumer (cost-effectiveness, safety, equity, and sustainability), balancing 'pro-innovation' and 'responsible innovation'. We will deliver the evidence, tools, standards and processes needed to support the sector and its regulators across the total product life-cycle. This CERSI is highly timely in directly addressing UK Government strategic priorities in relation to Al (global leadership, innovation and safety), building on both the RHC Report on AlaMD and the MHRA's Change Programme for SaMD/AlaMD. Our engagement with innovators and regulators has already identified opportunities/needs around post-market surveillance for SaMD/AlaMD, data availability and interoperability within the health system, algorithmic performance drift, algorithmic bias and health inequalities, frontier technologies such as large language models and foundation models, and direct-to-consumer health and well-being apps.
The CERSI for Al & Digital HealthTech will support the creation and deployment of products bringing benefit to patients and the health system, whilst reducing the burden on innovators and businesses, acting as a critical 'innovation optimiser' enabling the UK to unlock the opportunity of Al and digital healthcare for the health and wealth of the UK.
Having undertaken prioritisation exercises to map the needs of innovators and regulators in the Discovery Phase, we will now deliver solutions in the Implementation Phase. This will leverage the network's capability to address the needs of innovators (speed and market certainty) alongside those of the consumer (cost-effectiveness, safety, equity, and sustainability), balancing 'pro-innovation' and 'responsible innovation'. We will deliver the evidence, tools, standards and processes needed to support the sector and its regulators across the total product life-cycle. This CERSI is highly timely in directly addressing UK Government strategic priorities in relation to Al (global leadership, innovation and safety), building on both the RHC Report on AlaMD and the MHRA's Change Programme for SaMD/AlaMD. Our engagement with innovators and regulators has already identified opportunities/needs around post-market surveillance for SaMD/AlaMD, data availability and interoperability within the health system, algorithmic performance drift, algorithmic bias and health inequalities, frontier technologies such as large language models and foundation models, and direct-to-consumer health and well-being apps.
The CERSI for Al & Digital HealthTech will support the creation and deployment of products bringing benefit to patients and the health system, whilst reducing the burden on innovators and businesses, acting as a critical 'innovation optimiser' enabling the UK to unlock the opportunity of Al and digital healthcare for the health and wealth of the UK.
