The government has announced a new £100 million UK investment to support the use of AI in life sciences to treat previously incurable diseases. It comes as MHRA, the UK healthcare regulator, unveils plans for a “regulatory sandbox” to test AI programmes before they come to market.

The announcements are the latest in swathes of AI and medical innovation reforms with a focus on encouraging the use of AI within healthcare and life sciences, alongside a programme of regulatory change. A £30m fund for Integrated Care Systems to buy Med Tech products and a £21m NHS AI diagnostics fund were both announced earlier this year. The latest announcement is the largest sum committed to date and comes as the UK hosts the first global AI safety summit this week (w/c 30 October 2023).

The funding comes alongside a huge amount of regulatory change. We have summarised the key reforms in our latest Health Tech series:

HealthTech and AI – the current legal landscape (burges-salmon.com)

Health Tech Series: Key regulatory changes for Health Tech developers (burges-salmon.com)

£100 million for “life-changing” AI solutions

The Prime Minister announced a further £100 million worth of funding for the deployment of AI in areas likely to benefit from “transformational breakthroughs” linked to previously incurable diseases.  

In line with the seven key healthcare missions underpinning the government's Life Sciences Vision, the investment aims to support the introduction of AI designed to tackle incurable diseases such as cancer and dementia through early detection/intervention and increased efficacy of clinical trials.  Investment will be focused on areas of the UK with the greatest clinical need, with the aim to trial new technologies over the next 18 months. 

It is not clear exactly how or where the investment will be made available to the market and the announcement remains subject to a full business case. While the funding was described as “new” it is also not entirely clear whether there is any overlap with the £30m and £21m announced earlier this year. 

MHRA’s AI-Airlock

The Medical and Healthcare Regulatory Agency have confirmed plans for the development of a “regulatory sandbox” designed to test innovative AI programmes before they come to market.   

The MHRA recognise that regulatory requirements can be a major barrier in the route to market for AI products, as new technology may not be compatible with existing trial techniques. The sandbox initiative, dubbed “AI-Airlock”, will allow technology to be tested within a controlled NHS setting prior to market approval.  This will help developers to identify where they need to build more evidence for safety and efficacy assessments in order to support a successful application for market authorisation. 

The MHRA hope this will ensure that NHS patients are the first to access innovative AI-backed treatment and diagnostic care, whilst allowing developers to demonstrate the viability of their products in a lower risk environment.   

Further information on the delivery of the initiative and its regulatory overview will be available once the sandbox is launched in 2024.   

If you would like to discuss any issues relating to the regulatory framework surrounding Health Tech in the UK, or its reform, please contact a member of our Health Tech team.

This article was written by Rory Trust and Eilidh Sheach.