Experts have said Britain’s new approach to regulating AI in healthcare could give UK tech firms a “competitive edge” by letting them prove their technology in the NHS earlier.
The UK government on Tuesday accepted all 44 recommendations of the National Commission into the Regulation of AI in Healthcare, paving the way for a shake-up of how AI-powered medical devices are approved and monitored.
Martin Turner, director of policy and external affairs at the Bioindustry Association, told City AM the Medicines and Healthcare products Regulatory Agency’s (MHRA) approach “absolutely makes the UK a leading testbed for innovation”.
“Taking pro-innovation approaches such as this gives UK innovators a competitive edge, as they get to test and develop their products in collaboration with the regulator and gain proof of concept in a large healthcare system, often before their international peers”, he said.
The overhaul will move regulation away from relying heavily on a one-off assessment before an AI medical device enters the market and towards monitoring its performance throughout its working life.
The approach could lower barriers for health tech companies trying to bring products to market and make Britain more attractive to investors, but the benefits would depend on the NHS actually buying the technology.
Steve Lee, executive director of regulation at the Association of British Healthtech Industries, told City AM the plans were a “positive direction of travel for Healthtech companies and investors”.
“A proportionate, lifecycle-based approach could enable safe and innovative technologies to reach patients earlier, while providing greater regulatory clarity for companies developing and investing in AI”, he said.
But Lee warned that “continuous oversight should not mean continuous regulatory burden”.
“Regulation is also only part of the picture, companies still need a viable route into NHS adoption and procurement if innovation is to translate into commercial growth”.
Turner similarly said lower barriers to entry depended on promised improvements to adoption and the NHS’s willingness to reimburse companies being delivered.
UK bids to become AI health testbed #
Around two-thirds of respondents to the Commission said the existing regulatory framework restricts innovation, while 77 per cent of healthcare professionals who responded called for significant reform or a complete overhaul.
The MHRA on Tuesday also opened applications for the third phase of its AI airlock, a regulatory sandbox where companies can test AI medical devices alongside regulators.
Its latest phase will focus on monitoring the technology after deployment, with the first firms due to be selected next month. Draft guidance on how companies should handle AI medical devices that change and improve over time is due by December, while the regulator will consult next year on how to classify such products.
Turner said the approach should allow companies to demonstrate proof of concept and value faster, which could encourage investment and acquisitions.
“With the UK’s noted strengths in both life sciences and AI, we’re seeing huge interest in our ecosystem of startups and scaleups”, he told City AM. He added: “The MHRA’s approach should enable faster demonstration of concept and value, which we expect will lead to greater investment and acquisitions in the months and years ahead”.
However, he said the government and the MHRA needed to ensure the UK regime remained consistent with major overseas markets so firms gaining an early advantage at home did not face new barriers when expanding abroad.
Health innovation minister James Frith said the government wanted patients to benefit from AI more quickly but that “innovation must never come at the expense of patient safety”.