MHRA chief executive Lawrence Tallon made the comments during The Health Foundation's AI in the NHS 2025 event in London yesterday.

Tallon said: ‘The reality is the regularity framework is going to have come up a level because the technology is moving so quickly.'

The chief executive said guidance would have to be brought forward around ‘hot topics' such as ambient voice scribe and discharge summaries.

‘We need to bring those things forward even if they are guidance notes as opposed legislation or regulations,' he noted.

‘But ideally we will set out the overarching framework by the middle of next year.'

A National Commission into the Regulation of AI in Healthcare to review current regulations and provide recommendations for a new regulatory framework for AI in healthcare was established on 26 September.

The group is chaired by Professor Alastair Denniston, practising NHS clinician and head of the UK's Centre of Excellence in Regulatory Science in AI & Digital Health (CERSI-AI), and deputy chaired by the Patient Safety Commissioner Professor Henrietta Hughes.

Tallon said: ‘I believe that it we get this right we can indeed achieve our aspiration of a regulatory framework that moves at the pace of innovation.'