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NHS England is ‘reviewing safety regulations for GP diagnostic apps’

GP diagnostic apps such as Babylon’s GP at Hand may face additional regulation to ensure their safety, the health secretary has said.

Speaking today in the House of Commons, Matt Hancock said NHS England is currently ‘reviewing’ how patients can be reassured such new technology is safe and effective.

Meanwhile, a letter from former health secretary Jeremy Hunt revealed that the Government was reviewing whether there were any ‘gaps in the regulatory model’ with regards to these apps.

The concerns were raised by House of Commons Health Committee chair Dr Sarah Wollaston, a former GP, who asked Mr Hancock how he is planning to ensure diagnostic apps ‘have been properly evaluated for safety and effectiveness’.

This comes after Mr Hancock used his first speech as health secretary to say that Babylon-style GP models such as GP at Hand should become ‘available to all’.

Dr Wollaston said: ‘I wrote to his predecessor recently following concerns raised with me about Babylon’s apps, which could be missing symptoms, for example, of meningitis and heart attack.

‘Will the secretary of state set out what steps he is going to take to make sure that in rolling out these technologies, patients have the absolute confidence that they’ve been properly evaluated for safety and effectiveness?’ 

To which Mr Hancock responded: ‘I spoke to  [NHS England chief executive] Simon Stevens about this only this morning [and] he is reviewing this exact question. The thing about new technology is that sometimes the rules need to be updated to take into account the changes in technology.’

Meanwhile, Mr Hunt’s letter, sent to Dr Wollaston whilst he was still health secretary, said a ‘range of potential scenarios’ are being tested by a cross-governmental team ‘to assess how, if these scenarios were to arise, the current regulatory system would deal with the issue’.

He added: ‘Where it is found that there is a gap in the regulatory model, risk-based “fixes” are being evaluated.

‘Such scenarios include where diagnostic support software misses symptoms.’ 

A spokesperson for Babylon, which has claimed its app is able to provide clinical advice to patients that is ‘on par’ with doctors, referred Pulse to a briefing on the app’s clinical safety assurance processes.

The document says: ‘As senior clinicians and scientists at Babylon, we take our responsibilities to provide safe and effective care extremely seriously.

‘Creating services that are available anytime, anywhere at the touch of a smartphone button is core to what we do, but even more important is the ongoing testing, quality improvement and external assurance that we undertake to ensure the clinical safety of all elements of our work.’

Mr Hancock continued to defend the rise of Babylon-style technology in a hearing with the House of Commons Health Committee this afternoon.

He told the group of MPs that ‘the wrong solution would be to say these new technologies have no place, they are disrupting things’.

‘The right thing to do is to say these new technologies are disrupting things – how do we make sure the rules work for everybody?’

He added that the clinical algorithms were ‘constantly improving’ and that ‘humans aren’t perfect either’, and said ‘replacing “imperfect” with “imperfect but better” is worth doing’.

Pulse has approached NHS England for comment.