• Health and social care secretary’s chief tech adviser says some health apps in the NHS are “less than perfectly accurate”
  • Says it is still not clear how the NHS should regulate health apps
  • Proposes new flexible regulations based on Fintech industry

The regulation of “less than perfectly accurate” health apps is to be overhauled, Matt Hancock’s senior tech advisor has said.

Hadley Beeman told a conference the Department of Health and Social Care was looking at a “sandbox” approach, similar to that taken by the Financial Conduct Authority with FinTech [financial technology] firms.

She told the Digital Healthcare Show the centre had not worked out how to effectively regulate health apps used in the NHS, with some software giving “less than perfectly accurate” advice.

Ms Beeman said: “We know how to regulate a medical device like a pacemaker that won’t change much in its 15 years inside you. But we don’t know how to regulate an app that will monitor your heartbeat. Does it have to go through a full review process every time it’s patched and updated?”

Ms Beeman, who worked alongside the health secretary at the Department of Culture, Media and Sport, said the government was looking at a new approach to monitoring health apps that would allow regulators, the NHS and tech companies to test new products before full launch and “work out the rules together”.

The model would be based on the Financial Conduct Authority’s “regulatory sandbox”, which allows fintech companies to test and adapt products with the regulator before they are approved. The Authority has said the approach has helped fintech companies get their products to market faster and secure investment.

The comments echo Mr Hancock’s, who told HSJ in February there was a “big piece of work to be done” on ensuring apps used in the NHS were safe.

It is not the first time concerns have been raised that the regime for regulating the growing number of medical apps used in the NHS is fragmented and weak, potentially putting patients at risk. 

In February, HSJ revealed that the Care Quality Commission will start inspecting the use of triage apps. Medicines and Healthcare Products Regulatory Authority will also require independent assessments of medical software from 2020, while National Institue for Health and Care Excellence is increasingly involved in assessing new digital technology.