• Rapid growth in registered medical software in the past three years
  • Concerns about “fragmented” regulatory regime
  • New Europe wide regulation will expose industry to more scrutiny, but not till 2020

The rapid growth in medical apps will come under stricter regulatory scrutiny amid criticism that the current system is “fragmented”.

Regulator records reveal a sharp increase in companies registering as manufacturers of “standalone” software with a medical function, rising from just 10 in 2014 to more than hundred this year.

However, currently the regulator, the Medicines and Healthcare Products Regulatory Agency, does not require these companies to undergo any independent safety assessments of their software.

When registering, manufacturers are not required to tell MHRA what their medical software does or even what it is called.

An industry source familiar with the registration process told HSJ that most medical software was placed in “class I”, a low risk category alongside spectacles and bandages. MHRA conducted “no checks whatsoever” for the software’s safety, he said.

“You can literally produce no documentation, say that you have done it, and get registered.”

The British Medical Association’s GP chair, Richard Vautrey, told HSJ there was growing concern about the lack scrutiny and regulation for medical software under the current regime.

He said: “The current fragmented and insufficient regulatory system is being left behind by the rapidity of change in this area and could place patients at risk who may be left using apps and online resources that have not been properly assessed.” 

The concerns arise as the use of digital health services in the NHS continues to grow and regulators scramble to assess their impact on existing services and patient safety.

A Care Quality Commission review of digital primary care providers, published early this year, revealed half were “not safe”, with criticism centring around fragmentation of care and inappropriate prescribing.

Earlier this month, HSJ revealed that both the MHRA and CQC have been reviewing concerns raised about the safety of Babylon Healthcare’s symptom checker app for months.

Babylon, a registered manufacturer of medical software, told HSJ the concerns were groundless and MHRA has since closed the matter. MHRA does not comment on the status of specific complaints.

However, most medical software in the UK will come under more scrutiny from spring 2020, as part of Europe wide changes in the regulation of all medical devices.

Graeme Tunbridge, MHRA’s group manager for devices regulatory affairs, told HSJ some of these changes would specifically target gaps in the current regulation for medical software.

Under the new regime most of the medical software currently placed in low-risk “class I” category would have to move into the higher-risk “class IIa”.

Medical devices in this higher category will require an independent assessment of their safety and effectiveness before they can be sold in UK, he said.

“For some software products a greater degree of pre-market screening is needed.”

Mr Tunbridge said there were some specific risks associated with medical software, as opposed to other medical devices.

Traditional medical device manufacturers typically did more pre-market testing, whereas software developers were more likely to go market earlier and then adapt their product in response to feedback, he said.

MHRA currently relies heavily on manufacturers of medical software self reporting problems or members of the public complaining.

When problems do arise, its policy is to help bring manufacturers into compliance without taking enforcement action wherever possible.

To date, the regulator has not issued any safety alerts concerning faults in standalone software, although there have been dozens of alerts about faulty software embedded in physical medical devices, such as pacemakers or infusion pumps.

MHRA has also received few complaints from the public about “standalone” medical software to date, with just eight “reports” lodged in 2017-18.

Mr Tunbridge said MHRA had increased the size of its team dealing with medical software and was seeking to expand further to meet an expected rise in demand.

Currently registered manufacturers of medical software include private health IT suppliers, universities and NHS organisations.