latest health care news

30.08.16

MHRA issues patient safety warning over medical apps

Apps designed to help patients monitor their health must be assessed to ensure that they are medically accurate and safe to use, the Medical and Healthcare Products Regulatory Agency (MHRA) has said.

The MHRA has published new guidelines designed to allow users and designers to see if their app complies with safety regulations.

An increasing number of apps are classified as medical devices, used to gather and analyse data such as diet, heartbeat, or blood glucose levels.

John Wilkinson, MHRA’s director of medical devices, said: “We live in an increasingly digital world, both healthcare professionals, patients and the public are using software and standalone apps to aid diagnosis and monitor health.

“Where apps or standalone software make a diagnosis or recommend a treatment, people should check for CE-marking before using their apps and developers should make sure they are complying with the appropriate medical device regulations.

“Patient safety is our priority. We continue to encourage people to report any safety or performance issues involving medical devices, including apps, to MHRA via our Yellow Card Scheme online.”

The Yellow Card Scheme is used to collect and monitor information on suspected adverse drug reactions (ADRs) and adverse incidents with medical devices.

The MHRA warned: “Apps that give incorrect diagnoses or prescribe inappropriate treatments may have severe, potentially life-threatening consequences.”

NHS England recently announced a new innovation and technology tariff intended to make it easier to introduce digital innovations, including apps, in the NHS.

Have you got a story to tell? Would you like to become an NHE columnist? If so, click here.

Comments

Liz   19/09/2016 at 12:17

Did you know ORCHA review apps so people know what the risks are with apps and know whether it needs MHRA approval. "promoting better apps for better outcomes"

Liz   19/09/2016 at 12:18

Did you know ORCHA review apps so people know what the risks are with apps and know whether it needs MHRA approval. "promoting better apps for better outcomes"

Add your comment

national health executive tv

more videos >

featured articles

View all News

last word

Haseeb Ahmad: ‘We all have a role to play in getting innovations quicker’

Haseeb Ahmad: ‘We all have a role to play in getting innovations quicker’

Haseeb Ahmad, president of the Association of the British Pharmaceutical Industry (ABPI), sits down with National Health Executive as part of our Last Word Q&A series. Would you talk us throu more > more last word articles >

health service focus

View all News

comment

NHS England dementia director prescribes rugby for mental health and dementia patients

23/09/2019NHS England dementia director prescribes rugby for mental health and dementia patients

Reason to celebrate as NHS says watching rugby can be good for your mental ... more >
Peter Kyle MP: It’s time to say thank you this Public Service Day

21/06/2019Peter Kyle MP: It’s time to say thank you this Public Service Day

Taking time to say thank you is one of the hidden pillars of a society. Bei... more >

interviews

Matt Hancock says GP recruitment is on the rise to support ‘bedrock of the NHS’

24/10/2019Matt Hancock says GP recruitment is on the rise to support ‘bedrock of the NHS’

Today, speaking at the Royal College of General Practitioners (RCGP) annual... more >

the scalpel's daily blog

Covid-19 can signal a new deal with the public on health

28/08/2020Covid-19 can signal a new deal with the public on health

Danny Mortimer, Chief Executive, NHS Employers & Deputy Chief Executive, NHS Confederation The common enemy of coronavirus united the public side by side wi... more >
read more blog posts from 'the scalpel' >