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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.

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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"

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