Updated guidance has been issued to help nurses identify which smartphone applications or “apps” are classified as medical devices and, therefore, need to comply with safety regulations.
The Medicines and Healthcare products Regulatory Agency noted that, from counting steps to helping clinicians prescribe treatment for burns injuries, apps were now a “part of everyday life”.
“People should check for CE-marking before using their apps”
However, it warned that many apps and pieces of stand-alone software currently on the market were classified as medical devices.
The MHRA said the classification covered apps that gathered data from the person or a diagnostic device, such as diet, heartbeat, or blood glucose levels and then analyse and interpret the data to make a diagnosis, prescribe a medicine, or recommend treatment.
It is important that apps which are medical devices comply with medical device regulation and work as expected, stated the agency.
Apps that give incorrect diagnoses or prescribe inappropriate treatments may have severe, potentially life-threatening consequences, it warned.
The guidance comes in the form of a step-by-step interactive PDF. Nurses can use it to check if their app is a medical device, and what to look for to make sure the app is safe and works, said the MHRA.
It added that software and app developers could also use the guidance to identify if their product is a medical device.
Regulator issues updated guidance on ‘health apps’
John Wilkinson, the 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 stand-alone apps to aid diagnosis and monitor health.
“Where apps or stand-alone 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,” he said.
He added: “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.”