UK regulator updates guidance for health apps


The growth of health apps claiming to help manage health and certain conditions has been nothing short of explosive, giving regulatory bodies a headache over which should be classified as medical devices and which should not.

In response to the situation, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidelines to help with the classification process.

The changes, presented through a step-by-step interactive PDF, helps users identify which of their apps is in fact a medical device and whether they are suitably safe to use dependent on their compliance with the MHRA’s regulations.

For app developers, the changes help them navigate the regulatory system, explaining the steps they will need to take to obtain a CE mark for their medical device.

“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,” said John Wilkinson, MHRA’s Director of Medical Devices.

“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.”

Those apps that currently fit the MHRA’s medical device app remit are those that gather data from a person or diagnostic device and make a diagnosis, prescribe a medicine or recommend treatment based on analysis of the data. The data can include diet, heartbeat or blood glucose levels.

The guidance specifically mentions the potentially life-threatening consequences from apps “that give incorrect diagnoses or prescribe inappropriate treatments.”

“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.”

Meanwhile, the UK's Department of Health is also pursuing plans to providing the public with access to an accredited set of NHS and social care apps, working towards a strategy for personalised health and care.

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Marco Ricci