Medical apps - don't get burnt
Jinfo Blog

By Joanna Ptolomey

Abstract

The first medical app was registered as a medical device in the UK in January 2012. With more Smartphone apps becoming available for diagnosing and treating medical conditions the need for regulation is critical.

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If you have a smartphone then take it out of your pocket now and have a browse through the applications you could download in the health topics section. Chances are they are about losing weight, keeping track of your running habits, and mapping your general health and wellbeing trends. How many carbs have you had today?

Harmless, fun and possibly a fad – if I think back to my own personal new year resolutions. But when does an app make the transition into being a medical device that needs to be registered and licensed and controlled legally?

In January 2012 the first medical app was registered as a medical device in the UK and released on Apple’s App Store. The Mersey Burns iPhone app, developed by UK doctors at the Mersey Regional Burns and plastic surgery unit, helps healthcare professionals calculate burn area percentages, fluid prescriptions and background fluids, as well as recording patient details.

Designed by a former army officer who witnessed burns injuries on the frontline whilst in Afghanistan, he hopes it will reduce errors in treatment and management of burns patients. This app has been designated a medical device and as such requires to be regulated. In this case as a class 1 medical device regulated by the Medicines and Healthcare products Regulatory Agency.

A white paper and guidance document, by Bluelight partners and d4, anticipates the use of apps to aid medical diagnosis and treatment will gain in popularity. The mHealth market is set to continue its growth but the development of serious medical devices heralds the start of this sector maturing into the professional market. Surely the health, perhaps even survival, relies on confidence in these products. They need to be regulated.

What about possible apps in development? In a recent Pharmaphorum article the advice given out to pharmaceutical companies was not to jump on the bandwagon of going for the shiny new app just because a competitor has one.

The app is not the goal, nor should it be a marketing tool for the health care provider. Consider how your app may save a life, enhance treatments and diagnosis processes in acute situations or in public health. These apps have matured – they are possibly life savers and have the device upgrade to show they mean business.

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