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Healthcare apps grow up

The launch of the MHRA-approved Mersey Burns app and Pfizer's withdrawal of its Rheumatology calculator app should change the way pharma thinks about mobile technology

Between October 2011 and January 2012 two developments occurred that should change the way pharma thinks about mobile technology.

The humble app, for long an easy entry point into the mobile world, suddenly grew up to become, in certain cases at least, a medical device.

In January the first mobile health app to be registered as a medical device in the UK was released on Apple's App Store.

The free Mersey Burns iPhone app, which was developed by doctors at the Mersey Regional Burns and Plastic Surgery Unit, helps healthcare professionals calculate burn area percentages and record patients' details.

The app is regulated by the Medicines and Healthcare products Regulatory Agency (MHRA) as a Class I medical device under the remit of the EU Medical Device Directive.

Meanwhile, in October 2011 Pfizer was forced to pull its Rheumatology Calculator iPhone and Android app after errors were found in its calculation formulas.

Withdrawing the app the company undertook a 'field safety corrective action', notifying relevant Competent Authorities and writing to doctors as if the app were a faulty surgical system or other medical device.

In the UK Dr Beverley Phillips, Pfizer UK's medical director, wrote to doctors telling them to stop using the app, delete it from their device and review any calculations made using it.

In their 2012 guidance document, mobile consultants Bluelight and d4 suggest pharmaceutical companies should decide whether their app will be associated with, contribute to, or make a clinical decision.

If that's the case, the advice is to assume the app will be classified as a medical device, will have to conform to the regulations, and pharma should seek expert advice and prepare the necessary technical documentation required by the Competent Authority.

Both the launch of the Mersey Burns app and the withdrawal of Pfizer's Rheumatology Calculator app show how seriously certain types of mobile apps may need to be taken.

4th April 2012

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