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Are pharma apps medical devices?

As the first MHRA-registered mobile health app hits Apple's App Store, pharmaceutical companies should be asking questions of their own smartphone apps

Mersey Burns iPhone appLast week 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, fluid prescriptions and background fluids, as well as recording patients' details.

Regulated by the Medicines and Healthcare products Regulatory Agency (MHRA) as a Class I medical device under the EU Medical Device Directive Mersey Burns' App Store debut should make pharma stop and think about its use of mobile.

A new guidance document from mobile consultants Bluelight and d4 anticipates the use of apps to aid medical diagnosis and treatment will gain in popularity, but warns this could lead to a possible increase in risk to the general public.

Sam Walmsley, a digital and mobile consultant at Bluelight, said: “Health apps aren't like apps from other sectors; at the end of the day we are dealing with people's health. The mHealth market is only going to grow, and we need to provide confidence to healthcare professionals and patients that our apps are safe.

“Pharmaceutical companies should consider consulting with the MHRA (or an equivalent body in another European member state) during app development and verify the apps that have already launched.”

Bluelight and d4 suggest pharmaceutical companies check if 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.

“It is in the collective interest of pharmaceutical companies to support responsible development and deployment of these apps. It may only take one failure or misuse of an app to cause harm to a patient,” the consultants warn.

Pharma mobile apps

In the UK 81 per cent of healthcare professionals own a smartphone, and use it regularly in their day to day practice, and smartphone ownership amongst their patients currently runs at 30 per cent.

To capitalise on this the pharmaceutical industry has steadily launched smartphone apps – overwhelmingly for Apple's iPhone – since 2009, when Sanofi-Aventis' GoMeals and Novartis' VaxTrak apps led the charge.

One of the main types of pharma mobile app has been disease calculators. Like the Mersey Burns app these use the iPhone's intuitive, visual display to present complex clinical formulae in an easy to use form.

But the ranks of these available in the UK have been drastically slimmed down.

Eighteen months ago, disease calculators from UK pharma included Pfizer's patient prognosis Oncology RCC app, and three from Merck - two Remicade-branded apps and its Bridion Dose Calculator app.

Janssen Psoriasis iPhone app

The only app that was available then and can still be downloaded from the App Store is the Psoriasis app (see above) from Janssen, which is part of Johnson & Johnson (J&J). This is an unbranded disease calculator based on the Psoriasis Area Severity Index (PASI).

It has not yet been registered as a medical device, but Janssen has been collaborating with J&J's devices division to assess the Psoriasis app's potential as one.

• Read: Regulation of health apps: a practical guide

10th January 2012

From: Marketing


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