First EU-Approved Mobile App

How safe is that app? App released today is the first to be registered as a Class I medical device by the MHRA

UK charity draws attention to the regulation of health apps and publishes guidance document to help health professionals, organisations, patients and industry

10 January 2012, London – A new app, Mersey Burns, has been released on to the market that represents a first in the UK – it has been registered with the MHRA as a Class I medical device as per the EU Medical Device Directive.   To coincide with this, d4 have simultaneously published a new guidance document to help draw further attention to the issue of health app regulation and provide practical guidance to both users and manufacturers of apps for the healthcare market.

Health professionals make considerable use of mobile phones during their working day, as do their patients.  As the popularity of running software applications on mobile devices continues to increase, we anticipate that the use of apps to aid medical diagnosis and treatment will gain in popularity with a corresponding increase in risk to the general public.  Specific regulations that accompany this nascent technology are in their infancy, but should not be ignored.

For all stakeholders concerned, it is in our collective interest to support responsible use of this new technology. It will take one high profile failing to cause a loss of trust that can take months, if not years, to rebuild.  In their guidance document, Regulation of health apps: a practical guide, d4 make the following recommendations:

  1. Health professionals should carefully consider the risks when using apps to determine a patient’s care.
  2. Developers should test their apps thoroughly and maintain adequate technical documentation to evidence this.
  3. Publishers should ensure compliance with the necessary regulations before releasing apps on to the market.
  4. Organisations should investigate ways to manage the use of apps by their employees, and put in place mechanisms to identify those apps that are deemed fit for professional use.
  5. Patients should examine carefully the source of the apps they use to manage their health.  Within Europe, health apps that influence a patient’s treatment should carry the CE mark to demonstrate their conformity with the appropriate regulation.

“mHealth is a new industry and the regulatory environment is evolving,” said James Sherwin-Smith, CEO of d4. ”Regulators are necessary to safeguard the public and uphold confidence in markets that would otherwise be open to potential abuse. But regulations also need to support, and not stifle, innovation. The regulatory issues that surround health apps are complex and open to interpretation. We hope that this guide provides a useful steer for individuals and organisations alike.”

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