Are health apps medical devices? A white paper from Bluelight & D4

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 continue to 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.

The paper produced by Bluelight and d4 examines amongst other mobile healthcare topics the regulatory framework applicable to health apps. A number of pharmaceutical companies have over the last couple of years launched a variety of apps ranging from unbranded disease resources, to branded drug dosage information and some have included physical add-ons to the mobile device. Some of these apps were subsequently withdrawn.

However in our experience few pharma companies have systematically and consistently approached the area of app development.

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.

The Bluelight and d4 guide makes five recommendations for all app users. We would like to pick out the two which we feel are most relevant to pharmaceutical companies;

1. Developers either in-house, agency or freelance should test their apps thoroughly and maintain adequate technical documentation to evidence this. This should be planned at the beginning of the app development. If the app is to be certified as a medical device then a technical file will be needed.

2. Publishers e.g pharmaceutical companies, should ensure compliance with the necessary regulations before releasing apps on to the market. Again compliance with the regulations should be evaluated at the start of the app. It is much more expensive and time consuming to make changes to the documentation or amends to the app retrospectively.

To discuss this paper or for further information please contact Paul or Sam
Download full paper here: 

Press Release

Posted January 10th, 2012 by SamWalmsley & filed under Compliance, Mobile, Technology, White Papers .

One Response to “Are health apps medical devices? A white paper from Bluelight & D4”

  1. SamWalmsley

    Thanks for the feedback – Might be worth checking out the articles we have also written on the subject:
    Are apps medical devices:
    Regulatory framework:
    How to market your app:

    Another great article on this subject on this:
    Hope this helps


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