The regulatory landscape of mobile health apps.

If you are interested in the field of mobile health then you will be aware that regulatory bodies in the United States and the European Union have been working hard to increase scrutiny over mHealth solutions (whether apps or devices). These efforts have been concentrating on an interoperability standard which would be a key factor in the future approval of devices and medical apps. On September 25th 2013, the FDA issued its final guidance for medical app developers. This guidance, in draft form for over two years, describes how the FDA intends to apply existing regulations to the world of medical apps. I finally got round to reading this (as it has been in my ‘to read’ list for a long time) and my first impression is that in brief, the guidance hasn’t changed much.

Although the intention of the latest amendment to the 2011 guidance was to lay out a clear distinction between an unregulated mobile app and a mobile medical app subject to regulation- I have to admit that it has given me the impression that in their attempt to standardise a fast evolving and very complex ecosystem, the FDA ends up regulating only a (very) small subset of medical apps.

So what does this REALLY mean?

According to the updated guidance, the focus is on those apps that could be classified as medical devices and could potentially pose risks if they don’t function properly.

Applications that transform a mobile phone or any other electronic device into a medical device are considered HIGH RISK and are eligible for consideration for regulation.

Applications that are likely to perform clinical tests would still require approval, but applications that that seek to replace a doctor’s visit might not require approval (MEDIUM RISK)

Applications for general health and education purpose are considered LOW RISK


Nevertheless there is still a fine line between what kind of medical apps will be regulated by the FDA, and which not.For example an app that is intended for general patient education information and provide access to commonly used reference information about how to quit smoking will  NOT be regulate, but an app that provides education information, reminders or motivation guidance to smokes trying to quit WILL be regulated by the FDA.

An example, the FDA lists a medical apps that MAY meet the definition of medical device, for which they intend to exercise enforcement discretion. Examples of these include apps that provide tailored interaction to the user in the form of motivational guidance, alerts to high risk locations for particular conditions,  means to track condition or medication usage etc. A full list of those apps as described by the FDA can be found here

Issues & Challenges

  • The FDA does not intend to regulate any mobile health applications that are only available on external app platforms (such as Itunes store, Google play etc) or any health-specific app stores (such as Happtique etc.).  There are over 40,000 medical and health/wellness apps in the App Store alone (Ref) –  and the FDA simply can’t (and shouldn’t?) try to regulate the entire market.
  • Accelerated approval pathways for app updates is currently not available.
  • The FDA also recommends that manufacturers of all mobile apps that may meet the definition of a device follow the Quality System regulation (which includes good manufacturing practices) in the design and development of their mobile medical apps and initiate prompt corrections to their mobile medical apps, when appropriate, to prevent patient and user harm. Nevertheless, no specific support or guidance is given to user centred design methods and usability evaluation of mobile apps. Even though the FDA classifies apps that diagnose a condition as medium risk, there is no specific guidance on design methods to accommodate  the design of a healthcare journey that will be delivered entirely online.  Designing an interface for such settings requires special attention, in order to be sensitive to the potentially vulnerable user and to their emotional state. Furthermore, the FDA does not offer any specific guidance or clarification  on how to evaluate mobile health applications. I am personally very much interested in the updates to FDA’s document on ‘Applying Human Factors and Usability Engineering to Optimise Medical device design’.

As with everything in this technology driven world, only time will tell.

Will 2014 be the year where we see the first time the FDA rejects an app  submission on usability grounds???


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