How Does the FDA Regulate Mobile Medical Apps?

Illustration for article titled How Does the FDA Regulate Mobile Medical Apps?

Last month, the FDA released new guidance regarding the regulation of mobile medical apps, to replace its earlier version from 2011. Since that time, the amount of health and medical apps on the market has exploded, with the release of Apple's Health app with iOS 8 cementing mobile health as 'a thing'. Needless to say, it is about time for a regulatory update.


The FDA defines a 'mobile medical app' as a mobile app that is intended to either [1]:

  • Be used as an accessory to a regulated medical device; or
  • Transform a mobile platform into a regulated medical device.

What is a regulated medical device? The FDA guidance states that [1]:

When the intended use of a mobile app is for the diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body of man, the mobile app is a device.

Leaving the sexist nature of this terminology aside, we can see that the FDA takes a very clinical perspective on what types of apps they consider as falling in their domain. This approach is practical. It means that they a priori alleviate themselves of responsibility for the numerous health apps continually being produced, which allows them to focus on those apps posing the greatest risks to users. An app which intends 'to affect the structure or any function of the body of man' is potentially much more impactful than a simple diet tracking app. Or is it? And is it debatable whether diet and fitness apps intend to alter the structure or function of man?

Apps, which the FDA will not regulate, but will 'exercise enforcement discretion' over, are those that help users to self-manage their disease or conditions without providing specific treatment or treatment suggestions, help users track or manage their health (e.g. trackers for diet, exercise, sleep, mood), apps that provide access to electronic health records, apps that help patients communicate with doctors (e.g. by providing videoconference portals or allowing patients to take snapshots of their symptoms), or those that perform calculation for things like body mass index or pregnancy due date (1).

Apps that are regulated are those that, for example, turn the mobile into a control for a medical device such as a blood pressure cuff or insulin pump, or transform the mobile into a medical device such as an electronic stethoscope or a blood glucose reader (1). The rationale for regulation of these latter uses is that these types devices are already FDA-regulated, and would pose a risk to patients if improperly functioning (1).

Does this mean there is no risk associated with the 'softer' uses of medical apps, which are not regulated? Of course not. The risk is lower, perhaps, but apps may contain false or misleading health and medical information, which could be improperly used if taken uncritically. The growing knowledge economy of our society means that education and literacy are far more important than ever before, and this is true down to such a small issue as using health apps on a mobile phone to gain a real personal benefit.


Recently, we have seen the FTC fine the makers of apps that purported to aid in detecting malignant melanoma, which would qualify as being a medical device [2]. It will be interesting to see how the regulatory landscape evolves in the future, which will depend on whether there is real transformative power of these non-medical device health apps to influence people's behaviour and health decisions.


1. U.S. Department of Health and Human Services Food and Drug Administration, Center for Devices and Radiological Health, Center for Biologics Evaluation and Research. Mobile medical applications: Guidance for Industry and Food and Drug Administration Staff. U.S. Department of Health and Human Services Food and Drug Administration. 2015.


2. Dredge S. FTC fines app firms for claiming their technology could detect melanoma. The Guardian. Wednesday Feb 25 2015. (accessed 02 March 2015).

This article first appeared on PLoS Blogs and republished here under Creative Commons license.



Leaving the sexist nature of this terminology aside

It obviously was intended as genderless, how else would you say it? "The body of men and women and transsexuals and children"? "The body of the human species"? "The body of homo-sapiens"?

You people can complain of such petty little things...