Regulating Health Apps Seems Tricky

mHealth apps are available but most go unregulated

/ Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

(RxWiki News) While there are many smart phone apps marketed as aids to help you manage your health, not all of these health apps are necessarily safe or offer sound advice, according to the authors of a recent editorial.

The editorial points out that many people assume that fitness or health apps are regulated — and most are not. While there have been attempts to regulate health apps, there are simply too many of them, and cost is another issue, the authors noted.

"Check with your physician before relying on an app for medical advice."

There are more than 40,000 health, fitness and medical apps on the market, wrote the authors of this editorial, who included Adam Powell, PhD, of Payer+Provider Syndicate in Boston. Known as mHealth apps, these applications are intended to assist with medical research, deliver health services or improve health outcomes, they wrote. The difficulty is that the US Food and Drug Administration (FDA) cannot possibly regulate all of them.

The FDA's intent is to regulate those apps that act as medical devices or accessories to medical devices, the editorial authors noted. The FDA would like to control those apps that provide recommendations or diagnostic information, although doing so will be difficult, they noted.

“The bewildering diversity of apps available has made it difficult for clinicians and the public to discern which apps are the safest or most effective,” they wrote.

The question of who can control the mHealth apps comes down to the question of money, they wrote. Since not all mHealth apps cost money (indeed, many are free), and companies generally want to earn revenue, there is another question of who will pay to have all those apps certified as reliable.

Dr. Powell suggested there may be a way to get that done, possibly by using non-profit and profitable sources.

“Reviews could be funded by grants, health insurance companies, clinicians or other sources,” suggested Dr. Powell in an email interview.

Dr. Powell and colleagues noted that the startup Happtique began certifying the operability, privacy, security and content of apps. However, it ultimately suspended its operations after a developer discovered that two certified apps were insecure in their handling of data.

“The attention that Happtique received suggests that many people consider the security of mHealth apps to be important and want them to be evaluated rigorously,” the authors wrote.

“We feel that apps are not yet being given the detailed scrutiny that they deserve, and that they could potentially be examined more carefully in the future,” Dr. Powell said.

When patients choose apps, they should consider the sensitivity of the information that the app stores, and whether there is any evidence that the information is being carefully safeguarded, he advised.

Furthermore, people who use mHealth apps should discern where the information was obtained, and be wary if the source is not readily available or seems questionable, he said.

In the end, although mHealth apps are useful, and one day, physicians may even prescribe apps to patients, more regulation is needed before that can happen.

The authors concluded that “the potential of apps will only be realized if patients and clinicians trust apps, if apps are known to be effective, and if apps can communicate securely and meaningfully with EHRs (electronic health records) and personal health records. Establishing an unbiased review and certification process is a key step in helping mHealth apps achieve their potential.”

This editorial appeared online in the March 24 issue of the Journal of the American Medical Association (JAMA).

The authors disclosed a number of conflicts of interest at the end of their editorial, as all have been involved with the regulation or development of apps at some point in time.

Review Date: 
March 26, 2014
Last Updated:
January 30, 2015