Caution: Untested mHealth apps proliferate, but few good ones work well

There are more than 43,000 healthcare apps available through the Apple iTunes App Store. That sounds like a wealth of useful apps, but the truth is that only a handful of them are actually being used. According to a survey published in October 2013 by the IMS Institute for Healthcare Informatics, most have been downloaded less than 500 times, and very few offer robust functionality. Worse, many offer information to patients that is inaccurate or unproven. Worst of all, some apps that are designed for clinical use provide clinically inappropriate/inaccurate advice to physicians.

Finding a good one that provides useful functionality is the proverbial search for a needle in a haystack.

FDA provides limited regulation

Currently, the FDA does not regulate consumer medical apps, so, like the supplement industry, it’s a buyer-beware situation. Without rigorous clinical trials, there is no way to know which, if any, of these apps will actually improve health outcomes. Since few of these apps have been tested in clinical trials, their efficacy and safety are largely unknown.

Fortunately, in September 2013, the FDA announced that it will regulate non-consumer medical apps that have the potential to harm patients. The FDA is focusing its oversight on two kinds of apps:

  • Those intended to be used as an accessory to a regulated medical device – for example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet; or
  • Those that transform a mobile platform into a regulated medical device – for example, an application that turns a smartphone into an electrocardiography (ECG) machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.

Expect an update on this topic this week when FDA Commissioner Margaret Hamburg offers the closing keynote address at the 2013 mHealth Summit on Dec. 11.  

While that oversight is important, it leaves a vast, unregulated gray area of apps that are intended to offer health advice or monitor health status. The best guidance for finding the few good apps among the many questionable offerings comes from independent review sites, such as iMedicalApps, or from physician specialty and subspecialty groups, which provide ratings for apps used by their members. Many such groups, like the American Gastroenterological Association, offer apps for physicians that detail evidence-based treatment guidelines to help promote higher quality care. Because these are rigorously reviewed prior to being offered, they are likely to be accurate.

Remote patient monitoring tools are the standouts among apps

The apps that stand out from the crowd for being the most useful are those that have been developed as part of a comprehensive healthcare strategy for managing chronic diseases. Remote monitoring of patient clinical markers and general health status is proving to be an effective means of improving health in patients with chronic illnesses. Many of the apps developed for remote monitoring are undergoing rigorous testing in well-designed clinical trials, offering solid proof of their effectiveness. The Agency for Healthcare Research and Quality (AHRQ) has reported on several studies that have shown lower mortality and lower costs as a result of remote monitoring using cell-phone based technology.

As the healthcare industry becomes more attuned to mobile devices, I expect that there will be more app developers willing to test their tools in clinical trials like these, and the apps that prove themselves will be the ones that will be widely used.

In the meantime, physicians should be cautious about recommending apps for patients to use. Beyond usefulness and accuracy, the apps should be vetted for their ability to protect patient privacy and the security of patient data. Read the reviews online, check with your medical or specialty association for recommendations, and then test the app yourself. Patients likewise should ask tough questions about any app that involves the uploading of personal healthcare information. Consumers should also check with their physician or healthcare provider before following any advice.

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