The Big Problem With Mobile Health Apps

Use of Apps in Medicine Is Still Low

Surveys show that 90% of physicians use smartphones or tablets in their day-to-day professional activities.^[1] Most of us tell surveyors that we believe mobile apps downloaded onto these devices can improve patients' health outcomes. We say there is value in having these apps connect with electronic health records (EHRs) to share patient data. We tell surveyors that we would recommend appropriate apps to patients.^[2]

In a previous Medscape article, I discussed why. Among the benefits of apps: improving the patient/physician relationship by promoting shared health management; connecting patients with peer and support communities online to more actively engage them in their own care; assisting caregivers in following your instructions; and providing useful patient data to both the patient who is self-monitoring (as, for example, some diabetic patients are now doing) and the physician who may be monitoring patients with uncontrolled chronic conditions.^[3]

A recent study found that one third of physicians have already recommended an app to a patient for such reasons as these.^[4] Most, however, haven't. If such apps are truly useful, why not?

Actually, there are some pretty good reasons. What are some legitimate concerns about apps, and what might the future hold for us regarding them?

Trust and Quality Issues

When we recommend tests or procedures to our patients, we rely on evidence-based guidelines that have generally been developed as a result of clinical trials. Mobile apps—which can educate patients, as well as track vital signs, medication adherence, and other patient-derived data—would certainly be expected to do what they claim they do.

Unfortunately, this is not always the case. Recently, for example, one app claiming to give a smartphone the ability to measure blood pressure was assessed by an emergency physician and found to give inaccurate readings.^[5] The doctor contacted the app developer, who told him the app was only in the "beta-testing stage" (ie, not ready for prime time) and that its use was for "entertainment purposes only." None of these caveats were included in the app description at the online store from which it could be downloaded for $3.99.

Medical apps about which false claims are made may be useless at best and harmful at worst. For many years, app developers and clinicians anticipated that the US Food and Drug Administration (FDA) would serve as the guarantor of the accuracy and safety of mobile medical apps. Finally, in 2013, the FDA published its ruling on what it will regulate.^[6] The document stated that only apps that function as medical devices, transform a device into a medical device, or perform patient-specific analysis and then provide a diagnosis or treatment on the basis of it will be regulated.

Some examples of FDA-approved mobile medical apps include an app/device combination that transforms a smartphone into an ECG rhythm-strip recorder. Other FDA-approved app/device combinations transform a smartphone into an ultrasonography machine, blood pressure cuff, or pulse oximeter. Fifteen potentially game-changing app/device combinations (not all of them FDA-approved) were featured in a recent Medscape slideshow.^[7]

However, the vast majority of healthcare apps—there are an estimated 26,000, of which approximately 7400 are aimed at physicians^[8]—will not be regulated by the FDA. As such, doctor concerns about app quality remain valid.

One solution might be for specialty societies and hospitals to not only evaluate apps designed for their members and their members' patients, but also to develop their own branded apps targeted at both physicians and patients. For example, the University of Pittsburgh Medical Center in Pittsburgh, Pennsylvania, and Montefiore Medical Center in New York are developing apps for doctors affiliated with those institutions.

Another solution is for third parties (in academia or the private sector) to develop a certification system for medical apps. Kaiser Permanente and other integrated delivery systems have such quality-control programs for apps, which they certify and sanction for use by member physicians.

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