…and the downside. Even physicians who haven’t begun A weight loss app would be more likely to help this patient reach his goal than other diet programs because he "wouldn't lie" to an app.recommending apps to patients are aware that carefully tracking measures related to chronic conditions like hypertension or diabetes often results in better control. But in some cases, there may be too much of a good thing. Evidence suggests that for some patients with type 2 diabetes, glucose self-monitoring is associated with depression and may do more harm than good.12
Dr. Lowther has witnessed a similar phenomenon in patients using disease-tracking apps. “Sometimes people get too focused on the problem and drive themselves crazy,” she observed, adding that those with high blood pressure are particularly at risk. “I think sometimes it’s hard for patients to understand the concept of an average value and normal fluctuation,” Dr. Lowther said. When that happens, “I have to tell them to back off.”
Who's minding the (app) store?
The mHealth arena has been called “the wild West.”13 With at least one app for virtually every aspect of health and medicine you can think of, it’s not hard to understand why.
In an article on the use of symptom diaries in outpatient care, Bryan Hodge, DO, an FP in Hendersonville, NC, mentions mobile self-tracking apps as one of a number of ways for patients to keep symptom diaries.14 Given the fact that few of these apps have been validated, Dr. Hodge writes, “The best approach is to familiarize yourself with a few options that you can offer to your patients.”14
That depends on the nature of the app. An app that tracks calories consumed or simply keeps an organized file of patient symptoms may do little harm; an app that conveys physical measurements that a patient or physician may act on or calculates medication dosages requires a higher level of vigilance.
A recent study of smartphone apps that calculate opioid dosage conversion, for example, found a lack of consistency that raised a red flag about the reliability of information provided by unvalidated apps. Better regulation of medical apps is crucial to ensure that patient safety is maintained, the authors concluded.15
The FDA’s role
The US Food and Drug Administration, which has approved more than 75 medical apps, issued a proposed approach to its oversight of the apps in 2011.16
Under the proposed rules, the agency would regulate mobile apps that were either used as an accessory to a medical device already regulated by the FDA or that transform a smartphone or tablet into a regulated medical device. A final rule has not yet been issued, but a spokesperson told Congress that it will be forthcoming before the end of the year.17
False claims are a target of federal regulation, as well. In 2011, the Federal Trade Commission pulled 2 acne apps off the market because both advertised—without scientific evidence—that the light emitted by smartphones equipped with the apps could treat acne. “Smartphones make our lives easier in countless ways, but unfortunately, when it comes to curing acne, there’s no app for that,” the FTC chairman stated in a press release.18
In May 2013, the FDA sent an “It has come to our attention letter” to Biosense Technologies regarding its uChek urine analyzer app. The problem, the letter stated, is that the dipsticks that the app allows a mobile phone to analyze are cleared by the FDA only when interpreted by direct visual reading. But the phone and device together function “as an automated strip reader”—a urinalysis test system for which new FDA Smartphones make our lives easier in countless ways, but unfortunately, when it comes to curing acne, there's no app for that," the chairman of the Federal Trade Commission stated in a press release. clearance is required.19
Other ways of evaluating apps
Happtique, a mobile health solutions company, recently announced the launch of its Health App Certification Program—a voluntary program designed to help clinicians and patients easily identify apps that are credible and safe.20 “We will be certifying medical, health, and fitness apps, Corey Ackerman, president and CEO of Happtique, told JFP. The program is currently accepting medical education and nursing apps for review, and “discussions are underway with numerous other organizations that will provide experts for apps in additional subject matter areas,” Mr. Ackerman said.
There are other means of evaluating mobile medical apps that fall outside of the medical device realm, of course—starting by perusing the reviews posted at the app stores. Exchanging information with other clinicians using an app you’re interested in is another way to learn more about its efficacy. (Yes, there’s an app for that, too: Doximity, the professional network for clinicians.)