If you own a smartphone, you have more than 100,000 health or medical apps at your fingertips. Chances are you’ve downloaded an app to track your steps, count your calories, suggest healthy snacks, get you up off the couch to exercise or offer stress-management techniques. If an app miscalculates the caloric devastation of that banana split you just inhaled, it’s not the end of the world. It may destroy your diet for a day, but it won’t put your life at risk. Some other health apps just might.
Mobile apps that measure blood pressure, glucose levels and mood swings have created a wave of worry over malfunctions that could put their users in peril. The dangers of overreaching medical apps are real. People who have high deductible health insurance or none at all may be tempted to replace their yearly doctor visit with an app. Misdiagnosis of conditions like melanoma, high blood sugar or cholesterol, stroke or spikes in blood pressure could delay treatment. The medical information contained in the app could be inaccurate. Furthermore, using an app could expose your medical information to security breaches.
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A startling number of apps are not very good. In a February 2016 review of more than 1,000 medical and health apps, a mere 313 emerged as “possibly useful” by The Commonwealth Fund, a nonprofit dedicated to making healthcare accessible.
On the plus side, the best apps can help monitor your health status. “Mobile health applications designed for smartphones can help empower high-need, high-cost patients to self-manage their health,” the researchers write. To this end, developers like John Hopkins University have created apps such as Epiwatch, which uses an Apple Watch to capture data on heart rate and activity, to determine whether detection of seizures can be automated. The app does not diagnose the patient’s condition; it monitors it.
That’s an important distinction, because apps that diagnose pose a far greater risk. In fact, some diagnoses by app are overwhelmingly likely to be incorrect. Researchers at Johns Hopkins found that one instant blood pressure app was accurate only 20 percent of the time. An app designed to detect skin cancers via the phone’s built-in camera managed to accurately diagnose only one in 10 melanomas. In The Commonwealth Fund study, a number of mental health apps collected sensitive data, but had no mechanism for responding to “dangerous” input like suicidal or violent thoughts. The study’s conclusion: “There is a need for scientific validation and regulation of these apps before they reach consumers.”
Cue the Food and Drug Administration. The agency’s oversight of mobile medical apps dates back to 1997—the same year the term smartphone made its way into the lexicon—but most approvals are date-stamped 2012 and later. Instead of vetting all medically related apps, the FDA narrows its focus to apps that could cause a patient harm if they malfunctioned or gave an inaccurate reading. Bakul Patel, associate center director of digital health at the FDA’s Center for Devices and Radiological Health, told Life Reimagined that within the scope of medical apps regulated by his agency, there are three levels of risk profiles. Class 1 is the lowest risk: The product doesn’t pose significant risk but still requires good quality and an adherence to rules. Class 2 is moderate risk and includes applications like diagnostics (glucose, blood pressure, MRI, X-rays, etc.). Class 3 is higher risk, usually implantables like pacemakers. Once an app has been thoroughly vetted, it receives the FDA’s stamp of approval, offering some comfort to the user that the app is going to do what it claims. However, the FDA does not regulate health-related apps that track calories or offer weight loss advice because they do not pose a risk to the user, says Patel.
What do doctors think of mobile medical apps? Dr. David Layne, founder of Landmark MD in Belmont, North Carolina, has been practicing medicine for nearly 30 years and gives his perspective: “Technology is changing medicine. Patients can make appointments and request refills via smartphones. I receive photos of patients to monitor diabetic wounds or resolutions of rashes. I work with patients via portals regarding effects and side effects of medicine. We have group meetings with patients utilizing various technologies. Medication renewals are performed electronically.”
“However,” he cautions, “technology is only a tool, not a replacement. Elevation of temperature can be associated with an infection—or not. Most medical apps reduce medical disease to questionnaires filled out by patients or technicians. They are only as good as the person inputting the information. I frequently ask questions two or three different ways before arriving at the right answer.” Patients, he points out, do not have the medical background to interpret the data they are discovering on their apps.
“Mobile apps that measure blood pressure, glucose levels and mood swings have created a wave of worry over malfunctions that could put their users in peril.”
Layne goes on to explain another issue. “Apps usually do not take into account other medical problems. An app used to diagnose a respiratory infection might suggest using a decongestant. But if that person has an enlarged prostate this might cause a problem.”
Mobile medical apps weren’t even covered in his training, says Dr. Michael Solomon, a resident at Medical University of South Carolina in Charleston, yet he sees patients who’ve self-diagnosed via a health app. “Sometimes their diagnosis is correct, but more often it’s not, and there’s so much emotion that comes with all this self-diagnosing. Patients are anxious and overworried,” he says, “and they need reassurance. For diagnosing, an app is not useful.”
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Health apps can hurt you in another way too. Many apps contain serious cyber weaknesses, making all your stored health information vulnerable to hackers. In 2014, HP led a study that exposed the alarming number of internet-connected devices with serious security weaknesses. A stunning 70 percent of all commonly used mobile devices and apps have these vulnerabilities. Unprotected health data contained on apps is a real concern. “These vulnerabilities essentially render consumer health information unprotected and available for the taking,” officials at HP wrote. “Users are one network misconfiguration away from exposing this data to the world via wireless networks.”
In the face of all these problems, what’s a concerned consumer to do? “When picking an app,” Patel says, “people should be well informed. Before trying out any potentially risky or high-impact app where it’s going to alter your disease course or your treatment course, always consult with your doctor.”
So go ahead and download that fitness tracker or medication reminder. Ask a calorie counter to backstop your new diet. But when it comes to more ambitious health apps, check on their accuracy, security and reliability. And check in with your doctor.