Easy on those apps: Mobile medical apps gain support, but many lack clinical evidence

Mobile medical applications increasingly are being used by patients and consumers. Now healthcare providers are evaluating whether and how to work with their patients in tapping these apps. But they're proceeding cautiously because of the dearth of clinical evidence for many consumer apps, and because some developers may be misleading consumers by overstating their products' capabilities.

In September, developers of a consumer-marketed mobile app, UltimEyes, agreed to pay $150,000 to settle an enforcement action by the Federal Trade Commission based on the claim that the app was “scientifically shown to improve vision.” The promoters “did not have the scientific evidence to support their claims,” the FTC said.

Earlier this year, the federal agency went after marketers of two mobile apps, Mole Detective and MelApp, “for deceptively claiming their mobile apps could detect symptoms of melanoma even in its early stages.” The apps' marketers reached settlements that bar them from continuing to make such unsupported claims, the FTC said.

The FTC action on the melanoma apps followed research led by Dr. Laura Ferris, an assistant professor at the University of Pittsburgh, that was published in JAMA Dermatology in 2013. Her team looked at four such apps. “We saw that they didn't work all that well,” Ferris said in an interview. “You can't just put these out there with no validation or no data to back them up, because the stakes are too high.”

That's a particular issue for the poor, the uninsured, and the underinsured who might buy an app for a few dollars and diagnose themselves, rather than pay for a doctor's visit, she said.

Given the growing use of mobile medical apps, “I think we will be seeing an increase in scrutiny and enforcement by the FDA and the FTC,” said Monica Chmielewski, a partner at Foley & Lardner. She doubted that more “innocuous” apps like weight trackers would be subject to scrutiny. “But when you have these mobile medical devices treading in the areas of diagnosis and treatment, for those I think we'll see increased enforcement.”

Only 16% of healthcare professionals currently use mobile applications with their patients, but 46% plan to do so in the next five years, according to a 2015 survey of 500 professionals by Research Now, a Plano, Texas-based market research firm. Even so, 86% of the professionals surveyed said they believe mobile apps will increase their knowledge of their patients' conditions, while 46% said the apps will improve their relationships with patients.

Research Now also surveyed consumers who use medical apps and found that 96% said they believe the devices help them improve the quality of their lives. Sixty percent use them to monitor their activity and their workouts, 49% to count their calories and 42% to monitor weight loss.

“I have patients asking me all the time about health-related apps,” said Dr. Mike Sevilla, a family physician who belongs to a six-physician group practice in Salem, Ohio. “It's really a great way for me to talk to my patients and make them accountable” for managing their own health.

He recommends apps from the Mayo Clinic and WebMD to patients. “We're coming into the holidays and people are already thinking about weight loss and lowering their cholesterol and counting their steps.” Sevilla said. He believes home blood-pressure readings via apps often are more accurate because patients' blood pressure can rise when they come to the doctor's office.

Estimates of the size of the U.S. mobile health market vary widely. Manu Varma, head of strategy for Philips' Hospital to Home business unit, which sells devices and consults with providers setting up mobile health programs, said the market is growing 20% a year. For healthcare providers, a major factor driving that adoption is the shift to value-based payment, which creates a powerful incentive to keep patients healthier and reduce costs by avoiding unnecessary hospitalizations and emergency department use.

Banner Health in Phoenix has implemented a project called Intensive Ambulatory Care, which uses an array of mobile devices for home health monitoring of about 600 patients with multiple chronic conditions.

The program, which is free to patients, involves several ambulatory teams each consisting of two physicians, two nurses, two social workers, a pharmacist and a health coach who serve up to 40 patients. The devices, supplied by Philips, include a wireless scale and monitors for blood pressure, pulse rate, blood oxygen and glucose, plus video communication.

Results from the initial 135-patient pilot program indicated a 27% reduction in enrolled patients' cost of care, primarily because of fewer hospital admissions and shorter lengths of stay, as well as lower outpatient healthcare costs, said Dr. Hargobind Khurana, Banner's senior medical director of health management. “Patients like it a lot,” he said. “They adopted the technology more easily than we thought.”

As with the introduction of any new clinical-care process, there are safety issues with mobile health. “We're going from a situation where we had no data to one where we probably have more data than we need,” Khurana said. “You have to have processes in place where we don't respond to data that's flawed. You validate by talking with the patient. You understand that data is just one part of the decision tree.”

Research shows that mobile apps can offer clinical benefits, particularly when used in a structured healthcare program. A literature survey published in PLOS Medicine in 2013 by researchers at the London School of Hygiene & Tropical Medicine concluded that text messages to patients' mobile phones were effective with smoking cessation and in boosting patient compliance with antiretroviral medication regimes.

In September, the American Heart Association concluded that the evidence generally supports using mobile medical apps to address smoking, weight, healthful eating, regular physical activity, blood glucose, blood pressure and cholesterol levels. The association said heart researchers have found that consumer health-informatics tools have a positive impact on knowledge, adherence, self-management and behavior changes related to healthful eating, exercise and physical activity—but not on obesity.

Smartphone apps also were deemed “useful tools at the point of care and in mobile clinical communication, as well as in remote patient monitoring and self-management of disease.” But the association noted concerns that the apps generally “fail to incorporate evidence-based content” and lack “rigorous testing” for efficacy.

In another literature review, Spyros Kitsiou, an assistant professor in biomedical and health information sciences at the University of Illinois at Chicago, and his Canadian colleagues concluded that hard-wired telemonitoring and mobile telemonitoring were effective in reducing the risk of all-cause mortality and heart failure-related hospitalizations in intervention programs for patients with chronic heart failure.

The quality of the evidence is only “moderate,” Kitsiou said in an interview. But he argued that it's good enough to support using the devices and applications in clinical practice. “In the next five to 10 years we'll have even more evidence collected and be able to conduct more rigorous clinical trials,” he said.

Kitsiou and his co-authors wrote that “the key to the success of these programs is not the technology itself, but the coordination of care that needs to be in place along the continuum of health services delivered for (heart failure) patients within a healthcare system.”

He noted, however, that the digital interventions he and his colleagues evaluated were not the “run-of-the mill” mobile apps for consumers available from Apple or Google. The vast majority of consumer medical apps “have not been formally evaluated, so we know next to nothing about their effectiveness and whether they can actually harm the patient,” he said. “As the number of health apps is rapidly growing, there is an urgent need for greater regulation and oversight of these medical/health apps by FDA and other government entities.”

Healthcare lawyers caution that providers run a variety of legal risks in using mobile apps with patients. “If the patient brings in a bunch of stuff, if you rely on it and it's wrong, it's a problem,” said Kirk Nahra, privacy practice chairman at Wiley Rein in Washington. “But if you ignore it and it's right, it's a problem. You're damned if you do and damned if you don't.”

Robin Diamond, senior vice president at the Doctors Co., a medical liability insurer, said, “The physician needs to make sure patients know the limitations of the app” and how the provider organization handles the data produced by the app. “The patient may think, 'I don't have to worry about telling my physician my blood pressure is a little high this week,' ” she said. “But patients with mobile monitors need to be told, 'You still need to call me if you have this level.' ”

There is also a risk that the readings produced by a mobile device may be inaccurate. “There are a lot of untested apps on the market that may be unreliable or even dangerous,” Diamond said. If treatment is prescribed based on the wrong data, the provider could be found liable, though she knows of no such cases so far.

Dr. Art Papier, CEO and chief medical officer at Rochester, N.Y.-based VisualDX, which offers computerized diagnosis-support tools for medical professionals, noted that it's important to distinguish between medical apps for consumers and those for professionals.

“They're two different worlds,” he said. “You do want patients engaged in following their (skin) moles, and they can certainly track them by photographing them. But you need to be cautious about apps that give people mistaken information that the mole is OK.”