a commentary in the Journal of the American Medical Association (JAMA). But before that can happen, they cautioned, "real-world clinical trial evidence" is needed to confirm the benefits of mobile health apps for patients, clinicians and payers.
The three cardiologists who wrote the commentary all work at the Scripps Translational Science Institute, which does clinical trials of mobile health applications and devices. They include Eric Topol, the institute's director and a longtime mobile health advocate; Steven R. Steinhubl, director of digital medicine for Scripps Health; and Evan D. Muse, a clinical scholar and cardiovascular fellow at the institute.
Their central thesis is that mobile health presents an opportunity for consumers to diagnose their acute symptoms and better manage their chronic conditions. This would promote patient engagement and partnership in care, they said. It would also provide greater convenience to patients, allow for more rapid diagnosis of acute problems, and reduce the number of unnecessary visits to physicians' offices and emergency departments, which would decrease the cost of care.
Today, they noted, more than a third of physician office visits are related to an acute condition, and care for up to a quarter of patients presenting at emergency departments could have been managed in the ambulatory-care setting. "Innovative mHealth devices exist for all of the most common acute conditions and have the potential to allow individuals to forgo an office or emergency department visit through safe, effective and informed management from home."
[ Want to know more about the trouble with regulating mobile health apps? See Lawmakers Try To Sharpen FDA Focus On Healthcare Apps. ]
The authors cite a "thermometer-enabled smartphone" that can be used to send physicians data that indicates whether a patient might have an upper respiratory tract infection. Besides monitoring temperature and associated symptoms, it connects with a patient's "digital community" to see how many people at work or at school have the bug. Similarly, a smartphone-based otoscope can check for the presence of otitis media, and a home urinalysis kit can be used to test patients for urinary tract infections.
Home monitoring can also be used to check blood pressure and send the data to physicians. One of every three adults has hypertension, and the condition accounts for 40 million visits annually. The use of digital blood pressure cuffs at home could greatly reduce the number of these visits, the commentary noted.
But there are several barriers to the increased use of mobile health apps for acute and chronic conditions, the paper said. Among them are: financial incentives for providers to bring patients into the office; physicians' fear of weakening their relationships with patients; and the untried nature of most of these apps.
While there is a lot of evidence that home monitoring of blood pressure and glucose levels is reliable, very few rigorous trials of mobile health apps have been done, said Steinhubl in an interview with InformationWeek Healthcare. "What little published data there is is primarily from pilot studies, which will always cast the best light on it," he said. For example, Asthmapolis (now Propeller) did a study of its asthma app with just 30 patients, but is now planning a larger trial, he said.
In the absence of good evidence, it's hard for physicians or consumers to know what to trust, he said. The JAMA commentary noted there was an enormous gulf between the number of mobile health apps on the market -- between 20,000 and 90,000 -- and the 100 or so that the Food and Drug Administration (FDA) has approved.
The FDA's final rule on mobile health regulation said that apps that purport to be medical devices or that are adjuncts to regulated medical devices require approval. Some developers might balk at this, but a degree of regulation is needed in this market, Steinhubl noted. He cited a recent study of an app that was supposed to help people self-diagnose melanoma. "It showed that in the majority of cases they missed 30% of the melanomas and called them non-concerning," he said.
Beyond the question of FDA approval, there's a great deal of hype in the mobile health space, he pointed out. For example, Toronto researchers recently announced they'd developed a wristband device that can analyze the nutrients in a person's bloodstream after they've eaten. Based on his knowledge of the science, Steinhubl said, he highly doubts that will work.
The iTunes store recently started requiring references to be included in listings of medical apps, he said. But with 10,000 papers published every week, it's not hard for somebody to find a study to back their app. He views this requirement as a "very minimal standard."
Steinhubl said he welcomes the launch of the online social health community Wellocracy by Partners Healthcare's Center for Connected Health. The Wellocracy site will have experts advise consumers on which mobile apps, sleep trackers and activity trackers fit their lifestyles. "There's definitely a need for an unbiased clearinghouse for medical applications and other apps," the Scripps researcher said.