An estimated 40,000 health and wellness mobile apps are now on the market, a number that is growing at a rapid clip. Yet only about 25 have received clearance from the Food and Drug Administration. The vast majority are unregulated.
Many apps, including the ones that do not require FDA clearance, are starting to be used by hospitals and physicians seeking to improve care management of their patients, including those who are chronically ill. This growing use has raised unanswered questions about whether there is clinical benefit, how they should be regulated and how the apps are reimbursed.
That has led organizations like Happtique and its health system collaborators to step into the breach in an effort to come up with answers. Carolinas is putting together a pilot program that will provide Type 2 diabetes patients with access to a suite of 15 apps and digital tools that are expected to help them manage their diabetes and overall health. The system is developing an app formulary specifically for the six- to nine-month program, Weidner said.
“If the potential of mobile health is recognized, that will allow us to provide new ways to partner with and interact with our patients,” he said.
The formularies being developed by Carolinas and St. Luke's Episcopal will include apps that require federal oversight and those that do not.
WellDoc, a Baltimore-based technology firm, developed a mobile diabetes-management system that was one of the first of its kind to be cleared by the FDA in 2010.
The company chose to pursue the federal review process because it expected the FDA to eventually regulate the sector, said Demir Bingol, WellDoc's vice president of commercial marketing and commercial development.
“We wanted to take the higher standard because we thought it was important for patients,” he added.
WellDoc is preparing for a commercial launch of the product, which will then make it available by prescription. The system is now available to physicians. The company is also in discussions with payers about getting reimbursed for the system.
However, some app developers, investors and lawmakers say the burgeoning mobile health market has been held back by a lack of clarity from federal authorities about how they plan to regulate medical mobile apps. The FDA didn't issue draft guidance on its plans for regulating mobile medical apps until mid-2011.
The delay in issuing final guidance has drawn criticism from lawmakers and mobile app developers. Several testified at a House subcommittee hearing last week about the regulatory uncertainty and its impact on the market. “It's sort of created this little stalemate,” said Happtique CEO Ben Chodor. Developers “can't go to insurance companies saying, 'This should be reimbursable.'”
The FDA has promised to release the guidance by Oct. 1. An FDA official told lawmakers that the agency plans to focus on “higher-risk products” rather than low-risk technologies, such as apps that monitor the number of steps a patient takes each day or remind a patient to refill a prescription.
Some lawmakers are pushing legislation that would beef up the FDA's ability to oversee the medical app field. Rep. Mike Honda (D-Calif.), who represents Silicon Valley, plans to reintroduce a bill that would require the FDA to establish an office of wireless health technology as part of a broader effort to spur mobile health and health technology innovation and adoption. The bill will be reintroduced in April, a spokesman for Honda's office said.
As more Americans acquire smartphones and tablets, the expectation is that patients will increasingly seek out mobile medical apps that they plan to use as part of their personal healthcare. In some instances, patients are asking physicians whether they should use a particular app. In others, physicians are prescribing and recommending apps.
Patients, facing rising healthcare costs, may opt for an app that is free or costs much less than a $25 or $50 copayment for a doctor's visit. A recent study questioned the impact of certain apps developed for diagnosis.
The study, published in January in JAMA Dermatology, found that 3 out of 4 smartphone apps used to detect melanomas incorrectly defined 30% of melanomas as insignificant. One app missed 93% of all melanomas. None of the apps received FDA clearance.
Dr. Laura Ferris, a co-author of the study, said the results raised questions about how these apps are regulated, especially those developed to provide clinical information for a cancerlike melanoma. Delays in detection and removal can dramatically affect how long a patient will live. A patient's decision to buy a 99-cent app as opposed to paying a $50 copay for an office visit could have negative health consequences, she noted.
“People may be lulled into the idea that it's so technologically advanced and fancy,” Ferris said. “The technology has outpaced regulatory oversight.”
AliveCor, a San Francisco-based medical technology company, decided to seek FDA clearance for its mobile heart monitor, which it received in December. The device enables an ECG device's electronic monitors to be linked to a smartphone that has an app to record the signal.
Before the review process, the company considered whether the combination device was, in fact, a medical device. AliveCor executives knew the device would be used in a clinical setting to assist physicians with diagnoses rather than as a tool for patients to track and monitor their heart health.
“We did ask that question: Are we a medical device?” said Michael Righter, AliveCor's director of regulatory affairs. “It's very clear that what we have in our hands is a medical device.”
