News Feature | August 19, 2013

Mobile Health Apps: Safe And Effective?

By Katie Wike, contributing writer

Mobile Health

Prescribing mobile apps for chronic conditions is gaining in popularity; providers now need to ensure the apps’ safety and quality

According to Aquity Group (click on image to enlarge), “Simple apps that track user’s personal fitness goals have already gained wide traction.” Aquity posits apps related to chronic ailments will be the next market medical professionals and entrepreneurs will develop. What is driving this development, according to Aquity, is that, “Smartphone-based systems can reduce the amount of other medical care that patients need (and) the potential benefit to the healthcare system would be enormous.”

According to Aquity, there are more than 10,000 health-related apps available for download from the iTunes App store, and other sources estimate there are more than 40,000 healthcare apps total. But are they safe and accurate?

To date, the Food and Drug Administration (FDA) has reviewed less than 1 percent of them. MobiHealthNews investigated “the FDA’s database of summary decisions for 510(k) clearances, (and) found more than 75 510(k) clearances that included a mention or description of a mobile software component.” MobiHealthNews continues, “Are there more than 75 cleared mobile medical apps? In all likelihood. We only included medical devices that specifically included mobile software components in the summary description of their FDA clearance.”

Despite the low number of FDA-approved apps, the New York Times voiced optimism for healthcare apps with the following caveat: “A range of issues — around vetting, paying for, and monitoring the proper use of such apps — needs to be worked out.”

Apps cannot be released and then reworked to fix problems. When health monitoring apps become available for use, they must be fully functional and have no bugs. Some companies have successfully avoided the FDA’s magnifying glass and, until the FDA puts mobile app guidelines in place, will continue to do so.

While acknowledging the value health apps can provide, FDA policy adviser Bakul Patel told the Times, “The agency, which does not want to choke innovation, will regulate only applications that act as medical devices by making clinical or diagnostic decisions.”

Despite Patel’s insistence the FDA does not want to stifle innovation, VentureBeat reports app makers are claiming that is exactly what is happening. “The burgeoning med-tech community fears that the FDA will step up its enforcement, and shackle consumers health products,” writes VentureBeat, before quoting Ben Chodor, chief executive of the health app store Happtique, as saying innovation is being stifled with developers “waiting on the sidelines” for an official decision. FDA needs come up with their guidelines already — sooner rather than later.”

The FDA has been planning since 2011 to release the aforementioned mobile app guidelines, but has delayed release for a myriad of reasons. The latest delay, according to Mobi Health News, was the results of protests from the Bipartisan Policy Center which “got 129 companies and associations to sign a letter that urges the administration to hold off on publishing the FDA’s final guidelines on mobile medical apps until an ONC workgroup focused on developing a risk-based framework for health IT regulations finishes its work.” In response, the mHealth Regulatory Commission sent a letter urging the FDA not to delay its guidelines any longer.

It appears as if the dust is now beginning to settle as the FDA announced it will release mobile health app guidelines by October. iHealthBeat reports the “FDA is finalizing mobile health app guidance and expects to release the information before the end of the federal government's fiscal year.” According to Christy Foreman, director of the Office of Device Evaluation at FDA's Center for Devices and Radiological Health, “oversight will affect ‘a small subset of mobile medical apps that present a potential risk to patients if they do not work as intended.’" The FDA will not regulate:

  • Health-related lifestyle apps, such as pedometers or programs that remind patients to refill prescriptions; or
  • Apps that perform the functions of an electronic health record system or a personal health record system.

When the FDA does finalize its regulations for health apps, the good news for doctors is patients are willing and ready to give them a try. According to Fierce Mobile Healthcare, a recent survey from Digitas Health found 90 percent of patients would accept a prescription for an app, compared to only 66 percent that would accept a prescription for medicine from their doctor.

Geoff McCleary, VP and director of mobile innovation at Digitas Health, sees apps as the future. “Patients are taking adherence and treatment to a whole other level in their own hands, without going to pharma … and we as experts on the drugs and the products we make have a great opportunity to help them even more by providing even more information tools and resources for them to use in conjunction with our medicines.”

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