This article appears in the January 2013 issue of Medicine on the Net.
Healthcare apps for smart phones and other mobile devices have been flooding the market since 2010 and have proliferated so rapidly that efforts are under way to create a process to evaluate and certify them.
According to the U.S. Food and Drug Administration, there were 17,288 health and fitness apps on the market in mid-2012 along with 14,558 medical apps. And all those apps are being used in a vacuum with no government oversight or vetting by private companies, leaving users to rely on word-of-mouth, online reviews, or simple trial and error.
"There are hundreds of apps that really work and are completely legitimate," says Mark Anderson, CEO of healthcare IT consulting firm The AC Group. "But there are also a lot of apps manufactured by snake oil salesmen who promote them with a lot of misleading information."
Explosive growth
Like the early days of the Internet—when dozens of new websites popped up every day—the healthcare app industry is a boomtown generating hundreds of new apps each month with most designed for use on mobile devices. According to Washington, D.C.-based eHealth Initiative, the number of smart phone apps increased 120% during the past year.
And millions of people are using them. According to research firm Research2Guidance, an estimated 247 million mobile phone users worldwide downloaded a health app in 2012 despite the fact that there's very little evidence to show how well the apps work.
"We know they [healthcare apps] hold great promise," says Jason Goldwater, vice president of programs and research for the eHealth Initiative. "But in most cases, there's not enough data on sustained success to know which ones really work."
Federal government steps in
But that's starting to change. In May 2012, the FDA approved the first iPhone-enabled blood glucose meter for sale at retail. The iBGStar Diabetes Manager allows users to analyze blood glucose levels and insulin injections and share that information with healthcare providers. Another company called Philosys recently filed for FDA approval for its GMate Smart app, a blood glucose monitor that works with the iPhone and iPad.
Mobile apps for diabetes management are a hot spot in the app world. A 2012 study from the eHealth Initiative found that diabetes management apps for diabetes have increased by nearly 400% over the past three years—from 60 smart phone apps to more than 260 in 2012—making it "the fastest-growing sector of the patient-centered tools industry."
With the floodgates now open, the FDA is working to craft a framework for regulating and approving mobile healthcare apps. In July 2012, the FDA issued a draft guidance document for Mobile Medical Applications as part of its effort to "help clarify the types of mobile apps to which the FDA intends to apply its authority."
In its draft guidance overview, the FDA noted that "as is the case with traditional medical devices, mobile medical apps can pose potential risks to public health" but that they may pose "additional and different risks due to the unique characteristics of the platform."
For example, it noted that "the interpretation of radiological images on a mobile device could be adversely affected by the smaller screen size, lower contrast ratio, and uncontrolled ambient light of the mobile platforms" and that it intends to "take these limitations into account in assessing the appropriate regulatory oversight."
Since most mobile apps don't require that level of sophistication, the FDA says that, for now, it intends to apply its regulatory authority to a subset of mobile apps that it is calling mobile medical applications.
To handle those new responsibilities, some federal lawmakers are proposing that an Office of Mobile Health be established at the FDA. U.S. Congressman Mike Honda (D-CA) is expected to introduce legislation soon that would create a mobile health development program at the U.S. Department of Health and Human Services to encourage companies to create new apps.
"Currently, our healthcare system works against small-to-large startup entrepreneurs with a multitude of barriers to entry," says Honda in a statement. "The principles of competition, innovation and entrepreneurship need to be [fully] manifested in the healthcare information technology space."
Some lawmakers have taken an opposing view, suggesting the government should not get too involved in regulating or promoting the healthcare app industry. Last summer, a group of Republican lawmakers sent a letter to the Federal Communications Commission and the FDA stating that government intervention could "inhibit future growth and innovation in this promising market."