Medical and health-care apps, also known as mobile health or mHealth apps, are becoming ubiquitous. “Want to hypnotize yourself thin? There’s an app for that. Want to monitor your heart rate without buying another gadget? There’s an app for that too. With the emergence of countless mobile health applications, smartphones are quickly transforming health care at our fingertips,” writes Veronica Thomas in WBUR’s CommonHealth. (Read her article here.)
But what are the regulatory issues surrounding these apps? As my colleague Tom Lecklider pointed out earlier this year, “…the FDA has made it clear that it doesn’t intend to regulate every app with a medical flavor. Indeed, the intention is to focus only on ‘the apps that present a greater risk to patients if they don’t work as intended and on apps that cause smartphones or other mobile platforms to impact the functionality or performance of traditional medical devices.'” (Read Tom’s article here.)
And now, an article published in the New England Journal of Medicine points out that out of some 100,000 mHealth apps on the market, only about 100 have been cleared by the FDA. A news article on the SMU website quotes SMU Dedman School of Law Associate Dean of Research Nathan Cortez, lead author of the NEJM article, as saying, “Consumers will be spending a lot of money on these products, and venture capital is flying into the industry. He predicts that by 2017 mHealth apps could earn $26 billion—up from $2.4 billion in 2013.
Cortez says an under-regulated mobile health industry could create a Wild West market. “Most consumers take mobile health app claims at face value,” he says, “and think that because they’re available through a trusted retailer like the iTunes Store, they must have been reviewed by the FDA, which isn’t usually the case.”
He adds, “Although the vast majority of mHealth products are very low-risk, some apps make promises they can’t fulfill, and others make errors that could harm patients.”
Visit SMU for more and to download the complete NEJM article. See also “EE Live keynoter: killer apps leave 30 dead.”