The Affordable Care Act touches many aspects of the United States' health care system. Not every aspect of the ACA is an entirely new idea; many changes were already occurring before the act's passage. However, the ACA and the millions of new users it could bring to the system provide a jump start for many of these changes. One such shift is the movement away from a pay-for-service to a pay-for-performance, or outcome, model of care. Medical apps are one way to diagnose a patient's condition and monitor the outcome of their care.
"Mobile technology will bridge the gap between the traditional model of periodic observations with a doctor to continuous and daily assessments via your mobile device," says Chase Curtiss, CEO and founder of Sway Medical. The company's main product is Sway Balance, an app used to test for concussions.
The U.S. Food and Drug Administration defines a mobile medical application as software that runs on mobile devices and performs the same functions as traditional medical devices. A medical app may help health care professionals administer care, such as the Department of Health and Human Services' Radiation Emergency Medical Management app that gives guidance on diagnosing and treating radiation injuries. An app may also provide individuals with information about their own health. The National Institutes of Health's LactMed app gives nursing mothers information about the effects of medications on breast milk and nursing infants.
Just as the healthcare.gov website launched in October, the FDA issued a guidance document indicating how it will regulate mobile medical apps. For now FDA is focusing on medical apps that present greater risk to patients if they do not work as intended. Sway Medical's Sway Balance app cleared FDA regulations. The FDA process is fairly straightforward says Curtiss. "It is really just about proving your product is safe and effective—with proper documentation."