Is there any wonder why two years ago the American Dialect Society designated “App” its word of the year? The Apple app store offers around 850,000 apps, followed by Google Play with 800,000 and Microsoft with 145,000.
Candy Crush aside, one of the fastest growing segments of apps are a vast array of devices and technology being developed to advance mobile health care. Today, health apps used in conjunction with smartphones and tablets can help monitor blood pressure and glucose levels as well as transmit and read EKGs. The rapid rate at which broadband wireless services and handheld devices are becoming more widely available make it easier for physicians, hospitals and patients themselves to better manage, monitor and guide the delivery of health care in this country.
But as more consumers turn to mobile devices as assistive tools, pressure is building to meet their expectations. In mobile medical diagnostics, for example, software applications will be needed to make measurement data available for human interpretation through computational analysis, modeling and storage. Data can then be dispatched to a central location where it is available to any user or specialized professional.
In 2012, President Obama signed into law “The Food and Drug Administration Safety and Innovation Act” (P.L. 112-144) which includes provisions designed to help the FDA move forward on its plan to develop guidelines for regulating mobile health apps.
FDA says it does not plan to regulate all medical apps, only the ones that malfunction and cause harm to the user. If an app enables a mobile device to be used as a medical device that is FDA-regulated or as an accessory to an FDA-regulated medical device, the app will be subject to regulation.
However, many complain regulation in general stifles innovation. The steps required to comply with regulatory guidelines demand an investment of time and money—in an industry that’s not used to waiting. Medical device companies and app developers along with telecom and carrier giants like AT&T and Verizon want final guidance to be published as soon as possible. They feel regulatory standards should be clarified in order to move forward with development. App developers and medical device companies go on to argue that the lack of guidance is hampering progress and preventing developers who would otherwise create apps from doing so until standards are clearer.
Hospital, physician, patient organizations and IT companies seem to be in favor of a more gradual approach—preferring regulation to occur only after careful and detailed research and deliberation.
Many experts on mobile health regulations say that even the FDA’s final guidance on mobile health apps, which could be announced later this year, will not settle the debate. Hence, the next couple of years will see a lot of interaction between government and the private sector on what should and should not be regulated.
In the meantime, gamers will continue to prevail.
Nick Cavarocchi Jr.