With Great Potential Comes Regulation Uncertainty for Medical Mobile Apps

Photo: Drugsdb.com, 2012
Photo: Drugsdb.com, 2012

Ask the average smart phone user and he can probably show you a whole slew of apps he uses, providing a range of different services,  from keeping track of his schedule to streaming custom radio stations to paying for a meal with the scan of a barcode. But what about using your phone to monitor or diagnose your health? According to Research2Guidance, a mobile industry market research firm, approximately 247 million mobile phone users worldwide downloaded a health-related app in 2012. Health apps are on the rise, providing users with software to log exercise, count calories and even assess moles to decide whether they warrant a visit to the dermatologist. Some apps target doctors, allowing them to view X-rays on the go or communicate digitally with their patients. The US FDA noted that there were 17,288 health and fitness apps on the market in mid-2012, along with 14,558 medical apps. However, these mobile apps are the subject of debate as policy makers sort out how to ensure these health resources are credible and safe for consumers to use.

Currently, as is often the case in the tech world, health app technology has outpaced regulation. Heath-related mobile apps represent the intersection of consumer technology, communication, and medicine, making it unclear as to who the responsible regulatory body should be. Both Apple’s App Store and Google Play require that app developers meet some standards, but their guidelines do not currently pertain to content quality or validity. The FDA regulates medical devices, and provides oversight to certain health apps that in effect converts a phone into a medical device. "There are apps today that change a mobile platform into an EKG machine. When it's being used to diagnose patients, it's a medical device we believe is subject to FDA oversight," explained Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, in an NPR interview. But that still leaves the oversight of thousands of less technical apps up in the air.

At the moment, federal legislators are working to move a bill through Congress that would help clear up this regulatory ambiguity. Congressman Mike Honda (D-CA) has introduced The Healthcare Innovation and Marketplace Technologies Act, which proposes creating an Office of Mobile Health within the FDA. Establishing this new department would ensure that health apps actually provide users with credible and safe information.

We are inevitably going to see a shift towards mobile healthcare and a greater use of health-related consumer technology.  Local health care system Partners HealthCare has already established an entire Center for Connected Health to focus on efficiently and safely developing and implementing mobile health solutions. The recent focus on how to best regulate this new technology is a step in the right direction. The safety and security it will provide will enhance consumer confidence and ultimately accelerate the technology’s adoption.

Lucy Muscarella is a Consultant at Greenough. Follow her on Twitter: @lucymuscarella