FDA and the Future of Mobile Health Technology
Mobile devices increasingly diagnose and manage disease, putting them under the watchful eye of federal regulators, who could slow the pace of innovation.
The U.S. Food and Drug Administration is responsible for regulating anything closely tied to patient diagnosis and treatment, including a growing number of mobile apps and medical devices that plug into smartphones or tablets.
Technology progresses at a lightning-fast pace, pressuring the FDA to finalize mobile health guidelines and speed up the approval process to get the newest innovations to market before they are out of date. At the same time, federal regulators must stick to their mission of ensuring public safety and health.
Balancing Innovation with Regulation
A recently approved smartphone ultrasound device underscores this need for balance. Manufacturer Mobisante created an ultrasound wand that plugs into a smartphone, enabling technicians to see ultrasound images on the phone’s screen.
Traditional ultrasound machines provide higher quality images than the mobile device, but also can cost more than $100,000. Mobisante’s invention costs under $8,000, an advantage for smaller clinics and medical practices unable to afford their own ultrasound machines, requiring them to send patients elsewhere for testing.
Besides its low cost, the mobile nature of Mobisante’s device also allows healthcare practitioners to take and use it anywhere, a true advantage in remote areas or emergency situations where taking on on-the-spot diagnostic images could help improve health outcomes.
But Mobisante’s device was hung up in FDA approval cycles for eight months before the company released it last Fall. By the time it hit the shelves, it connected to an outdated smartphone. Its inability to plug into the iPhone or widely-used Android models could hamper its chances of coming into widespread use, lowering the device’s potential usefulness and advantages.
More Guidelines On the Way
The FDA sometimes takes years to approve conventional medical devices and drugs, a pace mobile health innovators will likely find frustrating as they try to get new technological advances to market in a timely fashion and meet burgeoning demand for mobile health apps and tools.
The FDA, however, pledges to work with manufacturers and app developers who are, understandably, apprehensive about the regulatory process. It says it will adjust to the new demands of the mobile technology field and will train its eyes on the apps and devices themselves, not the business practices or procedures of the companies that make them.
The FDA released preliminary guidelines regulating medical apps last year. The agency only oversees apps that directly impact patient diagnoses and treatment, so an app that diagnoses skin cancer is subject to regulatory approval, while one that stores medical records is not.
Federal regulators expect to release more complete guidelines later in 2012, including guidance on mobile health devices such as blood pressure cuffs, ultrasounds, glucose meters and other diagnostic and treatment tools that connect to smartphones or tablets.
Based on the FDA’s app guidelines, experts predict the agency will follow a similar plan for medical devices, focusing its efforts on those with the greatest potential to impact patients.
Explosive Growth Leads to Powerful Influence
The mobile health field is small now and most innovations are coming from small, entrepreneurial companies trying to get a single device or app to market. These tiny startups don’t yet have the power to lobby government officials in favor of their innovations and businesses, unlike established pharmaceutical firms and traditional medical device manufacturers.
Right now, this disparity puts the mHealth field at a potential disadvantage. However, experts predict the mHealth market will grow exponentially by 2015. Today’s small mHealth device manufacturers and app developers will likely grow as well into larger, more successful ventures capable of putting out several new devices and apps every year, and perhaps will gain the power to put more pressure on federal regulators to keep pace.
Mobile health device manufacturers and app developers could also gain from tighter federal regulation. Hospitals and large healthcare systems won’t invest heavily in devices or tools still waiting for government clearance, so the FDA “stamp of approval” will allow companies to sell their wares more successfully in the most lucrative markets.
