The Food and Drug Administration (FDA), which regulates everything from heart monitors to horse vaccines, will soon have its hands full with consumer health apps and devices.
The vast majority of the health apps you’ll find in Apple’s or Google’s app stores are harmless, like step counters and heart beat monitors. They’re non-clinical, non-actionable, and informational or motivational in nature.
But the next wave of biometric devices and apps might go further, measuring things like real-time blood pressure, blood glucose, and oxygen levels.
More clinical apps
The FDA is charged with keeping watch on the safety and efficacy of consumer health products. Lately, that includes more clinical apps as well as devices you might buy at the drugstore, like a home glucose testing kit.
“It’s these apps that the FDA says it will regulate,” David Bates of Brigham and Women’s Hospital and Physicians Organization told VentureBeat in June. These apps will have to go through the full 510(k) process,” he said.
Dr. Bates chaired a group to advise the FDA on how to review health apps for approval, and on how the FDA should advise developers.
“It was intended to help them think through the risk factors involved with these products and then give guidance on how to stay within the guidelines,” he said.
“The device makers were asking from some guidance from The FDA on what types of things would be accepted and what wouldn’t,” Bates said.
Bates believes the FDA wants to use a light regulatory touch when looking at new medical devices. “The FDA definitely wants innovation to continue in clinical devices,” he said. “In general the FDA knows that the vast majority of apps are just informational.”
The FDA’s final guidance focuses on a small subset of mobile apps that present a greater risk to patients if they do not work as intended.
Health apps go mainstream
The big software companies (Apple, Google, and Samsung) have brought attention to, and lent credibility to, apps and devices that do more than count steps. These companies are building large cloud platforms designed to collect health data from all sorts of health apps and devices.
more at http://venturebeat.com/2014/07/21/health-apps-are-changing-so-must-the-fda/
Source: venturebeat.com
