A survey by the Pew Internet Project found that 11 percent of adults with cellphones downloaded an app last year to help them manage their health. That same year, the mobile health-apps industry generated an estimated $718 million worldwide, seven times more than the previous year, according to Research2Guidance, a consulting firm.
The regulation debate
While the FDA currently regulates certain medical software, the agency wants to update its thinking now that smartphones have juiced the apps market.
A year ago, the agency proposed policing only a subset of those apps: ones that use supplemental attachments to transform a mobile platform into a medical device (such as AliveCor’s EKG app) and others that act as accessories to an already regulated medical device (such as MIM Software’s app).
Rather than overseeing all medical apps, agency officials said they want to limit regulation to a slice of the market and take a pass on low-risk apps, such as calorie counters, according to Bakul Patel, an FDA policy adviser.
“We are taking a proactive step by saying that from the FDA perspective,” Patel said. “We’re not concerned about all those other apps.”
Software makers, on the other hand, see an agency that currently regulates next to nothing in the mobile apps space taking a sudden interest in regulating more. The FDA proposal, they say, is vague and leaves many questions unanswered. For instance, given that apps can be updated daily, does a software developer have to seek FDA approval for each update?
Among the critics is a group called the Health IT Now Coalition. It represents health-care providers, patient advocates and health insurance companies, including Aetna, which last year bought iTriage — an app that helps consumers evaluate medical symptoms and find the proper care.
“The issue here is that they’re really using a process for approval of these mobile apps that was basically created when the 5 ¼ floppy disk was the latest technology,” said Joel White, the group’s executive director.
Dirk Hobbs, chief executive of Medical Voyce Sciences and Multimedia, said the FDA’s plan is ambiguous and he doesn’t know whether the apps his firm is developing would be regulated. The apps aim to speed communication among medical professionals in different facilities.