The U.S. Food and Drug Administration said its plans for regulating certain healthcare apps used on smartphones and tablets will not impose undue burdens on developers or stifle the growing mobile health industry.
Christy Foreman, director of the FDA’s device evaluation division, told a subcommittee of the House Energy and Commerce Committee on Thursday that the agency’s goal is to foster technological innovation while protecting public safety.
The agency would not, as some had feared, regulate the sale or general consumer use of mobile devices, she said.
Foreman’s comments came on the third day of hearings aimed at clarifying the types of health app to be regulated by the FDA and whether such apps would be subject to the 2.3 percent tax that some companies are required to pay on medical device sales under the Patient Protection and Affordable Care Act.
In July, 2011, the FDA published draft guidance in which it proposed regulating any mobile app deemed to be a medical device. It said it would not regulate personal wellness apps such as pedometers or heart-rate monitors, but would regulate an app that, for example, attaches to a mobile platform to collect and analyze heart and brain signals.
Foreman said that while the FDA is not responsible for taxation, a mobile app deemed to be a medical device would be subject to the medical device tax unless it is sold to consumers through retail stores, in which case it would be exempt.
Still, the FDA did not provide the detailed answers some had hoped for.
“The FDA says they are trying to limit the regulation to a small subset of apps but they have not clearly explained to the public what they consider a medical device,” said Areta Kupchyk, partner at the law firm Nixon Peabody whose clients include mobile app developers.
Foreman said the FDA plans to release the final guidance by October.
According to a report published in March by research2guidance, a research and consulting firm, the market for mobile health services will likely reach $26 billion globally by 2017.
According to the report, there are 97,000 mobile health applications in major app stores, of which some 15 percent are primarily designed for the healthcare profession, including continued medical education, remote monitoring and healthcare management applications.
Charles Yim, founder and chief executive of Breathometer, an experimental, key fob-sized breathalyzer that plugs into a smartphone and calculates a breath alcohol content reading, is a serial technology developer who discovered his product will need to be cleared by the FDA.
“I wouldn’t say it is preventing us from doing what we wanted to but it is an inhibitor,” he said in an interview. “Apple has approved our app contingent on it getting FDA clearance, so that means we are solely reliant on government now.”
Foreman said it takes the agency, on average, 67 days to clear a mobile app and that most will fall into the lower-risk categories of medical device that do not require onerous pre-market testing. The cost of an FDA application for a big company is $5,000, she said.
“For a small business,” she said, “It’s half that.”
By Toni Clarke