In a series of congressional hearings next week, lawmakers will hash out the regulatory framework for the so-called mobile medical app industry, which according to one estimate could reach $26 billion within the next five years.
There are thousands of health care apps for smartphones — think calorie counters and heart rate monitors, just for starters — and lawyers say the vast majority aren't expected to fall under the purview of the Food and Drug Administration.
But app developers, and the lawyers advising them, have been waiting since 2011 for formal guidelines on what types of apps will require FDA approval, and of what sort. Charles Yim is one such developer. Yim founded San Francisco-based Breathometer in September 2012 with the idea for a device to test blood alcohol level that plugs into the headphone jack of a smartphone and delivers a reading through an app. He is currently preparing a submission for FDA clearance.
In 2011 the FDA came out with draft guidance for regulation of mobile medical applications, with formal guidance expected sometime this year. The draft carves out a majority of health-related apps, stating the FDA will only regulate those used as accessories to existing medical devices or those used for diagnosis and treatment of illnesses and diseases.
For the first three months, Yim said he had no idea that his product would need regulatory approval. In fact it was not until he submitted the app to Apple Inc. last month, that he entered what he called the "legal morass" of obtaining clearance for a medical device.
The Breathometer device needs to pass a process known as pre-market notification, or 510(k) clearance, a less stringent procedure that does not include clinical trials. The application needs to be submitted at least 90 days prior to marketing and essentially the applicant needs to show "substantial equivalence" to another legally marketed device. Once that is demonstrated, the new device can be sold.
Yim said the company plans to submit its 510(k) application by the end of next week. The company is in the midst of a crowdfunding campaign on the website Indiegogo and intends to start shipping its devices in July, pending regulatory approval.
Breathometer is working with attorneys at Nixon Peabody, including corporate partner Mavis Yee in Palo Alto and FDA compliance partner Areta Kupchyk in Washington, D.C.
Kupchyk said she is getting an increasing number of inquiries from app developers, with calls coming in every other day.
While the FDA will likely never provide guidance on every possible intended use for every app, "the line between wellness and specific health care claims is incredibly gray," she said.
At this point having any formal guidance in place may be more important than the details, said Gerry Hinkley, a partner in the life science and compliance groups at Pillsbury Winthrop Shaw Pittman in San Francisco.
App makers may be holding up product announcements or altering designs to avoid regulatory approval, Hinkley said. "The tech developer side wants to say [regulation] is totally off limits, but the people who buy the products — consumers, hospitals, health care systems — need a bright line."
Breathometer is Yim's fifth startup, and the third one that he's founded. The others have "all been software companies, with no cogs and a smooth process," he said.
Yim said that Apple's app screeners were initially confused by the Breathometer app. Once he explained that there will be a device that connects to the phone, Apple told him that it wanted FDA clearance before placing the Breathometer in the App Store.
He said he realizes that the onus is on him, as the entrepreneur, to know which regulations he is dealing with, and doesn't quarrel with the need to protect consumers
"I just wish we had more information and guidance. There should be a framework for companies like us to coast through the process as easily as possible."
At next week's congressional hearings, some lawmakers will be looking for just that. The House Energy and Commerce Committee, and its subcommittees on technology, health and oversight, will hear from app developers, health care providers and regulators including the FDA and the U.S. Department of Health and Human Services.
U.S. Representative Marsha Blackburn, R-Tenn., the vice chair of the Energy and Commerce Committee, has publicly stated that she does not want the FDA regulating medical apps at all.
However, while it is difficult to balance regulation with industry concerns, it is necessary, Hinkley said. "We're a slippery industry and as soon as they say they won't regulate apps, there will be diagnostic apps which should be regulated."
This article originally appeared in The Recorder.
