What mobile health app developers need to know about looming government regulation

The booming mobile app economy is quickly expanding into health care — by 2017, market research firm Research2Guidance estimates the mobile health market will be worth $ 26 billion. But one specter hanging over the industry has been uncertainty around regulation.

In July 2011, the Food And Drug Administration issued draft guidance on the regulation of mobile apps. But since then, developers and health entrepreneurs have been waiting for the agency’s final word. In the absence of clarification, some say, the threat of intervention and uncertainty has already held innovation back.

This week, Congress held three days of hearings to explore how to regulate health apps on smartphones and tablets. Executives from technology companies like Qualcomm (QCOM) and health services giant McKesson joined economists, medical leaders and regulators to weigh in on the debate.

Ben Chodor, CEO of health app store and certification service Happtique and one of this week’s speakers, said that while the hearings and FDA testimony didn’t provide as much clarity as developers ultimately need, the hearings and the attention they generated gave the mobile growing health industry exposure to a larger audience.

“I think it moved the needle a little bit,” he said. But “the bottom line is … we still need to see the guidance.”

The industry will have to wait a bit longer for the FDA’s final decision — but this week still uncovered a few interesting details worth considering for developers and investors in mobile health. Take a look at seven below.

The FDA has been regulating mobile medical device software for more than 10 years, said Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health. In fact, she added, the agency’s first clearance of a mobile app goes back to 1997. So far, the agency has reviewed 100 mobile medical apps, including remote blood pressure, heart rhythm and patient monitors, as well as smartphone-based ultrasounds and glucose meters.
Some estimate that there are 40,000 health apps available globally, but during her testimony before the Committee on Energy and Commerce (video here), Foreman said the FDA focuses on a small subset of “mobile medical apps.” These are apps that meet the definition of a medical device according to the Federal Food, Drug and Cosmetic Act and are intended to be used as an accessory to a regulated medical device or turn a mobile platform (smartphone or tablet) into a regulated medical device. Among those apps, there are three classes of apps that vary in potential risk and regulation requirements. But, so far, the agency has only regulated the less risky class 1 and class 2 apps and has not yet seen a class 3 app.
The FDA does not intend to regulate apps that track a person’s daily steps, enable patients to refill prescriptions, search medical references, provide electronic health record services or offer similar services. The only thing that would change the FDA’s mind, Foreman said, is if they learned of anything related to those apps that compromise patient safety.
Despite concerns that the FDA will have trouble keeping up with technology, Foreman said the FDA receives less than 20 applications to review mobile health apps a year. Once the agency releases its final guidance, it’s very likely that number could climb, but to put it in perspective, she said that’s just 0.5 percent of the total number of medical device applications they receive each year.
Based on its performance over the past three years, the FDA estimates that it takes them about 67 days to review a mobile medical app. That is well within the 90-day time period the FDA has to review any medical device looking for a 510(k) clearance to come to market.
When pushed by members of Congress to share when the FDA plans to issue final guidance on regulating medical mobile apps, Foreman said it would come before Oct. 1 (the end of the government fiscal year).
Despite rumors that smartphones and tablets could be subjected to a new 2.3 percent medical device tax, Foreman said those devices would not be regulated as medical devices and therefore not subject to the new tax. During the week, others discussed the possibility of taxing mobile medical apps, with some saying that mobile health apps would be exempt from the tax if they were distributed through retail channels.