In the third and final Senate Energy & Commerce Committee hearing this week on health IT, Christy Foreman, director of device evaluation in FDA’s Center for Devices and Radiological Health, promised the release of the agency's final guidance on its oversight over medical mobile apps (MMAs) by the end of this fiscal year. Looming regulatory uncertainty dominated discussion with healthcare and mobile industry witnesses during the past two hearings, with many urging FDA to finalize its 2011 draft guidance detailing its oversight approach.
“We recognize that mobile health application developers and manufacturers need a clear, predictable and reasonable understanding of the agency’s expectations,” Foreman said at the March 21 Energy & Commerce Subcommittee on Oversight and Investigations hearing.
Also, Foreman put an end to circulating fears that a 2.3 percent medical device excise tax would be applied to mobile devices, such as smartphones and tablets.
“Thank goodness the myth of the iPhone tax has been put to rest,” said Rep. Diana DeGette (D-Colo.), calling the three hearings “redundant.”
Rep. Henry Waxman (D-Ca.) also lamented the amount of committee time and attention devoted to health IT. “This tax issue is a nonissue,” he said. “There are too many other pressing issues in this committee to get bogged down in inaccurate information and a nonexistent iPhone tax.”
“I don’t think [the hearings] are redundant, they are essential. We want innovators to know with certainty how they’ll be dealt with as an industry,” weighed in Rep. Marsha Blackburn (R-Tenn.).
At the hearing, Foreman elucidated FDA thinking on its regulatory approach that is expected “in coming months” in the final guidance. She said the agency is poring through 130 comments, which are mostly positive, on the 2011 draft.
“Just as important as what the policy proposes is what the policy does not propose,” Foreman stated. Specifically, she said FDA oversight:
- would not regulate the sale or general consumer use of smartphones or tablets;
- would not consider entities that exclusively distribute MMAs, such as the owners and operators of the iTunes App store or the Android market, to be medical device manufacturers;
- would not consider mobile platform manufacturers to be medical device manufacturers just because their mobile platform could be used to run an FDA-regulated mobile medical app;
- would not require mobile MMA developers to seek FDA re-evaluation for minor, iterative product changes; and
- would not regulate mobile apps that perform the functionality of an EHR system or personal health record system.
FDA, which has approved about 100 apps since 1997, will focus its resources on “a small subset of apps” that pose the greatest risk to patient safety, Foreman said. Lifestyle apps like pedometers and those that search medical books or remind a patient to refill a prescription do not apply.
Apps related to SPO2 monitors, ultrasounds, X-rays, central monitoring stations for nurses and others that measure “critical parameters” of patient conditions are under FDA’s regulatory arm, she said. FDA would ensure MMAs are sophisticated enough to assist in a diagnosis; for instance, whether a radiological imagine on a smartphone has sufficient specificity to detect cancer. Avoiding false negatives or positives that put a patient’s safety at risk is central to FDA oversight, she said.
“As an example, mobile apps that affect the programming of a drug infusion pump or computed tomography scanner could lead to a drug or radiation overdose. An inaccurate or malfunctioning mobile medical app that uses a sensor to diagnose skin cancer or to measure critically low blood oxygen levels in chronic lung disease patients, could delay lifesaving diagnosis and treatment,” Foreman elaborated in her testimony.
Apps under FDA oversight must meet the definition of a medical device. For the apps that require preapproval through the 510(k) process, she said that, on average, it takes the agency 67 days to make a decision, which is within its 90-day statutory deadline.
Foreman stressed that FDA has a long history of balancing innovation while assuring appropriate patient protections, with decades of experience reviewing medical device software. She said the agency preapproves about 20 apps per year, which is less than 5 percent of its workload.
On a side note, concerns about interoperability also played out in the hearing, and were explored with the second witness: Farzad Mostashari, national