FDA Regulation of Mobile Health – What It Means

May 3, 2013

The U.S. Food and Drug Administration (FDA) has little to no interest in regulating the vast majority of the 40,000 or more mobile-health applications that are available for various devices today. The FDA aims to oversee a small subset of mobile medical apps that present a potential risk to patients if they do not work as intended. It also wants to get involved with companies building wireless accessories for existing medical devices, as well as those that turn a phone or tablet into a clinical medical device. It would not regulate the sale or general consumer use of smartphones or tablets.

Mobile Health apps

Congress Meets for MHealth Regulation

Last month, 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 Happtique and one of the 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 growing mobile health industry exposure to a larger audience.

Remote Monitoring Regulation

Some of the pressure to ease regulatory guidelines has come from technology developments that have simply outpaced the regulatory environment. Another is that provisions of health care reform call for making greater use of remote monitoring, to reduce healthcare costs. Providers are pretty keen to reduce costs where they can as well. Remote monitoring would be particularly helpful when it comes to patients with chronic conditions, such as congestive heart failure or diabetes or both, so they can have shorter hospital stays and care managers can be alerted for any changes in their vital signs

Mobile Health Apps As Medical Devices

Mobile health apps would be treated as medical devices if they serve as implants, implements, instruments or in vitro reagents used in the diagnosis of a disease, or in the cure, mitigation, treatment or prevention of a disease or serve as an accessory in one of those functions. About 100 apps have been reviewed as medical devices by the FDA since 1997 and 67 have received 510(k) clearance through 2012. Though a fair few are remote monitors, the first iPhone medical app to be approved was Mobile Mim by Mim Software, which can shrink the size of radiology images and transfer them securely.

Interesting Details About mHealth Regulation

The mobile health industry will have to wait a bit longer for the FDA’s final decision on regulatory rules but has uncovered a few interesting details worth considering for developers and investors in mobile health. These are a few of them.

  • The FDA has been regulating mobile medical device software for more than 10 years. In fact, 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 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 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, 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, 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, the director of the FDA Office of Device Evaluation, said it would come before Oct. 1, 2013 (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, 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.

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