Today’s smartphone is a camera, a GPS system, an e-reader, a game console and even a remote car starter. Why can’t it also be a blood glucose meter, X-ray viewer, stethoscope or diagnostic aid?
That’s the idea behind many of the 17,000 health-related mobile applications available in major app stores, with nearly half aimed at health care professionals. Research consultancy research-2guidance projects that 500 million smartphone users will have used a mobile health application by 2015. Today, 80 percent of doctors use smartphones and mobile medical apps in their everyday practice, according to an industry report from physician recruitment firm Jackson & Coker.
“We’ve gone from zero to 60 in a very short time,” says Bradley Thompson, a member in the Health Care and Life Science Practice at Epstein Becker Green.
The sector’s tremendous growth has attracted the eye of the Food and Drug Administration’s Center for Devices and Radiological Health. A traditional electrocardiogram (ECG) instrument is subject to regulation as a medical device, so why not an iPhone app that claims to do the same thing?
“We weren’t seeing specific safety or privacy issues; however, we did see that people were making various mobile medical apps that were doing something that traditionally has been done by medical devices,” says Bakul Patel, policy adviser at the Center for Devices. “Anybody who has an idea of FDA regulation of medical devices would say an ECG is a medical device.”
In July, the Center for Devices released draft guidance on mobile medical apps and called for comments on the document for a period ending Oct. 19. A public workshop on the draft guidance was held Sept. 12-13. Patel says the goal of the document was to provide clarity among those who develop, use and invest in health-related mobile apps while supporting innovation.
“There are companies coming from previously unregulated spaces that are a bit bug-eyed looking at all the regulatory requirements and thinking, ‘That’s a lot of paperwork,’” Thompson says. “But among those already regulated by the FDA, so far the FDA’s actions look reasonably measured.”
Mobile apps that fall within the oversight will be subject to the same type of regulatory requirements as traditionally regulated devices. Such requirements may depend on the category of devices into which the apps fall, but they include annual registration and listing, clinical studies, labeling, premarket clearance, quality design and manufacturing practices, and adverse event reporting. Patel notes, however, that many mobile apps will be considered Class I medical devices: things like tongue depressors and surgical instruments, which are considered to present little risk and are subject to the least amount of FDA regulation.
For now, the FDA will consider three categories of mobile apps to be mobile medical apps subject to FDA regulatory oversight.
The first category covers mobile apps that are an extension of medical devices and act to control the device or display, store, analyze or transmit medical device data. This includes apps that allow, for instance, radiologists to view digital images on their devices, or diabetic consumers to collect and analyze historical data from their blood glucose meters.
The second category covers apps that transform mobile devices themselves into medical devices through the use of attachments or sensors—the aforementioned iPhone ECG, for example, which attaches to ECG leads, or apps that use a device’s built-in accelerometer to detect movement and monitor sleep phases.
The last category covers apps that allow for the input of patient-specific information to deliver a patient-specific result, diagnosis or treatment recommendation to be used in clinical practice or assist with clinical decisions. Such apps use formulas or algorithms to calculate, for example, the amount of chemotherapy or anesthesia a particular patient needs, or to predict how a patient might respond to treatment based on lab data.
Patel says finalized FDA guidance will aim to be clearer about what devices fall into a particular category, in response to comments. As for mobile apps that fall outside the guidance, the agency plans to monitor them and determine whether additional actions are necessary. It strongly recommends, however,that the makers of any mobile app that may qualify as a device follow the FDA’s Quality System rules, which specify good manufacturing and design practices.
“People should be taking a rational approach and considering and managing the risk that their devices or products would put on patients,” Patel says.
A broad range of companies are involved in the mobile medical apps space and may be affected by the FDA’s guidance. Some of them are familiar with FDA device regulation. For example, many of the big medical device and medical software companies are putting out mobile apps to complement and extend the utility of their current product lines. This year Medtronic released a mobile app to help physicians monitor data from Medtronic implantable cardiac devices.
For other affected parties—nonmedical software companies, including small and one-person startups, consumer electronic companies and telecoms—FDA device regulation is a new frontier. Many major hospitals also are getting involved, creating apps for patients to schedule an office visitor to manage chronic health conditions.
“There’s a need to reach out to folks who aren’t used to dealing with FDA regulation and language,” Patel says.
The FDA activity surrounding mobile medical apps is just one area the agency has begun to address as part of a broader focus on health IT (HIT). In February 2010, the director of the Center for Devices, Dr. Jeffrey Shuren, acknowledged in a speech before the Office of the National Coordinator for Health IT (ONC) Policy Committee that in the past, the agency has “largely refrained” from enforcement in the area. But he made the agency’s view clear. “HIT software is a medical device,” he said.
This is a critical juncture, Thompson says. The FDA plans to issue additional guidance covering the application of quality systems to software and the classification of decision-support software, which goes beyond mobile apps.
Meanwhile, as both consumers and the health care industry embrace them, the mobile medical apps space continues to grow under the watchful gaze of the FDA.
“Given what’s happening with apps and the creativeness there is out there, it’s going to continue being something the agency is concerned about,” says Peter Reichertz, leader of Sheppard Mullin’s Food and Drug Law Group and co-leader of its Life Sciences Group. “Technology is advancing quickly on stuff like this, and this issue is not going away.”