Future Tense

mHealth Care Crisis

Should the FDA regulate smartphone medical apps?

This article arises from Future Tense,a collaboration among Arizona State University, the New America Foundation, and Slate.

Should mobile health apps be regulated by the FDA?

It wasn’t very long ago that cell phone use in hospitals was verboten. While mobile phones are still banned in many Canadian hospitals, more than three-quarters of American doctors now have smartphones; some estimate that 30 percent carry iPads. Physicians fire up their phones to calculate prescription dosages, catch up with disease treatment guidelines, and explain diagnoses to patients. The doctor’s bag is going high tech as new devices turn a doctor’s smartphone into a stethoscope, ECG heart monitor, blood pressure cuff, glucose meter, and more.

Late last month, the FDA released draft guidelines on regulating this panoply of mobile health apps. A mobile medical app, as explained by the draft document, is something that “meets the definition of ‘device’ ” under the Federal Food, Drug, and Cosmetic Act and “is used as an accessory to a regulated medical device; or transforms a mobile platform into a regulated medical device.” (The FDA’s so-called 510(k) system for approving and regulating medical devices has just been blasted by the Institutes of Medicine, but that’s another matter entirely.) The guideline framework is still under review, and physicians and others have been invited to share feedback with the FDA. After the draft guidelines were released, the FDA’s Bakul Patel, a policy adviser, told reporters that the agency is only concerned with a “very small subset of all mobile apps which are out there.” Even so, the list of things that might be regulated as mobile medical apps is long and complicated. It includes programs and accessories that help develop and track data—like iPhones turned into glucose meters—as well as diagnostic imaging software for smartphones.

Indeed, there are a whole lot of health-related mobile apps out there. The medical department of the iTunes App Store features apps that help dieters track calories alongside programs that let doctors evaluate patient concerns while on call. In one sign of the mismatch between the consumer-focused App Store and medical practice, MD on Call has been rated 12+ because it contains “infrequent/mild alcohol, tobacco, or drug use or references” as well as “infrequent/mild mature/suggestive themes.”

The medical-app territory is a case study in how platform crossover can complicate matters for regulators. Apps that calculate the right prescription dosage for a patient—which would be covered under the draft guidelines—have been around since the days of the PalmPilot, says Dave Albert, a doctor developing an iPhone ECG. PalmPilot calculators were themselves just based on formulas that any doctor could find in a book. Why, he asks, should the FDA treat a smartphone app that does the same thing any differently? And if such calculators on smartphones are regulated, what about the many websites that offer the same service?

It wouldn’t be surprising if the calculator apps are dropped from the FDA’s final guidelines, since the agency seems most interested in new technologies. But given that some mobile health devices have already been cleared by the FDA under the existing 510(k) process, it’s worth asking why a new framework is necessary at all. Take Mobile Mim, an app that allows physicians to view radiology images on their smartphones. Mobile Mim entered the iTunes App Store a couple of years ago, only to be removed when the FDA deemed it a medical device that required approval. After some back and forth, the FDA cleared it in February 2011 under the 510(k) process, making it the first radiology app to earn the agency’s blessing. (Interestingly, Mobile Mim is intended for use only when a doc can’t make it to a computer, which would allow her to see higher-resolution images on a bigger screen.)

Iltifat Husain, the founder of iMedicalApps.com, says the FDA should focus specifically on apps that could encourage patients to delay medical care by telling them whether they really need to go see a doctor, or by offering questionable at-home treatment, like light therapy for acne and “relaxation.” Sometimes developers seemingly attempt to escape FDA notice by placing treatment apps under different categories. Come on—an “entertainment” app called BrainFreqz—Depression Relief?

As a patient, there’s one addition I’d like to see when the mobile-health guidelines move out of the draft stage: the word privacy. The doctors I spoke to said that they aren’t terribly concerned about mobile apps causing physicians to make mistakes or misdiagnoses, though that may just be because there are still relatively few apps that directly affect patient care. (Or it could just be a little old-fashioned doctor hubris.) Indeed, the FDA has as yet received no reports of adverse health outcomes connected to mobile health apps. But the physicians did share some concerns about keeping information secure when using smartphones and tablets to update health records, discuss patient care, and prescribe medications. Until I’m more comfortable with my health information’s security, I hope my doctor limits her in-office iPhone use to browsing Epocrates—and, of course, playing Angry Birds between appointments.