The FDA is drafting regulations that outline what types of health apps will need government approval before they can be marketed in the United States. But the regulations have been bogged down by debates, hearings and legislative back and forth over whether government oversight would stifle innovation.
“Applying a complex regulatory framework could inhibit future growth and innovation in this promising market,” six Republican members of Congress wrote last spring to the heads of the FDA and the Federal Communications Commission, reflecting some of the concern.
A few private groups, meanwhile, are working to assess the quality of various apps. Misra’s iMedicalApps gets health care professionals to review software applications that mainly interest physicians. Happtique, a subsidiary of the Greater New York Hospital Association, is about to launch the nation’s first app certification service which will evaluate apps for safety and effectiveness. It will award some apps the high-tech equivalent of the Good Housekeeping Seal of Approval.
“We truly believe people need a trusted source,” said Ben Chodor, Happtique’s CEO.
Smartphone stress test
Misra, an internal medicine resident at Johns Hopkins Hospital, says he’s most concerned about apps that claim to test or treat consumers for serious diseases. These apps can sometimes give inaccurate information or can lull people into ignoring symptoms that might need medical attention.
Cardiac Stress Test, for instance, says on Google Play (where it sells for $3.07) that it can determine “if you are ready for sports or if your heart is not in a healthy condition.” A person takes his heart rate after performing 30 squats in less than 60 seconds, and enters it into the app’s calculator, which then reports whether the user’s heart is in shape for exercise.
“It’s hard not to imagine how this app could give folks a false sense of security,” Misra says, noting that assessing someone’s cardiac status is not just a matter of looking at heart rate.