Mobile health apps are becoming more and more popular as a tool for consumers in maintaining healthy lifestyles. However, there is a growing concern that the health-related benefits are being over-stated by mobile health app developers. The New York Attorney General’s Health Care Bureau (“NYAG”) recently conducted a year-long investigation of mobile health app developers whose apps purported to measure vital signs and other indicators of health (referred to as “Health Measurement Apps”). For example, one such Health Measurement App used a smartphone’s camera and sensors, without any other external device, to measure consumer’s heartrate. The app would then compare the consumer’s heart rate readings at rest and before and after physical activity. The NYAG indicated these Health Measurement Apps could be harmful to consumers if the apps provide inaccurate or misleading results by either providing a false reassurance to the consumer that he or she is healthy or, on the other hand, incorrectly indicating that a medical issue exists.
The NYAG entered into settlements with three Health Measurement App developers for making misleading claims and for irresponsible privacy practices. The settlements required the Health Measure App developers to collectively pay roughly US$30,000 in penalties and take the following actions: (i) amend deceptive statements about the mobile health app; (ii) modify their privacy policies to better protect consumers; and (iii) provide clear notice to consumers that the mobile health app is not approved as a medical device by the U.S. Food and Drug Administration (“FDA”).
These recent settlements entered into by the NYAG may set the stage for other states to bring similar actions against mobile health app developers for misleading claims or inadequate privacy practices. In addition, federal regulators have mobile health app developers on their radar screens. Both the Federal Trade Commission (“FTC”) and the Department of Health and Human Services (“HHS”) have issued guidance aimed at app developer compliance. Under these circumstances, health app developers should consider whether their products adequately address requirements under federal and state law.