With the advent of the iPhone, mobile medical applications have increased in use for both patients and consumers. Companies capitalize on the relative cheapness of iOS development to build platforms around mobile health and fitness, and a plethora of these apps are available on the market now. Catchphrases such as “scientifically proven” and “medically tested” abound in many of these consumer marketed applications, but oftentimes the evidence to back up these claims are absent. Regulation and accountability of the mobile world has become somewhat of a grey zone in terms of who should control the screening and vetting process. Federal departments, such as the Food and Drug Administration (FDA) and Federal Trade Commission (FTC), have historically limited their jurisdiction to specific medical topics. This begs the question: who is responsible for this regulation?
Recently, state regulators have started investigating the claims of many fitness and health applications to ascertain their correctness. The Office of the Attorney General of New York (NYOAG) has cracked down on many of the heart rate monitoring apps and the marketing claims they have promoted. One such application is Cardiio, a heart rate monitor that advertised to “measure your heart rate, learn how the numbers relate to your general wellness, perform effective workouts to get in shape, and track your progress” in addition to calculating life expectancy based on heart rate. The NYOAG found that Cardiio, Inc.’s assertions that Cardiio-Heart Rate Monitor can calculate a user’s potential life expectancy and estimate how the user “stacks up” against “the average person” in the USA did not contain sufficient disclosures that these calculations were hypothetical and estimates not intended to measure accurately life expectancy. As a result of the investigation, many changes were made to the original application to notify users that the data was not always accurate. The emboldened tag, “The Cardiio app has not been tested with individuals with health conditions…and has not been cleared or approved by the U.S. Food and Drug Administration” is a reminder to be wary of the advertised benefits of healthcare apps.
An important outcome of the recent claims settled was the methods used to categorize the variety of medical applications in the app store. Medical devices are separated into classes by the FDA, ranging from low risk Class I devices such as dental floss, to higher risk Class III apparatus such as a heart replacement valve. Many medical mobile applications have been moved from Class I to Class II, representing a greater amount of regulation and control. While mobile applications provide a faster and more adaptable method of healthcare support, we should be aware of the evidence necessary to show their effectiveness and safety.
Assurance of Discontinuance with Cardiio, Inc.