Are Smartwatches and Fitness-tracking Wearables Medical Devices? Should They Be?


By: Matthew Jurgensmeier

Pedometers have been around for hundreds of years. More advanced GPS-tracking devices are much newer, and have been gaining popularity over the last decade. The first real “smartwatch” that could pair with a user’s phone emerged around the year 2012 and the market has exploded since then. Now, smartwatches can be seen nearly everywhere. Smartwatches provide convenience and ease of use for activities that range from answering phone calls and paying with a credit card to tracking heart rate and activity level. However, when these devices blur the line between something designed for convenience and a medical device, consumers should be aware that they aren’t buying an FDA-approved medical device. While the information provided by these devices may be useful, the accuracy of the information is contested. Given the dubious readings from these devices and the lack of governmental oversight, it is unlikely that a mass-marketed medical device exists.

Some of the main players in the smartwatch and fitness tracking marketplace include Apple, Samsung, Fitbit, and Garmin, among others. Smartwatches can track steps taken, distance walked (or run, or swam, or biked), and even quality and length of sleep. They allow people to play and control their music right from their wrists, respond to text messages, make phone calls, and see if a person has reached their “daily goals.”

These “daily goals” may be misleading and the data used to reach those goals is likely inaccurate. For example, the default step goal for Fitbit watches is 10,000 steps and many assume achieving this goal means they have a healthy lifestyle, or that they were especially active on a given day. Although this goal is provided for people of all shapes and sizes, it comes from a 1960s study based on a uniform lifestyle and population. Of course, 10,000 steps are better than zero, but users can’t quantify what exactly that 10,000 steps means.

Even assuming 10,000 steps is a healthy goal, a user may be thousands of steps from achieving that goal when their device alerts them about their achievement due to inaccurate measurements. A recent study (albeit small in terms of participants) tested the accuracy of pedometers and fitness trackers on a sample of college students. The study found that the most expensive fitness tracker they tested, a Fitbit ChargeTM, over-estimated by an average of 55 steps per five-minutes of walking, with a standard deviation of nearly 43 steps. Extrapolated over an hour, that is an average overestimation of more than 600 steps.

Another study, conducted at the University of Pittsburgh, tested whether tracking diet and exercise using a fitness-tracking wearable device would result in more weight loss than a separate, web-based portal. The study found that the group using a wearable lost about 5 pounds less over the 24-month study.

While encouraging people to move more, sit less, and generally be more active is not bad per se, it is important to note that what these devices tell us is not necessarily scientifically accurate. In fact, Fitbit faced at least one lawsuit due to the inaccuracy of its measurements. Another example comes from measuring heart rate via a wrist-based device. While these devices are accurate when stationary, they lose accuracy when moving. This is an important hurdle to overcome for a fitness tracker, whereas it may be less important for a lifestyle-oriented device. But what about a medical device? Or a lifestyle-oriented device that acts like a medical device? Who regulates these?

The Food and Drug Administration is tasked with regulating medical devices. As of 2015, the FDA was working on preliminary guidance for “low-risk medical devices.” In 2016, Bloomberg News reported that the FDA confirmed that it would not “enforce its rules over products that are intended only for general wellness, such as tools for weight management, physical fitness or mental acuity.” On the other hand, “[a]ny product that claims it can treat or diagnose a disease or condition won’t be considered a wellness product” and will therefore be regulated. In 2017, the FDA partnered with various technology companies, including both Apple and Fitbit, to help inform its regulatory scheme. As of early 2019, the FDA has outlined a pre-certification pilot program to offer a faster means of regulating and approving software-based medical devices for sale.

This means that software-based medical devices may soon be available for purchase. In fact, the newest version of the Apple Watch does have FDA clearance for a few features. The watch can function as an EKG to help monitor a user’s heart. However, although one aspect of a device may pass the FDA’s strict standards for medical devices, that does not mean all of the device’s functions pass that same demanding standard.

As the lines blur between fitness devices and medical devices, and technology continuously outpaces those regulating it, consumers need to learn to not be overly reliant on the data. While the information may be interesting, it is likely not yet reliable. Consumers should also understand why they are purchasing a device. If the device is intended to be a smartwatch that improves a phone’s usability and the general user experience, it is likely not regulated by the FDA. However, if a consumer wants something more specialized that does require FDA clearance, it is important to find out just what that device is cleared to do.

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