Can Wearable Technology Help You Hit Your Health Goals?

Fitness technology has come a long way since the Walk-a-matic Pedometer. Such technology seems quaint now, of course, considering we’ve moved past just counting our daily steps.

Now we can track our health in a variety of ways, from monitoring our blood oxygen and heart rate to how much water we’ve consumed and whether we’re getting enough sleep.

As the technology of these devices continues to evolve, wearable devices like fitness trackers are becoming more medically sophisticated. Some of the newest smartwatches can even conduct electrocardiograms (EKG) to monitor for atrial fibrillation (AFib), a type of irregular heartbeat with potentially life-threatening consequences.

If wearable devices like fitness trackers and smartwatches can monitor our hearts for symptoms of AFib, but aren’t considered medical devices, what are they?

“Fitness trackers are not medical-grade devices intended to treat specific diseases or conditions, at least not in the eyes of the Food and Drug Administration (FDA),” says Dr. Elvin Mendez, a board-certified physician and Medical Director of Academics, Clinical Research and Precision Medicine at Lee Health.

The difference between wearable technology, whether worn as a smartwatch, or as medical device like a glucose monitoring sensor, can be confusing, Dr. Mendez admits.

“Both are wearable products that monitor our health and capture data which informs our healthcare decision-making,” he says. “When our smartwatch beeps to inform us our heart rate is too high, we slow our running pace. When our glucose monitor alerts us that our blood sugar is above a certain level, we can take appropriate measures. But the two products are completely different in terms of FDA product classification.”

Wellness and medical devices

According to Dr. Mendez, a medical device, as defined by the FDA, is intended to be used to diagnose, treat, mitigate or prevent a disease. These devices are regulated by the FDA based on their classification, which assures the safety and effectiveness of the devices.

However, the FDA defines smartwatches and fitness trackers as general wellness use devices. These devices are intended to assist with weight management, physical fitness, relaxation or stress management, mental acuity, self-esteem, or sleep management.

“Most of these devices are non-prescription health devices that don’t require approval by the Food and Drug Administration (FDA),” Dr. Mendez explains. “Wearers use these devices to monitor their health and track their vital signs. These devices collect biometric data than can range from their heart rate to their blood oxygen levels.”

Dr. Mendez says that wearables aren’t considered medical devices because their manufacturers aren’t claiming the devices treat specific diseases or conditions, such as obesity, eating disorders, anxiety, and others.

However, when a manufacturer introduced a smartwatch with EKG capability, the FDA intervened. Because the device was intended to detect AFib, the manufacturer was not allowed to classify the feature as a general wellness device. The feature, not the smartwatch itself, needed to be FDA cleared.  

The presence of AFib can lead to increased risk for stroke, heart failure, and other serious health concerns. Features like the EKG draw FDA scrutiny because they have the potential for causing harm. For example, a user who misinterprets the data could stop taking their heart medication, or cancel a consult with a cardiologist, or ignore symptoms of a heart issue.

In its clearance note for one product with an EKG feature, the FDA noted that the manufacturer had done testing and labeled the device to mitigate those risks.

But “FDA cleared" differs from “FDA approved,” terminology which can also confuse consumers. There’s a big difference between the terms.

Dr. Mendez explains: “The FDA uses a risk-based, classification system for regulating medical devices for people. Medical devices are categorized into Class III, Class II and Class I.

Class III devices are complex medical devices such as pacemakers and replacement heart valves. These are devices that implanted in the body. They are life-sustaining, or have the potential to cause significant injury or illness.

Class II and Class I are lower-risk devices and products used outside the body. Examples include catheters, powered wheelchairs, pregnancy tests, and condoms. The FDA typically clears Class II and Class I medical devices, which means the manufacturer can demonstrate their product is ‘substantially equivalent to another (similar) legally marketed device’ that already has FDA clearance or approval.”

So, does wearable technology improve health?

Consumers should consider wearable technology as another tool among many that can help improve their health and wellness, according to Dr. Mendez.

“The technology is only as empowering to the user as the user intends it to be,” Dr. Mendez says. “If a user shares with me the data from a device in real-time to electronic medical records, then we can analyze the data together to develop recommendations to improve their health and enhance their lifestyle decisions.”

To Dr. Mendez’s point, NIH scientists conducted a study involving 40 adults who wore a commercially available smartwatch across a period of months. The devices were programmed to provide a continuous daily stream of accurate personal health data researchers could access and monitor. The data totaled more than 250,000 bodily measurements a day per person. When combined with standard laboratory blood tests, the information could detect early signs of infections simply through changes in heart rate.

Dr. Mendez notes it’s also vital that doctors embrace the emerging technology behind wearable technology. “Demand for wearables is only going to increase as more people become willing to share wearable data with their providers. Healthcare providers need to be open to harnessing the technology to provide real-time patient monitoring, which will help medical practitioners apply this data to best practices that will help detect disease and enhance preventive care.”