Business of Health Care: Clinical Wearables

Jun 28, 2019

One smart device maker recently issued an odd warning – its new smart watch technology to detect atrial fibrillation is not intended for people who have atrial fibrillation.


The truth is that a gadget worn on the wrist is simply not accurate enough to assess serious medical conditions.

It’s mostly a vehicle for conversations with your doctor.

Stanford researchers working with the smartwatch maker to detect atrial fibrillation probably won’t cause an epidemic of worrisome diagnoses, but it didn’t really answer most of the questions doctors or consumers have about using the watch as intended.

With that in mind, the smartwatch company is now teaming with a large healthcare company to a conduct a study of 180,000 people over the age of 65 to get a better understanding of its own device’s impact on health.

As wearable smart technology makers push more deeply into healthcare, their creations are crossing the line into becoming medical devices.

Although they may fit the definition of medical devices, the Food and Drug Administration has expressed little interest in regulating low-risk fitness monitors that are promoted for general “wellness.”

In practice, this means that companies can make exaggerated claims about the effectiveness of their devices for promoting wellness while doctors are puzzled about how to effectively use the sometimes-unreliable data the devices provide.

So for the time being, patients’ best bet is trusting their instincts and their medical providers – not their smart watches – for diagnosing potential serious health events.  

This report, and other episodes, are available at KWBU.org.

Business of Health Care is a production of KWBU and Baylor Scott & White Health.