May 01, 2015

Regulating Wearable Devices in the Healthcare Sector

Nina Kostyukovsky, Debevoise & Plimpton, LLP, Washington, DC

As of October 2014, at least one in five Americans owned an activity-tracking wearable device,1 such as a Fitbit or Jawbone, and more than 80 percent of consumers listed eating healthier, exercising smarter and accessing more convenient healthcare as important benefits of wearable technology.2  While wearable devices have been around for some time, manufacturers are constantly innovating the products, and many of the current models are so sophisticated that they can record a person’s physical activity, heart rate, geographic location, and even sleep hygiene from the wearer’s wrist 24 hours a day.3  As the data that wearable devices collect becomes more personal, entrepreneurs and regulators will face several challenges in trying to strike a balance between on the one hand encouraging the public to make healthy choices and on the other protecting their privacy and safety.  The Office for Civil Rights (OCR) and Food and Drug Administration (FDA), working under the U.S. Department for Health and Human Services (HHS), will play a major role in deciding how wearable devices can be used in the healthcare sector.4  

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