Is your activity tracker a medical device?

Activity tracker technology has come a long way.  The first Fitbit released in 2009 only measured movement, sleep, and calories burned.  In contrast, the Fitbit Ionic smartwatch released in 2017 has a much broader range of functions, including heart rate monitoring, personal coaching, and built-in GPS. Consequently, with this change in functionality comes a change in potential uses for activity trackers.  The target market is expanding beyond retail consumers.  Healthcare providers, insurance companies, and researchers are beginning to recognize how activity trackers can be used to achieve their goals.

A recent article in Wired dives into the transformation of Fitbit and how its products are moving from the role of fitness trackers to medical devices.  Fitbit’s newest device (the Ionic smartwatch) is currently seeking FDA approval to screen for atrial fibrillation.  The device uses a blood oxygen sensor to detect sleep apnea and heart arrhythmias.

Your insurance company might also be looking at how activity trackers can keep their members healthy and reduce healthcare costs.  UnitedHealthcare has a wellness program (UnitedHealthcare Motion) that allows users to track their movement and earn financial incentives for meeting activity goals.  Those enrolled in UnitedHealthcare can register and sync their device.  Per the UnitedHealthcare website, this would allow the user of the activity tracker to earn a $3-$4 incentive per day if activity goals are met.

Activity trackers have also saturated the field of research.  A quick search of the term “Fitbit” on clincialtrials.gov, came back with a total of 199 studies, 76 of which are listed as “recruiting.”  Further, an article in Modern Healthcare released last month discusses how the National Institutes of Health All of Us research program will incorporate Fitbits. To give you an idea of the magnitude of how much data is going to be collected, 10,000 volunteers will be given Fitbit devices (either the Alta HR or the Charge 2) to wear for a year. Researchers are going to assess the potential for these wearable devices to improve how population health is studied.

This breakneck development of technology associated with activity trackers has great potential to change healthcare and research, but, before we tout potential successes, let’s step back and take a look at the potential risks. The Wired article mentioned above discusses how, in the case of Fitbit, the company’s brand is already strongly associated with self-improvement and fitness which could potentially influence consumer acceptance and engagement.  The CEO of Fitbit (James Park) acknowledges in the article that when comparing a Medtronic medical device versus a Fitbit, one implies sickness, while the other is aspirational. Healthcare providers will need to adapt how they communicate the utility and importance of these devices to their patients.

With the expansion of medical device-like wearable devices coming to market, regulatory processes need to be reviewed and possibly updated to account for this category.  The FDA has launched a new precertification program that targets digital health products with the goal of “revolutionizing digital health regulatory in the US.” FDA Commission Scott Gottlieb said, “We need to modernize our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate, and helps foster beneficial technology while ensuring that consumers have access to high-quality, safe and effective digital health devices.”

Additionally, our prior post on The Medical Care Blog addresses the issue of activity tracker accuracy.  That post discusses a 2015 article in the International Journal of Behavior Nutrition and Physical Activity that reviews the reliability and validity of Fitbit and Jawbone activity trackers.  Recognizing and taking appropriate action to address these potential risks is vital for all stakeholders.  While these devices may have the potential to impact patients and healthcare positively, moving forward without mediating these risks may lead to more problems.

Alexa Ortiz

Alexa Ortiz

Health IT Scientist at RTI International
Alexa Ortiz graduated from the University of North Carolina at Charlotte in 2009 with a Bachelor of Science in Nursing. Before receiving her graduate degree she was a practicing nurse for five years and has clinical experience in the field of both Cardiology and Neurology. In 2014 she received a Master of Science in Nursing specializing in nursing informatics from Duke University. Presently, she works as a Health IT Scientist at RTI International in the Center for Digital Health and Clinical Informatics. Despite no longer working in a clinical setting, she continues to maintain an active nurse license in the state of North Carolina. Her primary areas of research at RTI International focus on the clinical implementation of health information technology and the evaluation of consumer wearable devices.
Alexa Ortiz

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Catherine Gupta

Catherine Gupta

Catherine Gupta graduated in 2011 from the University at Buffalo with a Bachelor of Science in Pharmaceutical Sciences. In 2015, she received her PhD from the University of North Carolina at Chapel Hill Eshelman School of Pharmacy. Presently, Dr. Gupta is working at RTI International as a health communication research scientist. Her research focuses on patient-provider communication, direct-to-consumer advertising of prescription medications, and the development and evaluation of decisions aids for HIV prevention and management and informed consent.
Catherine Gupta

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Category: Clinical trials General Health behaviors Public health Tags: , , , ,

About Alexa Ortiz and Catherine Gupta

Alexa Ortiz graduated from the University of North Carolina at Charlotte in 2009 with a Bachelor of Science in Nursing. Before receiving her graduate degree she was a practicing nurse for five years and has clinical experience in the field of both Cardiology and Neurology. In 2014 she received a Master of Science in Nursing specializing in nursing informatics from Duke University. Presently, she works as a Health IT Scientist at RTI International in the Center for Digital Health and Clinical Informatics. Despite no longer working in a clinical setting, she continues to maintain an active nurse license in the state of North Carolina. Her primary areas of research at RTI International focus on the clinical implementation of health information technology and the evaluation of consumer wearable devices.