By: Sofia Martinez-Guasch
The “before times” (what society now terms the pre-COVID-19 period) viewed wearable technology as something that only elite athletes use, perhaps highly health-conscious individuals too. But as we officially reach one year into the lock down in the United States, the idea of wearable technology has dramatically expanded. Over the past year, more consumers are looking to wearable tech such as the Apple Watch, Fitbit, and WHOOP, not only to track their active lifestyles–or lack thereof–, but rather to monitor health patterns in hopes of identifying potential health issues before symptoms arise.
Tech like WHOOP continues to be at the forefront of using the fitness tracker to track consumers respiratory rate in an effort to identify asymptomatic people with COVID-19 and in some instances detect COVID-19 before consumers experience the symptoms. While the global pandemic impacted the wearable tech market and introduced it into the health care industry, its increasing consumer attraction may subject wearable tech to federal regulations post-COVID-19.
Before an innovative entrepreneur can sell their medical device to the public, it needs to be approved by the Federal Drug Administration (“FDA”). As part of the FDA’s approval process, the FDA assigns one of three classifications–Class I, III, or III–to the medical device based on the device’s potential risk to the patient or user. Additionally, the entrepreneur will likely need to apply for Premarket Notification approval, when the entrepreneur must prove that their medical device is safe and effective just as another pre-existing product in the market. Important to note however is that this detailed approval process only applies for devices meant for diagnosis, prevention, cure, or mitigation of disease in either humans or other animals. That is, it must be a device listed in one of two medical drug lists – the National Formulary or United States Pharmacopoeia.
Wearable products such as the Apple Watch, WHOOP, or Fitbit can track consumers’ steps, standing hours, and their heart rate. Nonetheless, it is no surprise the companies brand themselves as recreational technology and purposely avoid any highly health-conscious claims including medical diagnosis or disease prevention claims. The wearable technology industry boomed over the last year, partly because as recreational products, they are not subject to federal regulations that may delay their entry to market by a total of 180 days.
While these wearable products typically do not require FDA approval, products that use certain apps to detect certain medical conditions may be subject to the federal regulations. Following approval of Apple’s and Samsung’s EKG feature, in April 2020 the FDA also required one app that uses FitBit’s heart rate monitor to detect atrial fibrillation to undergo FDA review, which was approved less than five months later.
Over the past year, consumers’ use of WHOOP’s fitness tracker influenced the expansion of wearable tech beyond elite athletes and towards your every-day consumer. In June 2020, golfer Nick Watney used respiratory data on his WHOOP to help detect COVID-19 symptoms. The week after Thanksgiving weekend, the tracker’s app noted the golfer’s resting heart rate 10 points up from his typical heart rate level – his respiratory rate was also elevated to 19 breaths per minute. That same afternoon after noticing heart rate changes, Watney tested positive for COVID-19.
Shortly after the makers of WHOOP teamed up with researchers from CQUniversity in Australia and the Cleveland Clinic to find out whether there is a link between a WHOOP user’s respiratory rate and possible COVID-19 infection. According to WHOOP, the goal of the study was to have a set of data that “no hospital has access to: contextual data prior to the onset of disease.” While this type of data may help WHOOP users detect the virus early on–as it has for many–the impact that COVID-19 has brought more every-day consumers onboard with wearable tech for health purposes.
As the pandemic comes to what is hoped to be an end, a new beginning may emerge for wearable tech. Yes, the COVID-19 virus may come to not be a prominent health issue, but the possibility of remote working becoming permanent for many will continue to create an increasing sense of need to track healthy habits. Additionally, since telehealth is also likely here to stay post-pandemic, users are increasingly looking for methods to collect data of their physical and mental health that they can potentially substitute for on-site tests at their primary doctor’s office.
Consequently, it is likely that the need for innovative fitness trackers will increase, thereby expanding the wearable tech industry. However, the business opportunities that COVID-19 has provided fitness trackers also suggests that wearable tech post-pandemic may get closer to crossing the line into the medical device market.
Once emerging tech companies, or existing companies like WHOOP, begin collecting data that a user can relay back to their doctor (as some already users do) for the purposes of diagnosis, cure, or disease prevention, federal regulators are more likely to intervene. If wearable tech is used to measure a user’s heart rate, temperature, and blood-oxygen saturation–the same metrics that medical professionals monitor for hospital patients–then the data from a user’s wearable tech could potentially be transferred to medical applicability and their patient health record.
In this situation, there would have to be a clear understanding between the wearable tech company and the hospital collecting data on the ownership of the patient’s data. Nonetheless, it is clear that the biggest hurdle to overcome for emerging wearable tech companies, is strict compliance with FDA approval, even if its tech avoids making explicit claims of diagnosis, cure, or prevention.
Student Bio: Sofia Martinez-Guasch is a second-year law student at Suffolk University Law School and serves as a Staff Member on the Journal of High Technology Law. Sofia holds a Bachelor of Arts in English and a minor in Law & Public Policy from Northeastern University
Disclaimer: The views expressed in this blog are the views of the author alone and do not represent the views of JHTL or Suffolk University Law School.
