Hey FDA, hands off my fitness tracker

Hey FDA, hands off my fitness tracker
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Two recent developments could significantly impact the future of health care in America. The first was widespread attention to Centers for Disease Control and Prevention (CDC) data showing that 94 percent of all COVID-19 deaths included other health conditions as a cause of death. The second was the news that a San Diego-based health system, Sharp, would start distributing Amazon’s new health and wellness tracker to some of their health plan members, and would work toward integrating the data into patient’s health records.

These two developments would not seem to be connected, but they may end up being significant building blocks in the transformation of America’s health care system from one that is focused almost exclusively on treating disease to one that gives equal importance to staying healthy.

The coronavirus pandemic is causing people to be much more conscious about their health. A survey of American adults by Samueli Integrative Health Programs and The Harris Poll showed that 80 percent of participants intended to be more mindful of their health practices after the pandemic.


This increased interest in health and wellness is accompanied by the adoption of health wearables by many Americans. A Gingrich 360 survey of 1,000 voters, conducted by the Winston Group in March, showed that over one-third own a wearable device to track fitness and health goals.

Wellness-focused wearables such as FitBit, Apple Watch, Oura Ring, WHOOP and Amazon Halo are helping people to better manage their health — particularly by helping them develop healthy sleep routines, get enough exercise, monitor what they eat, and manage their stress levels. This year, professional sports leagues are experimenting with using trackers to try to detect coronavirus symptoms in players.

As these devices become more sensitive and add capabilities, it only makes sense that your doctor advises you on how to respond to the information the wearables provide and, if useful, has access to the data. Our Gingrich 360 poll found that, almost by a two-to-one margin, Americans were comfortable with the idea of sharing data from their health wearables with their doctors.

Keeping patients healthy and away from the hospital comes at a perfect time, with the heightened interest in staying healthy because of the coronavirus pandemic. It would not be surprising to see more health systems, like Sharp in San Diego, that have their own insurance announcing similar initiatives.

However, with this step forward in integrating data from commercial health wearables into a patient’s relationship with their doctor, there are some dangers.

The biggest threat to progress is that the use of data by health care professionals to diagnose illnesses and recommend treatment could cause health and wellness wearables to cross into the realm of “medical devices,” which would put them under the regulatory thumb of the Food and Drug Administration (FDA). In fact, this intrusion already may have begun. The FDA has required apps that use the heart rate monitors of popular health wearables to detect atrial fibrillation to undergo agency review and approval.

One reason we have seen so much innovation in the commercial health wearable space has been the relatively light regulatory burden. It would greatly disrupt that progress if the FDA made it difficult to continue innovating by dumping layers of bureaucracy and regulations onto their development.

To continue the cycle of innovation and move health care forward in America, health wearables geared toward wellness must stay in the realm of commercial devices. There is plenty of precedent for medical professionals utilizing a patient’s commercial products to aid them in providing services.

For example, it is common for podiatrists to examine the wear pattern on a patient’s running shoes to help diagnose the cause of their foot pain, recommend treatment, and help them correct the issue. Even though the doctor used the shoes to help diagnose an injury, nobody would suggest that the shoes are medical devices.

Wellness-focused wearables should be thought of the same way: as commercial health devices controlled by the patient, whose information patients can choose to share with their doctor or their health plan to enhance their care.


A public policy that maintains the light regulatory burden on the health and wellness wearables market would allow for continued innovation in the space and be a key driver of the migration of our health care system to one that is focused on maintaining health through preventative care.

This much more health- and wellness-focused health system ultimately could make Americans more resistant to pandemics such as COVID-19, and help them be happier, more productive and more prosperous.

Joe DeSantis is chief strategy officer and director of the BetterCare Project at Gingrich 360.