Fitbit hints at FDA regulation, as it launches corporate wellness, population health biz

On the corporate wellness front, Fitbit has already made enormous inroads.  It is in use by more than 70 companies in the Fortune 500.  It is rolling up corporate wellness along with population health offerings into a new business known as Fitbit Group Health.  It also encompasses all its efforts with weight management companies, insurers and clinical researchers.

Fitbit is also hinting that it may be on the cusp of engaging with the FDA.  Thus far, it has avoided becoming a medical device that diagnoses or treats medical conditions.  However, on its most recent quarterly conference call, the company’s Chairman and CEO James Park noted a recent case that was published in April in the journal Annals of Emergency Medicine of a 42-year-old man who wound up in the emergency room with atrial fibrillation of unknown duration.  Physicians used the data from his Fitbit app, with the patient’s permission, to determine when the arrhythmia started and help determine the best course of treatment.  When queried on the potential legal issues this anecdotal case raises, Park said he thinks it is a pretty massive opportunity.  “I think these devices are going to get increasingly more sophisticated over time, but there is obviously a lot of legal and regulatory challenges that we’re going to have to navigate,” Park said.  “I think the great thing is that, due to our leadership position, we are very visible in Washington and I think we’re going to have a big seat at the table in driving those discussions, so it’s going to be a pretty big opportunity for us.”

Fitbit has more than 1,000 corporate wellness customers including Target and Barclays, as well as several deals with corporate wellness groups. It’s partnered with several major insurers including Anthem, Premera Blue Cross, Humana Vitality and Optum/United to offer health and wellness to insurers.

It is also increasingly employed by health researchers, with more than 100 studies using it at institutions including the Mayo Clinic and Johns Hopkins. Recently, the Dana-Farber Cancer Institute started a study looking at the impact of physical activity and weight loss on breast cancer recurrence that uses Fitbit wearables.  In addition, the fitness wearable company has partnered with Weight Watchers and Medifast on weight management.

As part of Fitbit Group Health, Fitbit is also rolling out a new service that enables corporate wellness gurus to benchmark their investment against their peers with data that’s intended to validate and shape their programs.  This is dubbed Wellness Insighter.

“The launch of Fitbit Group Health is a natural evolution for us, given our success in the corporate wellness category.  It positions the company to integrate more deeply into the population health space,” said Fitbit CBO Woody Scal in a statement.  “With corporate wellness, we’ve already shown that our connected platform can drive higher engagement and better health behaviors in companies and communities.”

REFERENCE:  Fierce Medical Devices; 08 JUN 2016; Stacy Lawrence

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