Dive Brief:

• Nearly four years after President Barack Obama announced a sweeping real-world data collection effort to improve precision medicine, Fitbit says it has kicked off the first digital health technology initiative part of the National Institutes of Health's All of Us research program.
• The so-called Bring-Your-Own-Device initiative gives Fitbit users the option to sync data collected by their wearable devices, like physical activity, heart rate, and sleep measurements, for analysis by NIH researchers. The ultimate goal is to better prevent and treat disease based on understandings of how lifestyle, environment and genetics play a role in health outcomes.
• NIH's All of Us program, conceptualized under the Precision Medicine Initiative, aims to collect data across diverse populations through surveys, electronic health records, physical measurements, biosamples and digital health technologies from at least one million volunteer participants. As of six months ago, NIH said 100,000 Americans had signed up to share data.

Dive Insight:

The Scripps Research Institute tapped Fitbit in November 2017 to be the first wearable or digital health tech partner for the program, citing the brand as the most commonly used tracker in biomedical research, including in published work, clinical trials and NIH-funded research, according to the Federation of American Societies for Experimental Biology Journal. Fitbit and Scripps' most recent analysis found more than 675 published studies had used a Fitbit device.

All of Us began official enrollment across the U.S. in May 2018. The Fitbit collaboration offers a push for those with the device to opt into the larger program.

Bring-Your-Own-Device and All of Us latch onto growing momentum in medtech and digital health for collection and use of real-world evidence. Elsewhere under HHS, FDA has made more noise about its own RWE goals, as it hopes to fund the National Evaluation System for health Technology Coordinating Center (NESTcc) this year to better collect postmarket data on medical devices.

As the concept of RWE collection catches on, so too do concerns over privacy and user understanding of the implications of data sharing. Some critics say All of Us and the Precision Medicine Initiative advertise on goals of curing disease and achieving personalized medicine they may not be able to make good on. Fitbit wrote in the news release that there would be "strict safeguards in place to protect participant privacy," but did not offer further detail.

While the Bring-Your-Own-Device push is open to anyone with a Fitbit account, the company will roll out a second All of Us initiative later in 2019 involving 10,000 participants randomly selected to receive a fitness tracker for purposes of the study.

Other collaborations for the lifestyle tracker brand in the past year include a chronic disease management partnership with Humana and a wearables acceleration initiative with Google Cloud.