Launched by Fitbit, Bring Your Own Device is the first digital health technology initiative. It is part of the National Institutes of Health’s All of Us research program and it is developed under the Precision Medicine Initiative. It consists in a fitness tracker that has the goal to collect data from a variety of populations drawing on surveys, physical measurements, EHRs, and digital health technologies. According to the NIH 100,000 Americans had signed up in this program and share their data.
The device was launched in a moment of big interest towards these technologies. The Federation of American Societies for Experimental Biology Journal has declared that this brand is the most commonly used tracker in biomedical research; it is very well known in published work, clinical trials, as well as in NIH-funded research.
The Bring-Your-Own-Device initiative consists in a great opportunity for Fitbit users to gather together different data such as physical activity, heart rate, and sleep measurements. This is part of the scenario where a RWE paradigmatic change is happening. As previously mentioned, FDA has already communicated its intention to actively push forward the research in the RWE field, with the specific goal to fund the National Evaluation System for health Technology Coordinating Center (NESTcc).
A second All of Us initiative is going to involve 10,000 subjects randomly selected to use a Fitbit tracker. The participants included in the collecting purpose of the study will become actors in changing the biomedical research structure.