In 2018, Scott Gottlieb, M.D., Commissioner of Food and Drugs, announced efforts to transform the FDA’s approach to digital health, including “tools such as digital biomarkers for early disease diagnosis, or using data from EHRs to enable pragmatic clinical trials at the point of care.” He went on to say, “These kinds of tools can help us make drug and device development more predictable, efficient and more reflective of patients’ real-world experience.”
While the FDA is working toward modernizing its framework for advancing the promise of digital health tools, there is a long way to go. Still, scientists and researchers can be creative and innovative using real-world data collected from wearable sensors and connected technologies. The key is to demonstrate well-defined practices to demonstrate sufficient data quality and fidelity to provide evidence in regulatory decision making.
In this infographic, we outline the essential steps required to get FDA approval for digital biomarkers.