Increasingly, health data are recorded electronically and can be leveraged to better understand health outcomes. The 2018 Framework for FDA’s Real-World Evidence Program defines real-world data (RWD) as data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. RWD can come from a number of sources, for example:

  • Electronic health records (EHRs)
  • Administrative claims
  • Product and disease registries
  • Patient-generated health data, including those from surveys, mobile applications, and at-home sensors

The FDA Foundation has several projects aimed at understanding how RWD can be used to inform decision making processes for regulators, clinicians, patients, and payers.