STAT

Re-centering real-world data on the individual

Today’s health care leaders are awash in data. There’s no shortage of organizations collecting, structuring, and licensing massive real-world data sets, each touting millions of de-identified “patient ...
Forbes

Inside The Race To Harness Real-World Data: Who Will Build Healthcare’s Most Powerful Platform?

In the late 1800s, the U.S. railroad system didn’t just revolutionize transportation—it catalyzed entirely new industries. Refrigerated railcars enabled a national meatpacking economy. Standard time ...
FierceBiotech

FDA opens door to massive real-world datasets in medical device submissions

The FDA said it plans to accept new forms of real-world evidence in product applications, starting with a subset of medical device submissions. The agency said the policy change aims to enable the use ...
JD Supra

Awash in Data? FDA Removes a Barrier in Real-World Evidence Generation

On December 15, 2025, the US Food and Drug Administration (FDA) issued a press release announcing that FDA eliminated a major barrier to the use of real-world evidence (RWE) in medical device ...