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Since the start of the pandemic, the health care and life sciences sectors have relied more heavily on real-world data and real-world evidence as they work to develop new drugs and devices and survey the world outside of clinical trials. Hospitals and health systems are key to these efforts.

The Food and Drug Administration defines real-world data as data relating to a patient’s health status and/or the delivery of health care routinely collected from a variety of sources, such as electronic health records, claims and billing activities, and product and disease registries. Real-world evidence is the clinical evidence regarding the use and potential benefits — or risks — of a medical product derived from analysis of real-world data.


The FDA has used real-world data from Israel to make decisions on Covid-19 boosters based on evidence of fading vaccine immunity over time. Real-world data and real-world evidence are also currently being used to examine the effectiveness of treatments for conditions ranging from sickle cell disease to atopic dermatitis, metastatic renal cell carcinoma, and many others.

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