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  • Data relating to patient health status and/or the delivery of health care routinely collected from sources other than traditional clinical trials. Examples of sources include data derived from electronic health records (EHRs); medical claims and billing data; data from product and disease registries; patient-generated data, including from in-home-use settings; and data gathered from other sources that can inform on health status, such as mobile devices. (21 U.S.C. 355g(b)).5 and Framework for FDA\'s Real-World Evidence Program December 2018)
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