Real-World Evidence: Leveraging Electronic Health Records to Improve Patient Outcomes September 2017 Personalized care is shaping today’s healthcare industry and fueling the interest of using real-world evidence (RWE) to evaluate and approve individualized treatment options for even the rarest of medical conditions. In December 2016, the bipartisan 21st Century Cures Act, established by President Obama, charged the Food and Drug Administration (FDA) to evaluate the expanded use of RWE, including its potential to support the approval of new drugs as well as expansions for previously approved drugs. 1 The goal of the act was to use RWE to authenticate the value of pharmaceuticals and tailor healthcare decision-making more closely to the characteristics of individual patients for

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