New Federal Rules Pave The Way For Patient-Driven Health Information Exchange And Real-World Evidence On COVID-19 Surveillance And Treatment

Health Affairs May 10, 2020
Sanket Dhruva, Joseph S. Ross, Nilay Shah, Rachael Fleurence, Harlan M. Krumholz

Now nearly forgotten in the midst of the worst global pandemic of the past century, the recently released federal rules governing electronic health data presage an era in which patient-driven health information exchange enables patients to have greater agency over all of their health care data. This could transform evidence generation and accelerate the discovery and delivery of novel drugs and medical devices to patients, including for COVID-19, by overcoming challenges inherent in traditional clinical research. The rules, which derive from the 21st Century Cures Act, will enable researchers and the Food and Drug Administration (FDA) to partner with patients to produce real-world evidence (RWE) to support regulatory decision making spanning the total product life cycle, including drug and vaccine...

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