Law Commons^™

The Patient's Voice: Legal Implications Of Patient-Reported Outcome Measures, Sharona Hoffman, Andy Podgurski

Faculty Publications

In recent years, the medical community has paid increasing attention to patients' own assessments of their health status. Even regulatory agencies, such as the Food and Drug Administration and the Centers for Medicare and Medicaid Services, are now interested in patient self-reports. The legal implications of this shift, however, have received little attention. This Article begins to fill that gap. It introduces to the legal literature a discussion that has been ongoing in the health care field.

Patient-reported outcome measures (PROMs) are reports of patients’ symptoms, treatment outcomes, and health status that are documented directly by patients, typically through electronic …