Reg-ent within the Learning Health System

Abstract

Clinical data registries are perhaps one of the most powerful outcomes of electronic medical records, and their benefits are projected to redound to patients and clinicians across the nation. The American Academy of Otolaryngology—Head and Neck Surgery Foundation’s Reg-ent fits within the conceptual framework of a learning health system. Because the data within this system are deidentified, research informed consent is not legally required. But ethical concerns remain regarding whether and how to best notify, and whether to obtain consent from, patients whose data are included. Particularly because data corroborate that a substantial minority of survey respondents believe that consent should be obtained for each research protocol (even for deidentified research) and because data breaches are, unfortunately, a serious risk, we recommend that the American Academy of Otolaryngology—Head and Neck Surgery Foundation ensure best practices for patient engagement as it continues to build Reg-ent.