Privacy policies for FDA-authorized or FDA-recognized digital therapeutics impose high digital health literacy demands: a cross-sectional analysis.

Abstract

Although digital health literacy is often framed as an individual skill, participation in digitally mediated care is shaped by the demands built into system documents. Inaccessible privacy policies may represent a document-level pathway through which digital health systems contribute to digital exclusion and inequitable participation, particularly for underserved or disadvantaged populations. We examined the accessibility of privacy policies for US FDA-authorized or FDA-recognized digital therap