Privacy policies for FDA-authorized or FDA-recognized digital therapeutics impose high digital health literacy...

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 therapeutics as system-level digital health literacy demands.

We conducted a cross-sectional document analysis of 36 publicly accessible privacy policies for digital therapeutics with FDA marketing authorization (510(k), De Novo, or Premarket Approval) or FDA provisional/discretionary recognition (e.g., enforcement discretion or Breakthrough Device Designation). Accessibility was assessed in two domains: (1) readability burden, summarized as a Composite Grade Mean derived from the Flesch-Kincaid Grade Level, SMOG Index, Gunning Fog Index, and Coleman-Liau Index; and (2) structural and design support, assessed using a prespecified 10-item rubric and summarized as the Structural and Design Support Score (SDSS) compliance rate. Findings were described relative to the prespecified grade 8 benchmark for readability burden and the prespecified 70% SDSS compliance benchmark.

All 36 policies exceeded the grade-8 benchmark. The mean Composite Grade Mean was 16.40 ± 1.60 and the mean Structural and Design Support Score compliance rate was 48.89% ± 11.90%. Only 2 policies (5.6%) met or exceeded the prespecified 70% benchmark. Logical sequencing, descriptive headings, and typographic emphasis were common; internal navigation, key-information summaries, visual aids, and text-visual integration were uncommon. A two-axis mapping analysis showed that 34 of the 36 policies fell within the high readability burden/SDSS <70% quadrant.

On average, privacy policies for FDA-authorized or FDA-recognized digital therapeutics were written above commonly cited public-facing reading-level benchmarks and provided limited structural and design support. These document-level characteristics may plausibly contribute to system-level digital health literacy demands. Improving document accessibility may therefore represent a modifiable target to support more informed participation in digital care and may be conceptually relevant to Sustainable Development Goals 3 (Good Health and Well-being) and 10 (Reduced Inequalities).