Safety Signals in Telehealth Primary Care and Outpatient Settings: Incident and Reporting Analysis Using World Health Organization Classification

Objectives: Patient safety in primary health care remains understudied compared with hospital settings, with particularly scarce comparative evidence on incident profiles across outpatient and telehealth modalities. This study addresses these gaps by characterizing safety signals and reporting dynamics in a Brazilian supplementary health program. Methods: This observational, retrospective study analyzed incident notifications from an institutional reporting system (January 2019 to October 2024), adhering to EQUATOR and STROBE guidelines. Incidents were classified using the World Health Organization International Classification for Patient Safety. Distributions of incident types, harm severity, reporter categories, and adverse events between outpatient and telehealth settings were compared using the χ 2 or Fisher exact tests, with associations quantified through univariable logistic regression as odds ratios (OR) and 95% confidence intervals (CI). Results: Among 3,287 incidents, telehealth reports were dominated by infrastructure (46.0%) and behavioral (36.0%) issues, while outpatient reports emphasized clinical processes/procedures (25.7%) and medication events (17.8%; P <0.001). Telehealth reports were more concentrated in risk circumstances and less often classified as near misses, incidents without harm, mild adverse events, or adverse events, with no significant difference in moderate or severe adverse events. Nurses submitted significantly more telehealth than outpatient reports (85.1% vs. 38.3%; P <0.001). Conclusion: Telehealth and outpatient primary care have distinct safety profiles shaped by differences in incident type, report behavior, and care context. A one-size-fits-all approach is inadequate —while institutional interventions can quickly shift reporting culture, lasting improvement requires modality-specific strategies. Policymakers should adopt tailored safety frameworks for both virtual and outpatient care to translate reporting gains into real harm reduction.