Objectives To review the evidence on harms associated with patient–clinician real-time encounters using video-based telehealth and determine the effectiveness of any related patient safety practices (PSPs), which are interventions, strategies, or approaches intended to prevent or mitigate unintended consequences of healthcare delivery and improve patient safety. Methods We searched PubMed, EMBASE, and Cochrane to identify eligible studies published from 2012 to 2022, supplemented by grey literature search. Outcomes of interest included adverse events and other specified harms (i.e., preventable hospitalizations, inappropriate treatment, missed or delayed diagnoses, duplication of services, privacy breaches). Findings Our search retrieved 7155 citations, of which 23 studies (including six randomized controlled trials [RCTs]) were eligible for review. Fourteen studies reported on adverse events or unintended effects of telehealth conducted in diverse settings. Adverse events such as death, reoperation, infection, or major complications were infrequent in both telehealth and usual care groups. Thirteen studies examined preventable hospitalizations or emergency department (ED) visits and reported mixed findings. Of the six RCTs, three showed no difference in risk of hospitalization or ED visits for telehealth compared to usual care and three showed reduced risk for patients receiving telehealth. We found no studies on the effectiveness of PSPs in reducing harms associated with real-time telehealth. Conclusions Telehealth was not inferior to usual care in terms of hospitalizations or ED visits. No studies evaluated a specific PSP. More research is needed to improve understanding of harms associated with real-time use of telehealth and how to prevent or mitigate those harms.
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