Health care facilities adopting electronic health record (EHR) systems have realized several benefits, but there have also been patient safety risks.1,2 Similar to US Food and Drug Administration postmarket safety surveillance of medical devices, the Department of Health and Human Services’ Office of the National Coordinator (ONC) has the authority to conduct EHR surveillance.3 The ONC’s surveillance investigations seek to determine whether EHR systems, referred to as vendor products, which were certified as meeting specific design, functionality, and security standards set forth by the ONC, still meet those standards when implemented and used. Electronic health record surveillance of vendor products may occur in response to a reported issue (reactive) or can be randomly selected for investigation (randomized).4 Randomized surveillance was formerly required of at least 2% of certified products, although this is no longer mandated.5
Pacheco TB, Hettinger AZ, Ratwani RM. Identifying Potential Patient Safety Issues From the Federal Electronic Health Record Surveillance Program. JAMA. 2019;322(23):2339–2340. doi:10.1001/jama.2019.17242
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