Pew Analysis: Despite ONC’s EHR Oversight, Patient Safety Issues Persist

According to a new analysis from the Pew Charitable Trusts, despite the Office of the National Coordinator for Health Information Technology’s (ONC’s) new regulations on electronic health record (EHR) oversight, gaps will persist that could put patients at risk.

On Oct. 14, the ONC issued a final rule that updates the ONC Health IT Certification Program which sets up a regulatory framework for ONC to directly review certified health IT products and gives the agency more direct oversight of health IT testing labs, as reported by Healthcare Informatics. According to an ONC blog post about the rule, specifically, the final rule focuses on: (1) establishing a regulatory process for the direct review of certified health IT by ONC; (2) updating ONC authorization and oversight of accredited testing labs (ONC-ATLs); (3) and making identifiable surveillance results of ONC-Authorized Certification Bodies (ONC-ACBs) available on ONC’s Certified Health IT Products List (CHPL).

But according to the Pew analysis, published last week, “Unfortunately, even with this rule in place, gaps will persist in the ability of hospitals, doctors, and the developers of these systems to detect flaws that could put patients at risk. That’s because the ONC requires only limited testing of EHRs to check for flaws before the products are installed, and no comprehensive system exists to collect information on safety problems related to these records.”

As such, Pew recommends further steps to improving the safety of EHRs. First, it says ONC should require that vendors better test EHRs for safety before their products are brought to market and after the products have been installed and customized at facilities.  “This would help mitigate the need for the ONC to perform a direct review of an installed product, because flaws would have a higher likelihood of detection beforehand,” the analysis read. And second, “EHR developers, hospitals, clinicians, government, patient organizations, and other healthcare stakeholders should come together to identify common safety problems with these records and work together on solutions. Congress should pass legislation to establish this collaborative.”

Pew says that these steps would help detect and prevent safety problems during the development and implementation of EHRs and reduce patient harm related to these products. Following the release of the certification rule, stakeholders responded with mixed feelings, with some trade groups questioning ONC’s oversight ability, and others, like the American Medical Association (AMA), applauding steps taken by the agency to strengthen the monitor and testing of certified EHRs.