Lack of testing rules could frustrate ONC’s EHR oversight

A new regulation from the Office of the National Coordinator for Health Information Technology designed to increase federal oversight of electronic health records needs better testing requirements for EHR vendors.

Without an upgrade in testing requirements, the rule will struggle to achieve its stated goal of improving patient safety, says Ben Moscovitch, manager of health IT at The Pew Charitable Trusts. Moscovitch authored a report providing an assessment of ONC’s Enhanced Oversight and Accountability Rule released last month.

In theory, the regulation would enable ONC to review EHRs suspected of posing serious risks to patients, require the developer of an EHR to correct identified flaws, and, if necessary, suspend the certification of products with unresolved issues.

“Unfortunately, even with this rule in place, gaps persist in the ability of hospitals, vendors, providers and other organizations to obtain data on the safety implications of EHR usability and develop best practices to address safety errors that are identified,” says Moscovitch.

Also See: ONC releases final rule for Health IT Certification program

According to Moscovitch, the problem is that EHR certification and testing regulations require 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.

To address these issues, he makes two recommendations to help detect and prevent safety problems during the development and implementation of EHRs, while reducing patient harm related to these products:

  • ONC should require vendors to 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 agency to perform a direct review of an installed product, because flaws would have a higher likelihood of detection beforehand.
  • EHR vendors, hospitals, clinicians, government, patient organizations, and other healthcare stakeholders should come together to identify the most common and significant safety problems associated with EHRs and work together on solutions as well as disseminate those best practices.

When it comes to the second recommendation, Moscovitch says he would like to see Congress pass legislation to establish a Health IT Safety Collaborative, which an expert panel from the Institute of Medicine recommended creating in 2011.

The Health IT Safety Collaborative is envisioned as a public‐private partnership designed to “provide a confidential space for developers and providers to address concerns and cultivate new educational resources and training materials to build health IT safety competencies” while identifying and strengthening ways to “encourage better reporting of health IT‐related safety events.” However, for years now, Congress has refused to authorize $5 million in funding to initially establish the Health IT Safety Collaborative, despite repeated annual budget requests by ONC.

On December 6, ONC and The Pew Charitable Trusts will co-host a Health IT Safety Day in Washington to explore the root causes of and solutions to patient safety errors associated with EHRs. Specifically, the meeting will look at how the EHR certification criteria and testing programs can help improve patient safety and how the federal government and private sector can advance the development of a HIT Safety Collaborative.

Those interested in registering for the Health IT Safety Day can do so here, as well as find additional information about the agenda and scheduled speakers.

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