More Steps Needed as Part of Electronic Health Records Oversight

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The Office of the National Coordinator for Health Information Technology (ONC) has released new regulations that increase federal oversight of electronic health records (EHRs) in an effort to improve patient safety. These regulations allow the ONC to review EHRs suspected of posing serious risks to patients, require the developer of an electronic records system to correct identified flaws, and, if necessary, suspend the certification of products with unresolved issues. With this authority, the ONC hopes to address problems with systems that are already installed and in use at health care facilities.

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.

Two further steps are critical to improving the safety of electronic health records.

• The 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.
• EHR developers, hospitals, clinicians, government, patient organizations, and other health care 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.

These additional steps would help detect and prevent safety problems during the development and implementation of EHRs and reduce patient harm related to these products.