Good News for Vendors: ONC to Significantly Ratchet Back EHR Certification and Enforcement

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By Michael Burger and Chuck Frederick, Senior Consultants

EHRVendors of electronic health records (EHRs) should be doing a happy dance over the recent announcement from the Office of the National Coordinator for Health Information Technology (ONC). It proposes to significantly ease the testing of EHR certification requirements as well as lessen the burden of enforcement for both EHR vendors and ONC Authorized Certification Bodies (ONC-ACBs).

Vendors should be happy because the changes should significantly reduce time and effort currently spent on certification testing. Now vendors will be able to “self-declare” that their products meet 30 of 55 certification categories, although they will have to undergo testing to demonstrate compliance with the remainder. On the enforcement side, ONC-ACBs will have discretion to prioritize surveillance based on complaints received rather than the current requirement to conduct randomized surveillance on a tiny percentage of the heath information technology certifications they issue. This modification moves the surveillance from a proactive to a reactive mode. Reported problems about EHRs or certification standards will be reviewed and investigated by testing authorities.

Aside from relieving burden and reducing costs on vendors and testing authorities, the proposed changes should open the door for innovation. Vendors will be able to redirect the time and resources spent on certifying basic functionality to improving usability, creating new features and meeting demand for data sharing.

A potential downside to the change from proactive to reactive compliance surveillance is that vendors could be subjected to more claims from users claiming substandard functionality. Absent a broad certification process, compliance with the requirements will be subjective, based on each vendor’s interpretation.

We look forward to the industry stepping up to take advantage of the found bandwidth to radically improve usability and innovate game-changing features. Tell us what you think. Reach us at michael.burger@pocp.com or chuck.frederick@pocp.com.