Health groups applaud new 'direct review' rule for certified health IT

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The American Medical Association (AMA) lauds the framework for increased oversight and transparency in the process of certifying electronic health records systems laid out by the Office of the National Coordinator for Health IT (ONC) last week.

"Physicians are captive to the IT products, and these steps will give regulatory certainty to them. ... We agree more emphasis must be placed on supporting the physician as an end-user and furthering their consumer power," Steven Stack, immediate past president of the AMA, said in a statement.

The rule expands ONC's ability to identify issues with EHRs in the field, specifically where there are risks to public health and safety, and situations that pose challenges to ONC-authorized certification bodies.

ONC will require corrective action for non-conformities and may suspend or terminate certification for existing systems or modules. Vendors must follow comprehensive corrective action plans that will be publicly available. That transparency, according to AMA, will help make EHR developers more accountable to their customers.

The American Hospital Association (AHA) also gave thumbs-up to the new rule, saying the information will be valuable to providers as they evaluate and select products, and that coordination across agencies is necessary to avoid provider penalties in the case of decertification.

To date, there’s been a lot of “carrot” and little “stick” in the certification process, and little done to address EHR customers' complaints, DirectTrust CEO and President David Kibbe said in a statement. He was glad the final rule was scaled back from the March proposal.

"[T]his ongoing program of oversight and accountability by ONC for the nation’s EHRs is a good thing; it balances the protections we want with the minimum amount of regulatory hassles possible," Kibbe said. "[I]n other words, it’s a balanced carrot and stick approach."