The Office of the National Coordinator for Health Information Technology has finalized an update to rules for certifying electronic health records. The new rules on oversight and accountability, released Friday morning, are intended to address issues of public health and patient safety, as well as provide additional transparency into the surveillance of certified EHR products, federal officials said.
This rule does not supplant the existing, much-criticized EHR certification program that has been in place since Meaningful Use came about in 2011. Instead, it focuses on concerns about oversight, including, to an extent, the problem of “information blocking” by EHR vendors.
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“Our work builds upon that rule,” new national health IT coordinator Dr. Vindell Washington said about the 2015 edition of EHR certification criteria. He spoke to media in a teleconference Friday.
This add-on rule to EHR certification is also is meant to put more of a focus on public health and safety, according to an ONC blog post. “It’s a key part of our commitment to accelerate interoperability and the free flow of data,” Washington said in the conference call.
ONC said that the rule has three major components: a mechanism to review certified EHRs if there might be a risk to health or safety; additional oversight for accredited testing laboratories; and transparency by way of making public the results of ONC safety surveillance of health IT products.
Washington said that ONC will emphasize the development of corrective-action plans by any vendor found to be selling a product that could pose a safety risk. He noted that the 2015 EHR certification standards include “safety-enhanced design” provisions.
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What the new rule does not do is shift EHR certification testing from functionality to usability, something critics say has been missing for years. “It’s really not a place where you want a strong federal arm,” Washington said. “We have to decide where we’re going to draw the line with usability from the vendor perspective.”
That line, he reiterated, is as usability threatens public health or safety. In such cases, ONC could “take action,” Washington said.
He noted that this rule is intended to work in concert with newly released standards for implementing the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). “This isn’t the only lever that is in place for addressing information blocking,” Washington said.
Photo: Flickr user Luis Marina
