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DirectTrust Hopeful for Impending ONC EHR Certification Rule

DirectTrust's David Kibbe challenges EHR industry stakeholders, saying ONC should play a role in developing EHR certification and oversight rules.

By Sara Heath

- EHR oversight and certification may be best left in the hands of ONC, according to DirectTrust.


According to the DirectTrust President & CEO, David Kibbe, MD, MBA, the EHR industry’s self-oversight may not be enough to ensure technology transparency and accountability, despite what critics of the Office of the National Coordinator for Health Information Technology may say.

Instead, Kibbe explained, the industry should open a dialogue between key stakeholders and leaders at the ONC about the issues at hand. This level of collaboration may be more useful in establishing an effective oversight and certification process.

Earlier this week, Kibbe issued a statement on behalf of DirectTrust describing his stance on the impending ONC final rule on EHR oversight and certification:

This is for some an unpopular rule in the current anti-regulatory environment and coming near the end of the Meaningful Use era.  However, it does beg the question whether EHR industry oversight by itself is going to be adequate to improve the usability and safety of EHR technologies in the coming months and years. It also assumes that the ONC will have continuing jurisdiction over the testing labs and the certification process itself. There has been criticism that the current certification program will not easily or nimbly make the transition from MU to value-based payment/MIPS, for physicians at least.  This is a debate we ought to have openly and, as a proponent of the ONC’s often very good work, I have to ask the critics, “would you rather be responsible for the certification program?” I would hope the new administration will tackle this issue early in January 2017. A new Final Rule would create momentum for that debate, no matter how controversial.

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Industry considerations for the ONC and its authority in making EHR certification rules are growing increasingly relevant, as the ONC is expected to issue the final rule in the near future. According to a report from Politico, the Office of Management and Budget issued a statement late last week teasing the impending release of the final rule.

ONC published a proposed rule in March of this year, detailing its protocol on EHR certification and testing lab oversight. The proposal elucidated three key points:

  • Direct Review: Enabling ONC to directly review certified health IT products, including certified electronic health records systems (EHRs), and take necessary action to address circumstances such as potential risks to public health and safety. This will complement existing ONC-Authorized Certification Bodies (ONC-ACBs) responsibilities.
  • Enhanced Oversight: Increasing ONC oversight of health IT testing bodies to align with ONC’s existing oversight of ONC-ACBs and provide the means for ONC to quickly, directly, and precisely address testing issues.
  • Greater Transparency and Accountability: Making identifiable surveillance results of certified health IT publicly available to provide customers and users with valuable information about the overall performance of certified health IT, including illuminating good performance and continued compliance.

Following that proposal, ONC opened communication lines for public comments and was received with general backlash.

Leaders from the Health Information Management Systems Society (HIMSS) commented that ONC should take a less punitive approach to EHR oversight and instead foster continuous industry improvement.

“While the NPRM’s stated goals are to enhance program oversight and health IT developer accountability for the performance, reliability, and safety of certified health IT, HIMSS encourages ONC to use this rule to promote a climate of continuous improvement through policy actions rather than punitive approaches that focus on certification suspension and/or termination processes,” HIMSS said in a public statement.

The HIMSS EHR Association said that this proposed rulemaking extends beyond the scope of ONC’s authority:

The Association believes strongly that this ONC proposal for direct review of certified health IT inappropriately expands ONC’s role in certification far beyond its current scope. ONC’s claimed authority for this expansion is inappropriate, counter to what we believe to be Congressional intent in HITECH, and inconsistent with how that intent has been interpreted by ONC for more than six years. We are specifically very concerned with and opposed to the proposal to extend certification authority to non-certified capabilities, as this would require new and complex processes to assess such capabilities where there are no criteria against which to evaluate conformance.

This feedback is an example of what Kibbe was commenting on, stating that ONC had some authority over the subject of EHR certification and regulation. Should industry stakeholders and ONC have more open discussions, Kibbe suggested, the agency may be able to work a final rule that better satisfies critics.

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