Highlights: Supporting the Reliability and Safety of Certified Health IT through an ONC Direct Review Process

Elise Sweeney Anthony | October 14, 2016

Today we issued the “ONC Health IT Certification Program: Enhanced Oversight and Accountability” final rule. This is a key part of the Office of the National Coordinator for Health Information Technology’s  (ONC) commitment to accelerate the interoperable flow of electronic health information by supporting the reliable and safe use of certified health information technology (health IT). We truly appreciate the comments we received on this rule from the stakeholder community and we look forward to working with stakeholders as we implement its provisions.

The final rule updates the ONC Health IT Certification Program (Certification Program) to continue to support physicians and hospitals using certified electronic health records (EHRs) and to support the rapid innovation in the health IT market. Specifically, the final rule focuses on: (1) establishing a regulatory process for the direct review of certified health IT by ONC; (2) updating ONC authorization and oversight of accredited testing labs (ONC-ATLs); (3) and making identifiable surveillance results of ONC-Authorized Certification Bodies (ONC-ACBs) available on ONC’s Certified Health IT Products List (CHPL).

In addition to the other two areas of the rule, we know that the ONC direct review regulatory process provisions have received a fair amount of interest.  We have included highlights of the ONC direct review provisions below. For example, in response to stakeholder comments, the final rule focuses on risks to public health or safety, as well as circumstances that present practical challenges for ONC-ACBs. We invite you to join our upcoming webinars for a more detailed discussion of all three areas of the final rule.

The direct review regulatory process:

  • Stands Up a Regulatory Process for ONC Direct Review. With the vast majority of physicians and hospitals now using certified health IT, ONC plays an important role in helping ensure that these products operate safely and reliably in the field. The direct review regulatory process is an important complement to the work performed by ONC-ACBs to support that goal. The final rule focuses on risks to public health or safety, as well as circumstances that present practical challenges for ONC-ACBs—such as when issues arise involving a developer’s products that have been certified by multiple ONC-ACBs. The final rule itself includes examples for when ONC direct review may occur.
  • Recognizes the Real World Uses of Certified Products. We recognize that certified health IT often does not operate in a vacuum.  In order for ONC to properly evaluate certified health IT, we may have to look at whether certified health IT may fail to perform as it should when it interacts with uncertified capabilities within the product or with other technology. In these situations, ONC’s actions under the direct review process would focus on the certified health IT and not on the uncertified capabilities or other technology. It is important to note that a developer of certified health IT would not be held responsible for non-conformities that are not reasonably within its ability to influence or control.
  • Concentrates on Corrective Action Plans to Fix Problems. Because ONC’s goal is for any concerns found with certified health IT to be corrected and for certified health IT to function as intended for clinicians, the final rule concentrates on corrective action plans as a means of addressing issues that arise. Where direct review reveals a problem with certified health IT (a non-conformity), ONC will provide direction to and work with developers on comprehensive corrective action plans. If these corrective action plans are not implemented or do not resolve the issue, similar to the ONC-ACB approach in addressing non-conformities, ONC may seek to suspend and/or terminate a certification if necessary.
  • Provides Opportunities for Health IT Developers to Inform the Direct Review Process and Appeal Certain Decisions. We are committed to productive communication with developers to successfully address any non-conformities that may be identified. Accordingly, the direct review process includes opportunities for developers to respond to ONC concerns, and to appeal suspension and termination determinations made by ONC.
  • Keeps Clinicians and Users Informed Throughout the Process. Certified health IT is intended to support clinicians in providing patient care. As part of corrective action plans that may result from direct review, developers must notify all potentially affected customers of the non-conformity and the plan for a resolution. In addition, developers must notify customers when the certification of their health IT is suspended or terminated, which ONC will also post on the ONC Certified Health IT Products List. Further, ONC will coordinate with other Department of Health and Human Services programs, such as the Medicare and Medicaid Electronic Health Record Incentive Programs, to help identify and make available appropriate remedies to users of terminated certified health IT.

Please visit HealthIT.gov to access the final rule, a fact sheet, press release and other educational materials. Look out for our upcoming webinar on the final rule. We will post dates and times on HealthIt.gov.