On Friday, Oct. 14, 2016, the Office of the National Coordinator for Health Information Technology (ONC) released the ONC Health IT Certification Program: Enhanced Oversight and Accountability Final Rule. The final rule updates the ONC Health IT Certification Program (Program) with provisions that are intended to enhance oversight and health IT developer accountability. The final rule focuses on three specific areas: 1) direct review; 2) enhanced oversight; 3) increased accountability.
The final rule creates a regulatory framework for ONC to directly review health IT certified under the Program, if there is a reasonable belief that certified health IT may present a serious risk to public health or safety or if certified health IT could present practical challenges for ONC-Authorized Certification Bodies (ONC-ACBs). Additionally, it allows ONC to take appropriate responsive actions to address potential non-conformities. The provisions are intended to: 1) support provider confidence in certified health IT; and 2) facilitate ONC and health IT developers working together to create corrective action plans to address problems.
ONC’s direct review will focus on capabilities and aspects of health IT that are certified under the Program. ONC does not intend to review uncertified capabilities, unless they interact with or affect capabilities of certified health IT. ONC’s review is intended to complement surveillance conducted by ONC-ACBs to promote health IT developer accountability for the performance, reliability, and safety of health IT.
The final rule:
- addresses ONC actions and procedures in the event that a direct review identifies a non-conformity in certified health IT. Corrective action will be required for non-conformities and, when necessary, suspension or termination certificates will be issued to health IT under the Program.
- includes a Certification Ban that precludes any health IT product in a developer’s health IT portfolio from being certified through the ONC-ACB program, if one or more of the developer’s products has lost certification for non-conformity or is has been removed by the ONC-ACB or the developer from consideration for certification.
- highlights ONC’s commitment to help developers identify and address non-conformities in health IT that providers use to support patient care. It is emphasized that ONC’s primary goal is to work with the health IT developer community to remedy non-conformities.
The final rule sets forth processes for ONC to directly address testing issues in a timely manner by aligning accredited testing laboratory oversight under the Program with the existing process for ONC-ACBs. ONC will conduct direct oversight of testing labs under the Program to ensure that it can be similarly applied to all stages. The final rule also allows for ONC to have direct oversight of National Voluntary Laboratory Accreditation Program (NVLAP)-accredited testing labs by having them apply to become ONC-Authorized Testing Labs (ONC-ATLs). Processes have been established in the final rule for authorizing, retaining, suspending, and revoking ONC-ATL status under the Program in an effort to enable ONC to oversee and address testing and certification performance issues throughout the Program.
The final rule provisions are intended to increase transparency and availability of information about certified health IT through the publication of identifiable surveillance results. Under the final rule, ONC ACBs will be required to make identifiable surveillance results publically available on the Certified Health IT Product List (CHPL) on a quarterly basis, allowing results to be more readily accessible and result in enhanced transparency and accountability of health IT developers.