The HHS Office of the National Coordinator for Health Information Technology (ONC) has proposed changes to the ONC Health IT Certification Program that are intended to “further enhance the safety, reliability, transparency, and accountability of certified health IT for users.”  Notably, the proposed rule would:

  • Establish a process for ONC to directly review certified health IT products, including certified electronic health records systems, and take action when necessary to address situations in which certified health IT may not conform to the requirements of its certification. Corrective action could include requiring the correction of non-conformities and suspending or terminating certifications. According to the preamble, ONC anticipates that such direct review “would be relatively infrequent and would focus on situations that pose a risk to public health or safety” (e.g., the certified health IT may lead to medical errors or breaches in the security of a patient’s health information).
  • Enable ONC to authorize and oversee accredited testing laboratories under the ONC Health IT Certification Program, which “would enable ONC to oversee and address testing and certification performance issues throughout the entire continuum of the Program in a precise and direct manner.”
  • Require ONC-Authorized Certification Bodies to make identifiable surveillance results publicly available on their web sites to promote transparency and accountability.

ONC will accept comments on the proposed rule until May 2, 2016.