A federal rule published October 19, 2016, changed more than the handling of faulty medical records software. The Office of the National Coordinator for Health Information Technology, known as ONC, established a direct review framework for certified health IT, processes for authorizing and overseeing accredited testing laboratories, and expanded public access to surveillance results. The regulations were effective December 19. [onc-release][2016-24908]

Direct review concerned whether certified products continued to meet program requirements. ONC's October 14 explanation highlighted serious health or safety risks and problems difficult for authorized certification bodies to handle, such as overlapping responsibility across certifiers. The final rule also identified impediments involving inaccessible information or limits on a certification body's resources or expertise. That was a defined oversight route, not regulation of all software. [onc-release][2016-24908]

Laboratory oversight concerned the organizations conducting testing. Surveillance transparency concerned what users could learn about products after certification. Keeping those functions separate helps explain why a laboratory authorization, a product's certification and a published surveillance result are not interchangeable assurances. The rule anticipated the first expanded identifiable surveillance postings in early 2017; it did not report that those future postings had occurred. [onc-release][2016-24908]

The announcement explains the policy's intended operation; the full rule establishes its scope and procedures. They come from the same ONC policy process, not independent corroborating investigations. As of this coverage date, the documents supported a description of new oversight machinery. Whether that machinery would find problems promptly, secure durable fixes or improve care remained an implementation question, not an achieved benefit. [onc-release][2016-24908]

Source documents

  1. ONC direct review process announcementhttps://healthit.gov/blog/healthit-certification/highlights-supporting-reliability-safety-certified-health-onc-direct-review-process/
  2. ONC Health IT Certification Program: Enhanced Oversight and Accountabilityhttps://www.govinfo.gov/content/pkg/FR-2016-10-19/html/2016-24908.htm