Clinicians using certified health software would have to be told when a developer's corrective action plan addressed a problem affecting them. That customer notice requirement was part of the federal oversight rule published October 19, 2016. For people delivering care, the important distinction was between a product carrying certification and a product whose identified problems were actually being resolved. [onc-release][2016-24908]

The Office of the National Coordinator for Health Information Technology, or ONC, explained in its October 14 announcement that developers must notify potentially affected customers about a nonconformity and the plan to resolve it. Customers also had to be notified of certification suspension or termination. ONC said it would post those status changes on its certified products list. [onc-release][2016-24908]

The final rule supplied the operational detail: a corrective plan had to identify affected customers, explain how they would be notified, describe resolution across affected locations and specify supporting documentation. These were requirements for certified health IT within the program, not a general warranty for every application used in a hospital. The rule's effective date was December 19, not publication day. [onc-release][2016-24908]

Repair was central, but it was not the only protection. The rule allowed suspension at any time when ONC reasonably believed certified technology might pose a serious public health or safety risk. For care teams, our reading is that notice and evidence of correction deserved separate attention. The announcement and rule describe one agency policy, not independent proof that patient safety had already improved. [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