E2. How are violations handled in the ONC Health IT Certification Program?

There is a specific course of action for violations in the ONC HIT Certification Program. There are Type-1 and Type-2 violations, both described below, and they each have different criteria and follow-up actions.

Type-1 violations: The National Coordinator may revoke an ONC-Authorized Certification Body's (ONC-ACB) status for committing a Type-1 violation. Type-1 violations include violations of law or ONC HIT Certification Program policies that threaten or significantly undermine the integrity of the ONC HIT Certification Program. These violations include, but are not limited to: False, fraudulent, or abusive activities that affect the ONC HIT Certification Program, a program administered by HHS or any program administered by the Federal government.

Type-2 violations: The National Coordinator may revoke an ONC-ACB's status for failing to timely or adequately correct a Type-2 violation. Type-2 violations constitute noncompliance with Sec. 170.560.

  • Noncompliance notification. If the National Coordinator obtains reliable evidence that an ONC-ACB may no longer be in compliance with Sec. 170.560, the National Coordinator will issue a noncompliance notification with reasons for the notification to the ONC-ACB requesting that the ONC-ACB respond to the alleged violation and correct the violation, if applicable.
  • Opportunity to become compliant. After receipt of a noncompliance notification, an ONC-ACB is permitted up to 30 days to submit a written response and accompanying documentation that demonstrates that no violation occurred or that the alleged violation has been corrected.
Content last reviewed on November 17, 2017
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