Complaints and Violations

E1. What do I do if I have a complaint about an ONC-AuthorizedTesting Laboratory (ONC-ATL) and/or an ONC-Authorized Certification Body (ONC-ACB), a vendor or a product?

Issue

Contact

Eligible Professionals & Eligible Hospital complaints regarding an EHR product

Please reference the Provider Complaint Process page

Developer complaint against an ATL or ONC-ACB

Please contact the ATL or ONC-ACB first, to resolve the issue. Complaints should be escalated to NVLAP or the ONC-AA if the issue persists.

Product Listing on the CHPL

Please contact the ONC-ATCB or ONC-ACB that certified the product

Other comments or complaints

Health IT related complaints can be submitted via the ONC Health IT Feedback form. Other comments or concerns can be submitted to the ONC Health IT Certification Program via ONC.Certification@hhs.gov.

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.

E3. What is proposed revocation?

The National Coordinator may propose to revoke an ONC-ACB's status if the National Coordinator has reliable evidence that the ONC-ACB has committed a Type-1 violation. The National Coordinator may propose to revoke an ONC-ACB's status if, after the ONC-ACB has been notified of a Type-2 violation, the ONC-ACB fails to:

  • To rebut the finding of a violation with sufficient evidence showing that the violation did not occur or that the violation has been corrected; or
  • Submit to the National Coordinator a written response to the noncompliance notification within the specified timeframe.

Can’t find the answer to your question? Contact ONC Health IT Certification Program via ONC.Certification@hhs.gov.

The Temporary Certification Program FAQs have been archived here.

Content last reviewed on September 24, 2018
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