§ 170.575 - [Reserved]

§ 170.575 Removal of the ONC-AA.

Cross Reference

Link to an amendment published at 85 FR 25953, May 1, 2020.

(a) Conduct violations. The National Coordinator may remove the ONC-AA for committing a conduct violation. Conduct violations include violations of law or ONC Health IT Certification Program policies that threaten or significantly undermine the integrity of the ONC Health IT Certification Program. These violations include, but are not limited to: false, fraudulent, or abusive activities that affect the ONC Health IT Certification Program, a program administered by HHS, or any program administered by the Federal government.

(b) Performance violations. The National Coordinator may remove the ONC-AA for failing to timely or adequately correct a performance violation. Performance violations constitute a failure to adequately perform the ONC-AA's responsibilities as specified in § 170.503(e).

(1) Noncompliance notification. If the National Coordinator obtains reliable evidence that the ONC-AA may no longer be adequately performing its responsibilities specified in § 170.503(e), the National Coordinator will issue a noncompliance notification with reasons for the notification to the ONC-AA requesting that the ONC-AA respond to the alleged violation and correct the violation, if applicable.

(2) Opportunity to become compliant. The ONC-AA is permitted up to 30 days from receipt of a noncompliance notification to submit a written response and accompanying documentation that demonstrates that no violation occurred or that the alleged violation has been corrected.

(i) If the ONC-AA submits a response, the National Coordinator is permitted up to 60 days from the time the response is received to evaluate the response and reach a decision. The National Coordinator may, if necessary, request additional information from the ONC-AA during this time period.

(ii) If the National Coordinator determines that no violation occurred or that the violation has been sufficiently corrected, the National Coordinator will issue a memo to the ONC-AA confirming this determination. Otherwise, the National Coordinator may propose to remove the ONC-AA in accordance with paragraph (c) of this section.

(c) Proposed removal.

(1) The National Coordinator may propose to remove the ONC-AA if the National Coordinator has reliable evidence that the ONC-AA has committed a conduct violation; or

(2) The National Coordinator may propose to remove the ONC-AA if, after the ONC-AA has been notified of an alleged performance violation, the ONC-AA fails to:

(i) Rebut the alleged violation with sufficient evidence showing that the violation did not occur or that the violation has been corrected; or

(ii) Submit to the National Coordinator a written response to the noncompliance notification within the specified timeframe under paragraph (b)(2) of this section.

(d) Opportunity to respond to a proposed removal notice.

(1) The ONC-AA may respond to a proposed removal notice, but must do so within 20 days of receiving the proposed removal notice and include appropriate documentation explaining in writing why it should not be removed as the ONC-AA.

(2) Upon receipt of the ONC-AA's response to a proposed removal notice, the National Coordinator is permitted up to 60 days to review the information submitted by the ONC-AA and reach a decision.

(e) Retention of ONC-AA status. If the National Coordinator determines that the ONC-AA should not be removed, the National Coordinator will notify the ONC-AA in writing of this determination.

(f) Removal.

(1) The National Coordinator may remove the ONC-AA if:

(i) A determination is made that removal is appropriate after considering the information provided by the ONC-AA in response to the proposed removal notice; or

(ii) The ONC-AA does not respond to a proposed removal notice within the specified timeframe in paragraph (d)(1) of this section.

(2) A decision to remove the ONC-AA is final and not subject to further review unless the National Coordinator chooses to reconsider the removal.

(g) Extent and duration of removal.

(1) The removal of the ONC-AA is effective upon the date specified in the removal notice provided to the ONC-AA.

(2) An accreditation organization that is removed as the ONC-AA must cease all activities under the ONC Health IT Certification Program, including accepting new requests for accreditation under the ONC Health IT Certification Program.

(3) An accreditation organization that is removed as the ONC-AA is prohibited from being considered for ONC-AA status for a period of 1 year from the effective date of its removal as the ONC-AA.

[76 FR 72643, Nov. 25, 2011, as amended at 77 FR 54291, Sept. 4, 2012

[Reserved]