45 CFR § 170.581 - Certification ban.

§ 170.581 Certification ban.

(a) Circumstances that may trigger a certification ban. The certification of any of a health IT developer's health IT is prohibited when:

(1) The certification of one or more of the health IT developer's Health IT Modules is:

(i) Terminated by ONC under the ONC Health IT Certification Program;

(ii) Withdrawn from the ONC Health IT Certification Program by an ONC-ACB because the health IT developer requested it to be withdrawn (for reasons other than to comply with Program requirements) when the health IT developer's health IT was the subject of a potential non-conformity or non-conformity as determined by ONC;

(iii) Withdrawn by an ONC-ACB because of a non-conformity with any of the certification criteria adopted by the Secretary under subpart C of this part;

(iv) Withdrawn by an ONC-ACB because the health IT developer requested it to be withdrawn (for reasons other than to comply with Program requirements) when the health IT developer's health IT was the subject of surveillance for a certification criterion or criteria adopted by the Secretary under subpart C of this part, including notice of pending surveillance; or

(2) ONC determines a certification ban is appropriate per its review under § 170.580(a)(2)(iii).

(b) Notice of certification ban. When ONC decides to issue a certification ban to a health IT developer, ONC will notify the health IT developer of the certification ban through a notice of certification ban. The notice of certification ban will include, but may not be limited to:

(1) An explanation of the certification ban;

(2) Information supporting the certification ban;

(3) Instructions for appealing the certification ban if banned in accordance with paragraph (a)(2) of this section; and

(4) Instructions for requesting reinstatement into the ONC Health IT Certification Program, which would lift the certification ban.

(c) Effective date of certification ban.

(1) A certification ban will be effective immediately if banned under paragraph (a)(1) of this section.

(2) For certification bans issued under paragraph (a)(2) of this section, the ban will be effective immediately after the following applicable occurrence:

(i) The expiration of the 10-day period for filing a statement of intent to appeal in § 170.580(g)(3)(i) if the health IT developer does not file a statement of intent to appeal.

(ii) The expiration of the 30-day period for filing an appeal in § 170.580(g)(3)(ii) if the health IT developer files a statement of intent to appeal, but does not file a timely appeal.

(iii) A final determination to issue a certification ban per § 170.580(g)(7) if a health IT developer files an appeal timely.

(d) Reinstatement. The certification of a health IT developer's health IT subject to the prohibition in paragraph (a) of this section may commence once the following conditions are met.

(1) A health IT developer must request ONC's permission in writing to participate in the ONC Health IT Certification Program.

(2) The request must demonstrate that the customers affected by the certificate termination, certificate withdrawal, or noncompliance with a Condition or Maintenance of Certification requirement have been provided appropriate remediation.

(3) For noncompliance with a Condition or Maintenance of Certification requirement, the noncompliance must be resolved.

(4) ONC is satisfied with the health IT developer's demonstration under paragraph (d)(2) of this section that all affected customers have been provided with appropriate remediation and grants reinstatement into the ONC Health IT Certification Program.

[85 FR 25954, May 1, 2020]