45 CFR § 170.581 - Certification ban.

§ 170.581 Certification ban.

(a)Ban. The certification of any of a health IT developer's health IT is prohibited when the certification of one or more of the health IT developer's Complete EHRs or Health IT Modules is:

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

(2) Withdrawn from the ONC Health IT Certification Program by an ONC-ACB because the health IT developer requested it to be withdrawn when the health IT developer's health IT was the subject of a potential non-conformity or non-conformity as determined by ONC;

(3) Withdrawn by an ONC-ACB because of a non-conformity with any of the certification criteria adopted by the Secretary under subpart C of this part; or

(4) Withdrawn by an ONC-ACB because the health IT developer requested it to be withdrawn when the health IT developer's health IT was the subject of surveillance for a certification criterion or criteria adopted by the Secretary under subpart C of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.

(b)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 or withdrawal have been provided appropriate remediation.

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

[81 FR 72471, Oct. 19, 2016]