§ 170.503 - Requests for ONC-AA status and ONC-AA ongoing responsibilities.

§ 170.503 Requests for ONC-AA status and ONC-AA ongoing responsibilities.

Cross Reference

Link to an amendment published at 85 FR 25950, May 1, 2020.

(a) The National Coordinator may approve only one ONC-AA at a time.

(b) Submission. The National Coordinator will publish a notice in the Federal Register to announce the 30-day period during which requests for ONC-AA status may be submitted. In order to be considered for ONC-AA status, an accreditation organization must submit a timely request in writing to the National Coordinator along with the following information to demonstrate its ability to serve as an ONC-AA:

(1) A detailed description of the accreditation organization's conformance to ISO/IEC17011 (incorporated by reference in § 170.599) and experience evaluating the conformance of certification bodies to ISO/IEC 17065 (incorporated by reference in § 170.599).

(2) A detailed description of the accreditation organization's accreditation, requirements as well as how those requirements would complement the Principles of Proper Conduct for ONC-ACBs and ensure the surveillance approaches used by ONC-ACBs include the use of consistent, objective, valid, and reliable methods;

(3) Detailed information on the accreditation organization's procedures that would be used to monitor ONC-ACBs;

(4) Detailed information, including education and experience, about the key personnel who review organizations for accreditation; and

(5) Procedures for responding to, and investigating, complaints against ONC-ACBs.

(c) Preliminary selection.

(1) The National Coordinator is permitted up to 60 days from the end of the submission period to review all timely submissions that were received and determine which accreditation organization is best qualified to serve as the ONC-AA.

(2) The National Coordinator's determination will be based on the information provided, the completeness of an accreditation organization's description of the elements listed in paragraph (b) of this section, and each accreditation organization's overall accreditation experience.

(3) The accreditation organization that is determined to be the best qualified will be notified that it has been selected as the ONC-AA on a preliminary basis, subject to the resolution of the reconsideration process in § 170.504. All other accreditation organizations will be notified that their requests for ONC-AA status have been denied. The accreditation organization that is selected on a preliminary basis shall not represent itself as the ONC-AA or perform accreditation(s) under the ONC Health IT Certification Program unless and until it receives written notice from the National Coordinator that it has been approved as the ONC-AA on a final basis pursuant to paragraph (d) of this section.

(4) Any accreditation organization that submits a timely request for ONC-AA status and is denied may request reconsideration in accordance with § 170.504.

(d) Final approval.

(1) If the National Coordinator determines that an accreditation organization has met the standard specified in § 170.504(b), then that organization will be approved as the ONC-AA on a final basis. The accreditation organization that was selected as the ONC-AA on a preliminary basis pursuant to paragraph (c) of this section will be notified of this final decision and cannot request reconsideration or further review.

(2) If the National Coordinator determines that no accreditation organization has met the standard specified in § 170.504(b), then the organization that was selected as the ONC-AA on a preliminary basis pursuant to paragraph (c) of this section will be approved as the ONC-AA on a final basis.

(e) ONC-AA ongoing responsibilities. An ONC-AA must:

(1) Maintain conformance with ISO/IEC 17011 (incorporated by reference in § 170.599);

(2) Verify that the certification bodies it accredits and ONC-ACBs conform to, at a minimum:

(i) For fiscal years 2014 and 2015, ISO/IEC Guide 65 (incorporated by reference in § 170.599); and

(ii) For fiscal year 2016 and subsequent years, ISO/IEC 17065 (incorporated by reference in § 170.599).

(3) Ensure the surveillance approaches used by ONC-ACBs include the use of consistent, objective, valid, and reliable methods;

(4) Verify that ONC-ACBs are performing surveillance as required by and in accordance with §§ 170.556, 170.523(k), and their respective annual plans; and

(5) Review ONC-ACB surveillance results to determine if the results indicate any substantive non-conformance by ONC-ACBs with the conditions of their respective accreditations.

(f) ONC-AA status.

(1) An accreditation organization has not been granted ONC-AA status unless and until it is notified by the National Coordinator that it has been approved as the ONC-AA on a final basis pursuant to paragraph (d) of this section.

(2) An ONC-AA's status will expire not later than 3 years from the date its status was granted by the National Coordinator.

(3) The National Coordinator will accept requests for ONC-AA status, in accordance with paragraph (b) of this section, at least 180 days before the current ONC-AA's status is set to expire.

[76 FR 1325, Dec. 7, 2011, as amended at 76 FR 72642, Nov. 25, 2011; 77 FR 54291, Sept. 4, 2012; 79 FR 54479, Sept. 11, 2014; 80 FR 62755, Oct. 16, 2015]