2014-00797. 30-Day Submission Period for Requests for ONC-Approved Accreditor (ONC-AA) Status

AGENCY:

Office of the National Coordinator for Health Information Technology, Department of Health and Human Services.

ACTION:

Notice.

SUMMARY:

This notice announces the 30-day period for submission of requests for ONC-Approved Accreditor (ONC-AA) status.

Authority: 42 U.S.C. 300jj-11.

DATES:

The 30-day submission period begins January 16, 2014 and will end on February 18, 2014.

FOR FURTHER INFORMATION CONTACT:

Judy Murphy, Deputy National Coordinator for Programs and Policy, Office of the National Coordinator for Health Information Technology, 202-690-7151.

SUPPLEMENTARY INFORMATION:

On June 6, 2011, ONC approved the American National Standards Institute (ANSI) as the ONC-AA. In accordance with 45 CFR § 170.503(f)(2), an ONC-AA's status will expire not later than 3 years from the date its status was granted by the National Coordinator. To ensure the continuity of the accreditation process and the ongoing responsibilities of the ONC-AA under the ONC HIT Certification Program, we are seeking requests for ONC-AA status for the 3-year term that would follow the term of the current ONC-AA (ANSI). Accordingly, this notice is issued pursuant to § 170.503(b), which requires the National Coordinator for Health Information Technology (the National Coordinator) to 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 written request to the National Coordinator that includes the information required by § 170.503(b) within the 30-day period specified in this notice. Section 170.503(b) requires an accreditation organization to submit 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/IEC17011:2004 (incorporated by reference in § 170.599) and experience evaluating the conformance of certification bodies to ISO/IEC Guide 65:1996 (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.

Requests for ONC-AA status may be submitted by email to [e-mail] and should include “Request for ONC-AA Status” in the subject line. Alternatively, requests for ONC-AA status may be submitted by regular or express mail to: Office of the National Coordinator for Health Information Technology, Attention: ONC HIT Certification Program—Request for ONC-AA Status, 330 C Street SW., Washington, DC 20201. In accordance with § 170.505, the official date of receipt of an email submission will be the date on which it was sent, and the official date of a submission by regular or express mail will be the date of the delivery confirmation. To clarify, email submissions may be sent up to and through 11:59 p.m. on the last day of the submission period. Additional information about requesting ONC-AA status and the ONC HIT Certification Program can be found on the ONC Web site at: http://healthit.hhs.gov/​certification.

Dated: January 10, 2014.

Jacob Reider,

Acting National Coordinator for Health Information Technology.