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 upon publication of this notice in the Federal Register and will end on March 10, 2011.

FOR FURTHER INFORMATION CONTACT:

Carol Bean, Director, Certification Division, Office of the National Coordinator for Health Information Technology, 202-690-7151.

SUPPLEMENTARY INFORMATION:

The Department of Health and Human Services issued a final rule establishing a permanent certification program for the purpose of certifying health information technology (HIT). Establishment of the Permanent Certification Program for Health Information Technology, 76 FR 1262 (Jan. 7, 2011) (the “Permanent Certification Program final rule”). The Permanent Certification Program final rule became effective on February 7, 2011 and added a new “Subpart E—Permanent Certification Program for HIT” to part 170 of title 45 of the Code of Federal Regulations (CFR). This notice is issued pursuant to § 170.503(b), which provides that the National Coordinator for Health Information Technology (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. The 30-day period for submission of requests for ONC-AA status begins upon publication of this notice in the Federal Register and will end 30 days thereafter, as specified in the DATES section of this notice. 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 by 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 e-mail to ONC-AA@hhs.gov 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: Permanent Certification Program—Request for ONC-AA Status, 200 Independence Avenue, SW., Suite 729D, Washington, DC 20201. In accordance with § 170.505, the official date of receipt of an e-mail 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, e-mail submissions may be sent up to and through 11:59 p.m. on the last day of 30-day submission period. Additional information about requesting ONC-AA status and the permanent certification program can be found on the ONC Web site at: http://healthit.hhs.gov/certification .