The American National Standards Institute
(ANSI), coordinator of the U.S. voluntary standardization system, is pleased to announce the first accreditations of health information technology certification bodies under the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Permanent Certification Program for Health Information Technology
(HIT). In June 2011 ANSI was selected as the Approved Accreditor for the ONC program, which was established by regulation in a final rule published in the Federal Register
on January 7, 2011. The program provides a way for organizations to become authorized by ONC to test and certify electronic health record (EHR) technology. As Approved Accreditor, ANSI reviews and accredits all certification bodies seeking to participate in the ONC program. ANSI's Accreditation Committee confirmed the following accreditations on July 10, the first to be announced as part of the ONC program:
- Certification Commission for Health Information Technology (CCHIT)
- Drummond Group, Inc.
- ICSA Laboratories, Inc.
- InfoGard Laboratories, Inc.
- Orion Register, Inc.
The scopes for these accredited certifiers include complete EHRs and EHR modules. A complete EHR refers to EHR technology that has been developed to meet, at a minimum, all applicable certification criteria adopted by the HHS Secretary. An EHR module refers to any service, component, or combination thereof that meets at least one certification criterion adopted by the Secretary. It is anticipated that these accredited certification bodies, after approval by ONC, will provide certification under the criteria to be published under the final rule for 2014 Edition Certification Criteria. "Accreditation by ANSI creates a valuable distinction for these five certification bodies," said Lane Hallenbeck, ANSI vice president of accreditation services. "The ONC program helps to instill confidence in EHR technology among health IT developers, health professionals and hospitals, and the general public." This program seeks to enhance the certification processes for health information technology in the United States by improving comprehensiveness, transparency, reliability, and efficiency. Accreditations have been granted based on the assessment of a certification body's competence in accordance with ONC and ANSI requirements, including demonstrated compliance with:
- ISO/IEC Guide 65 - General requirements for bodies operating product certification systems
- IAF Guidance on the application of ISO/IEC Guide 65
- 45 CFR PART 170 - Health Information Technology Standards, Implementation Specifications, and Certification Criteria and Certification Programs for Health Information Technology
ANSI's portfolio of accreditation services includes programs for a broad range of certification and verification bodies, including those for products, personnel, greenhouse gas emissions, as well as standards developers. For more information, visit www.ansi.org/accreditation
. "We appreciate and respect the ONC's trust in the value and integrity of ANSI accreditation, and are committed to build on the record of confidence established via public-private partnerships with many other government agencies relying on ANSI accreditation," said Mr. Hallenbeck. The Institute is accepting applications from additional certification bodies interested in participating in the ONC Permanent Certification Program for Health Information Technology. To learn more about the requirements or to obtain an application, please contact Reinaldo Figueiredo, ANSI senior program director (firstname.lastname@example.org
; 202-331-3611) or Nikki Jackson, ANSI program manager (email@example.com