Featured Product
This Week in Quality Digest Live
Standards Features
Grant Ramaley
FDA seeks to align Part 820 with ISO 13485:2016; why that may not be enough.
ISO
MSMEs are encouraged to uphold the highest standards
Steven Brown
21st-century standard candles at NIST
Kath Lockett
ISO standard for the cleaning, inspection, repair of firefighter PPE

More Features

Standards News
Demonstrating a commitment to keeping people safe and organizations running
Making the new material freely available to testing laboratories and manufacturers worldwide
Run compliance checks against products in seconds
Aug. 25, 2022, at 3:00 p.m. Eastern
Could be used for basic performance information on raw materials used in the most common 3D printers
Now is not the time to skip critical factory audits and supply chain assessments
Google Docs collaboration, more efficient management of quality deviations
Program inspires leaders to consider systems perspective for continuous improvement and innovation

More News

American National Standards Institute ANSI

Standards

ANSI Accredits First Five Health IT Certification Bodies

Accredited organizations can test and certify electronic health record (EHR) technology

Published: Thursday, July 19, 2012 - 13:44

(ANSI: New York) -- The American National Standards Institute (ANSI), coordinator of the U.S. voluntary standardization system, has announced the first accreditations of health information technology (HIT) 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. 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 Jan. 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, 2012, 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,” says 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 HIT 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 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, contact Reinaldo Figueiredo, ANSI senior program director, by email rfigueir@ansi.org, or telephone (202) 331–3611; or Nikki Jackson, ANSI program manager, by email njackson@ansi.org, or telephone (202) 331–3623.

Discuss

About The Author

American National Standards Institute ANSI’s picture

American National Standards Institute ANSI

The American National Standards Institute (ANSI) coordinates the U.S. voluntary standardization and conformity assessment system, serving the diverse interests of more than 270,000 companies and organizations and 30 million professionals worldwide. ANSI is the official U.S. representative to the International Organization for Standardization (ISO) and, via the U.S. National Committee, the International Electrotechnical Commission (IEC).