ONC Issues Final Rule for Permanent Certification Program for Health Information Technology

Steps to create permanent health IT certification program 

The Office of the National Coordinator for Health Information Technology (ONC) issued a final rule to establish the permanent certification program for health information technology. The permanent certification program provides new features that will enhance the certification of health information technology, including increasing the comprehensiveness, transparency, reliability, and efficiency of the current processes used for the certification of electronic health record (EHR) technology. Meaningful use of “Certified EHR Technology” is a core requirement for eligible health care providers who seek to qualify to receive incentive payments under the Medicare and Medicaid Electronic Health Record Incentive Programs as authorized by the Health Information Technology for Economic and Clinical Health (HITECH) Act.

“This final rule completes the two-phased approach ONC began with the proposed rule issued in Spring 2010 and includes several important improvements to our certification processes,” said David Blumenthal, M.D., M.P.P., national coordinator for health information technology. “Our goal is to make the transition to the permanent certification program as seamless as possible.”

The temporary certification program, established through a final rule published on June 24, 2010, will continue to be in effect until it sunsets on December 31, 2011, or at a later date when the processes necessary for the permanent certification program to operate are completed. ONC expects to stand-up the programmatic activities necessary to implement the permanent certification program throughout 2011.

Features of the permanent certification program include:

• Organizations must first be accredited in order to test and/or certify health information technology;
• Certification bodies authorized by the National Coordinator (ONC-Authorized Certification Bodies or ONC-ACBs) are required to conduct post-certification surveillance; and
• ONC-ACBs are permitted to perform “gap certification.”

As proposed, ONC will request that the National Institute of Standards and Technology (NIST) through its National Voluntary Laboratory Accreditation Program (NVLAP) develop a laboratory accreditation program for organizations to be accredited to test health information technology for purposes of the permanent certification program. Based on NIST’s technical expertise and the strong relationship formed between ONC and NIST during the successful implementation of the temporary certification program, the use of NVLAP is expected to enhance testing under the permanent certification program and its objectivity overall.

This final rule is issued under the authority provided to the National Coordinator for Health Information Technology in section 3001(c)(5) of the Public Health Service Act, as added by the Health Information Technology for Economic and Clinical Health Act.

For more information about the permanent certification program and the final rule, please visit http://healthit.hhs.gov/certification.