Certification Program Proposed by ONC
Facts-At-Glance, FAQs Posted
The official Notice of Proposed Rulemaking (NPRM) on EHR Certification was posted on March 2, 2010 by the Office of National Coordinator for Health IT, in addition to the release of Letter #10 from National Coordinator David Blumenthal on the same subject.

ONC Page on EHR Certification Programs

Facts-at-a-Glance
excerpted from ONC site on Mar 2, 2010 

• Section 3001(c)(5) of the Public Health Service Act (PHSA) as added by the Health Information Technology for Economic and Clinical Health (HITECH) Act, requires the National Coordinator, in consultation with the Director of the National Institute of Standards and Technology, to keep or recognize a program or programs for the voluntary certification of health information technology (health IT)as being in compliance with applicable certification criteria.

• Certification of EHR Technology will provide assurance to purchasers and other users of health IT that an EHR system offers the necessary technological capability, functionality, and security to meet meaningful use criteria.

• Under this authority the Office of the National Coordinator for Health Information Technology (ONC) has issued a Notice of Proposed Rulemaking (NPRM) proposing the establishment of two certification programs for the purposes of testing and certifying health IT, one temporary and one permanent.

• As required by statute, ONC has consulted with NIST on all aspects of developing the proposed certification programs, and will continue to consult and collaborate with NIST during the implementation and operational phases of both temporary and certification programs.  NIST is developing a test method and infrastructure that will be used by testing laboratories in the testing component of both certification programs.

• Certified EHR technology is a requirement for providers to receive incentive payments for the adoption and meaningful use of EHRs under the Medicare & Medicaid Incentives Program. The development of these programs is also authorized by the HITECH Act and a separate proposed regulation has been published that outlines provisions governing the program.  The proposed rule may be viewed at http://edocket.access.gpo.gov/2010/E9-31217.htm.

• An initial set of standards, implementation specifications, and certification criteria for Complete EHRs and EHR Modules was also published in a related Interim Final Rule. This rule may be viewed at http://edocket.access.gpo.gov/2010/E9-31216.htm.

• The first proposal within the NPRM would establish a temporary certification program whereby the National Coordinator would authorize organizations to test and certify Complete EHRs and/or EHR Modules, thereby assuring the availability of Certified EHR Technology prior to the reporting period in which health care providers may seek the incentive payments available under the Medicare and Medicaid EHR Incentives Program demonstrating meaningful use of Certified EHR Technology. 

• The second proposal within the Certification Programs NPRM would establish a permanent certification program to replace the temporary certification program.  The permanent certification program would separate the responsibilities for performing testing and certification, introduce accreditation requirements, establish requirements for certification bodies authorized by the National Coordinator to related to the surveillance of Certified EHR Technology, and would include the potential for certification bodies authorized by the National Coordinator to certify other types of health besides Complete EHRs and EHR Modules.

• The temporary program would end once the permanent certification program is established and at least one certification body has been authorized by the National Coordinator.

• The public comment period for the temporary certification program will be open for 30 days after publication. The public comment period for the permanent certification program will be open for 60 days after publication.   

• While two certification programs are described in this proposed rule, ONC anticipates issuing separate final rules for each of the programs.

• To inform the rulemaking processes, ONC received recommendations from the HIT Policy Committee (a Federal Advisory Committee), and input from technical subject matter experts, health care providers, and other stakeholders.                                                        

  FAQs as posted on ONC site 2010/03/02