C1. I have an EHR technology ready for market. Is there anything I can do to get the technology certified now so that I can start marketing to hospitals and physicians?

In the Temporary Certification Program (TCP), Developers and Vendors worked with ONC-Authorized Testing and Certification Bodies (ONC-ATCBs) to test and certify their EHR products based on the standards and certification criteria adopted by the HHS Secretary.

In the current program, the ONC HIT Certification Program, Developers and Vendors will first test their EHR products with an Accredited Testing Laboratory (ATL). Then, if their product meets the requirements, they will work with an ONC-Authorized Certification Body (ONC-ACB) to certify the product.

Eligible Providers (EPs) and Eligible Hospitals (EHs) will then purchase certified EHR products and use them in accordance with MU objectives and measures.

C2. Where can I find the list of ONC Certification Bodies and Testing Laboratories?

The list is available on ONC’s website here.

C3. How long will it take for an EHR technology to be certified? 

This will vary according to the process used by the Certification Body and Testing Laboratory and on the EHR product or module being tested. Certification Body and Testing Laboratories will report to the National Coordinator information about all certified EHR technology. ONC will maintain on its website a list of certified EHR technology as reported by the Certification Body and Testing Laboratories.

C4. What does a developer of EHR technology need to do to get its EHR technology tested and certified?

In the ONC HIT Certification Program, Developers and Vendors first test their EHR products with an Accredited Testing Laboratory (ATL). Then, if their product meets the requirements, they work with an ONC-Authorized Certification Body (ONC-ACB) to certify the product.

C5. What criteria will ONC-ACBs use to test and certify EHR technology?

Accredited Testing Laboratories (ATLs) are required to use ONC-approved test procedures to test EHR technology against the standards, implementation specifications, and certification criteria adopted by the HHS Secretary.

C6. How much will ATL and ONC-ACBs charge for testing and certifying my EHR technology? Does ONC control the cost of certifying or suggest a pricing schedule for the ATLs and ONC-ACBs?

Accredited Testing Laboratories (ATLs) and ONC-Authorized Certification Bodies (ONC-ACBs) will individually and independently determine their pricing structure for the testing and certification of EHR technology. They should be contacted directly for this specific information.

ONC does not control the prices charged by the ATLs and ONC-ACBs to test and certify EHR technology.

C7. How can developers of EHR technology prove that their products have been certified by an ONC-ACB? Will we receive a "seal of approval" or "certificate"?

Each tested and certified EHR product will receive a unique certification number from the ONC-ACB. In addition, certified EHR technology will be listed on the Certified Health IT Product List (CHPL) on the ONC website.

C8. Where can I find out information about EHR technology that has been certified?

ONC will maintain on its website a Certified HIT Product List (CHPL) as a single, aggregate source of all certified Complete EHRs and EHR Modules reported by ONC-ATCBs and ONC-ACBs to the National Coordinator. The CHPL will comprise all of the certified Complete EHRs and EHR Modules that could be used to meet the definition of Certified EHR Technology. It will also include the other pertinent information we require ONC-ATCBs and ONC-ACBs to report to the National Coordinator, such as a certified Complete EHR's version number. Eligible professionals and eligible hospitals that elect to use a combination of certified EHR Modules may also use the CHPL webpage to validate whether the EHR Modules they have selected satisfy all of the applicable certification criteria that are necessary to meet the definition of Certified EHR Technology.

C9. Will EHR technology previously certified under any other programs or organizations automatically be certified by this new process?

No. In order to meet regulatory requirements implementing the HITECH Act, including the definition of "Certified EHR Technology," EHR technology (Complete EHRs and/or EHR Modules) must be tested and certified by an ONC-ATCB or an ATL/ONC-ACB. Any other certifications issued by an organization that is not an ONC-ATCB or an ATL/ONC-ACB at the time of issuance will be invalid for purposes of meeting the definition of Certified EHR Technology and cannot be used to qualify for incentive payments under the Medicare and Medicaid EHR Incentive Programs. Unless reissued in accordance with the requirements of the temporary certification program or ONC HIT Certification Program, certifications previously issued by an organization that has subsequently become an ONC-ATCB or ONC-ACB will also be invalid for purposes of satisfying the definition of "Certified EHR Technology," because such certifications were issued prior to the organization achieving ONC-ATCB or ONC-ACB status.

Certification by an ONC-ATCB or ONC-ACB means that the EHR technology meets specific standards, implementation specifications, and certification criteria established by the HHS Secretary.

C10. Will EHR technology certified under the Temporary Certification Program be automatically certified under the ONC HIT Certification Program?

The act of transitioning from the Temporary Certification Program to the ONC HIT Certification Program has no impact on certifications issued to EHR products.

EHR products are certified against the Standards and Certification Criteria established by the HHS Secretary, independent of the Temporary Program and the ONC HIT Certification Program. In short, an EHR product certified against the 2011 Edition EHR Certification Criteria during the Temporary Program is valid in the ONC HIT Certification Program.

C11. Whose responsibility is it to make sure that EHR technology gets tested and certified as required to meet the certification criteria adopted to support Meaningful Use?

In most cases it will be the responsibility of developers of EHR technology that sell EHR technology. However, a health care provider that has developed its own EHR technology and is eligible under Medicare and Medicaid EHR Incentive Programs likely will be responsible for getting it tested and certified.

C12. If I buy an EHR technology that is tested and certified, does that qualify me for the Medicare or Medicaid EHR incentive payments?

Having EHR technology that is certified by an ONC-ATCB or ONC-ACBs is an essential part of qualifying for EHR incentive payments; however, providers and hospitals still need to successfully attest to Meaningful Use objectives and measures.

Medicare and Medicaid EHR Incentive Programs

C13. I have developed my own EHR technology. Does it have to be tested and certified by an ATL and ONC-ACB? Can I submit my own EHR technology even though I am not a developer/vendor?

Participation in the ONC Certification Program is "voluntary" as described in the HITECH Act. Eligible Professionals and Eligible Hospitals need to meaningfully use EHR technology certified by an ONC-ATCB or ONC-ACB to qualify for Medicare and Medicaid EHR incentive payments. Certification is used to provide assurance that the EHR health care providers adopt has been tested and includes the required capabilities they need in order to use the technology in a meaningful way.

"Self-developed" or custom-developed EHR technology can be tested and certified by ATLs and ONC-ACBs.

D1. Where can I learn about how my comments on the proposed rule on the Establishment of Certification Programs for Health Information Technology issued in March were addressed in the temporary certification program final rule?

ONC staff carefully reviewed and considered each comment received on the proposed rule. Section III of the Temporary Certification Program Final Rule includes a discussion of how the comments were incorporated.

E1. How does this Final Rule relate to the Medicare and Medicaid EHR Incentive Programs Proposed Rule?

The National Coordinator used the Temporary Certification Program to authorize organizations to test and certify EHR technology (Complete EHRs and/or EHR Modules). Health care providers who are eligible to qualify for incentive payments under the Medicare and Medicaid EHR Incentive Programs are required to use Certified EHR Technology, as promulgated in the CMS Final Rule.

HHS has issued the Final Rule related to the initial set of standards, implementation specifications, and certification criteria.

E2. When will the Permanent Certification Program Final Rule be published?

The Permanent Certification Program Final Rule was published in January 2011. The ONC HIT Certification Program (formerly known as the Permanent Certification Program) became fully constituted (operational) on October 4, 2012.

Establishment of the Permanent Certification Program for Health Information Technology [PDF - 521 KB]