CCHIT launched its Office of the National Coordinator (ONC) Authorized Testing and Certification Program (ONC-ATCB) on September 20, 2010 with a Town Call Web-cast describing its application and testing process. CCHIT is now taking new applications from health IT developers for this program and plans to announce the first group of ONC-ATCB certified complete EHRs and EHR modules soon.
Listen to a summary of the Town Call
Listen to a recording of the Town Call
Download the slides from the Town Call
Frequently Asked Questions
CCHIT Town Call: ONC-ATCB 2011/2012 Certification Program
Monday, September 20, 2010 12:00 PM Central time
The NIST test scripts are pretty vague. Will CCHIT be creating their own scripts to complement the NIST scripts? If yes, will CCHIT add anything to the NIST test scripts?
Nothing was added to the CCHIT Test Scripts, and those seeking certification are free to use these or the NIST procedures as they were published. The Toolkit is available at
http://www.cchit.org/get_certified.
Do you expect EHR vendors to continue to get CCHIT certification when it seems ONC ATCB certification is really the only thing that counts?
Many providers are not eligible for the HITECH incentives, or have a longer range IT strategy beyond the expiration of these incentives. Many providers will be looking for EHR products with both certifications. We believe they will want greater assurance of integrated functionality and workflow support and a more rigorous security inspection. Additional inspection of usability and verification of successful implementations in live sites in the CCHIT Certified® program will also boost their confidence in making an EHR selection. For providers with specific specialty medicine or special care site needs, CCHIT certification is even more desirable.
When will the Marketing Policies be available for the ONC-ATCB 2011/2012 certification program?
The Marketing Policies are contained in the Certification Handbook which is also part of CCHIT”s Get ONC-ATCB Certified 2011/2012 Toolkit.
Can you address the advantages of using CCHIT for testing and certification vs. your ONC/ATCB competitors?
CCHIT’s work has been focused on health IT adoption. CCHIT, as an independent 501(c)3 nonprofit organization, has certified over 250 electronic health records in the past five years. Our testing personnel are the most experienced in working with EHR developers. We have established certification programs that professional associations have endorsed and buyers recognize. We provide a rich set of policies, test scripts and guidance documents to help prepare our applicants for an efficient and successful certification.
Can vendors seeking to certify an EHR Module certify criteria on two separate testing dates without retesting all of the previously certified criteria?
Yes, if the security module has already been certified.
Is the new ONC-ATCB certification for providers only or health IT companies as well?
CCHIT’s ONC-ATCB 2011/2012 certification program launching on September 20, 2010 is primarily for health IT companies with commercially distributed products. CCHIT is also developing an EHR alternative certification for hospitals (EACH™) with self-developed EHR technology, older uncertified EHR technology, or those hospitals needing to close a certified EHR technology gap due to their mix of certified and uncertified EHR products. This program will test hospital technology against the same HHS criteria using the same NIST test procedures as are used in the ONC-ATCB 2011/2012 certification program for vendor-developed EHRs. Additional online educational materials and guidance will be provided. CCHIT plans to make this program available for hospitals in fall 2010 and will consider a similar program for eligible providers later.
What can you say regarding the cost for CCHIT’s independently developed certification versus ONC-ACTB certification for a vendor?
The costs for a CCHIT Certified® Ambulatory EHR certification and an ONC-ATCB Complete EHR certification are close. The ONC-ATCB certification program only tests to the federal minimum standards necessary to qualify the technology to be certified under the 2011/2012 requirements. It does not test any additional functionality, interoperability or security that providers may seek for their practices and facilities to reduce risk and fully document patient care. These are available in the CCHIT Certified program Products applying for the CCHIT Certified program may also apply for the ONC-ATCB 2011/2012 program at no additional cost. Note that the ONCATCB program can test single or bundled modules. There are multiple tiers of costs for these modules, depending on their complexity.
We are a RIS (Radiology Information System) software vendor looking at getting partial EHR (modular) certification. How many privacy and security modules are required for certification?
The privacy and security modules required are dependent upon the criteria you choose to certify but in most cases, they will be required.
What about the obsolete brand name drugs and non-existent formulations found in the NIST test data?
In consultation with your Tester, you may substitute accurate drug test data for those test steps that require them. You may also use CCHIT’s test scripts and test data. We have reported these issues to NIST and we anticipate they will be corrected in future test procedure revisions.
Does an EHR vendor have to demonstrate and have certified a quality reporting measure for a customer to be able to use the measure for meaningful use?
Yes.
Can you test the criteria individually? Will the fee schedule apply to EHR module testing?
The “Criteria” for certification of EHRs and EHR Technology have been defined by ONC in the Final Rule.
There are 23 criteria, numbered 170.302(a) through 170.302(w), that apply to both EHRs for ambulatory and inpatient settings. Of those criteria, 9 of them -- 170.302(o) through 170.302(w) -- are considered Security criteria.
In addition there are 10 criteria, numbered 170.304(a) through 170.302(j) that apply only to EHRs for ambulatory settings. There are 9 criteria, numbered 170.306(a) through 170.306(i) that apply only to EHRs for inpatient settings.
With that definition in place, here is what can you bring to CCHIT for ONC-ATCB certification:
a) You can bring a Complete EHR for ambulatory settings, which must satisfy all of the 170.302(…) and 170.304(…) criteria. There are, however, some special circumstances regarding the Security criteria – see below.
b) You can bring a Complete EHR for inpatient settings, which must satisfy all of the 170.302(…) and 170.306(…) criteria. There are, however, some special circumstances regarding the Security criteria – see below.
c) You can bring EHR Technology to be certified as an EHR Module, which satisfies one or more of the criteria. You’ll have to specify which criteria you’re attempting to satisfy when you apply to us. Special circumstances apply regarding the Security criteria – see below.
The Security criteria are treated specially:
a) One of the security criteria, 170.302(w) – Accounting of Disclosures -- is treated as optional for all applicants. Not satisfying 170.302(w) does not disqualify any Complete EHR or EHR Technology module from certification.
b) For Complete EHRs and EHR Technology modules, all the other security criteria, 170.302(o) through 170.302(v) must be either satisfied or granted an exemption from testing. Reasons for exemption are described in the Final Rule.
c)
There is a special case for an EHR Technology module which only seeks certification for Security criteria, and no other functionality. In this case a vendor may seek certification for one or more of the Security criteria, and is not required to satisfy all of them. The exemption provision does not apply in these cases.
Will ONC-ATCB 2011/2012 certified EHR vendors later get a discount if they add CCHIT 2011 certification?
No.
If we get CCHIT 2011 certification first, can we come back later and get ONC-ATCB certified for free?
Yes.
Do you have guidance on preparing the attestation documents?
Guidance is contained in the Get ONC-ATCB Certified 2011/2012 Toolkit.
For vendors with EHRs already certified in a previous CCHIT program, do we need to once again do the self attestation for ONC-ATCB certification?
Yes.
If our product is already in process of scheduling CCHIT Certified® 2011 testing, can the ONC-ATCB application, self attestation and testing be conducted at the same time?
You may apply for both programs at the same time but all testing is separate.
Do ONC-ATCB certified products have to undergo re-certification for each new release?
Following ONC/HHS Final Rules,
Establishment of the Temporary Certification Program for Health Information Technology, certification is completed with a specific version of the technology that was tested by CCHIT and found compliant with the relevant certification criteria. For the purpose of maintaining certification, “minor product changes” are those modifications and updates to a certified product that are unlikely to affect the product’s compliance with the certification criteria. Retesting may not be required but the vendor is required to notify the ONC-ATCB and provide self-attestation that the changes are minor.
Modifications with a significant risk of affecting the product’s compliance are considered to be a “significant product change.” Retesting is required.
Applicants are required to self-classify their product modifications and updates into one of these two categories.
Even though official certification evaluation and notification takes time, will a vendor know if their tests passed at the end of the testing day?
The Tester can only notify the vendor of test steps requiring retesting at the end of the day. The Tester gives no notification of a pending certification.
If a vendor does not pass a criterion or any number of criteria, will they have the opportunity to retest? What are the conditions?
Yes. Conditions are described in the Handbook in the Get ONC-ATCB Certified 2011/2012 Toolkit.
What is the time between the application and the test date? Are we obliged to pick a date within a certain timeframe?
The test date is dependent upon the vendor’s preparedness for testing and the available testing dates. Vendors must choose a date when they apply; testing is generally completed within 90 days of application.
Can you explain the difference between a complete EHR and an EHR module?
A complete EHR meets all of the ONC-specified criteria within a specific domain – eligible provider or hospital – to be considered qualified to support meaningful use. And EHR module meets one or more of the criteria in either domain. EHR modules must be combined to qualify as a complete EHR. A provider must be using certified EHR technology that meets all of the criteria to apply for ARRA incentive funding.
If a hospital has several modules of an EHR that are certified by different vendors, is the data reported considered certified or is a site certification needed?
If a hospital’s assembled EHR modules are all certified as meeting all of the ONC criteria in the hospital domain, the hospital would have a qualified EHR for the purposes of applying for ARRA funding. If some criteria are not covered by certified EHR modules purchased by vendors, the hospital may want to consider certifying that gap in technology itself.
Is there a different branding/logo for the "complete EHR" vs. EHR module?
ONC has not indicated its intention of supplying a logo or seal for ONC-ATCB certified products. According to ONCs published rules, a vendor must declare if they are promoting a “complete EHR” or an “EHR module”. Other reporting requirements also apply. Those are contained in the final rule and in CCHIT’s Handbook contained in Get ONC-ATCB Certified 2011/2012 Toolkit.
If a technology can meet only half of a specific criteria’s test procedures (supporting a specific meaningful use objective), because it is not an EHR, still be certified for that criteria?
Each criterion or criteria set supporting a meaningful use objective must be met in its entirety to become certified.
Do vendors that rely on products that interface with their software, such as e-Prescribing, have to wait until those products are ONC-ATCB certified before applying for certification?
No; you may certify your technology as an EHR module for the criteria you already meet. Your alternative is to apply as an integrated bundle, as described in the Final Rule.
If you choose to certify a Complete EHR, will you also get the individual module certifications for customers who do not install all parts of a complete EHR?
You may test them together, but you must apply for and list them separately in order for a provider to obtain the unique identification number for that module and to combine them with the other EHR modules numbers they will need to qualify as having certified EHR technology for ARRA funding.
Does provider amount of incentive money vary according to number of modules certified?
No. A provider cannot apply for incentive funding unless they have certified EHR technology (complete or modular) that meets all of the criteria for their domain – eligible provider or hospital.
How many times can a vendor return for certification for failed criteria?
Answers to relatively complex policy questions such as this are detailed in the Handbook available in the Get ONC-ATCB Certified 2011/2012 Toolkit. Our intent is to assure that you are well prepared for certification and the risk of failure is minimized.
Can you purchase the Get ONC-ATCB Certified 2011/2012 Toolkit now and return later to go through the certification process?
Yes; your Toolkit purchase price will be discounted from any future CCHIT 2011 program application.
For consumers, will CCHIT list specifically the criteria for which an EHR is certified?
Yes, this is published on the CCHIT Web site and on ONC’s Certified HIT Products List (CHPL) Web page.
If an EHR vendor develops software for Eligible Provider and Hospital use, and is planning to certify to exchange electronic records, would certification for Hospital use include Eligible Provider as well?
The programs are separate and require separate applications, testing and listing.
If you are an EHR vendor that uses a third party application for a patient portal, how should we proceed for certification?
You may apply as an EHR module for the criteria you already meet, or you may join with your third party supplier and test a complete EHR as a bundle. The products in the bundle are certified together; they cannot claim separate certification unless they also certify individually as an EHR module.
Will software re-certification be required for each "meaningful use" stage?
Yes; the criteria, standards and test procedures will change for each stage. ONC has retained the right to change certification criteria at any time, but it is most likely that this will not occur until the next stage. The Final Rule states that the Temporary Certification Program is scheduled to sunset on December 31, 2011, unless HHS/ONC decides to extend it or hasn’t defined the permanent program.
Is there an effective period for certification? For example, if an EHR is certified in January 2011, when would the certification end and when would the technology need to be retested?
The effective period certification is determined by when ONCs publishes new rules for standards and certification criteria. If you are selling your software to providers who wish to meet the requirements of all three stages of meaningful use, you will need to recertify your EHR technology for 2013/2014 and 2015/2016.
Does the hospital's interface engine have to be certified?
Are there any certification criteria or test scenarios specifically for a health information exchange vendor?
No; a health information exchange vendor may apply to test and be certified for any of the EHR module criteria they wish to meet.
There is some uncertainty about certification of Practice Management Systems that feed into EHR. Can you provide some insight on that?
Can we certify a pre-market version of our product in the ONC-ATCB program?
Unlike the CCHIT Certified® program, there is no requirement in the ONC-ATCB program for live site verification. Your product does not have to be operating in live sites to achieve full ONC-ATCB certification.
If we choose to go for dual certification, are CCHIT and ONC-ATCB certification completed simultaneously or can you choose to get ONC-ATCB certified first then follow up with CCHIT certification?
These are separate programs and testing occurs separately. You may schedule them in any order you choose.
Can a healthcare provider modify a vendor's EHR product from a version that the vendor has not chosen to certify and submit it for certification? For example, Vendor X is certifying version 2.0 through CCHIT but Healthcare Provider Y is using version 1.0. Is it possible to "self-develop" version 1.0 to the appropriate level and submit it for certification?
Yes, but the vendor cannot claim certification for your modification of version 1.0. Your certification of that “self-developed” technology is only applicable to your installed site.
Would currently CCHIT Certified® 2011 EHR's with CCHIT’s preliminary ARRA certification be required to retest previously published (before the Final Rule) ONC criteria?
Yes. While criteria changes were minimal, ONC approved NIST test procedures were mandated as the required testing process in the final rule.
ONC allows for modular certification. If we certify our EHR as a complete EHR, but a provider uses another EHR technology to meet some objectives (e.g., patient portal or immunization registry), do we need to also apply for modular certification?
No, but the provider must show evidence that the other technology they are using to meet those objectives is “certified EHR technology.”
Would you certify modules of PHR systems even though certification may not be required?
In the ONC-ATCB program, we can only test and certify criteria published in the Final Rule. We cannot expand that government program beyond the Rule. If a PHR meets one or more of the Final Rule criteria, we can test and certify it as an EHR module.
If my EHR software relies upon a third party e-prescription module, should I seek EHR module certification or complete EHR certification?
That is your choice. If you would like to be certified as a complete EHR, you may bundle your product with the third party e-prescribing software and submit them for testing together. In this case, they are not independently certified and can’t claim separate certification.
Or you can certify your product independently as an EHR module. Providers using your certified EHR module would also need to show evidence of use of a certified e-prescribing module to be eligible for incentive funding.
Do Emergency Department specific products test against Complete EHR or EHR Module test scripts?
Since it’s unlikely that an ED EHR could meet all of the criteria for a Hospital domain Complete EHR, the vendor offering the product could choose to certify the product as an EHR module, meeting just the Hospital domain criteria for which its EHR is compliant.
Do all ONC-ATCB's have to provide the exact same testing service?
All ONC-ATCBs must test EHR technology using the same ONC criteria and NIST test procedures. Their additional supporting customer services (e.g., test scripts that manage inspection workflow and set up data, FAQs, guidance documents, etc.) and pricing may be different. These differences are a reflection of their overall experience and competitive approach to the market. This competition is encouraged by ONC.
