An Open Letter to ONC on Certification Program

Jim Tate, Meaningful Use Expert

Open Letter to ONC Regarding Temporary Certification Program

One of the foundational elements of the CMS EHR Incentive Program is the use of certified EHR technology. On June 18, 2010 HHS issued a final rule to create a Temporary Certification Program “for purposes of testing and certifying health information technology.” This rule also outlined how organizations can apply, meet stringent requirements, and become ONC Authorized Testing and Certification Bodies. View the list of ONC-ATCBs here.

Their job is to test (based on NIST’s approved test procedures) and certify that products meet the criteria to support meaningful use. To maintain the integrity of the certification process it is vitally important that all ONC-ATCBs are testing vendors with the same consistent requirements across all functionality that must be demonstrated. ONC has been providing regular guidance to the ONC-ATCBs to clarify the details of the NIST requirements and the testing requirements.I have worked with well over 100 EHR vendors on their certification projects and have been through numerous EP, EH, complete, and modular certifications with all major ONC-ATCBs.

Since the inception of the Temporary Certification Program I have been concerned that the current process of ONC guidance to the ONC-ATCBs could possibly lead to inconsistent interpretations of testing requirements which could lead to vendors shopping for the “easiest” test environment. I am starting to see that happen. On February 23, 2011 ONC held a Certification Town Hall at the HIMSS conference. In attendance was ONC staff as well as representatives of all then current ONC-ATCBs. During the public Q/A I expressed my concern that guidance from ONC to the Testing Bodies was not public and could lead to the ATCBs arriving at different interpretations of the same ONC clarification and guidance. This could potentially lead to inconsistent testing requirements among the Testing Bodies. I was told my concern would be taken “under advisement”.

Over the past few weeks I have become aware that in at least one major area there is a significant inconsistency among the ONC-ATCBs as to how guidance from ONC is interpreted. The bottom line is that in some instances it is significantly easier to successfully test and become certified depending on which ONC-ATCB a vendor selects. Nobody is doing anything wrong here or trying to bend the rules. Every ONC-ATCB I have worked with has shown a high level of professionalism and integrity. However, the process by which ONC provides clarification to the ONC-ATCBs must be modified so all ONC-ATCBs know exactly what functional elements and specifications are required during testing. There must be some type of feedback loop so ONC knows testing is 100% consistent and their guidance is interpreted by every ONC-ATCB in the same way. This is a small issue now but if not corrected could well lead to bringing the integrity of the entire certification process into question. That is the real risk.

As a consultant I am in a bit of an uncomfortable position because my job is to help vendors achieve certification. But there is something much larger at stake. This country is involved in a massive effort to roll out Health Information Technology through certification, meaningful use, and incentives.  I do not want my knowledge of inconsistency in the interpretation of requirements to be used for the benefits of my clients. I do not want any vendors, including my own clients, to bottom fish. This need to be fixed before it becomes a larger issue. I’m not saying I know the answers, but I know a few of the questions.  I welcome contact from anyone with ONC or other appropriate regulatory body to contact me at to discuss the details of this issue.

Jim Tate is author of The Incentive Roadmap® The Meaningful Use of Certified Technology: Stage 1. Version 3.0 now available for purchase.