The number of ONC-Authorized Testing and Certification Bodes (ATCBs) grew by one, with the addition of InfoGard Laboratories, announced last week. This brings to 3 the number of organizations authorized to test Electronic Health Records (EHRs) and Certify them – necessary for access to Meaningful Use incentive payments through CMS beginning next year.
The process of selecting ACTBs is significant, in that it represents a profound change in the way EHRs become Certified. Previously, only one contracted certifying body existed – CCHIT (Certification Commission for Health Information Technology). CCHIT began certifying EHRs in 2006, and used internally-derived testing criteria for this activity. It grew out of a vendor trade organization, HIMSS, and has faced criticism of being unduly influenced by the large, legacy EHR vendors who developed criteria based on an assumption that EHRs were locally-installed enterprise systems – the emergence of web-based EHRs and other forms of health IT was poorly addressed by the traditional CCHIT criteria.
The Office of the National Coordinator for Health IT (ONC) recognized this dilemma, and set out to separate the Certification testing criteria from those who carry out the testing. The testing criteria resulted from Meaningful Use criteria, which in turn were derived from a set of 5 National Health Policy Priorities. In order to access Meaningful Use incentive payments from CMS, a clinician must satisfy 15 “core” criteria, and 5 of 10 additional “menu” items (20 of 25 criteria).
A Certified EHR, therefore, must allow a clinician access to all 25 such criteria. The Certification criteria have been specified by the National Institutes of Standards and Technology (NIST), and are the same for all products.
Two kinds of Certification can be carried out: (1) Complete EHRs, which cover all 25 Meaningful Use criteria, and (2) EHR Modules, which are certified to carry out some (but not all) of the 25 criteria. Using Modules, therefore, a clinician would need to assemble several pieces of software in order to do all 25 things – many hospitals and other clinicians that have already invested in legacy systems have stated that they will need to use several pieces of technology to accomplish Meaningful Use.
Such a separation of testing requirements from the organizations that implement the tests changes the role of CCHIT – they no longer are the ones to both create the rules and test for the rules. This also opens the door for other organizations, not necessarily having roots in healthcare (but having roots in other areas of software testing and technology), to carry out EHR Certification testing. An ACTB, depending on their scope, expertise and desire, may be authorized to test for either Complete EHRs or just for specific Modules. To date, the 3 ACTBs that have been announced are full-spectrum testing bodies, authorized to test for everything. No Module-specific ACTB has yet to be announced.
The three ACTBs may not (yet) be household names to those familiar with healthcare. The 3 so far are CCHIT, Drummond, and InfoGard.
CCHIT is likely familiar to all, as they were the exclusive certification body prior to Meaningful Use. Their strength is that they come from a Health IT background. This is also their weakness, as they have systems in place built for testing legacy CCHIT criteria, and (like everyone else) need to re-create their testing capacity to address the new NIST criteria. Nevertheless, CCHIT will likely be the pathway for many EHRs to become HHS Certified.
Drummond Group, Inc (DGI) was also named as an ACTB at the same time as CCHIT. DGI has a rich history of testing for conformance and interoperability of software technology. Founded in 1999, DGI has offered interoperability testing for over 1,000 international software products in vertical industries such as automotive, consumer product goods, healthcare, energy, financial services, government, petroleum, pharmaceutical and retail. Their appointment as an ACTB raises the bar for conformance testing, and helps bring health IT up-to-speed with other areas of software. Their EHR Blog is a useful resource to track.
InfoGard is another well-respected testing laboratory, founded in 1993. Their primary strength has been in security assurance testing, and are accredited by the NIST, the Payment Card Industry Security Council, and Postal authorities. Their appointment as an ACTB is another indication of the maturation of health IT, and represents another option for EHR vendors to become Certified.
Again, regardless of which ACTB is used to carry out the Certification testing, the criteria are the same. The ONC will publish its Certified Health IT Products List (CHPL) once EHRs are tested by one of these ACTBs, both for Modules and for Complete EHR solutions. As yet, no such products have gone through the process, though many are lining up for testing as of now.
It is heartening to watch the maturation of health IT, as it plays out in the evolution of Certification. InfoGard is a welcome addition to the mix. The hoped-for direction for health IT – of truly interoperable, robust, secure and usable technology that moves health care delivery forward – is something we are watching unfold before us.
Robert Rowley, MD
Chief Medical Officer
Practice Fusion EMR
