The U.S. Commission for Certification of Health Information Technology (CCHIT) is developing criteria for certification of health information exchange (HIE) - including a process of public comment accessible through their website. This agency (a government contractor) shows a bias in favor of proprietary software solutions in certification for ambulatory, inpatient, emergency department and enterprise EHR. Health information exchange, however, poses a particular challenge to CCHIT as it really cannot be defined as a software product - as evident in the minutes of meetings of the HIE (formerly Network) Working Group. On October 28, 2008, the WG considered the results of a Gartner report on vendors providing services to HIEs - commissioned in 2007 by the ONC. (This report has not been made available for public review, probably because it contains evidence that existing HIEs are unsustainable; no viable business model has been identified, and these organizations generally fail after initial public or private funding is exhausted. In my opinion, such a report belongs in the public domain and should be required to inform public consultations.)
The WG mentioned that discussions would be continued to decide whether vendor certification should be different than HIE certification. (See page 3.) On November 25, 2008, questions were raised concerning the location of patient and document registries as well as the content of current HIE data exchange. Confusion over the parallel roles of CCHIT and the Healthcare Information Technology Standards Panel (HITSP) was resolved by asserting that HITSP should adapt its standards to CCHIT certification requirements.
The WP seemed to recognize that the interoperability construct is difficult to address in the absence of "an overarching plan for how HIEs will interact as mediators of information exchange." (See page 2.) On January 27, 2009, a substantial commentary and discussion explored the distinctions between HIE certification and accreditation under the Electronic Healthcare Network Accreditation Commission (EHNAC) . According to this discussion and ISO definitions, certification is more appropriate to software products and vendors, while accreditation applies to organizational entities. (ISO definitions: Accreditation is a "third‐party attestation related to a conformity assessment body conveying formal demonstration of its competence to carry out specific conformity assessment tasks" in other words an organization or entity can be accredited. "Certification is a third‐party attestation related to products, processes systems or persons" in other words not an organization. See comment 7 on page 5, minutes of the January 27 WH meeting.)
While the minutes of WG meetings raised the critical need for HIE definition, this question was never directly addressed. What are HIEs? How will they be connected to form the Nationwide Health Information Network (NHIN)? What organizations and institutions may join in these networks? Where does health information reside in the HIE context? The document for public comment offered by CCHIT suffers from this lack of clarity, with the probable result that comments will focus on trivial technical details rather than the more important "big picture".