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Gliklich RE, Dreyer NA, editors. Registries for Evaluating Patient Outcomes: A User's Guide. 2nd edition. Rockville (MD): Agency for Healthcare Research and Quality (US); 2010 Sep.

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Registries for Evaluating Patient Outcomes: A User's Guide. 2nd edition.

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Appendix CRelevant Entities in Health Information Technology Standards

The Clinical Data Interchange Standards Consortium, or CDISC, is a multidisciplinary nonprofit organization that is focused specifically on medical research and that works toward developing and supporting global, platform-independent data standards that enable information system interoperability. It is a membership organization made up of more than 170 academic research centers, global biopharmaceutical companies, technology and service providers, and institutional review boards (IRBs).1 CDISC has established standards to support the acquisition, exchange, submission, and archiving of clinical research data and metadata, such as case report tabulation data definitions, submission data, and operational data modeling; these standards are intentionally vendor neutral, platform independent, and freely available. CDISC has formed key partnerships with other standards bodies, vendors, and research groups to further the creation and use of these and other industry standards. CDISC’s Healthcare Link project is an initiative that specifically focuses on the mission of interoperability between health care and clinical research.

Health Level Seven, or HL7, is an American National Standards Institute (ANSI)–accredited organization that produces specifications and protocols for clinical and administrative health care data.2 HL7 is a global organization with corporate and individual membership consisting of providers, vendors, payers, consultants, and government groups. Like CDISC, HL7 does not develop software, but instead creates specifications. HL7’s original specification was a messaging standard that enables disparate health care applications to exchange key sets of clinical and administrative data.3 This standard defines the structure and content of the messages that are exchanged between systems in either batch mode, which facilitates transfer of a collection of individual messages labeled by a single header, or interactive mode, which transmits a single message. HL7 then extended this idea to a Clinical Document Architecture (CDA), which is designed to support standards for storing and retrieving file-level information such as electronic health records (EHRs).3 The Reference Information Model (RIM) then specifies the details, results, and contexts of clinical informatics by defining subject areas, classes, attributes, use cases, and trigger events (such as a followup clinical visit).4 HL7 also houses important specifications and tools relating to electronic documentation of standards, for example, the Continuity of Care Document (CCD).

The Healthcare Information and Management Systems Society, or HIMSS, is an industry membership organization that focuses on knowledge sharing, advocacy, and collaboration among its members. HIMSS is a longstanding advocate of using information management systems to improve health care, and represents a large portion of the industry (more than 20,000 individuals and 350 corporations).5 HIMSS plays a critical role in this discussion through the HIMSS Electronic Health Record Association, and also through its role in partnering with two other key standards groups: the Health Information Technology Standards Panel (HITSP) and Integrating the Healthcare Enterprise (IHE).

The HIMSS Electronic Health Record Association (EHRA) is a trade association specifically made up of EHR companies. This association is a key player in the interoperability discussion. EHRA focuses on creating interoperable EHRs in hospital and ambulatory care settings by providing a forum and structure for EHR leaders to work toward standards development, interoperability, the EHR certification process, performance and quality measures, health information technology legislation, and other EHR issues.6

Integrating the Healthcare Enterprise is an initiative sponsored by HIMSS that is designed specifically to bridge the gap between existing standards and the implementation of integrated systems. IHE does this by creating Profiles, which specify precisely how standards are to be used in integration implementations. It is important to note that IHE does not develop standards; instead, it provides a link point between the standards that exist and the problems among the industry that need to be solved. The initiative is focused on eliminating ambiguities, reducing configuration and interfacing costs, and ensuring a higher level of practical interoperability for users and developers of health care information technology as they implement standards-based communication between systems and then perform tests to determine that the implementation conforms to the specifications.7 Standards from different organizations that achieve the same goal can be inserted into an IHE Profile, and IHE will then produce technical specifications that can be used by developers and vendors to build products compliant with those standards. Because of IHE’s practical approach, its value has been recognized by other standards organizations, particularly CDISC. For example, IHE has defined a simple four-step process that carries a specific problem from problem definition, through implementation and testing, to the real world:

  1. Identify interoperability problem.
  2. Specify Integration Profiles.
  3. Test systems at Connectathon (an annual weeklong interoperability-testing event); demo at HIMSS Interoperability Showcase.
  4. Implement in real world.

The Healthcare Information Technology Standards Panel serves as a partnership between the public and private sectors with the purpose of identifying a widely accepted set of standards for interoperability of health care applications. HITSP is funded by the U.S. Department of Health and Human Services (HHS), administered by ANSI, and tightly partnered with HIMSS; Federal agencies are mandated to use interoperability standards that have been harmonized by HITSP.8

The Certification Commission for Health Information Technology (CCHIT) is a private nonprofit organization with the “sole public mission of accelerating the adoption of robust, interoperable health information technology by creating a credible, efficient certification process.”9 It is divided into workgroups that address the standards for specific functional areas such as ambulatory care, behavioral health, personal health records, and cardiovascular care. Since being recognized as a certifying body by HHS in 2006, it remains the only federally approved organization to certify health information technology products and systems.

Table C-1Relevant Entities in Health Information Technology Standards

GroupYear establishedNumber of membersMissionRelevant standards/specifications
CDISC2000>170 (corporate)Developing and supporting data standards.CDASH
HL71987>2,200 (individuals)Producing specifications and protocols for clinical and administrative health care data.CDA, RIM, CCD
HIMSS1961>350 (corporate)
>22,000 (individuals)
Knowledge sharing, advocacy, and collaboration.
EHRA2004~40 (corporate)Creating interoperability between existing EHRs.EHRA Interoperability Roadmap
IHE1997>230 (organizations)Providing a link point between the standards that exist and the problems among the industry that need to be solved.RFD, CRD
HITSP2005>550 (corporate and organizations)Partnering with public and private sectors to achieve standards to support interoperability among health care software applications.TP50, C76
CCHIT200426 products certified under 2008 CCHIT ambulatory EHR criteriaDefines the requirements for an EHR to be certified in the United States.CCHIT certification criteria (available at

Note: C76 = HITSP Case Report Pre-Populate Component. CCD = HL7 Continuity of Care Document. CCHIT = Certification Commission for Health Information Technology. CDA = HL7 Clinical Document Architecture. CDASH = Clinical Data Acquisitions Standards Harmonization. CDISC = Clinical Data Interchange Standards Consortium. CRD = IHE Clinical Research Data Capture. EHR = electronic health record. EHRA = Electronic Health Record Association. HIMSS = Healthcare Information and Management Systems Society. HITSP = Healthcare Information Technology Standards Panel. HL7 = Health Level Seven. IHE = Integrating the Healthcare Enterprise. RFD = IHE Retrieve Form for Data Capture. RIM = HL7 Reference Information Model. TP50 = HITSP Retrieve Form for Data Capture Transaction Package.

References for Appendix C

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[Accessed August 13, 2010]. Available at http://www​


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