Healthcare It Standards and the Standards Development Process: Lessons Learned from Health Level

Standardization of information in healthcare is critical to the ability of a diverse community of caregivers to reliably exchange complex data without ambiguity. Perhaps more importantly, every member of the healthcare team must be able to re-use the data within increasingly diverse applications and environments. In order to improve quality and to constrain the escalating costs of delivering care and preventative medicine, the strategies for developing these standards have attempted to keep pace with the developments in information technology, human biology, healthcare policy, social science, and economics. For more than two decades, Health Level 7 has been at the forefront of those processes for an international community. New technologies, and new applications of existing ones, foster standards development against a complex backdrop of social and political demands. Healthcare IT Standards: An International Perspective ! e history of standards has made the creation of standards diffi cult. ! e global community of today did not exist when the healthcare IT community recognized the necessity for health data standards to reduce the costs of interfacing systems and to permit the exchange of data. ! e health-related community began to be interested in standards during the early 1980s, and several organizations were created during the late 1980s and early 1990s. For clinical systems, the needs were primarily within a hospital and included the domains of patient admission, transfer and discharge; lab test ordering and result reporting; prescriptions and dispensing; materials management; images; reimbursement; and other similar domains. New standards-developing organizations were created, mainly focusing on only one component of the many recognized needs. Standards developing organizations (SDOs) that were creating standards in communications, banking, manufacturing, and other non-health areas were quite mature by this time. In the United States, ASTM American Society for Testing and Materials created E31 for health data standards, focused initially on standards for the reporting of laboratory test data. Health Level Seven (HL7) was organized in 1987 to create standards to support the development of best-of-breed hospital information systems. “Health Level Seven (HL7) was organized in 1987 to create standards to support the development of best-ofbreed hospital information systems.” Charles Jaffe Health Level 7 W. Edward Hammond Duke University John Quinn Accenture Robert H. Dolin Health Level 7 Healthcare Information Standards Health Level 7 HEALTHCARE IT STANDARDS AND THE STANDARDS DEVELOPMENT PROCESS: LESSONS LEARNED FROM HEALTH LEVEL 7 Intel Technology Journal | Volume 13, Issue 3, 2009 Healthcare IT Standards and the Standards Development Process: Lessons Learned from Health Level 7 | 59 In Europe, the Comité Européen de Normalisation (CEN) formed Technical Committee 251 in the early 1990s to create health data standards. ! ere was little competition between CEN and HL7, simply because there was no apparent common market. In fact, the methodology that was used to create later HL7 standards was infl uenced by CEN. In 1995, Germany became the fi rst international affi liate of HL7, followed shortly thereafter by the Netherlands. From then on, the competition between HL7 and CEN began. ! e relationship between members of both organizations was cordial, but both HL7 and CEN were vying to have their standards used in Europe. All countries have a national standards body: the American National Standards Institute (ANSI) in the United States; the British Standards Institution (BSI) in the United Kingdom, the German Institute for Standardization (DIN), the French national organization for standardization, known as Association Française de Normalisation (AFNOR), and so on. ! e International Standards Organization (ISO) was founded just after the end of World War II in 1947 and is an international, standard-setting body composed of representatives from these various national standards’ organizations. ISO Technical Committee 215 was formed in 1998 through eff orts of the U.S. and the U.K. to create standards in Health Informatics. Since most countries, by law, require the use of an ISO standard if one exists, ISO became a key player in international standards. In 1991, recognizing that there were not suffi cient expert resources available for ISO and CEN to conduct their standardization activities independently, ISO and CEN signed the Vienna Agreement to work together to produce standards. ! e impact of this agreement, including the joint development of standards and the sharing of standards, was felt independently within each organization. In 2002, HL7, following the lead of IEEE, signed an agreement with ISO, through ANSI, that permitted HL7’s work and standards to be brought into ISO upon approval of ISO TC 215. Although both of these agreements resulted in a move toward the consolidation of work, standards continued to be duplicated. In the spirit of harmonization, eff orts were put into mapping one similar standard to another across organizations where multiple standards exist. An example of one such activity was the eff ort to create a single standard for defi ning data types, by combining similar work from ISO, CEN, and HL7. After over fi ve years of work, a single standard had still not been defi ned. Similarly, approaches to defi ne a single global Reference Information Model (RIM) failed, because of diff erences between the CEN standard EN 13606 and the HL7 RIM. ! is latter issue was further compounded when the HL7 RIM was approved as ISO/HL7 21731:2006-Health Informatics-HL7 version 3-Reference Information Model. “! e International Standards Organization (ISO) was founded just after the end of World War II in 1947 and is an international, standard-setting body composed of representatives from these various national standards’ organizations.” “After over fi ve years of work, a single standard had still not been defi ned.” Intel Technology Journal | Volume 13, Issue 3, 2009 60 | Healthcare IT Standards and the Standards Development Process: Lessons Learned from Health Level 7 Over the next few years, HL7 submitted several HL7 standards to the ISO to become joint HL7/ISO standards. ! ese included HL7 version 2.5 Messaging Standards; HL7 version 3.0 Clinical Document Architecture, R2; Common Terminology Server, R1; HL7 EHR–Functional Model; and Clinical Genomics-Pedigree. In late 2005, HL7 submitted four regulatory standards to ISO: Structured Product Labeling, Release 1; Individual Case Safety Report; Stability Study; and Annotated Electrocardiogram. None of these standards were accepted by TC 215 (most nations abstained). In addition, the International Committee on Harmonization (ICH) was very concerned, because they themselves had standards in some of these areas. In 2006, at the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH meeting in Yokohama, leaders from ISO TC 215, CEN TC 251, and HL7 made presentations to the group about their respective organizations. As a result, ICH became Class D Liaison with ISO and developed relationships with both CEN and HL7. ! ere was a real interest among the leaders of ISO, CEN, and HL7 to work together, largely driven by the limited resources available to produce standards, as well as by the confusion in the marketplace because of multiple standards. At the Global Health Information Technology Standards Summit in Geneva in 2006, presentations by Dr. Yun Sik Kwak, Chair, ISO/TC 215; Kees Molenaar, Chair, CEN TC 251; and Dr. Ed Hammond, Chair-elect, HL7 suggested the three SDOs might be able to work jointly to produce a single global standard for a single business purpose. After additional discussions, a charter was written and was subsequently ratifi ed by all three SDOs. ! e charter establishes a Joint Initiative Council (JIC) that includes the chairs of the three participating organizations plus two additional representatives from each SDO. Figure 1 shows the global healthcare landscape. ! e JIC serves as a collaborative forum for the international standards community. Within the US, the Federal Health Architecture coordinates 55 Federal agencies. Vocabulary standards are depicted in the oval boxes. “Over the next few years, HL7 submitted several HL7 standards to the ISO to become joint HL7/ISO standards.” “! ere was a real interest among the leaders of ISO, CEN, and HL7 to work together.” “! e charter establishes a Joint Initiative Council (JIC) that includes the chairs of the three participating organizations plus two additional representatives from each SDO.” Intel Technology Journal | Volume 13, Issue 3, 2009 Healthcare IT Standards and the Standards Development Process: Lessons Learned from Health Level 7 | 61 Joint Initiative Council (JIC)