The field of healthcare informatics standards started in the late 1960s. One of the earliest efforts took place under the jurisdiction of ASTM (American Society for Testing and Materials). Standards for laboratory message exchange, properties for electronic health record systems, data content, and health information system security were among the first healthcare informatics standards that ASTM developed.
The College of American Pathologists started developing a nomenclature for pathology in 1965, which has now become the internationally recognized Systematized Nomenclature of Human and Veterinary Medicine13 In 1974, the first Uniform Hospital Discharge Data Set (UHDDS) was promulgated by the Secretary of the HHS, based on advice from NCVHS.14 In 1987 Health Level Seven (HL7) began to develop a wide range of message format standards for patient registration, orders, and observations reporting and published its first version in October of that year.15 In 1991, the Accredited Standards Committee (ASC) X12N Insurance subcommittee started developing standards for interactive communication of health claims and other financial and administrative transactions.16
Initially, a need for a standard in a specific area was often identified by a clinical specialty group or by a professional or trade association. For example, the American College of Radiology and National Electrical Manufacturers Association identified a need in 1985 for a non-proprietary data interchange protocol, digital image format, and file structure for biomedical images and image-related information, now the Digital Imaging and Communications in Medicine (DICOM) standard. The National Council for Prescription Drug Programs (NCPDP) is another group that created a successful standard focused on a very specific niche area of health care – transactions between community pharmacies, payers, and pharmacy benefits managers. The Logical Observations Identifier, Names and Codes (LOINC) database is used widely by commercial labs and government agencies and has been provided at no cost on the Worldwide Web since 1995.17
Standards in other industries often arise from a dominant vendor (e.g., Microsoft Disk Operating System) or industry action group of vendors willing to converge on a standard in order to enable widespread use of a technology (e.g., ATM banking transactions). In contrast, healthcare standards developed by specific vendors often do not rise to dominance because there are no truly dominant vendors in the industry, nor are there industry action groups powerful enough to achieve voluntary convergence.
Standards development organizations (SDOs)
As a result of the diverse needs and fragmentation in health care, many different standards development organizations have emerged. Many of these groups are highly focused and fill a very specific need. When a standards development organization recognizes a need, which may also be related to another focus area, this creates the potential for coordinated standard development. For example, many of the nursing terminologies focus on a specific aspect of nursing, but by necessity must incorporate some common data elements. In the absence of a coordination point for healthcare informatics standards, the potential for overlaps or gaps occurs, where no organization is addressing a standards need.
The American National Standards Institute (ANSI) has been the “accreditor and coordinator of the U.S. private sector voluntary standardization system” since 1918, “ensuring that its guiding principles – consensus, due process, and openness – are followed by the entities accredited under one of its three methods of accreditation (organization, committee, or canvass).” ANSI “promotes the use of U.S. standards internationally, advocates U.S. policy and technical positions in international and regional standards organizations, and encourages the adoption of international standards as national standards where these meet the needs of the user community." “A Standards Board is a standing organization within ANSI having planning and coordination responsibilities on a continuing basis for a defined scope of activity.”18
In 1991, the predecessor organization to the ANSI Healthcare Informatics Standards Board (HISB) was created, initially to respond to European efforts in healthcare informatics standards. It exists currently to coordinate national healthcare informatics standards. ANSI HISB has conducted an extensive inventory of standards that contributed to the selection process for the proposed transaction and code set standards under HIPAA Administrative Simplification. ANSI HISB is voluntary in nature, and it focuses primarily on establishing communications among standards development organizations. As a result of this communication focus, several bilateral and multi-lateral agreements among standards groups have developed. Still, the state of healthcare informatics standards remains complex and underdeveloped.
The healthcare delivery system today employs many different information systems from different vendors, both within a single organization and across multiple organizations. For example, a hospital may have a laboratory system from one vendor, a pharmacy system from another vendor, and a patient care documentation system from a third vendor. Physicians affiliated with the hospital also have different systems in their offices, yet need access to data from the hospital on their patients.
Existing message format standards intended to achieve interoperability between different information systems have a high degree of optionality and are often not implemented in a standard manner. Options were incorporated into these standards in order for vendors to accommodate the variability of workflow and the availability of information in different healthcare settings. This optionality can require costly and time-consuming custom programming. Even larger issues relate to non-standard implementations of the standards and the enormous variability of vocabulary.
13 Kudla K, College of American Pathologists
14 U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Center for Health Statistics, The National Committee on Vital and Health Statistics, 1992
15 Hammond, W. Ed. “Health Level 7: An Application Standard for Electronic Medical Data Exchange,” Topics in Health Record Management, 1991, 11(4), 59-66
16 Data Interchange Standards Association (DISA) web site (www.disa.org)
17 Forrey AW, McDonald CJ, DeMoor G, et al. The Logical Observation Identifier Names and Codes (LOINC) Database: A Public Use Set of Codes and Names for Electronic Reporting of Clinical Laboratory Test Results,” Clinical Chemistry, 1996, 42, 81-90.
18 American National Standards Institute, Questions & Answers