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Health Information Architecture, Data Modeling, and Enterprise Architecture Planning |
U.S. Health Informatics Standards Development Activities |
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ANSI Accredited Standards Developers:
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ANSI Accredited U.S. Health Informatics Standards Activities The principal functions of the American National Standards Institute is the coordination of standards activities within the United States and representing the official United States standards position in the international arena. Also within the coordination of standards activities is ANSI’s role of accrediting standards development organizations. ANSI accreditation ensures the organization complies with practices like openness of process and balance of interests. The following list cites the national health informatics standards activities accredited by the American National Standards Institute:
The following non-ANSI accredited organizations sponsor major standards activities that have an impact health informatics or healthcare systems development:
This review will focus on ANSI Accredited standards developers.
Association for the Advancement of Medical Instrumentation The Association for the Advancement of Medical Instrumentation (AAMI) was founded in 1965. AAMI is an alliance of approximately 6,000 individual and organizational members sharing a common goal of increasing the understanding and beneficial use of medical instrumentation. AAMI is the primary source of national and international consensus standards and timely information on medical instrumentation and technology for the health care and supporting industries, the health professions and organizations, and the government. AAMI provides a critical forum for members. Its user community includes clinical and biomedical engineers and technicians, physicians, nurses, and hospital administrators. The industry membership includes manufacturers, distributors, testing houses and consultants. Government participation includes the FDA, NIH, and CDC. General interest membership includes academic researchers and educators, along with individuals outside of the health and healthcare industry having an interest in medical devices. Designers, users, managers, and regulators of medical technology have been instrumental in making AAMI the leading source of essential information on medical devices and equipment for over 30 years. Recently personnel at the FDA Center for Devices and Radiological Health team regulating Software and Intelligent Medical Devices have been increasingly involved in establishing relevant standards. The FDA will be using these and other industry standards as references in their medical software regulation program. The American Society for Testing and Materials The American Society for Testing and Materials (ASTM) was organized in 1898 and has grown to be one of the largest voluntary standards developers in the world. ASTM develops standards for a variety of materials, products, systems, and services, including medical device, emergency medicine, forensics, and health informatics. ASTM is a self-directed ANSI-accredited standards developer that provides a forum for producers, users, ultimate consumers and those with a general interest (representatives of government and academia) to meet on common ground and create standards for materials, products, systems, and services. ASTM technical committees operate in accordance with a rigorous set of regulations that define the procedures for developing consensus standards, the establishment and operation of committees, the definition of membership classifications, and voting procedures. Each year, through the work of the current 130 standards-writing committees, ASTM publishes more than 10,000 standards and other related technical information that are used throughout the world. In 1970 ASTM established the ANSI accredited standards committee (ANSI ASC) E31 on Health Informatics. This committee develops standards for health information and health information systems. The committee designs these standards to assist vendors, users and anyone interested in systematizing health information. Current E31 activities address the architecture, content, portability, format, privacy, security and communications of health and healthcare information, performed in thirteen expert subcommittees:
Committee E31 has a wide variety of published standard classifications, guides, specifications, practices, and terminologies and coordinates its efforts with those of other standards developers. E31 standards activities also address policies for integrity and confidentiality of information per HIPAA requirements, and for computer procedures that support the acquisition, storage, transmission and use of data and healthcare decision making. ASTM recently published a new compilation, titled “Standards for Security and Electronic Signatures in Health Care.” It includes the E31 standards related to the security and digital signature segments of HIPAA legislation. Subcommittee E31.19 is currently in the process of revising its standards dealing with aspects of the electronic patient record. The subcommittee is basing these revisions and new work in a data-level model – selecting the ANSI/ADA 1000 Specification as the starting point for future work. Subcommittee E31.19 is also revising the Standard Practice for Modeling in Health Informatics. This document identifies industry best practices for modeling and provides a quality assurance guide for those organizations that perform modeling as part of their analysis, design, or development processes. This subcommittee is also updating several of the traditional systems development methodology standards prepared by ASTM and targeting these for the specific requirements of the health information technology environment. An important new initiative of ASTM is the standards activities by E31 Subcommittee on Personal Health Records. The work of this committee is specifically targeted toward personal electronic health information via Internet technology. Areas of interest are access, privacy, confidentiality and security in the Internet environment, along with the content and utility of personal health information. Subcommittee E31.25, together with the Massachusetts Medical Society, sponsored a workshop on XML for Document Type Definitions (DTDs) in Healthcare. The workshop consisted of an international group representing CEN TC 251, as well as representatives from HL7 and the Massachusetts Medical Society. The meeting goals were to develop a common set of sections for clinical reports of a specific type and across types. ANSI Accredited Standards Committee on Dental Informatics - American Dental Association The American Dental Association (ADA) is the principal organization for standards that affect the dental profession and dental care delivery in the U.S. Through resolution by its House of Delegates in 1996, the ADA has become the stakeholder for electronic health records standards because patient health and healthcare information now crosses the traditional boundaries of healthcare profession, specialty and care delivery environment. No other healthcare professional organization has vested this level of authority in a standards development organization. The ADA health informatics standards program draws upon over 70 years experience in ANSI accredited standards activities. The ADA has sponsored ANSI accredited standards activities since 1928, initially through the Council on Dental Research and subsequently through the Council on Scientific Affairs. The ASC on Dental Informatics activities continues a program whose origins are from the mid-1980s. Volunteers under the auspices of the ANSI Accredited Standards Committee MD156 (ASC MD156) conducted preparatory work through the early 1990s as the Task Group on Dental Informatics. The ASC MD156 is an independent committee of both ANSI and the ADA, with the ADA appointed secretariat by ANSI upon its formation. The dental informatics work subsequently became a subcommittee of the ASC, and in 1999 became a separate ANSI accredited standards developer. The ASCDI is currently composed of four working groups dealing with:
On February 2, 2001, the ASCDI achieved its first American National Standard with the completion of ANSI balloting on the ANSI/ADA SPECIFICATION NO. 1000: A STANDARD CLINICAL ARCHITECTURE FOR THE STRUCTURE AND CONTENT OF THE COMPUTER-BASED HEALTH RECORD. The ANSI/ADA 1000 was the first and remains the only American National Standard for the data level of electronic health records. This standard is a model-based generic blueprint from which developers can create both object-oriented and relational computer-based patient record systems. This standard is the first to be fully based in a top-down business and data model methodology, and as such covers the entire healthcare spectrum. Physicians, dentists, veterinarians, allied health professionals, and administrators reviewed specification components from 1996-1998. In early 1999 all parts of this specification were circulated for an all interested parties to review according to the ANSI approved consensus process of the standards committee. The ADA ASCDI also produced significant contributions to the dental profession and in the larger healthcare arena:
ANSI Accredited Standards Committee X12N on Insurance The ANSI ASC X12N is the prominent electronic data interchange (EDI) standards developer in the area of health care management information. Its standards have been recommended by the ANSI HISB to the federal government as the primary means to implement a major portion of the Health Insurance Portability and Accountability Act (HIPAA). The ANSI ASC X12N Insurance Subcommittee develops EDI standards for all aspects of the insurance industry, promoting widespread implementation of standard format and uniform data content. ASC X12 approved Establishment of the ASC X12N as a subcommittee by the ANSI ASC X12, Electronic Data Interchange, on February 4, 1991. The principal responsibilities of the X12N Insurance Subcommittee are development and maintenance of X12 standards, UN/EDIFACT Messages, standards interpretations and guidelines, as they relate to all aspects of insurance and insurance-related business processes including, but not limited to, property, casualty, health care, life, annuity, reinsurance, pensions and reporting to regulatory agencies. X12N is one of the leaders in model-based standards development. It currently operates Task Group 3 on Business & Information Modeling. Business and Data Models were seen as a means to facilitate exploration of data and business requirements for development and maintenance of EDI transaction sets, and continue to be under development. ASC N12N has a large number of publications including healthcare EDI standards, implementation guides and tutorials. Works in progress include the proposed standard 269 Healthcare Benefit Coordination Inquiry & Response Transaction, and a Business Primer. The Business Primer, first published in 1994, is being updated to educate those outside the X12 membership, reports the business use of transaction sets currently approved through the X12 process for trial use. Tutorials currently available include Claims, Enrollment, Eligibility Request, Healthcare Claim Payment, Patient Information Record, Healthcare Claim Status, Healthcare Services Review, and Eligibility Response. Several implementation guides have been published and have been referenced in the administrative transactions required by HIPAA:
A draft implementation guide, 269 Healthcare Benefit Coordination Inquiry & Response Transaction, is in preparation. ANSI Accredited Standards Committee Z16 – National Safety Council The National Safety Council Accredited Standards Committee Z16 was formed in 1926 to revise the U.S. Bureau of Labor Statistics Bulletin No. 276, Standardization of Industrial Accident Statistics. Increasing use of information technology in the acquisition, transmission, storage and analysis of occupational health and safety information has prompted this SDO to enter the informatics standards arena. Key standards in this area include:
The National Traffic Safety Board of the NSC is especially interested in information system standards that will enable rigorous statistical studies of injury and mortality associated with traffic accidents. NTSB members actively participate in a number of other consensus standards organizations. ANSI Accredited Standards Committee Z80 for Ophthalmics The informatics activities of the ASC Z80 for Ophthalmics grew out of need to standardize the increasingly electronic technology of this health service. This ASC oversees all IT standards relating to optical devices and ophthalmology including data processing, data structures, data interchange and adoption of international standards. The principal informatics standard produced by this SDO is the ANSI Z80.26 Data Processing and Information Interchange for Ophthalmic Instruments. This standard was adopted in 1996 and has an editorial update from September, 1998. Health Industry Business Communications Council The Health Industry Business Communications Council is an industry-sponsored, not-for-profit, ANSI Accredited standards development organization. The HIBCC mission is to facilitate electronic commerce by developing appropriate standards for information exchange among health care trading partners. Standards development scope includes electronic data interchange message formats, bar code labeling data standards, universal numbering systems, and the provision of databases, which assure common identifiers. The HIBCC views its most important role is as a facilitator to the industry as it electronically transforms itself for twenty-first century commerce. THE HIBCC sponsors a number of technical committees, addressing issues of electronic data interchange, automatic identification, and health industry and product identification. The Electronic Data Interchange (EDI) Technical Committee has completed the review and upgrade of several supply chain transactions to the ANSI X12 4010 version to be Y2K compliant. This committee is also starting to provide business case examples for each transaction and combination of transactions, along with initial XML definitions. The HIBC Automatic Identification Technical Committee is creating a draft specification for the use of two-dimensional symbologies to carry the HIBC data messages, a draft specification for the use of OCR in healthcare product data marking and data capture applications, and radio frequency identification specifications for healthcare. The Health Industry Number User Group has four subgroups: Pilot Project, Linkages, Requirements for HIN web site, and Database population strategies. The Universal Product Number Development Committee is addressing the maintainability of the UPN repository along with developing a generic definition of UPN. Health Level Seven Health Level Seven (HL7) was founded in 1987. The scope of HL7 activities is to develop standards for the electronic interchange of clinical, financial and administrative information among independent computer systems. HL7 clinical data transmission standards are used widely throughout the U.S. healthcare delivery environment. With the addition of affiliates such as in South Africa and the sub-Sahara nations Angola, Zambia, Malawi, Namibia, Botswana, Zimbabwe, Mozambique, Swaziland, and Lesotho, HL7 has a growing international presence. The current version of the HL7 Application Protocol for Electronic Data Exchange in Healthcare Environments, v.2.3.1, is an approved American National Standard. Two additional HL7 standards have been granted ANSI approval, the Arden Syntax for Medical Logic Systems (standard activity recently transferred from ASTM), and the Clinical Context Management System. The HL7 XML special interest group has prepared a standard Patient Record Architecture (PRA) that defines an XML architecture for exchange of clinical documents. Encoding is based on XML Data Tag Dictionaries (DTDs) that are included in the specification and its semantics are defined using the draft proposed HL7 RIM. Version 1.0 of the HL7 PRA will provide the DTDs for the message header and level one, which will specify one core document type definition. The HL7 Reference Information Model (RIM) is an extensive work representing many years of effort by a core of modeling experts with review by subject matter experts throughout the HL7 working groups. The RIM is an object-oriented model of the healthcare delivery environment and is intended to be the foundation for the HL7 version 3 of the Application Protocol for Electronic Data Exchange in Healthcare Environments. This model is the product of a bottom-up methodology where initially several object-oriented health domain models from various sources were merged and harmonized. HL7 interest groups then used this model in specific healthcare subject areas and subsequently integrated and harmonized into a master model. Integration of domain models is difficult on this large scale and as yet not all healthcare delivery and professional domains (e.g. dentistry) have been represented. The RIM has been substantially simplified into a very generic, and heavily type coded structure. It passed technical committee ballot late in 2002 and is now (Mar 2003) undergoing organization-wide balloting. Version 2.4 of the HL7 Standard is balloted as of November 2000. V2.4 includes new messages for Personnel Management and Laboratory Automation and includes updates to previously published chapters. Institute for Electrical and Electronic Engineers The Institute for Electrical and Electronic Engineers, through its predecessors, the American Institute of Electrical Engineers (AIEE) and the Institute of Radio Engineers (IRE), is one of the oldest standards developers in the United States, dating from 1884. Throughout its existence, the IEEE has advanced the theory and application of electrotechnology and allied sciences, served as a catalyst for technological innovation and supported the needs of its members through a wide variety of programs and services. The IEEE is a non-profit technical professional association of more than 330,000 individual members in 150 countries. Through its members, the IEEE is a leading authority in technical areas ranging from computer engineering, biomedical technology and telecommunications, to electric power, aerospace and consumer electronics, among others. From its technical publishing, conferences and consensus-based standards activities, the IEEE produces 30% of the world’s technical literature in the fields of electrical engineering, electronics, and computers. The IEEE Division VIII Computer Society hosts many standards activities and is responsible for standards in: Bus architecture, Microprocessor and Microcomputers,
The Medical Device Communications Industry Group (MDCIG) provides a forum for medical device vendors to work together to support and accelerate the development of the IEEE 1073 (Medical Information Bus) Standards, as well as market and demonstrate the capabilities of standardized medical data communications. The Medical Device Communications Industry Group was formed to accelerate, promote, and support the activities of the Medical Information Bus Standards Committee of the IEEE Standards Association, and to foster adoption of the IEEE 1073 family of standards by medical device vendors and healthcare providers. The IEEE 1073 Standard for Medical Device Communications allows clinicians to link patient connected bedside medical devices to a bedside patient monitoring device or a computer network in a simple fashion. This permits comprehensive data capture from devices such as infusion pumps, ventilators, and patient monitors connected to acutely ill patients. IEEE Standard P1157 Medical Data Interchange (MEDIX) was revised in 1997 to provide a standard for healthcare data interchange. This standard is based on an object-model and is applicable to registration/admission, laboratory, imaging, and clinical data interchange among systems and between independent system components. This standard also addresses EDI, knowledge representation and the computerized medical record. The IEEE also is the leading standards developer for software engineering practices. These standards are targeted for general use throughout business and industry, and these are the foundation for software engineering and development methodology standards specific to health and healthcare information technology as developed by organizations such as ASTM. National Committee for Clinical Laboratory Standards The National Committee for Clinical Laboratory Standards (NCCLS), an international voluntary consensus standards organization headquartered in the United States, is one of the largest ANSI Accredited standards developers in the United States. NCCLS is the secretariat of the ISO Technical Committee (ISO/TC) 212, Clinical laboratory testing and in vitro diagnostic test systems. Formed in 1995, the scope of ISO/TC 212 is the standardization and guidance in the field of laboratory medicine and in vitro diagnostic test systems, including quality management, pre- and post-analytical procedures, analytical performance, laboratory safety, reference systems and quality assurance. NCCLS manages the U.S. TAG for ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems, and the U.S. TAG for ISO/TC 76, Transfusion, infusion, and injection equipment for medical use, on behalf of the American National Standards Institute (ANSI). NCCLS enhances the value of medical testing and healthcare services through the development and dissemination of consensus standards, guidelines, and best practices. NCCLS benefits the public and its industry, professional, and government constituencies by facilitating the development and availability of useful, accurate, medical services, providing professionals information to have the appropriate services performed correctly, and supporting the efforts of responsible bodies to assure the quality or products and practices. Among its activities, the Area Committee on Automation with its five subcommittees are responsible for the following standards and standards development:
During the revision process starting early 2000, the Area Committee on Automation began considering strategies to integrate all five standards at the approved stage. NCCLS recently accepted a number of clinical laboratory standards from ASTM, demonstrating a cooperation among standards developers aimed at keeping standards activities within scope of the developing organization. National Committee for Information Technology Standards The National Committee for Information Technology Standards (NCITS) was formerly designated ANSI Accredited Standards Committee X3. The NCITS prepares generic standards for use by application-specific groups. Working groups relevant to the healthcare industry include NCITS/B10 Identification Cards and Related Devices, and NCITS/H2 Databases. The identification cards group addresses physical, data, communications and security issues with standards that will impact on health identifiers and personal medical cards. The NCITS database group is home for the Structured Query Language standards. National Council for Prescription Drug Programs The National Council for Prescription Drug Programs (NCPCP) is one of the largest developers of ANSI accredited standards in the nation. The mission of the NCPDP is to create and promote data interchange standards for the pharmacy services sector of the healthcare industry, and to provide information and resources that educate the industry and support the diverse needs of our members. Membership is open to, and comprised of, individuals and organization representatives from all segments of the third-party prescription drug program industry, including drug manufacturers, drug distributors, insurance carriers, prescription benefit managers, independent pharmacies, chain pharmacies, federal and state government agencies, computer companies, telecommunication system vendors, consultants, and mail service companies. Many processors, carriers and State Pharmacy Boards are currently utilizing the NCPDP Pharmacy Numbering System. The NCPDP developed this system of 7 digit numbers assigned to every licensed pharmacy (and qualified ASEP sites) in the United States to uniquely identify the pharmacy to all third-party processors and carriers. The NCPDP currently maintains and updates this list, and makes it available for processing and reference purposes. NCPDP is also very active in federal and state legislation on issues such as pharmacy cards, unique identifiers, privacy and confidentiality, etc. National Electrical Manufacturing Association Since 1926, the National Electrical Manufacturing Association has been developing standards for the electrical manufacturing industry and is today one of the leading standards development organizations in the world. As such, it contributes to an orderly mark |
