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AN OVERVIEW OF HEALTHCARE INFORMATION STANDARDS

Jeffrey S. Blair, Program Manager, IBM Healthcare Solutions, Atlanta, Georgia

INTRODUCTION

The rising cost of health care throughout the world has created an urgency to improve healthcare productivity and quality. This sense of urgency has led to the development of new healthcare delivery models, broad organizational restructuring, and the redesign of healthcare business and clinical processes. Not only are these changes redefining the healthcare environment, they are also creating a demand for a new healthcare information infrastructure. The creation of this healthcare information infrastructure requires the integration of existing and new architectures, application systems, and services. Core elements of this infrastructure include patient-centered care facilitated by Computer-based Patient Record (CPR) systems, continuity of care enabled by the sharing of patient information across information networks, and outcomes measurement aided by the greater availability and specificity of healthcare information.

To make these diverse components work together, healthcare information standards (classifications, guides, practices, and terminology) are required. This article gives you an overview of the major existing and emerging healthcare information standards, as well as the efforts to coordinate, harmonize, and accelerate these standards activities. It is organized into the following topics:

identifier standards communications (message format) standards content and structure standards clinical data representations (codes) confidentiality, data security, and authentication quality indicators, data sets, and guidelines international standards standards coordination and promotion activities summary

IDENTIFIER STANDARDS

There is a universal need for healthcare identifiers to uniquely specify each patient, provider, site-of-care, and product; however, there is not universal acceptance and/or satisfaction with these systems.

Patient Identifiers:

The Social Security Number (SSN) is being considered for use as a patient identifier in the United States today. However, critics point out that it is not an ideal identifier. They say that not everyone has an SSN; several individuals may use the same SSN; and the SSN is so widely used for other 1 purposes that it presents an exposure to violations of confidentiality. On the other hand, it may be some time before funding is available to develop, disseminate, and maintain a more ideal patient identifier.

Two work efforts have emerged to address these issues. ASTM's (formerly known as the American Society for Testing and Materials) E31.12 Subcommittee developed the "Guide for the Properties of a Universal Health Care Identifier (UHID) E1714.95." It presents a set of requirements outlining the properties of a national system creating a UHID, includes critiques of the SSN, and creates a sample UHID. (ASTM, 1995) The Computer-based Patient Record Institute's (CPRI's) Codes and Structures Work Group has a Patient Identifier Project Team. This project team has also investigated these issues and is preparing a comprehensive position paper. (CPRI, 1995)

Provider Identifiers:

The Health Care Financing Administration (HCFA) has created a widely used provider identifier known as the Universal Physician Identifier Number (UPIN). (Terrell et al., 1991) The UPIN is only assigned to physicians who handle Medicare patients. To address this limitation, HCFA is developing the National Provider File (NPF). It will create a new provider identifier for Medicare, which will include all caregivers and sites-of-care. It will also be available for use by Medicaid programs and other government agencies if they decide to adopt it. This new provider identifier is targeted to be available April, 1996. However, there are no plans at this time to extend HCFA's new provider identifier to the private sector. (HCFA, 1995)

Site-of-Care Identifiers:

Two site-of-care identifier systems are widely used. One is the Health Industry Number (HIN), issued by the Health Industry Business Communications Council (HIBCC). The HIN is an identifier for healthcare facilities, practitioners, and retail pharmacies. HCFA has also defined provider of service identifers for Medicare usage. Both HCFA's provider of service identifer and the UPIN identifier will be replaced by HCFA's National Provider File for Medicare usage. (HIBCC, 1994)

Product and Supply Labeling Identifiers:

Three identifiers are widely accepted. The Labeler Identification Code (LIC) identifies the manufacturer or distributor and is issued by HIBCC. (HIBCC, 1994) The LIC is used both with and without bar codes for products and supplies distributed within a healthcare facility. The Universal Product Code (UPC) is maintained by the Uniform Code Council and is typically used to label products that are sold in retail settings. The National Drug Code (NDC) also serves as an identifier and is described later in the Clinical Data Representations section.

COMMUNICATIONS (MESSAGE FORMAT) STANDARDS

Although the standards in this topic area are still in various stages of development, they are generally more mature than those in most of the other topic areas. They are typically developed by committees within standards development organizations (SDOs) and have generally been accepted by users and vendors. The profiles of these standards below were derived from many sources, but considerable content came from the CPRI's "Position Paper on Computer-based Patient Record Standards" (CPRI, 1994), and the Agency for Health Care Policy and Research's (AHCPR's) "Current Activities of Selected Health Care Informatics Standards Organizations." (Moshman Associates, 1995)

o Accredited Standards Committee (ASC) X12N: This committee is developing message format standards for transactions between payors and providers. They are being accepted by both users and vendors. They define the message formats for the following transaction types. (DISA, 1995):

- 148 - Report of Injury, Illness, or Incident - 270 - Eligibility, Coverage, or Benefit Inquiry - 271 - Eligibility, Coverage, or Benefit Information - 276 - Healthcare Claim Status Request - 277 - Healthcare Claim Status Notification - 278 - Healthcare Service Review Information - 834 - Benefit Enrollment and Maintenance - 835 - Healthcare Claim Payment/Advice - 837 - Healthcare Claim (Submission)

ASC X12N has also developed the following interactive UN/EDIFACT message standards:

- X12.345 Interactive Healthcare Eligibility/Benefit Information Message (IHCEBR) - X12.346 Interactive Healthcare Eligibility/Benefit Inquiry Message (IHCEBI)

ASC X12N is also working on the following standards to be published in the near future:

- 274 - Healthcare Provider Information - 275 - Patient Information

The above transactions (274 and 275) will be used to request and send patient data (tests, procedures, surgeries, allergies, etc.) between a requesting party and the party maintaining the database. This patient data message format has the ability to encapsulate Health Level 7, ASTM, or American College of Radiology - National Electrical Manufacturers' Association (ACR-NEMA) clinical data. (McDonald, 1995)

The secretariat for ASC X12 and the Pan American EDIFACT Board is the Data Interchange Standards Association (DISA). ASC X12N is recognized as an Accredited Standards Committee (ASC) by the American National Standards Institute (ANSI).

o ASTM Message Format Standards: The following standards were developed within ASTM Committee E31. This committee is recognized as an accredited organization by ANSI.

- ASTM E1238 Standard Specification for Transferring Clinical Observations Between Independent Systems: E1238 was developed by

- ASTM Subcommittee E31.11. This standard is being used by most of the largest commercial laboratory vendors in the United States to transmit laboratory results. It has been incorporated into the Japanese Image Store and Carry (ISAC) standard. Health Level Seven (HL7) has incorporated E1238 as a subset within its laboratory results message format. (CPRI, 1994; McDonald, 1995)

- ASTM E1394 Standard Specification for Transferring Information Between Clinical Instruments: E1394 was developed by ASTM Subcommittee E31.14. This standard is being used for communication of information from laboratory instruments to computer systems. This standard has been developed by a consortium consisting of most U.S. manufacturers of clinical laboratory instruments. (CPRI, 1994)

- ASTM E1460 Specification for Defining and Sharing Modular Health Knowledge Bases (Arden Syntax): E1460 was developed by ASTM Subcommittee E31.15. The Arden Syntax provides a standard format and syntax for representing medical logic and for writing rules and guidelines that can be automatically executed by computer systems. Medical logic modules produced in one site-of-care system can be sent to a different system within another site-of-care and then customized to reflect local usage. (CPRI, 1994)

- ASTM E1467 Specification for Transferring Digital Neurophysical Data Between Independent Computer Systems: E1467 was developed by ASTM Subcommittee E31.16. This standard defines codes and structures needed to transmit electrophysiologic signals and results produced by electroencephalograms (EEG) and electromyograms. The standard is similar in structure to ASTM E1238 and HL7, and it is being adopted by all of the EEG systems manufacturers. (CPRI, 1994)

o Digital Imaging and Communications (DICOM): This standard is developed by the American College of Radiology - National Electrical Manufacturers' Association (ACR-NEMA). It defines the message formats and communications standards for diagnostic and therapeutic images. DICOM is supported by most radiology Picture Archiving and Communications Systems (PACS) vendors. It has also been incorporated into the European MEDICOM (Medical Image Communication) standard and the Japanese "second common" standard for medical communications over networks. DICOM medical content is supported by the Japanese Image Store and Carry (ISAC) optical disk system and is being planned for incorporation by Kodak's PhotoCD. ACR-NEMA is considering applying for recognition as an accredited standards committee by ANSI. (CPRI, 1994)

o Health Level Seven (HL7): HL7 defines transactions for transmitting data about patient registration, admission, discharge and transfers, insurance, charges and payors, orders and results for laboratory tests, image studies, nursing and physician observations, diet orders, pharmacy orders, supply orders, and master files. The HL7 standard is supported by most system vendors and used in most large U.S. hospitals today. It also is used in Australia, Austria, Canada, Germany, Israel, Japan, New Zealand, The Netherlands, and the United Kingdom.

HL7 is also developing transactions to exchange information about appointment scheduling, problem lists, clinical trial enrollments, patient permissions, voice dictation, advanced directives, and physiological signals. Furthermore, task forces in HL7 are developing prototype transactions with new object oriented technologies such as CORBA and Microsoft's OLE objects. HL7 is recognized as an accredited organization by ANSI. (CPRI, 1994; McDougall, 1995)

o Institute of Electrical and Electronic Engineers, Inc. (IEEE) P1157 Medical Data Interchange Standard (MEDIX): IEEE Engineering in Medicine and Biology Society (EMB) is developing the MEDIX standards for the exchange of data between hospital computer systems. (Harrington, 1993; CPRI, 1994) Based on the International Standards Organization (ISO) standards for all seven layers of the OSI reference model, MEDIX is working on a framework model to guide the development and evolution of a compatible set of standards. This activity has been carried forward as a joint working group under ANSI HISPP's Message Standards Developers Subcommittee (MSDS), described later in this article. IEEE is recognized as an accredited organization by ANSI.

o IEEE P1073 Medical Information Bus (MIB): This standard defines the linkages of medical instrumentation (e.g., critical care instruments) to point-of-care information systems. (CPRI, 1994)

o National Council for Prescription Drug Programs (NCPDP): This council has developed standards for communication of billing and eligibility information between community pharmacies and third party payors. They have been in use since 1985 and now serve almost 90 percent of the nation's community pharmacies. They are working on standards for adverse drug reactions and utilization review. NCPDP has applied for recognition as an accredited organization by ANSI. (CPRI, 1994; McDonald, 1995)

CONTENT AND STRUCTURE STANDARDS

Guidelines and standards for the content and structure of computer-based patient record systems are being developed within ASTM Subcommittees E31.12 and E31.19. They have been acknowledged by other standards organizations, and they are now beginning to gain some user acceptance.

A major revision to E1384, now called a "Standard Description for Content and Structure of the Computer-based Patient Record," has been made within Subcommittee E31.19. (ASTM, 1994) This revision includes work from HISPP on data modeling and an expanded framework that includes master tables and data views by user. It has been selected as the foundation CPR content requirement in the I/S plans for Group Health Cooperative of Puget Sound, as well as a component in the CPR plans of the Veterans' Administration (VA). (Goverman, 1994)

Companion standards to E1384 have been developed within Subcommittee E31.19. They are:

o E1633, "A Standard Specification for the Coded Values Used in the Automated Primary Record of Care"

o E1239-94, "A Standard Guide for Description of Reservation/Registration-A/D/T Systems for Automated Patient Care Information Systems" (ASTM, 1994)

o E1715-95, "Practice For An Object-Oriented Model for Registration, Admitting, Discharge, and Transfer (RADT) Functions in Computer-based Patient Record Systems."

Within the E31.12 Subcommittee, domain-specific guidelines for emergency room data within the CPR (E1744) are available and domain-specific guidelines for nursing and anesthesiology within the CPR are being developed. (Moshman Associates, 1995; Waegemann, 1995)

The newly formed E31.22 Subcommittee on Health Information Transcription and Documentation is developing standards for the processes, systems, and management of medical transcription and its integration with other modalities of report generation.

A Computer-based Oral Health Record (COHR) Concept Model has been developed by the COHR Working Group of the Council on Dental Practice (CDP) of the American Dental Association (ADA). The ADA has released this document for comment. (ADA, 1995)

CLINICAL DATA REPRESENTATIONS (CODES)

Clinical data representations have been widely used to document diagnoses and procedures. There are over 150 known code systems. The codes with the widest acceptance in the United States include:

o International Classification of Diseases (ICD) codes, now in the ninth edition (ICD-9): These codes are maintained by the World Health Organization (WHO) and are accepted worldwide. In the United States, HCFA and the National Center for Health Statistics (NCHS) have supported the development of a clinical modification of the ICD codes (ICD-9-CM). WHO has been developing ICD-10 and HCFA has formed a voluntary technical panel to assist with the development of the ICD-10 Procedure Coding System (ICD-10-PCS). However, HCFA projects that ICD-10 will not be available for use within the United States for a few years. Payors require the use of ICD-9-CM codes for reimbursement purposes, but they have limited value for clinical and research purposes due to their lack of clinical specificity. (Chute, 1995)

o Current Procedural Terminology (CPT) codes: These codes are maintained by the American Medical Association (AMA) and are widely used in the United States for reimbursement and utilization review purposes. The codes are derived from medical specialty nomenclatures and are updated annually. (Chute, 1995)

o The Systematized Nomenclature of Human and Veterinary Medicine (SNOMED) International: This code structure is maintained by the College of American Pathologists (CAP) and is widely accepted for describing pathological test results. It has a multi-axial (eleven fields) coding structure that gives it greater clinical specificity than the ICD and CPT codes, and it has considerable value for clinical purposes. The CAP has begun to coordinate SNOMED development with the message standards organizations HL7 and ACR-NEMA. SNOMED is a leading candidate to become the standardized nomenclature for computer-based patient record systems. (Chute, 1995)

o Laboratory Observation Identifier Names and Codes (LOINC): These codes were developed by an ad hoc group of clinical pathologists, chemists, and laboratory service vendors with support from the Hartford Foundation, the NLM, and the AHCPR. The goal of this project is to create universal test codes to be used in the context of existing ASTM E1238 and HL7 Version 2.2 laboratory results and observation messages. The LOINC database contains records representing more than 6300 laboratory observations including chemistry, toxicology, serology, microbiology, and some clinical variables. It is being incorporated into the Unified Medical Language System (UMLS) and is being adopted by at least two medical information system vendors. It is now available for downloading and free public use on the Internet. (McDonald, 1995)

o Diagnostic and Statistical Manual of Mental Disorders (DSM), now in its fourth edition (DSM-IV): This code structure is maintained by the American Psychiatric Association (APA). It sets forth a standard set of codes and descriptions for use in diagnoses, prescriptions, research, education, and administration. (Chute, 1995)

o Diagnostic Related Groups (DRGs): These codes are maintained by HCFA. They are derivatives of ICD-9-CM codes and are used to facilitate reimbursement and case-mix analysis. They lack the clinical specificity to be of value in direct patient care or clinical research. (Chute, 1995)

o The National Drug Code (NDC): This code is maintained by the Food and Drug Administration (FDA) and is required for reimbursement by Medicare, Medicaid, and insurance companies. It is sometimes included within the UPC format.

o Gabrieli Medical Nomenclature (GMN): This nomenclature was developed and is maintained by Computer-based Medicine, Inc. It is designed to represent every medical word or phrase in a canonical or vernacular form that may occur in clinical records. It is a computer-based nomenclature that self-updates with new words. The nomenclature partitions the entire field of medicine into six main branches or axes. It includes 189,000 primary terms and 300,000 synonyms. The Australian Medical Society is testing the GMN. (Gabrieli, 1995)

o Unified Medical Language System (UMLS): This system is maintained by the National Library of Medicine (NLM). It contains a metathesaurus that links biomedical terminology, semantics, and formats of the major clinical coding and reference systems. It links medical terms (e.g., ICD, CPT, SNOMED, DSM, CO-STAR, and D-XPLAIN) to the NLM's medical index subject headings (MeSH codes) and to each other. The UMLS also contains a specialist lexicon, a semantic network, and an information sources map. Together, these elements should eventually represent all of the codes, vocabularies, terms, and concepts that will become the foundation for an emerging medical informatics infrastructure. The 1995 UMLS metathesaurus contains 223,000 concepts and 442,000 terms. (Cimino et al., 1993; EHRR, 1995)

The Large Scale Testing of Health Vocabularies is a project co-sponsored by the NLM and the AHCPR. It will determine the completeness of the metathesaurus of the UMLS and of the vocabularies that soon will be added to it. At least eight medical institutions are contributing domain-specific medical vocabularies for this project. The test, which is targeted to begin in November of 1995, will probably involve many of these same medical institutions plus several federal and state healthcare departments/agencies. The importance of this test is its potential to define both the framework and much of the content of a common medical vocabulary which would be available for use by developers and vendors of computer-based patient record systems. (CPRI, 1995; EHRR, 1995)

An evaluation of clinical code systems has been made by participants of the Codes and Structures Work Group of the CPRI. This work effort was supported in part by NIH grants. It evaluated eight major clinical classifications for their content coverage. This research was based on clinical text from four major medical centers. Although no classification system captured all concepts, SNOMED International demonstrated the highest score in every category. This paper has been reviewed by the CPRI Board of Directors and has been submitted for publication. (CPRI, 1995)

CONFIDENTIALITY, DATA SECURITY, AND AUTHENTICATION

The development of computer-based patient record systems and healthcare information networks have created the need for more definitive confidentiality, data security, and authentication guidelines and standards. The following activities address this need:

o The Fair Health Information Practices Act (HR 435), sponsored by Rep. Gary Condit (D-CA), was re-introduced in the House of Representatives in January, 1995. A companion bill, The Healthcare Privacy Protection Act, sponsored by Sen. Robert Bennett (R-UT), is being drafted for introduction in the Senate. These bills address the need for uniform, comprehensive, federal rules governing the use and disclosure of identifiable health information of individuals. They specify the responsibilities of those who collect, use, and maintain health information about patients. They also define the rights of patients and provide a variety of mechanisms that will allow patients to enforce their rights. (Frawley, 1995)

o ASTM Subcommittee E31.12 on Computer-based Patient Records is developing "Guidelines for Minimal Data Security Measures for the Protection of Computer-based Patient Records." (Moshman Associates, 1995)

o ASTM Subcommittee E31.17 on Access, Privacy, and Confidentiality of Medical Records is working on standards to address these issues. They are expected to be approved by ASTM before the end of 1995. (Moshman Associates, 1995)

o ASTM Subcommittee E31.20 is developing standard specifications for electronic authentication of health information. They are expected to be approved by ASTM before the end of 1995. (Moshman Associates, 1995)

o The Committee on Regional Health Data Networks convened by the Institute of Medicine (IOM) has completed a definitive study and published its findings in a book titled, "Health Data in the Information Age: Use, Disclosure, and Privacy." (Donaldson & Lohr, 1994)

o The Computer-based Patient Record Institute's (CPRI) Work Group on Confidentiality, Privacy, and Security has completed a white paper that addresses access to patient data and another that addresses authentication. (CPRI, 1995) They are also developing a series of guidelines on information security and, as of this date, have published, "Guidelines for Establishing Information Security: Policies at Organizations Using Computer-based Patient Records" (CPRI, 1994), and "Guidelines for Information Security Education Programs at Organizations Using Computer-based Patient Record Systems," (CPRI, 1995).

o The American Association for Medical Transcription (AAMT) is preparing guidelines on confidentiality, privacy, and security of patient care documentation through the process of medical dictation and transcription. (Tessier, 1995)

QUALITY INDICATORS, DATA SETS, AND GUIDELINES

Although there is not an accredited standard to measure healthcare quality, there are several quality indicators, data sets, and guidelines which have been developed and are gaining acceptance. They include:

o The Joint Commission on Accreditation of Health Care Organizations (JCAHO) has been developing and testing the Indicator Measurement System (IMSystem). The IMSystem includes 25 indicators addressing obstetrics, perioperative, oncology, trauma, and cardiovascular care. These indicators are intended to facilitate measurements of provider performance. Several vendors are planning to include JCAHO clinical indicators in their performance measurement systems. (JCAHO, 1994; JCAHO, 1995)

o The Health Plan Employer Data and Information Set (HEDIS) version 2.0 and 2.5 has been developed with the support of the National Committee for Quality Assurance (NCQA). It identifies data to support performance measurement in the areas of quality (e.g., preventive medicine, prenatal care, acute and chronic disease, and mental health), access and patient satisfaction, membership and utilization, and finance. The development of HEDIS has been supported by several large employers and managed care organizations. (NCQA, 1993; NCQA, 1995)

o There are many organizations that have developed practice guidelines/parameters during the last several years. These guidelines have been developed by national, regional, and local organizations, such as professional associations, government agencies, providers, consulting firms, and vendors. The AMA publishes the Directory of Practice Parameters, which includes about 1600 listings (including 100 developed by the AMA). (Business and Health, 1994)

o Within the federal government, the AHCPR has developed 16 practice guidelines written by interdisciplinary panels of practitioners. The AHCPR is within the Public Health Service, which is part of the Department of Health and Human Services.

o Additionally, there are some private organizations which have developed and marketed practice guidelines (Business and Health, 1994). The organizations include:

- Health Risk Management's Institute for Healthcare Quality: It has developed over 480 diagnosis-based guidelines for more than 2000 treatment options for its self-insured clients nationwide.

- Value Health Sciences: It has developed the Medical Review System, which uses practice guidelines to evaluate the appropriateness of a proposed procedure. The Medical Review system is being used to pre-certify 34 major medical and surgical procedures for more than 10 million individuals in the United States.

- Milliman & Robertson, Inc.: It has developed healthcare management guidelines for inpatient and surgical care, return to work planning, ambulatory care, and home health care.

INTERNATIONAL STANDARDS

o The International Organization for Standardization (ISO) is a worldwide federation of national standards organizations. It has 90 member countries. The purpose of ISO is to promote the development of standardization and related activities in the world. ANSI was one of the founding members of ISO and is the representative for the United States. (Waegemann, 1995)

ISO has established a communications model for Open Systems Interconnection (OSI). IEEE/MEDIX and HL7 have recognized and built upon the ISO/OSI framework. Further, ANSI HISPP has stated as one of its objectives the encouragement of U.S. healthcare standards compatibility with ISO/OSI. The ISO activities related to information technology take place within the Joint Technical Committee (JTC) 1.

A proposal to form an ISO Technical Committee (TC) on Healthcare Informatics, with ANSI as the Secretariat, was presented to ANSI HISPP in August 1995. The ISO TC's scope includes: healthcare models; healthcare records and care functions; privacy, confidentiality, and security; content and structure; concept representations; communications; and application functions. ANSI HISPP declared its intent to support this initiative and plans to review and vote on the actual proposal document by November 1995.

o The Comite Europeen de Normalisation (CEN) is a European standards organization with 16 TCs. Two TCs are specifically involved in health care: TC 251 (Medical Informatics) and TC 224 WG12 (Patient Data Cards). (Waegemann, 1995)

The CEN TC 251 on Medical Informatics includes work groups on: Modeling of Medical Records; Terminology, Coding, Semantics, and Knowledge Bases; Communications and Messages; Imaging and Multimedia; Medical Devices; and Security, Privacy, Quality, and Safety. The CEN TC 251 has established coordination with healthcare standards development in the United States through ANSI HISPP.

o United Nations (UN) Electronic Data Interchange For Administration, Commerce, and Transport (EDIFACT) is a generic messaging-based communications standard with health-specific subsets. UN/EDIFACT is often parallel to X12 and HL7 in terms of message content, although X12 and HL7 have a different syntax (transaction-based). Recently, X12.345 and X12.346 were developed and are recognized as UN/EDIFACT message format standards. They support interactive healthcare eligibility/information and inquiry. UN/EDIFACT is widely used in Europe and in several Latin American countries. As indicated earlier, the Data Interchange Standards Association, Inc. (DISA) is the Secretariat and administrative arm for the Pan American EDIFACT Board (PAEB) and for ASC X12. (DISA, 1995; UNECE, 1994)

o The READ Classification System (RCS) is a multi-axial medical nomenclature used in the United Kingdom. It is sponsored by the National Health Service and has been integrated into computer-based ambulatory patient record systems in the United Kingdom. (CAMS, 1994)

o A Japanese consortium that includes Sony, Toshiba, and Canon has implemented a video disk-based patient record system called Image Store and Carry (ISAC). This standard provides structures for storing patients' demographic data, all kinds of medical images, electrocardiograms, laboratory data, and clinical information. (McDonald, 1995) ISAC includes both the ASTM E1238 and DICOM standards.

o The Japanese Association of Healthcare Information Systems Industry (JAHIS) was established in April 1994 for the purpose of: contributing to the development of the healthcare information systems industry; the improvement in the health, medical treatment, and welfare of the nation; technological improvement; the ensuring of quality and safety; and the promotion of the standardization of healthcare information systems. It also plans to promote international cooperation in the fields of health, medical treatment, and welfare. (CPRI, 1995)

STANDARDS COORDINATION AND PROMOTION ACTIVITIES

In the United States, there are several organizations and/or initiatives to help coordinate, promote, or accelerate the development of healthcare information standards. For the last several years, the primary organization working to coordinate healthcare information standards was the ANSI Healthcare Informatics Standards Planning Panel (HISPP). A transition plan has been developed to evolve ANSI HISPP into the ANSI Healthcare Informatics Standards Board (HISB), which would give it greater authority to achieve its missions.

o The major missions of ANSI HISSP have been:

1. to facilitate the coordination of SDOs for healthcare data interchange (e.g., ACR/NEMA, ASTM, HL7, IEEE/MEDIX, X12) and other relevant standards groups (e.g., X3, ASC MD156) toward achieving the evolution of a unified set of non-redundant, non-conflicting standards. This activity has occurred within the ANSI HISPP Message Standards Developers Subcommittee (MSDS).

2. to interact with and provide input to CEN TC 251 (Medical Informatics) in a coordinated fashion and explore avenues of international standards development.

o While some have been frustrated with the rate of progress of the ANSI HISPP MSDS, many of the SDO collaborations fostered by this subcommittee are likely to continue on their own. These include:

- NCPDP continues to meet with HL7 and X12 to ensure compatibility with the drug prescription messages of HL7 and the billing messages of X12. (McDonald, 1995)

- ACR-NEMA has prepared a draft proposal to create a joint working relationship with HL7 to develop message formats for the Information System - Imaging System interface. (Bidgood, 1995; ACR-NEMA, 1995)

- The Joint Working Group to Create a Common Data Model, formed by IEEE/MEDIX and MSDS, continues as an open standards effort to support the development of a common data model that can be shared by developers of healthcare informatics standards. (IEEE, 1994)

- HL7's working groups continue to work with other SDOs: The HL7 Automated Data and Waveforms Working Group is coordinating with ASTM E31.16, IEEE P1073 MIB, and LOINC; the Control/Query Working Group is coordinating with CEN and the CDC; the Inter-Enterprise Working Group is coordinating with ASC X12N; and, the Order Entry/Ancillary Working Group is coordinating with the CDC. (Health Level Seven, 1995)

- Several Joint Standards Developers' Meetings on Healthcare Information Process Modeling have recently been held. These meetings have included representatives from ASTM, ACR-NEMA, ASC X12N, ADA, IEEE\MEDIX and MIB, HL7 and NCPDP. It plans to define healthcare scenarios, the roles of significant individuals involved in these scenarios, the resulting healthcare information system processes, as well as include specific examples of these processes.

- The Computer-based Patient Record Institute (CPRI) is not an SDO, but its mission includes the promotion of standards related to computer-based patient record systems. Activities within several CPRI working groups reflect this mission of standards promotion:

o The CPR Description Work Group has work efforts to promote common definitions and concepts for the computer-based patient record system; o The Codes and Structures Work Group has a work effort to evaluate clinical code systems which was described in the Clinical Data Representations (Codes) section earlier;

o The Confidentiality, Privacy, and Security Work Group has created several white papers and guidelines which were mentioned in the Confidentiality, Data Security, and Authentication section earlier. (CPRI, 1995)

CPRI is partnering with the Center for Healthcare Information Management (CHIM) on the Health Information Interchange Standards Implementation Project (HIISIP). CHIM is an association of healthcare software vendors. The HIISIP project would help identify standard vocabularies which could be used in vendor-developed CPR products. It also plans to demonstrate the use of these standard healthcare vocabularies among vendor systems by 1997. (CHIM/CPRI HIISIP, 1995)

The Workgroup on Electronic Data Interchange (WEDI) was a voluntary, public/private task force formed in 1991 as a result of the call for healthcare administrative simplification by the director of the Department of Health and Human Services. WEDI incorporated as a formal organization in 1995. They have developed an action plan to promote healthcare EDI which includes promotion of EDI standards, architectures, confidentiality, identifiers, health cards, legislation, and publicity. (CPRI, 1995)

SUMMARY

This article has presented an overview of major existing and emerging healthcare information standards. It describes the efforts to coordinate, harmonize, and accelerate these standards activities.

Healthcare informatics is a dynamic area characterized by changing business and clinical processes, functions, and technologies. The effort to create healthcare informatics standards is therefore also dynamic. For the most current information on standards, refer to the "For More Information" section at the end of this article.

AKNOWLEDGEMENTS

This article is a significant update of the subject matter included in "Overview of Standards Related to the Emerging Health Care Information Infrastructure" published by CRC Press as a chapter in The Biomedical Engineering Handbook in May 1995.

While many contributed information to this article, the following individuals deserve special acknowledgement:

o Margret Amatayakul, M.B.A. o W. Dean Bidgood, Jr., M.D. o Christopher G. Chute, M.D., Ph.D. o Paul Clayton, Ph.D. o Kathleen Frawley, J.D., R.R.A. o W. Edward Hammond, Ph.D. o Terri L. Luthy o Clement J. McDonald, M.D.

o Claudia Tessier o C. Peter Waegemann

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o ASTM, 1994. "Standard Guide for Description of Reservation/ Registration-Admission, Discharge, Transfer (R-ADT) Systems for Automated Patient Care Information Systems, E1239-94," ASTM Subcommittee E31.19, Philadelphia, PA.

o ASTM 1995. "A Standard Specification for the Coded Values Used in the Automated Primary Record of Care, E1633-95," ASTM Subcommittee E31.19, Philadelphia, PA.

o Bidgood, W.D., 1995. Personal communication, August 95.

o Business and Health, 1994. "Special Report on Guidelines," Montvale, NJ.

o Cannavo, M.J., 1993. "The Last Word Regarding DEFF & DICOM," Healthcare Informatics, October 93: 32-34.

o CHIM/CPRI Health Information Interchange Standards Implementation Project, 1995. "Minutes of Meeting, May 16, 1995," Atlanta, GA.

o Chute, C.G., November, 1991. "Tutorial 19: Clinical Data Representations," Symposium on Computer Applications in Medical Care, Washington, D.C.

o Chute, C.G., 1995. Personal communication, August 95.

o Cimino, J.J., Johnson, S.B., Peng, P., Aguirre, A., 1993. "From ICD9-CM to MeSH Using the UMLS: A How-to-Guide," SCAMC, Washington, D.C.

o Computer Aided Medical Systems Limited, 1994. "CAMS News," Vol. 4/1, January, 94, Leicestershire, U.K.

o Computer-based Patient Record Institute, 1994. "CPRI-Mail," Vol. 3/1, February 94, Chicago, IL.

o Computer-based Patient Record Institute, 1994. "Position Paper on Computer-based Patient Record Standards," Chicago, Il.

o Computer-based Patient Record Institute, 1995. "CPRI-Mail," Vol. 4/ 2, April 95, Chicago, IL.

o Computer-based Patient Record Institute, 1995. "Codes and Structures Patient Identifier Work Group Working Paper, June 1995" Version 2.1, Chicago, Il.

o Computer-based Patient Record Institute, 1995. "CPRI Major Codes Evaluation, Phase II," CPRI Codes and Structures Work Group, July 95, Chicago, Il.

o Data Interchange Standards Association, 1995. "ASC X12 Status Report, June 1995," Alexandria, VA.

o Donaldson, M.S. & Lohr, K.N. (Eds.), 1994. "Health Data in the Information Age: Use, Disclosure, and Privacy," Institute of Medicine, National Academy Press, Washington, D.C.

o Electronic Health Records Report, 1995. "Move Aside, Roget, Make Room for Metathesaurus. But Is It Ready For Records Prime Time?" August 1, 1995.

o Evans, D.A., Cimino, J.J., Hersh, W.R., Huff, S.M., Bell, D.S. 1994. "Toward a Medical-concept Representation Language," Journal of the American Medical Informatics Association, 1(3):207-217.

o Frawley, K., 1995. Personal communication, August 95.

o Gabrieli, E.R., 1995. Personal communication, August 95.

o Goverman, I.L., 1994. "Orienting Health Care Information Systems Toward Quality: How Group Health Cooperative of Puget Sound Did It," Journal on Quality Improvement, 20(11):595.

o Hammond, W.E., 1993. "Overview of Health Care Standards and Understanding What They All Accomplish," HIMSS Proceedings, American Hospital Association, Chicago, Il.

o Hammond, W.E., McDonald, C., Beeler, G., Carlson, D., Barrett, L., Bidgood, D., McDougall, M. 1994. "Computer Standards: Their Future Within Health Care Reform," HIMSS Proceedings, Health Care Information and Management Systems Society, Chicago, Il.

o Harrington, J.J. 1993. "IEEE P1157 MEDIX: A Standard for Open Systems Medical Data Interchange," Institute of Electrical and Electronic Engineers, New York City, NY.

o Health Care Financing Administration, 1995. "National Provider Identifier/National Provider File," Baltimore, MD.

o Health Industry Business Communications Council, 1994. "Description of Present Program of Standards Activity," Phoenix, AZ.

o Health Level Seven, 1995. "HL7 News," Summer 1995, Ann Arbor, MI.

o Humphreys, B., November, 1991. "Tutorial 20: Using and Assessing the UMLS Knowledge Sources," Symposium on Computer Applications in Medical Care, Washington, D.C.

o Institute of Electrical and Electronics Engineers, 1994. "Trial-Use Standard for Health Care Data Interchange - Information Model Methods: Data Model Framework," IEEE Standards Department, New York, NY.

o Joint Commission on Accreditation of Healthcare Organizations, 1994. "The Joint Commission Journal on Quality Improvement," Oakbrook Terrace, IL.

o Joint Commission on Accreditation of Healthcare Organizations, 1995. "The 1995 Guide to Hospital Accreditation Resources," Oakbrook Terrace, IL.

o McDonald, C., 1995. "Laboratory Observation Identifier Names and Codes (LOINC) Users Guide vs. 1.0," Regenstrief Institute, Indianapolis, IN.

o McDonald, C., 1995. "News on U.S. Health Informatics Standards," M.D. Computing, New York, NY.

o McDougall, M., 1995. "Standard Gains Healthcare Industry Acceptance & Support," Healthcare Informatics, July 1995.

o Medical Records Institute, 1995. "International Directory of Organizations, Standards, and Developments in the Creation of Electronic Health Records, Second Edition," August, 1995, Newton, MA.

o Moshman Associates, Inc., 1995. "Current Activities of Selected Health Care Informatics Standards Organizations," Office of Science and Data Development, Agency for Health Care Policy and Research, Bethesda, MD.

o National Committee for Quality Assurance, 1993. "Hedis 2.0: Executive Summary," Washington, D.C.

o National Committee for Quality Asurance, 1995. "HEDIS 2.5: Updated Specifications for HEDIS 2.0," Washington, D.C.

o Rothwell, D.J., Cote, R.A., Cordeau, J.P., Boisvert, M.A., 1993. "Developing a Standard Data Structure for Medical Language - The SNOMED Proposal," SCAMC, Washington, D.C.

o Terrell, S.A., Dutton, B.L., Porter, L., Cowles, C.M., American Health Care Association, 1991. "In Search of the Denominator: Medicare Physicians - How many are there?" Health Care Financing Administration, Baltimore, MD.

o Tessier, C., 1995. Personal communication, August 95.

o United Nations Economic Commission for Europe, 1994. "UN/EDIFACT: A Short Introduction," Geneva, Switzerland.

o Waegemann, C.P., 1995. Personal communication, August 95.

o Workgroup for Electronic Data Interchange, 1993. "WEDI Report: October 1993," Convened by the Department of Health and Human Services, Washington, D.C.

FOR FURTHER INFORMATION

o For copies of AAMT's guidelines on confidentiality, privacy, and security of patient care documentation through the process of medical dictation and transcription, contact the American Association for Medical Transcription, P.O. Box 576187, Modesto, CA 95357-6187, (209) 551-0883.

o For copies of standards accredited by ANSI, contact the American National Standards Institute, 11 West 42nd St., NYC, NC 10036, (212) 642-4900. For information on ANSI Health Care Informatics Standards Planning Panel (HISPP), contact Steven Cornish, (212) 642-4900.

o For copies of individual ASTM standards, contact ASTM Customer Service, 1916 Race Street, Philadelphia, PA 19103-1187, (215) 299-5585, fax: (215) 977-9679, email: service@local.astm.org.

o For more information on CEN TC 251, contact Georges De Moor, at Comite Europeen de Normalisation (CEN), Central Secretariat, Rue de Stassart 36, B-1050, Brussels, Belgium, telephone: 011-32-9-240-3436.

o For more information on CPRI publications and services, contact the Computer-based Patient Record Institute, Margret Amatayakul, 1000 E. Woodfield Road, Suite 102, Schaumburg, IL 60173, (847) 706-6746.

o For more information on electronic data interchange standards by ASC X12 and EDIFACT, contact the Data Interchange Standards Association (DISA), 1800 Diagonal Road, Suite 200, Alexandria, VA 22314, (703) 548-7005 ext. 155, fax: (703) 548-5738.

o For information on the Gabrieli Medical Nomenclature, contact Computer Based Medicine, Inc., 4 Cambridge Center, Cambridge MA, 02042, (617) 494-0909, fax: (617) 621-6982.

o For information on provider identifier standards and proposals, contact the Health Care Financing Administration (HCFA), Bureau Program Operations, 6325 Security Blvd., Baltimore, MD 21207, (410) 966-5798.

For information on ICD-9-CM codes, contact HCFA, Medical Coding, 401 East Highrise Bldg., 6325 Security Blvd., Baltimore, MD 21207, (410) 966-5318.

o For information on site-of-care and supplier labeling identifiers, contact the Health Industry Business Communications Council (HIBCC), 5110 N. 40th Street, Suite 250, Phoenix, AZ 85018, (602) 381-1091.

o For copies of standards developed by Health Level 7, contact HL7, 3300 Washtenaw Avenue, Suite 227, Ann Arbor, MI 48104, (313) 677-7777. For draft proposals, meeting minutes, and proceedings, contact HL7 electronically, e-mail: dumccss.mc.duke.edu.

o For copies of standards developed by the Institute of Electrical and Electronic Engineers/Engineering in Medicine and Biology Society, in New York City, call (212) 705-7900. For information on IEEE/MEDIX meetings, contact Jack Harrington, Hewlett-Packard, 3000 Minuteman Rd., Andover, MA 01810, (508) 681-3517.

o For more information on the Japanese Association of Healthcare Information Systems Industry (JAHIS), please contact JAHIS, Toranomon TBL Building, 1-19-9, Toranomon, Minto-Ku, Tokyo 105. Phone: 011-81-3-3506-8010, fax: 011-81-3-3506-8070.

o For more information on clinical indicators, contact the Joint Commission on Accreditation of Health Care Organizations (JCAHO), Department of Indicator Measurement, One Renaissance Blvd., Oakbrook Terrace, IL 60181, (708) 916-5600.

o For more information on ISAC, contact the ISAC Committee, 2-3-4-10F Akasaka, Minato Ku, Tokyo 107, Japan, fax: 011-81-3-3505-1996.

o For more information on LOINC, contact Kathy Hutchins at the Regenstrief Institute, 1001 W. 10th Street, RG-5, Indianapolis, IN 46202, (317)630-7400, fax: (317)630-6962, and Internet address: loinc@regenstrief.iupui.edu.

o For information on pharmaceutical billing transactions, contact the National Council for Prescription Drug Programs (NCPDP), 2401 N. 24th Street, Suite 365, Phoenix, AZ 85016, (602) 957-9105.

o For information on HEDIS, contact the National Committee for Quality Assurance (NCQA), Planning and Development, 1350 New York Avenue, Suite 700, Washington, D.C. 20005, (202) 628-5788.

o For copies of ACR/NEMA DICOM standards, contact David Snavely, National Electrical Manufacturers Association (NEMA), 2101 L. Street N.W., Suite 300, Washington, D.C. 20037, (202) 457-8400.

o For information on standards development in the areas of computer-based patient record concept models, confidentiality, data security, authentication, and patient cards, and for information on standards activities in Europe, contact Peter Waegemann, Medical Records Institute (MRI), 567 Walnut Street, P.O. Box 289, Newton, MA 02160. (617) 964-3923.

o For information on the UMLS and the Large Scale Testing of Health Vocabularies project, contact the National Library of Medicine, Betsy Humphries, 8600 Rockville Pike, Bethesda, MD 20894 Bldg, 38, Room 2W06,(301) 496-6921, fax: (301) 496-6923.

AUTHOR BIOGRAPHY

Jeffrey Blair is a program manager with IBM Healthcare Solutions. For the last 15 years, he has focused on patient care systems, clinical information systems, and computer-based patient record systems.

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