STANDARDS DEVELOPMENT ORGANIZATIONS

Dr. O.P.Sharma, MS, FIAMS
Director Ind Medica Ltd.
SCO 827, Sector 22-A, Chandigarh - 160022, India
Phone: 91-172-387358, 702045; Fax: 91-172-706202
Mobile: 098140-51444
Email: opsharma@indmedica.com ; URL: www.indmedica.com www.nationaltelemedicine.net      

The Proliferation of digital information technologies and their application in addressing the rapid growth of health care costs has brought the issue of standardizing medical information to the forefront of a national agenda. In 1996, President Clinton signed into law the Health Insurance Portability and Accountability Act (HIPAA). A section of this new law (commonly referred to as administration simplification) is intended to reduce the costs and administrative burdens of health care by making possible the standardized, electronic transmission of certain administrative and financial transactions that are currently carried out manually on paper. To accomplish this goal, the law required the Secretary of Health and Human Services (HHS) to adopt national uniform standards for these transactions. Although the law does not specifically require the collection or electronic transmission of any health information, it does require that the standards be followed anytime the transactions are conducted electronically. To implement these provisions, HHS has established a process that incorporates internal federal working groups, liaison with external groups of experts, and a federal advisory committee. The process provides opportunity for public and industry input and feedback to ensure acceptance by the entire health care community. As the technologies allowing the electronic exchange of this information steadily infiltrate our clinical environments, standardization issues are becoming more relevant to the individual practitioner.

Which organizations are developing health-related standards? A listing of several of the major SDOs with their specific areas of standardization interest, follows:

American standards and Testing Materials (ASTM) Committee on Health Informatics E-31 creates standards for exchanging messages about clinical observations, medical logic electrophysiologic signals, health care identifiers, and system functionality. It has technical subcommittees developing standards for computer-based patient records (CPRs), clinical laboratory systems, laboratory instrument interfaces, health knowledge representation, electro-physiology waveforms and signals, security, privacy and confidentiality, vocabulary structure for CPRs, and medical transcription. 

Accredited Standards Committee (ASC) X12 creates standards for exchanging insurance, eligibility, and managed care information. The principal responsibilities of the X12N Insurance Subcommittee and development and maintenance of these guidelines as they relate to all aspects of insurance and insurance-related business processes, such as but not limited to government health care programs like Medicare and Medicaid, administrative services-only products, risk management services, and others. In 1979, ANSI Chartered ASC X12 to develop uniform standards for interindustry electronic interchange of business transactions - electronic data interchange (EDI). 

Digital Imaging and Communications in Medicine (DICOM) for the exchange of digital biomedical images. Originally designed to address point-to-point (non-networked environment) exchange of digital images in radiology, the DICOM Standard has expanded to include networked environments across medical specialties and many different imaging modalities. DICOM current standard has been expanded to all types of biomedical imaging- ultrasound, visible light imaging (photography, endoscopy, microscopy) and other traditional radiology imaging modalities (MR, CT, digital radiography, nuclear medicine, and radiotherapy). Recent work within DICOM is expanding the standard to incorporate structured reporting for these imaging studies. 

Health Level 7 (HL 7) develops standards for exchanging data among clinical systems. It was founded in 1987 to develop standards for the electronic interchange of clinical, financial, and administrative information among independent health care computer systems such as hospital information systems, clinical laboratory systems. HL 7 is supported by a variety of system vendors and is used in many US hospitals and institutions in Australia, Austria, Germany, Holland, Israel, Japan, New Zealand, and the United Kingdom. HL 7 released its fourth version of the standard (Version 2.2) in December 1994, and more recent efforts are focused on accelerated development of a new version (3.0) of the standard. 

Institute of Electrical and Electronics Engineers (IEEE) develops standards for medical device information and a general informatics framework. There are tow major IEEE standards efforts in health care: (1) a standard for medical device communications that defines the entire seven-layer communications requirements for the "medical information bus" (MIB), a robust, reliable communication service designed for the intensive care unit, operating room, and emergency room bedside devices; and (2) a standard for health data interchange-defining communications models for medical data interchange between diverse systems (MEDIX). 

Logical Observation Identifier Names and Codes (LOINC) is developing standards that provide a set of universal names and ID codes for identifying laboratory and clinical test results. The purpose is to facilitate the exchange and pooling of results, such as blood hemoglobin, serum potassium, or vital signs for clinical care, outcomes management, and research. Most laboratories identify test in these messages by means of their internal (and idiosyncratic) code values. Receiving medical informatics systems cannot fully "understand" the result they receive unless they either adopt the producer's laboratory codes (which is impossible if they receive results from multiple source laboratories, e.g., the hospital lab, the local commercial lab, and a nursing home lab), or invest in the work to map each laboratory's code system to their internal code system. If medical information producers who wish to communicate with each other used standard codes to identify their results in data transmissions, this problem would disappear. LOINC codes are not intended to transmit all possible information about a test or observation. They are only intended to identify the test result or clinical observation. Other fields in the message can transmit the identity of the source laboratory and very detailed information about the sample. 

National Council for Prescription Drug Programs (NCPDP) develops standards to create and promote data interchange and processing standards to the pharmacy services sector of the health care industry. Membership comprises of drug manufactures, drug distributors, insurance carriers, prescription benefit mangers, independent pharmacies, chain pharmacies, federal and state government agencies, computer companies, telecommunication system vendors, consultants, and mail service companies. NCPDP has defined a standard for sending prescription information from pharmacies to payers, for prescription management service, and for receiving approval and payment information back in near-real time. They are developing standards for adverse drug reactions and use review. Ninety percent of community pharmacies and nearly 70% of the nation's outpatient prescriptions use NCPDP standard. 

Systemized Nomenclature of Human and Veterinary Medicine (SNOMED) is a standardized coded system for representing clinical information developed and maintained by the College of American Pathologists. Unlike ICD-9 and CPT4 classification systems, SNOMED is a multiaxial coded medical nomenclature that allows a comprehensive and highly specific coded expression of clinical information. A number of separate codes, one per axis, might constitute a diagnosis. For example, lung (topographic axis) plus granuloma (morphologic axis) plus fever (functional axis) plus mycobacterium tuberculosis (cause axis) might add up to a diagnosis of tuberculosis (disease axis). SNOMED was introduced in September 1993 and the current version of SNOMED International is a multiaxial nomenclature classification scheme created for the indexing of the entire medical record, including signs and symptoms, diagnoses, and procedures. Its unique design will allow full integration of all medical information in the electronic medical record into a single data structure. The SNOMED editorial board provides updates at least twice each year, and SNOMED International is being translated into 13 languages other than English, and is the global standard for indexing medical record information.