The creation of the 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, analysis aided by the greater availability and specificity of healthcare information, and ...all integrated with a good business information system.  

To make these diverse components work together, healthcare information standards (classifications, guides, practices, and terminology) are required that integrate with a good management system. This article gives you an overview of the major existing and emerging healthcare information standards.

Standardization has been one of the most difficult problems to solve in International Statistics and especially in Health Care. Many working committees have been formed to solve everything from patient identification, networking protocols to standardization for diseases. However, not much has been done to investigate how these systems can be use to actually manage the organization and health care. 

While health care standards are generally thought of only in terms of "medical" events, the standards used to indicate social-economic events are equally important in understand the health status of individuals and health research.  

New Work

• Clinical Data Interchange Standards Consortium (CDISC).  An international, non-profit organization that develops and supports global data standards for medical research. CDISC is working actively with EVS to develop and support controlled terminology in several areas, notably CDISC's Study Data Tabulation Model (SDTM). SDTM is an international standard for clinical research data, and is approved by the FDA as a standard electronic submission format

Classification Systems

• Coding Systems in General
• Health Care
• Nursing Terminology
• Social and Economic

Public Health Indicators are generally divided into the following classifications:

• Demographic Indicators

• Socioeconomic Indicators

• Mortality Indicators

• Morbidity Indicators

• Indicators of Resources, Access, and Coverage

• Others

Standards Development

AdvaMed. AdvaMed advocates for a legal, regulatory and economic environment that advances global health care by assuring worldwide patient access to the benefits of medical technology.

Certificate Commission for Health Information Technology  (CCHIT)

CCHIT has outlined five health outcome policy priorities areas and are:

• Improve quality, safety, efficiency, and reduce health disparities

• Engage patients and families

• Improve care coordination

• Improve population and public health

• Ensure adequate privacy and security protection for personal health information

InHCc will pursue the Commission for Health Information Technology (CCHIT) Certification. At this time, there are requirements that have not been implemented in the system that deals directly with features that are only used in the US. All other feathers have been implemented.

Consolidated Health Informatics (CHI)

The Consolidated Health Informatics (CHI) initiative has established several "domains" for standards. However, it seems that many of the standards that have been "established", were established because they already existed and little thought have been given to how good they were are how they could be integrated with IT technology and Data Analysis. It was lasted update in 2005 !

• Messaging
  • Health Level7 (Clinical Data)
  • National Council on Prescription Drugs Programs (NCPDP)
  • Institute of Electrical and Electronic Engineers 1073 (IEEE 1073)
  • Digital Imaging Communications in Medicine (DICOM)
  • X12N (Financial data, HIPAA mandated Transactions)
• Laboratory Results
  • Laboratory Logical Observation Identifier name Codes (LOINC)
• Medication
  • NDF-RT
  • RxNorm
  • Structured Product Labeling Sections
  • Drug Product
  • Packaging
  • Active Ingredients
  • Clinical Drug
  • Manufactured Dosage Form
• Anatomy
  • SNOMED
• Billing/Financial
  • CPT
  • ICD-9CM
  • HIPAA
  • X12N
• Chemicals
• Clinical Encounters
  • HL7
• Demographics
  • HL7
• Diagnosis and Problem Lists
  • SNOMED
• Health Care Education and Competence Assessment
  • MedBiquitous
• Genes and Proteins
  • Human Gene Nomenclature (HUGN)
• Images
  • DICOM
• Immunizations
  • HL7
• Interventions & Procedures Laboratory Test Order Names
• Interventions and Procedures, non-Laboratory
  • SNOMED
• Laboratory Result Contents
  • SNOMED
• Nursing
  • SNOMED
• Presciption from provides to pharmacies
  • DCPDP
• Text-Based Reports
  • HL7
• Units
  • HL7
• Disability
• History and Physical
• Medical Devices and Supplies
• Multimedia
• Physiology
• Population Health

The US Departments of Health and Human Services (HHS), Defense (DoD) and Veterans Affairs (VA) recognizes the following set of uniform standards for the electronic exchange of clinical health information to be adopted across the federal government

• American Society for Testing and Materials (ASTM) A component of the American National Standards Institute (ANSI) that has a subcommittee (E31) for general healthcare informatics. This E31 Subcommittee on Healthcare Informatics develops standards related to the architecture, content, storage, security, confidentiality, functionality, and communication of information used within healthcare and healthcare decision making, including patient-specific information and knowledge. URL: www.astm.org

• Current Procedural Terminology (CPT) CPT® Current Procedural Terminology was developed by the American Medical Association in 1966. These codes are used for the billing of medical procedures. Each year, an annual publication is prepared, that makes changes corresponding with significant updates in medical technology and practice. The most recent version of CPT, CPT 2003, contains 8,107 codes and descriptors. URL: http://www.ama-assn.org/ama/pub/category/3113.html

  • e.g., health insurance claims, billing, ordering

  • HIPAA Administrative Simplification provisions

  • Designated DHHS national standards for electronic healthcare transactions

• Digital Imaging and Communications in Medicine (DICOM) The Digital Imaging and Communications in Medicine (DICOM) Standard was developed for the transmission of images and is used internationally for Picture Archiving and Communication Systems (PACS). This standard was developed by the joint committee of the ACR (the American College of Radiology) and NEMA (the National Electrical Manufacturers Association) to meet the needs of manufacturers and users of medical imaging equipment for interconnection of devices on standard networks. URL: www.xray.hmc.psu.edu/physresources/dicom/basicinfo.html

• European Committee for Standardization (CEN)

• Health Level 7 (HL7) HL7 is an accredited ANSI standard organization that produces the HL7 messaging standard. It is the accepted messaging standard for communicating clinical data. It is supported by every major medical informatics system vendor in the US. The HL7 mission is to provide a comprehensive framework and related standards for the exchange, integration, sharing, and retrieval of electronic health information that supports clinical practice and the management, delivery and evaluation of health services. Specifically, to create flexible, cost effective standards, guidelines, and methodologies to enable healthcare information system interoperabilityandsharingofelectronichealthrecords.TheHL7ReferenceInformation Model (RIM) is an object model with a large pictorial representation of the clinical data (domains) and identifies the life cycle of events that a message or groups of related messages will carry. URL: www.hl7.org

• Health Information Standards Board (HISB) A subgroup of the American National Standards Institute (ANSI). The American National Standards Institute's Healthcare Informatics Standards Board (ANSI HISB) provides an open, public forum for the voluntary coordination of healthcare informatics standards among all United States' standard developing organizations. Every major developer of healthcare informatics standards in the United States participates in ANSI HISB. The ANSI HISB has 27 voting members and more than 100 participants, including ANSI-accredited and other standards developing organizations, professional societies, trade associations, private companies, federal agencies, and others. URL: www.ansi.org/standards_activities/standards_boards_panels/hisb/overview.aspx?menuid=3

• International Organization for Standardization (ISO)

• The IOM Committee on Patient Safety Data Standards This group within the Institute of Medicine has the charge of producing a detailed plan to facilitate the development of data standards applicable to the collection, coding, and classification of patient safety information. URL: www.iom.edu/psds

• Some of the National Council on Prescription Drug Programs (NCDCP) standards for ordering drugs from retail pharmacies to standardize information between health care providers and the pharmacies. These standards already have been adopted under the Health Insurance Portability and Accountability Act (HIPAA) of 1996, and today’s announcement will make sure that parts of the three federal departments that aren’t covered by HIPAA will also use the same standards.

• Institute of Electrical and Electronics Engineers 1073 (IEEE1073) series of standards that allow for health care providers to plug medical devices into information and computer systems that allow health care providers to monitor information from an ICU or through telehealth services on Indian reservations, and in other circumstances.

• Digital Imaging Communications in Medicine (DICOM) standards that enable images and associated diagnostic information to be retrieved and transferred from various manufacturers’ devices as well as medical staff workstations.

• Laboratory Logical Observation Identifier Name Codes (LOINC) Coding system for the electronic exchange of laboratory test results and other observations. LOINC development involved a public-private partnership comprised of several federal agencies, academia, and the vendor community. This model can be applied to other standards setting domains

  • E.g., lab test results, problems, diagnoses, history, physical

  • Electronic exchange of clinical health information in U.S Government systems

• MedBiquitous MedBiquitous is the ANSI-accredited developer of information technology standards for healthcare education and competence assessment. Our XML and Web Services Standards enable communications among diverse entities in professional medicine and provide opportunities to seamlessly support the clinician learner. MedBiquitous has developed standards for healthcare learning objects (HLOs), discrete units of online instruction that may be used at the time of need, as well as standards for communicating clinician profile information, education and certification activities, journal information, and educational metrics. These standards will facilitate collaboration across organizations and make it easier to track licensure, certification, and educational changes or activities. URL: http://www.medbiq.org

• National Council for Prescription Drug Programs (NCPDC ) Founded in 1978, the NCPDC focuses on prescription drug messages and works to create and promote data interchange and processing standards for the pharmacy services sector of the health care industry. This is the standard for billing retail drug sales. The NCPDP is currently working on a standard for physicians to submit prescriptions electronically. URL: www.ncpdp.org

• National Drug File Reference Terminology (NDF-RT) and RxNorm The NDF-RT and the RxNorm projects are focused on improving interoperability of drug terminology. The area of clinical drugs is seen as important in the growing issues of patient safety; The National Drug File, Reference Terminology is being developed for the Veterans Administration as a reference standard for medications to support a variety of clinical, administrative and analytical purposes.

• Systematized Nomenclature of Medicine (SNOMED)

• Unified Medical Language System (UMLS) Metathesaurus The UMLS is a long term research and development project of the National Library of Medicine (NLM) that began in 1986. This project develops and distributes multi-purpose, electronic "Knowledge Sources" and associated lexical programs. System developers can use the UMLS products to enhance their applications -- in systems focused on patient data, digital libraries, Web and bibliographic retrieval, natural language processing, and decision support. Researchers will find the UMLS products useful in investigating knowledge representation and retrieval questions. URL: http://www.nlm.nih.gov/research/umls/

• X12N Dominant standard for electronic commerce. The American National Standards Institute Accredited Standards Committee X12 (ASC X12) selected X12N as the standard for electronic data interchange (EDI) used in administrative and financial health care transactions (excluding retail pharmacy transactions) in compliance with the Health Insurance Portability and Accountability Act of 1996. Used for external financial transactions, financial coverage verification and insurance transactions and claims. URL: www.x12.org/x12org/index.cfm

• ICD

  • e.g., disease surveillance, immunization rates, environmental monitoring

  • CDC designated standards for public health reporting

Other standards are:

• Health Care
  • International Standards
  • 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
  • Standards Coordination and Promotion Activities
  • Symptoms (symptoms)
  • Findings (results)
  • Diagnosis Procedures
  • Therapeutic, Interventions, and Procedures (management)
  • Functional status and Outcome Variables
  • Clinical Observations
  • Anatomic sites
  • Medications, Drugs, and chemical compounds
  • Microbes and etiologic agents (identification of agent)
  • Findings
  • Units Of measure
• Health Indicators
• Social and Economic
  • Education 
  • Economics
  • Race
• Coding Systems (a list)

Definition:

A "code set" is any set of codes used for encoding data elements, such as tables of terms, medical concepts, medical diagnosis codes, or medical procedure codes. Medical data code sets used in the health care industry include coding systems for diseases, impairments, other health related problems, and their manifestations; causes of injury, disease, impairment, or other health-related problems; actions taken to prevent, diagnose, treat, or manage diseases, injuries, and impairments; and any substances, equipment, supplies, or other items used to perform these actions. Code sets for medical data are required for data elements in the administrative and financial health care transaction standard for diagnoses, procedures, and drugs.

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History (US)

• HIPAA (1996) - Health Insurance Portability and Accountability Act of 1996 requires administrative standards

• NCVHS - National Committee on Vital and Health Statistics, a long long- standing (50+ years) advisory committee to HHS expanded by HIPAA, recommends standards

• CHI (2001) Consolidated Health Informatics project, a cross cross-agency eGov initiative designates U.S. gov gov’t-wide clinical data standards

• Medicare Modernization Act (2003) - requires e e-Prescribing standards; establishes Commission on Systemic Interoperability

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Uses of Standard Coded Data 

• Primary Patient Care
• Medical Health Care Organization Management
• Information transfer (messaging)
• Information retrieval
• Clinical research
• Health Care Policy formation

Current Standards

As the current standards are always changing a separate page (current standards) has been created for the most notable. It is also possible to follow the "links to standards"

Discussion

Although standards form the basis to enable major cost savings, improved operating efficiencies, effectiveness, timeliness, interoperability, data exchange, analysis, and quality (USAID), standards can also slow down the rate of change in these very items that standards are used to affect. Comforting to old outdated standards is the number one reasons that keeps organizations from moving forward into newer and better systems. 

Consistency analysis should shift focus from the "past" to the "future." This analysis should address issues of emerging technologies and plan for future events in order to ensure for effective and efficient use of investment resources. Special attention should not be placed on existing standards as such, but rather on the analysis of long term technology changes. This will prevent the purchasing or implementing of systems that will soon be obsolete. A good example is to look at the recommendations made by USAID as few as two years ago and the technology that is available today. 

A particular concern for standardization is the rapid pace of technology. Development of HL7 has been in progress for 12 years yet many of its standards are obsolete already. The new XML (eXtended Markup Language) has redefined the way to access and exchange of information between disparate systems and is turning upside down much of the previous work.

In regards to clinical guidelines and protocols, attention must be given to continued research. Once guidelines and protocols are developed, it may then be difficult to find new and better methods. 

Version Control

Because even Standards Organization frequently change their coding schemes (example WHO's ICD series), there must be some way to historically view data and ensure that the results that are obtained are the correct identifications for that time period.

Problems with Standardization and Classification

• Each Classification is only primarily valuable to the specialist group that designed it

• Even users with that group can find it too rigid or need considerable training

• The limited vocabulary constrains natural expressively and may artificially skew information  

• It may be difficult to link terms together meaningfully

• There may be insufficient room within the code set for the future expansion medical knowledge

• The concepts behind the structure eventually become outdated

(GEHR, 1995)

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Standards Development Organizations (SDO's) and Standards

Blood and Blood Products

• ISBT 128. ISBT 128 sets a global standard for the identification, labeling and information processing of human blood, tissue and organ products across international borders and disparate health care systems. The standard has been designed and perfected over a period of almost two decades to ensure the highest levels of accuracy, safety and efficiency for the benefit of donors, patients and official ISBT 128 licensed facilities worldwide.

Clinical data Standards 

• ASTM The American Society for Testing and Materials ASTM E-1384, E-1633, and E1869.  

• HL7  Health Level 7 version 3 enables systems to create XML

Data Modeling and Data Sharing Schemes 

• IEEE. International Electronic and Electrical Engineers (IEEE P1157 and P1073 committees)

• ASTM The American Society for Testing and Materials ASTM E-1384, E-1633, and E1869.  

• HL7 Health Level Seven (HL7) Defines a standard structure for messages between health information systems. Although by itself outdated, HL7 has recently join forces with XML technology. 

• CDA Clinical Document Architecture (CDA) by using XML provides an exchange model for clinical documents (such as discharge summaries and progress notes). CDA is expected to be published as an ANSI approved standard in late 2001. By leveraging the use of XML, the HL7 Reference Information Model, and coded vocabularies, the CDA makes documents both machine readable and human readable. CDA documents can be displayed using XML aware Web browsers or wireless applications such as cell phones. 

• Good Electronic Health Record (EU based). 

Geographical location

• GIS

Images

• DICOM The Digital Imaging and Communications in Medicine (DICOM) Standard was developed for the transmission of images and is used internationally for Picture Archiving and Communication Systems (PACS). This standard was developed by the joint committee of the ACR (the American College of Radiology) and NEMA (the National Electrical Manufacturers Association) to meet the needs of manufacturers and users of medical imaging equipment for interconnection of devices on standard networks

Insurance and remittance Standards 

• ASC X12N American Standards Committee (ASC X12, X12N and Z80 committees). Dominant standard for electronic commerce. The American National Standards Institute Accredited Standards Committee X12 (ASC X12) selected X12N as the standard for electronic data interchange (EDI) used in administrative and financial health care transactions (excluding retail pharmacy transactions) in compliance with the Health Insurance Portability and Accountability Act of 1996. Used for external financial transactions, financial coverage verification and insurance transactions and claims. 

• HIPAA The Health Insurance Portability and Accountability Act had attempted to standardize is reimbursement procedures. "The Administrative Simplification (AS) provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) are intended to reduce the costs and administrative burdens of health care by making possible the standardized, electronic transmission of many administrative and financial transactions that are currently carried out manually on paper." http://aspe.os.dhhs.gov/admnsimp/

Laboratory

• LOINC. Coding system for the electronic exchange of laboratory test results and other observations. LOINC development involved a public-private partnership comprised of several federal agencies, academia, and the vendor community. This model can be applied to other standards setting domains.

WHO FIC Network

• WHO-FIC Network

• ICD-10

• ICPM International Classification of Procedures in Medicine (Replaced by ICHI)

• ICHI International classification of Health Interventions

• ICF  International Classification of Functioning, Disability and Health

• ICD-O International Classification of Disease for Oncology

Medical Devices and Emergency Medical Services 

• ASTM The American Society for Testing and Materials ASTM E-1384, E-1633, and E1869.  A component of the American National Standards Institute (ANSI) that has a subcommittee (E31) for general healthcare informatics. This E31 Subcommittee on Healthcare Informatics develops standards related to the architecture, content, storage, security, confidentiality, functionality, and communication of information used within healthcare and healthcare decision making, including patient-specific information and knowledge

Medical Knowledge

• Arden syntax

• Medcin System

Messaging Formats

• ANSI American National Standards Institute Healthcare Informatics Standards Board (ANSI HISB)

• IEEE. Institute of Electrical and Electronics Engineers 

• HL7  HL7 is an accredited ANSIstandard organization that produces the HL7 messaging standard. It is the accepted messaging standard for communicating clinical data. It is supported by every major medical informatics system vendor in the US. The HL7 mission is to provide a comprehensive framework and related standards for the exchange, integration, sharing, and retrieval of electronic health information that supports clinical practice and the management, delivery and evaluation of health services. Specifically, to create flexible, cost effective standards, guidelines, and methodologies to enable healthcare information system interoperability and sharing of electronic health records. The HL7 Reference Information Model (RIM) is an object model with a large pictorial representation of the clinical data (domains) and identifies the life cycle of events that a message or groups of related messages will carry.

• National Drug File Reference Terminology (NDF-RF) and RxNorm. The NDF-RT and the RxNorm projects are focused on improving interoperability of drug terminology. The area of clinical drugs is seen as important in the growing issues of patient safety; The National Drug File, Reference Terminology is being developed for the Veterans Administration as a reference standard for medications to support a variety of clinical, administrative and analytical purposes. The RxNorm Project is a developing project of the NLM where new concepts are being added to the UMLS for clinical drug representations

Medical Diagnosis and Problem List (From CHI)

Standards that catalog a patient's medical, nursing, dental, social, preventative and psychiatric events and issues

• DSM-IV

• ICD-10-CM

• ICPC

• MEDCIN

• MedDRA

• SNOMED-CT

Medical Disability

ICF International Classification of Functioning, Disability and Health

Disability terms and concepts are covered in the following systems or surveys:

• Nursing Home Minimum Data Set (MDS)

• Home Health Outcome and Assessment Information Set (OASIS)

• Functional Independence Measure (FIM) for Rehabilitation

• Residual Functional Capacity Form (RFC)

• National Health Interview Survey and National Health and Nutrition Examination Survey

Medical Coding Standards 

There are two related classifications of diseases with similar titles, and a third classification on functioning and disability. The International Classification of Diseases (ICD) is the classification used to code and classify mortality data from death certificates. The International Classification of Diseases, Clinical Modification (ICD-CM) is used to code and classify morbidity data from the inpatient and outpatient records, physician offices, and most NCHS surveys.

After nine years of international revision efforts coordinated by the World Health Organization (WHO), the World Health Assembly on May 22, 2001, approved the International Classification of Functioning, Disability and Health and its abbreviation of "ICF." This classification was first created in 1980 (and then called the International Classification of Impairments, Disabilities, and Handicaps, or ICIDH) by WHO to provide a unifying framework for classifying the consequences of disease.

The ICF classification complements WHO’s International Classification of Diseases-10th Revision (ICD), which contains information on diagnosis and health condition, but not on functional status. The ICD and ICF constitute the core classifications in the WHO Family of International Classifications (WHO-FIC).

• Code on Dental Procedures and Nomenclature, as updated and distributed by the American Dental Association, for dental services.

• ICIDH International Classification of Functioning, Disability and Health (ICIDH-2)

• ICD-10 International Classification of Diseases (ICD9-CM, ICD10)

• ICF work by CDC

• ICPC International Classification for Primary Care. ICPC-2 classifies patient data and clinical activity in the domains of General/Family Practice and primary care, taking into account the frequency distribution of problems seen in these domains. It allows classification of the patient’s reason for encounter (RFE), the problems/diagnosis managed, interventions, and the ordering of these data in an episode of care structure

• HCPCS Health Care Procedure Coding System

• MedDRA.  MedDRA (the Medical Dictionary for Regulatory Activities), the new global standard medical terminology, will soon supersede or replace terminologies currently in use with the medical product development process.

• MESH Medical Subject Headings  by U.S. National Library of Medicine  

• NANDA North American Nursing Diagnosis Association

• National Drug Code Directory (NDC) The NDC System was originally established as an essential part of an out-of-hospital drug reimbursement program under Medicare. The NDC serves as a universal product identifier for human drugs. The current edition of the National Drug Code Directory is limited to prescription drugs and a few selected OTC products

• NHS (England) National Health System Information Authority

• OPCS Office of Population, Censuses and Surveys - Classification of Surgical Operations and Procedures - 4th revision. This links to background information, product description plus licensing and publication information.

• SNOMED Standard Nomenclature for Medicine (SNOMED III)

• UMLS Unified Medical Language System  The National Library of Medicine (NLM) and Unified Medical Language  System (UMLS)Read Codes (British) Read Clinical Codes version 3: Records symptoms, diagnoses, pathology tests, etc. by selection of concepts and qualifiers. The project develops and distributes multi-purpose, electronic "Knowledge Sources" and associated lexical programs. System developers can use the UMLS products to enhance their applications -- in systems focused on patient data, digital libraries, Web and bibliographic retrieval, natural language processing, and decision support. Researchers will find the UMLS products useful in investigating knowledge representation and retrieval questions." http://www.nlm.nih.gov/research/umls/

• The combination of Health Care Financing Administration Common Procedure Coding System (HCPCS), as updated and distributed by HHS; and Current Procedural Terminology, Fourth Edition (CPT-4), as updated and distributed by the American Medical Association, for physician services and other health related services. These services include, but are not limited to, the following:
  1. Physician services.
  2. Physical and occupational therapy services.
  3. Radiological procedures.
  4. Clinical laboratory tests.
  5. Other medical diagnostic procedures.
  6. Hearing and vision services.
  7. Transportation services including ambulance.
• The Health Care Financing Administration Common Procedure Coding System (HCPCS), as updated and distributed by HCFA, HHS, for all other substances, equipment, supplies, or other items used in health care services. These items include, but are not limited to, the following:
  1. Medical supplies.
  2. Orthotic and prosthetic devices.
  3. Durable medical equipment.

The NLM has Mapped many of the other coding to its UMLS standard. 

Patient Record  (also see Patient Record at this site)

• CPRI Computer-based Patient Records Institute. 

Performance Indicators (See Management - Indicators)

Drugs and Prescriptions

• RxNorm Project

• PCPDP pharmacy transaction standards 

• National Drug Codes. The NDC System was originally established as an essential part of an out-of-hospital drug reimbursement program under Medicare. The NDC serves as a universal product identifier for human drugs.

• NCPDP National Council on Prescription Drug Programs. Develops standards that define how prescription information is sent between interested parties and how payments are to be made. Implementation guides can be obtained at http://www.ncpdp.org/

• NCHS National Center for Health Statistics - The Ambulatory Care Drug Database System (CDC) search system. Uses the NDC classification system.

• NCPDP Standards Information.

• The Society of Hospital Pharmacists of Australia. SHPA structured Drug Codes. The codes, originally developed for the Health Department of Victoria in 1981, were given national endorsement by Federal Council in 1986. The SHPA drug code is a five digit structured code which enables each therapeutic substance to have a unique code number indicative of the class of drug to which it belongs. Thus the code has been designed to be used in full or in a truncated form to provide as fine or as course a grouping as is wished.

• WHO Adverse Reaction Terminology (WHO-ART), and DD Access

Procedures and Protocols