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The section includes but is not imited limited to other CBIIT internal requirements and national standards:

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At the heart of many HL7 specifications is the Reference Information Model (on the HL7 site) (RIM). An object model created as part of the HL7 Version 3 methodology, the RIM is a large, pictorial representation of the HL7 clinical data (domains) and identifies the life cycle that a message or groups of related messages will carry. It is a shared model between all domains and, as such, is the model from which all domains create their messages. The RIM is an ANSI approved standard.

The Clinical Document Architecture, a V3-based standard, provides an exchange model for clinical documents (such as discharge summaries and progress notes) - and brings the healthcare industry closer to the realization of an electronic medical record. CDA leverages the use of XML, the HL7 Reference Information Model (RIM) and coded vocabularies.

Common Message Element Types (CMETs) are standardized model fragments intended to be building blocks that individual content domains can "include" in their designs. These blocks reduce the effort to produce a domain-specific design and assure that similar content across multiple domains is consistently represented.

The Model Interchange Format (MIF) is a set of XML formats used to support the storage and exchange of HL7 version 3 artefacts as part of the HL7 Development Framework. It is the pre-publication format of HL7 v3 artefacts used by tooling. It is also the formal definition of the HL7 metamodel. The MIF can be transformed into derived forms such as UML/XMI or OWL.

The HL7 Version 3 Development Framework (HDF) is a continuously evolving process that seeks to develop specifications that facilitate interoperability between healthcare systems. The HL7 RIM, vocabulary specifications, and model-driven process of analysis and design combine to make HL7 Version 3 one methodology for development of consensus-based standards for healthcare information system interoperability. The HDF is the most current edition of the HL7 V3 development methodology. The HDF documents the processes, tools, actors, rules, and artifacts relevant to development of all HL7 standard specifications, not just messaging.

The growing adoption of HL7 standards (for example, the HITSP/C32 specification called out in the meaningful use final rule) throughout the world suggests that aligning Semantic Infrastructure 2.0 around these specifications will streamline attainment of Semantic Infrastructure 2.0 objectives.

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• Initiative 1. Distributed, federated metadata repositories and model repositories and operations.
• Initiative 2. Automated generation of metadata from line-of-business artifacts.
• Initiative 3. Rules management and contracts support (behavioral semantics)
• Initiative 4. Semantics support for W3C service oriented architecture resources.
• Initiative 5. HL7 CTS II/ OMG MIF compliant federated terminology services.
• Initiative 6. Controlled biomedical terminology, ontology and metadata content.
• Initiative 7. Assessment of semantic unification of compositional and derivational models

Terminology and Data Types

Terminology and data type standards referenced during requirements gathering process included:

SNOMED CT (Systematized Nomenclature of Medicine--Clinical Terms) is a comprehensive clinical terminology, originally created by the College of American Pathologists (CAP) and, as of April 2007, owned, maintained, and distributed by the International Health Terminology Standards Development Organisation (IHTSDO), a non-for-profit association in Denmark.

SNOMED CT is one of a suite of designated standards for use in U.S. Federal Government systems for the electronic exchange of clinical health information and is also a required standard in interoperability specifications of the U.S. Healthcare Information Technology Standards Panel. SNOMED CT is also being implemented internationally as a standard within other IHTSDO Member countries.

UCUM (Unified Code for Units of Measure). The Unified Code for Units of Measure is a code system intended to include all units of measures being contemporarily used in international science, engineering, and business. The purpose is to facilitate unambiguous electronic communication of quantities together with their units.
The Unified Code for Units of Measure is inspired by and heavily based on ISO 2955-1983, ANSI X3.50-1986, and HL7's extensions called “ISO+”.

WHO Drug dictionary. The WHO Drug Dictionary is an international classification of medicines created by the WHO Programme for International Drug Monitoring and managed by the Uppsala Monitoring Centre. It is used by pharmaceutical companies, clinical trial organizations and drug regulatory authorities for identifying drug names in spontaneous ADR reporting (and pharmacovigilance) and in clinical trials.

MedDRA dictionary. MedDRA or Medical Dictionary for Regulatory Activities is a clinically validated international medical terminology used by regulatory authorities and the regulated biopharmaceutical industry throughout the entire regulatory process, from pre-marketing to post-marketing activities, and for data entry, retrieval, evaluation, and presentation. In addition, it is the adverse event classification dictionary endorsed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). MedDRA is used in the US, European Union, and Japan. Its use is currently mandated in Europe and Japan for safety reporting.

The FDA has committed to keeping current on MedDRA, and it has become the standard for adverse event reporting in the USA.

RxNorm terminology released by the National Library of Medicine (NLM). RxNorm provides normalized names for clinical drugs and links its names to many of the drug vocabularies commonly used in pharmacy management and drug interaction software, including those of First Databank, Micromedex, MediSpan, Gold Standard Alchemy, and Multum. By providing links between these vocabularies, RxNorm can mediate messages between systems not using the same software and vocabulary.

RxNorm now includes the National Drug File - Reference Terminology (NDF-RT) from the Veterans Health Administration, which allows for
classification of the RxNorm terms into their chemical and physiological effect categories. NDF-RT is a terminology used to code clinical drug properties, including mechanism of action, physiologic effect, and therapeutic category.

UNII The overall purpose of the joint FDA/USP Substance Registration System (SRS) is to support health information technology initiatives by generating unique ingredient identifiers (UNIIs) for substances in drugs, biologics, foods, and devices.

The UNII may be found in:

• NLM's Unified Medical Language System (UMLS)
• National Cancer Institutes Enterprise Vocabulary Service
• USP Dictionary of USAN and International Drug Names (future)
• FDA Data Standards Council website
• VA National Drug File Reference Terminology (NDF-RT)
• FDA Inactive Ingredient Query Application

NDC The National Drug Code (NDC) is a unique product identifier used in the United States for drugs intended for human use. The Drug Listing Act of 1972 requires registered drug establishments to provide the Food and Drug Administration (FDA) with a current list of all drugs manufactured, prepared, propagated, compounded, or processed by it for commercial distribution. Drug products are identified and reported using the NDC.

FDA MedWatch MedWatch is the Food and Drug Administration’s reporting system for adverse events, founded in 1993. An adverse event is any undesirable experience associated with the use of a medical product. The MedWatch system collects reports of adverse reactions and quality problems, primarily with drugs and medical devices, but also for other FDA-regulated products (e.g., dietary supplements, cosmetics, medical foods, and infant formulas).

NLM DailyMed DailyMed provides high quality information about marketed drugs. Drug labeling and other information in the SPL is what has been most recently submitted by drug companies to the Food and Drug Administration (FDA) as drug listing information.

OMG

Model-driven architecture (MDA) is a software design approach for the development of software systems. It provides a set of guidelines for the structuring of specifications, which are expressed as models. Model-driven architecture is a kind of domain engineering, and supports model-driven engineering of software systems.

The MDA model is related to multiple standards, including the Unified Modeling Language (UML), the Meta-Object Facility (MOF), XML Metadata Interchange (XMI).
Of particular importance to model-driven architecture is the notion of model transformation. A specific standard language for model transformation has been defined by OMG called QVT.

The Ontology Definition MetaModel is an Object Management Group (OMG) specification to make the concepts of Model-Driven Architecture applicable to the engineering of ontologies. Hence, it links Common Logic (CL), the Web Ontology Language (OWL), and the Resource Description Framework (RDF).

The Object Constraint Language (OCL) is a declarative language for describing rules that apply to any Meta-Object Facility (MOF) Object Management Group (OMG) meta-model, including UML. The Object Constraint Language is a precise text language that provides constraint and object query expressions on any MOF model or meta-model that cannot otherwise be expressed by diagrammatic notation. OCL is a key component of the OMG standard recommendation for transforming models, the Queries/Views/Transformations (QVT) specification.

The Common Terminology Services 2.0 Specification will be an extension the HL7 CTS Specification.