5.2.1.3.4 - Model Sept. 6, 2010

Model Functional Profile

Create, destroy, edit, and maintain models.

Support is needed for forms data and common clinical document standards, such as HL7 CDA.

HL7 domain models.

HL7 SAIF behavioral model (which provides a formal model and grammar for service contracts)

Meta Models, including UML, HL7, Schema

Orchestration dynamic models.

Service specification content, primarily unstructured text

UML domain models.

Vocabulary models.

XML Schemas.

This Functional Profile includes, but is not limited to, the following capability elaborations:

Derived From Requirements

Semantic Infrastructure Requirements::Artifact Management::Artifact Lifecycle Management Artifact lifecycle management and metadata requirements include the ability to: * Manage lifecycle, governance and versioning of the models, content and forms * Establish relationships and dependencies between models, content and forms * Determine provenance, jurisdiction, authority and intellectual property * Create represention and views of the information, realized through the appropriate transforms * Provide access control and other security constraints * Create annotations for better discovery and searching of artifacts * Develop usage scenarios and context for the information * Provide terminology and value set binding The artifacts are bound to the services via the service metadata. The service metadata combined with the artifacts and supporting metadata provide a comprehensive service specification. The artifact management requirements listed above are derived from the following use cases: * caEHR: The caEHR project has adopted ECCF for specifications and CDA documents for interoperability. The caEHR project requirements include the need for an infrastructure for managing all the artifacts generated during specification process, including HL7 models and documents. The caEHR project also intends to publish these artifacts for the community and vendors. The infrastructure needs to support better discovery, making all the relevant information available in the right context. * ONC and other external EHR adopters: ONC has adopted CCD and CCR for meaningful use. All national EHR implementations are expected to support forms and the semantics of these forms play a critical role in interoperability. The semantic infrastructure must provide a mechanism to create, store and manage these forms. * Clinical Trials: Clinical trials use forms to capture clinical information, and the semantics captured by these forms are critical for interoperability and reporting. The semantic infrastructure must provide a mechanism to manage the lifecycle of these forms.
Semantic Infrastructure Requirements::Artifact Management::Behavioral Models Behavioral dynamic models capture the behavior of services. Behavior of services provides an unambiguous definition of the service constraints, capabilities, dependencies and interactions. The metadata and grammar required to realize service behavior is called behavioral semantics. Behavioral semantics provide a mechanism for better service discovery and enforcing the constraints at design and runtime.
Gap Analysis::BRIDG::BRIDG-2 - Handle ISO-11179 specification handling of early binding of attribute context The ISO-11179 metadata specification specifies that a concept definition should be applied to each data element concept that is rigorous, noncircular, and granular enough to separate the definition of the concept in question from a closely related concept. When the concept definition that is applied to a data element concept is so specific that it attempts to disambiguate not just related concepts, but different uses of the same concept, it creates a situation of early binding of the concept definition that prevents its reuse in a broader manner. In the case of a domain analysis model that is meant to be abstract, this early binding prevents the reuse of domain analysis attributes across a broad range of use cases and leads to segregation of an individual concept into multiple sub concepts usable only in extremely narrow use cases, outside the scope of a domain analysis model representation.
Gap Analysis::caEHR::caEHR 2 - CDA,CCD Document Handling caEHR performs many of the behavior functions via the creation and parsing of clinical documents in the HL7 CDA format. While other methods exist, the KR system should provide the ability to represent the content structure of standard documents in such a way as to assist in the generation and understanding of these documents. CDA documents have sections that are composed of defined clinical statements. These sections and statements are derived from HL7 definitions. The definition of a document should be made available via the KR system. This includes constraints on certain elements for a given section. For example, if a section contains the set of declared allergies for a patient, then the KR system should identify the component elements, and the constrained value sets for representing allergies. The CDA document also has the ability to express information using negation indicators. As in, a patient does not have a specific symptom. The KM system should allow for the definition of alternate representations of such elements so as to allow for consistent understanding and transformations of such elements. That would be one requirement, but probably the function of the CTS2 service. The negationInd attribute is just another attribute in a V3 class and requires no special handling from the metadata repository.
Gap Analysis::CDISC::CDISC-13 - Provide the ability to retrieve CDISC Standards in a machine interpretable format CDISC has to deliver its standards and the MDR approved content to the authorized CDISC member. Currently a major format for clinical trial data delivery is PDF. The PDF publication format is gradually expected to fade. A CDISC Knowledge Repository should support Files and Services to distribute information. In particular, the existing CDISC standards should be aligned with each other; this includes CDASH, SDTM, BRIDG, and Controlled Terminology. The knowledge repository should make it easy to consume this metadata information and provide detailed explanations to the membership in real-time. This is a major issue because shifting to the use of CDISC standards or using updated CDISC standards can turn the world of a clinical research project upside down. CDISC needs to be able to explain and justify the changes the use of CDISC standards would mandate (e.g., switch from PDF to CDASH). The CDISC meta-model explicitly calls for the storage of SDTM, CDASH, and ADaM and that these standards should be derivable from an underlying BRIDG-based meta-model. The KR should be able to export all or subsets of its content in a machine-readable format (e.g., XML, ASCII). Source * CDISC SHARE Meta Data Model, V 0.1 May 7, 2010 CDISC Share Pilot Report and CDISC Requirements Package 1 - NCI Semantic Infrastructure, 5/28/2010, Section 2.2 * 5/20/2010 Interview, David Iberson-Hurst in response to a David Hau question.
Gap Analysis::CDISC::CDISC-7 - Support the meta-model being developed by CDISC SHARE CDISC is developing a meta-model for CDISC Share. These meta-model requirements should be supported in the NCI Knowledge Repository. This meta-model shall support ISO 11179, which provides the foundation for data elements and concepts. ISO 21090 data types are the foundation for repository data types. As noted in CDISC-8 BRIDG concepts are also a foundation for the repository objects. This repository should include object names, attributes. The attributes include variable definitions, code lists, data types (e.g., ISO 21090), object variable groupings, observation classes, observation class attributes, observation class rules, special purpose classes, domain level attributes, domain level rules, domain level examples, object level rules, relationships among objects, object level examples, define file rules, and define file examples. The relationships between each object should be fully specified. This also includes the requirement that every object (e.g., class, attribute, association, concept, term) in the repository must have a definition. The meta-model defines the structures and rules used to define CDISC standards. It outlines how clinical research and treatment firms, health agencies and regulators should gather, retain, and disseminate health domain specific knowledge. The repository also provides content governance support mechanisms. Sources * CDISC SHARE Meta-Model Paper; CDISC Share Pilot Report and CDISC Requirements Package 1 - NCI Semantic Infrastructure, 5/28/2010, Section 2.1; Section 2.6 * CDISC Team 2 Meetiing 5/27/2010 , David Iberson-Hurst
Gap Analysis::CDISC::CDISC-8 - Support the BRIDG (Biomedical Research Integrated Domain Group) Domain Analysis Model (DAM) The BRIDG DAM is designed to integrate clinical research trial and clinical care domains so that research results can inform healthcare more quickly and so that healthcare outcomes can be used in designing clinical trial protocols. The goal is to enable information system interoperability to improve both medical research and related areas of healthcare. BRIDG already incorporates a number of CDISC standards (e.g., STDM) and is working to harmonize other CDISC standards. *Source: * * CDISC SHARE: A Briefing on CDISC Share, Oct 6, 2009 E. Helton, R Kush, F Newby, M Haber, & D Iberson-Hurst; * CDISC SHARE: Pathway into the Future for Standards Development and Delivery, April 10, 2010, Brow W. Kisler, CDISC Senior Director
Gap Analysis::HL7 CIC::CIC-11 - Support reuse of existing vocabularies to build new vocabularies There is a need to support a feature, like a shopping cart in caDSR, to allow for building of streams (data collection of screens) from existing vocabularies – consider looking at using caDSR Forms to do this
Gap Analysis::HL7 CIC::CIC-9 - Provide a common interface for different clinical specialties There is a need to permit the user to enter data from their perspective, but have the entered data converted into a standard and consistent metadata format.
Semantic Infrastructure Requirements::Artifact Management::Content Content includes all unstructured text and other forms of content that make up a service specification. Examples include storyboards, and scope. Content is an integral part of service specification, and content is leveraged across the enterprise for documentation and communicaitons.
Semantic Infrastructure Requirements::caGRID 2.0 Platform and Terminology Integration::Data Representation and Information Models This set of requirements includes providing an application developer with the ability to define application-specific attributes (for example, defined using ISO 21090 healthcare datatypes) and an information model that defines the relationships between these attributes and other attributes in the broader ecosystem. In particular, the last requirement suggests linked datasets, where application developers can connect data in disparate repositories as if the repositories are part of a larger federated data ecosystem. Additional requirements include the ability to publish and discover information models. Support is needed for forms data and common clinical document standards, such as HL7 CDA. To support the use of binary data throughout the system, the binary data must be typed and semantically annotated. All Information models, their representation and binding to data-types and terminologies will be managed by the semantic infrastructure. The ability to publish and discover information models will be supported by the semantic infrastructure, and the platform will leverage these capabilities. Link to use case satisfied from caGRID 2.0 Roadmap: The pathology, radiology and other data have various data formats which must be described, and the information model for the patient record must link between these various datatypes. The complete information model includes semantic links between datasets to build a comprehensive electronic medical record. Annotations on data are defined and included in the information model.
Semantic Infrastructure Requirements::caGRID 2.0 Platform and Terminology Integration::Data Semantics In a diverse information environment, semantics must be used to clearly indicate the meaning of data. This requirement is expected to be addressed by the Semantic Infrastructure, although there will be a touchpoint between the caGrid 2.0 and the Semantic Infrastructure to annotate data with semantics. Integration with the Semantic Infrastructure will enable reasoning, semantic query, data mediation (for example, ad hoc data transformation) and other powerful capabilities. Data semantics are captured in the Semantic Infrastructure and the platform will leverage the Semantic Infrastructure interfaces for reasoning and analysis. Link to use case satisfied from caGRID 2.0 Roadmap: The oncologist accesses the TCGA database to search for de-identified glioblastoma tumor data that is similar to the patient data exported from the hospital medical record. During this search, the semantics of the data fields are leveraged to indicate matches between TCGA data fields and the hospital medical record data fields.
Gap Analysis::EVS::EVS-2 - Implement HL7 formal naming conventions KR needs to implement metadata object names that bind to HL7 version 3 artifacts according to the HL7 formal naming conventions
Semantic Infrastructure Requirements::Conformance Testing::Search and Access Conformance Statements Conformance testing leverages the artifact and service metadata to validate that an implementation adequately addresses the requirements stated in the service specification. An example of service requirement is the ability to specify a response time in the specification (design time) and validate that this response time is valid for an implementation of the service. Aadditional test points include but are not limited to binding to specific terminologies and domain models.
Semantic Infrastructure Requirements::Artifact Management::Static Models Static models include a variety of models with different representations.
Semantic Infrastructure Requirements::Conformance Testing::Test for Conformance Conformance testing allows both CBIIT and other HL7 SAIF adopters to validate specifications.

cdiscModel

CDISC Model API

hl7CdaModel

HL7 CDA Model management, including create, destroy, edit.

caEHR performs many of the behavior functions via the creation and parsing of clinical documents in the HL7 CDA format. While other methods exist, the KR system should provide the ability to represent the content structure of standard documents in such a way as to assist in the generation and understanding of these documents.

CDA documents have sections that are composed of defined clinical statements. These sections and statements are derived from HL7 definitions. The definition of a document should be made available via the KR system. This includes constraints on certain elements for a given section. For example, if a section contains the set of declared allergies for a patient, then the KR system should identify the component elements, and the constrained value sets for representing allergies.

The CDA document also has the ability to express information using negation indicators. As in, a patient does not have a specific symptom. The KM system should allow for the definition of alternate representations of such elements so as to allow for consistent understanding and transformations of such elements.

That would be one requirement, but probably the function of the CTS2 service. The negationInd attribute is just another attribute in a V3 class and requires no special handling from the metadata repository.

There is a need to permit the user to enter data from their perspective, but have the entered data converted into a standard and consistent metadata format.

hl7Model

HL7 Model maintenance

KR needs to implement metadata object names that bind to HL7 version 3 artifacts according to the HL7 formal naming conventions

saifModel

SAIF Model maintenance

metaModel

Meta Model maintenance

orchestrationModel

Orchestration Model maintenance

unstructuredDocument

Service specification content, primarily unstructured text

umlModel

UML Model maintenance

The BRIDG DAM is designed to integrate clinical research trial and clinical care domains so that research results can inform healthcare more quickly and so that healthcare outcomes can be used in designing clinical trial protocols. The goal is to enable information system interoperability to improve both medical research and related areas of healthcare. BRIDG already incorporates a number of CDISC standards (e.g., STDM) and is working to harmonize other CDISC standards.

vocabularyModel

Vocabulary Model maintenance

Support reuse of existing vocabularies to build new vocabularies.

schemaModel

Schema Model maintenance

Content

Space Tools