1.3.4 - Model

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::Artifact Lifecycle Management

vocabularyModel

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.

Semantic Infrastructure Requirements::Artifact Management::Behavioral Models

orchestrationModel
saifModel

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::BRIDG::BRIDG-2 - Handle ISO-11179 specification handling of early binding of attribute context

vocabularyModel

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::caEHR::caEHR 2 - CDA,CCD Document Handling

hl7CdaModel

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-13 -  Provide the ability to retrieve CDISC Standards in a machine interpretable format

cdiscModel

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-7 -  Support the meta-model being developed by CDISC SHARE

cdiscModel

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::CDISC::CDISC-8 -  Support the BRIDG (Biomedical Research Integrated Domain Group) Domain Analysis Model (DAM)

umlModel

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-11 -   Support reuse of existing vocabularies to build new vocabularies

vocabularyModel

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.

Gap Analysis::HL7 CIC::CIC-9 -  Provide a common interface for different clinical specialties

hl7CdaModel

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::Artifact Management::Content

unstructuredDocument

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 Representation and Information Models

hl7CdaModel

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.

Semantic Infrastructure Requirements::caGRID 2.0 Platform and Terminology Integration::Data Semantics

hl7Model
vocabularyModel
saifModel

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

Gap Analysis::EVS::EVS-2 - Implement HL7 formal naming conventions

hl7Model

Service Oriented Architecture is an architectural paradigm for organizing and utilizing distributed capabilities that may be under the control of different ownership domains. Consequently, it is important that organizations that plan to engage in service interactions adopt governance policies and procedures sufficient to ensure that there is standardization across both internal and external organizational boundaries to promote the effective creation and use of SOA-based services. SOA governance requires numerous architectural capabilities on the Semantic Infrastructure: Governance is expressed through policies and assumes multiple use of focused policy modules that can be employed across many common circumstances This is elaborated in the inherited Policy profile. Governance requires that the participants understand the intent of governance, the structures created to define and implement governance, and the processes to be followed to make governance operational. This is provided by capabilities specialized from the inherited Management Profile. Governance policies are made operational through rules and regulations. This is provided by the following capabilities, most of which are specializations of the inherited Artifact Profile: * descriptions to enable the rules and regulations to be visible, where the description includes a unique identifier and a sufficient, and preferably a machine process-able, representation of the meaning of terms used to describe the rules and regulations; * one or more discovery mechanisms that enable searching for rules and regulations that may apply to situations corresponding to the search criteria specified by the service participant; where the discovery mechanism will have access to the individual descriptions of rules and regulations, possibly through some repository mechanism; * accessible storage of rules and regulations and their respective descriptions, so service participants can understand and prepare for compliance, as defined. * SOA services to access automated implementations of the Governance Processes. Governance implies management to define and enforce rules and regulations.. This is elaborated in the inherited Management profile. Governance relies on metrics to define and measure compliance. This is elaborated in the inherited Metric profile.

Semantic Profile::OASIS SOA::Governance Model

discovery from inherited abstract profile Artifactidentity from inherited abstract profile Artifactmetadata from inherited abstract profile Artifactstore from inherited abstract profile Artifact

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::Conformance Testing::Search and Access Conformance Statements

saifModel
hl7Model
vocabularyModel

A service description is an artifact, usually document-based, that defines or references the information needed to use, deploy, manage and otherwise control a service. This includes not only the information and behavior models associated with a service to define the service interface but also includes information needed to decide whether the service is appropriate for the current needs of the service consumer. Thus, the service description will also include information such as service reachability, service functionality, and the policies and contracts associated with a service. A service description artifact may be a single document or it may be an interlinked set of documents. Architectural implications of service description on the Semantic Infrastructure are reflected in the following functional decomposition: * Description will change over time and its contents will reflect changing needs and context. This is elaborated in the inherited Change profile. * Description makes use of defined semantics, where the semantics may be used for categorization or providing other property and value information for description classes. This is elaborated in the inherited Semantic Model profile. * Descriptions include reference to policies defining conditions of use and optionally contracts representing agreement on policies and other conditions. This is elaborated in the inherited Policy profile. * Descriptions include references to metrics which describe the operational characteristics of the subjects being described. This is elaborated in the inherited Metrics profile. * Descriptions of the interactions are important for enabling auditability and repeatability, thereby establishing a context for results and support for understanding observed change in performance or results. This is elaborated in the inherited Interaction profile. * Descriptions may capture very focused information subsets or can be an aggregate of numerous component descriptions. Service description is an example of a likely aggregate for which manual maintenance of all aspects would not be feasible. This is elaborated in the inherited Composition profile. * Descriptions provide up-to-date information on what a resource is, the conditions for interacting with the resource, and the results of such interactions. As such, the description is the source of vital information in establishing willingness to interact with a resource, reachability to make interaction possible, and compliance with relevant conditions of use. This is elaborated in the inherited Interoperability profile. Policy capabilities are specialization of Artifact capabilities.

Semantic Profile::OASIS SOA::Service Description Model

versioning from inherited abstract profile ChangeconfigurationManagement from inherited abstract profile Changetransition from inherited abstract profile Changediscovery from inherited abstract profile Artifactidentity from inherited abstract profile Artifactmetadata from inherited abstract profile Artifactstore from inherited abstract profile ArtifactsemanticConversion from inherited abstract profile Semantic Model

One of the key requirements for participants interacting with each other in the context of a SOA is achieving visibility: before services can interoperate, the participants have to be visible to each other using whatever means are appropriate. The Reference Model analyzes visibility in terms of awareness, willingness, and reachability. Visibility in a SOA ecosystem has the following architectural implications on mechanisms providing support for awareness, willingness, and reachability: Mechanisms providing support for awareness will likely have the following minimum capabilities: * creation of Description, preferably conforming to a standard Description format and structure; * publishing of Description directly to a consumer or through a third party mediator; * discovery of Description, preferably conforming to a standard for Description discovery; * notification of Description updates or notification of the addition of new and relevant Descriptions; * classification of Description elements according to standardized classification schemes. In a SOA ecosystem with complex social structures, awareness may be provided for specific communities of interest. The architectural mechanisms for providing awareness to communities of interest will require support for: * policies that allow dynamic formation of communities of interest; * trust that awareness can be provided for and only for specific communities of interest, the bases of which is typically built on keying and encryption technology. The architectural mechanisms for determining willingness to interact will require support for: * verification of identity and credentials of the provider and/or consumer; * access to and understanding of description; * inspection of functionality and capabilities; * inspection of policies and/or contracts. The architectural mechanisms for establishing reachability will require support for: * the location or address of an endpoint; * verification and use of a service interface by means of a communication protocol; * determination of presence with an endpoint which may only be determined at the point interaction but may be further aided by the use of a presence protocol for which the endpoints actively participate.

Semantic Profile::OASIS SOA::Service Visibility Model

discovery from inherited abstract profile Artifact

Static models include a variety of models with different representations.

Semantic Infrastructure Requirements::Artifact Management::Static Models

vocabularyModel
hl7Model
metaModel
umlModel
schemaModel

Conformance testing allows both CBIIT and other HL7 SAIF adopters to validate specifications.

Semantic Infrastructure Requirements::Conformance Testing::Test for Conformance

saifModel