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The requirements listed above address one or more use cases in each domain. In addition to the domain specific use-cases, the requirements also address CBIIT internal development and architecture requirements. Specifically, CBIIT has standardized on Service-Oriented Architecture (SOA) as the foundational principle for applications architecture and interoperability. CBIIT has also adopted a formal approach, Enterprise Conformance and Compliance Framework (ECCF), for defining service specifications. The specifications address both the requirements for supporting semantic interoperability, and the need to publish formal specifications that can be adopted by external organizations and vendors.

The following sections provide a detailed description of the requirements categories. Where possible the requirements are tied to specific use cases described in the previous section.

Artifact Management

Artifacts include Artifact management includes support for different formats of models, both static and dynamic. Artifact management also includes , as well as the ability to manage content and clinical forms. Artifact management primarily deals with managing artifact lifecycle and authoring of artifact metadata.

A service specification is made up of service metadata, artifacts and the metadata supporting these artifacts. Artifact management primarily deals with managing artifact lifecycle and authoring of artifact metadata.enables creating a service specification and provides the following benefits:

Improves Improve visibility through publication. By providing a service which When the management service can be integrated into the development/, testing /and production cycle, artifacts become available for review and discussion, as well as reference for supporting development.  This This helps insure proper understanding of applications and services being developed, and provides a standard and controlled method of access.

Annotated artifacts to expand understanding. To further improve the understanding of artifacts, the management service provides the ability to add annotations to both the parts of an artifact (depending on artifact type) and the artifact as a whole.  Adding Adding additional semantic definitions to an artifact allows for the searching and location of elements across artifact type, as well as make makes clear the intent of a given artifact.

Support for Governance. By allowing When the management services allows for artifact versioning, along with state representation, artifact elements which require governance can be located and interacted with.  This This functional aspect of the artifact management provides a change history as well as links to external change control systems.

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Static models include a variety of models with different representations. Static models include but are not limited to:

• Syntactical and semantic models  models
  • XML, OWL, RDF
• Information Models
  • UML, HL7 MIF, 11179
• Meta Models
  • HL7 RIM (Reference Information Model)
  • BRIDG (Biomedical Research Integrated Domain Group)
  • LS-DAM (Life Sciences Domain Access Model)
• Transforms
  • Object Management Group (OMG) Ontology Definition Metamodel Tranforms
• Model Constraints
  • Object Constraint Language (OCL), Schematron
• Data Types
  • ISO 21090 /and HL7 R2
  • HL7 R1
  • Primitives

Behavioral Models

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Dynamic models include but are not limited to:

• HL7 SAIF (Service-Aware Information Framework) behavioral model (which provides a formal model and grammar for service contracts)
• Orchestrations and Workflows
• Business Rules

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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 communicaitonscommunications. Content includes:

• Service specification content, primarily unstructured text
• Images and other representations of static content

Forms

Forms include Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM), HL7 Clinical Document Architecture (CDA) documents, and HL7 Version 3 RIM derived forms. This includes all aspects of the document including the style, definitions and semantics. CDISC and CDISC and NCI CBIIT require a require a Distributed, Collaborative Form Template Development Environment and a Distributed Knowledge Repository to capture and manage its Metadata.metadata. The following are required:

• Form Templates
• Reusable Form Sections
• Form Definitions

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The National Cancer Institute has created many specification documents which include extended datatype flavors for the iso-ISO 21090 datatypes as well as the ECCF specifications for the behavioral framework, information framework, and governance framework. The specifications are an integral part of the semantic infrastructure, allowing the user to fully understand and appropriately apply the many artifacts stored in the ECCF registry.

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Electronic Health Records: The caBIG® Clinical Information Suite project has adopted ECCF for specifications and Clinical Document Architecture (CDA) documents for interoperability. Project requirements include the need for an infrastructure for managing all the artifacts generated during specification process, including HL7 models and documents. The project also intends to publish these artifacts for the community and vendors. The infrastructure must support better discovery, making all the relevant information available in the right context.

ONC Office of the National Coordinator and other external EHR adopters: ONC has adopted the Continuity of Care Document (CCD) and Continuity of Care Record (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.

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Service discovery and governance allows service developers to specify rich metadata about services. This enables better discovery, and governance of services. Service discovery and governance help to accomplish the following.

Promote Service Reuseservice reuse: The use of well defined service metadata promotes better discovery and reuse of services during design and run time. Service metadata includes information about service interactions and dependencies. It also includes a classification scheme for organizing services based on business objectives, domain, and usage. It also links services to all the supporting artifacts in the specification and provides a placeholder for conformance statements. This enables better reuse across the enterprise and eliminates redundancy.

Establish Service service policies: Service policies help establish constraints on the service specifications and mandate an approach. Policies can be specified around governance, access control and other design and runtime constraints.

Provide Governancegovernance: This includes predefined templates, workflows, and governance policies for governing the service lifecycle as well as an approval and review process for service specifications and the ability to promote services through the stages of the service lifecycle.

Enable Better Discoverybetter discovery: Complex search offers a natural and user-friendly way to find services by progressively refining search results using a variety of criteria including attributes, artifacts, classification, usage scenarios, and dependencies. This includes runtime contract discovery, a powerful query mechanism that allows either the service orchestrator or a program to find the services that best fit the requirements of a given process. This increases both runtime and design time flexibility by enabling selection of services based on computable metadata.

Service Discovery Functions

Service discovery functions include the ability to:

• Identify the service endpoint for analysis
• Identify the service directory endpoint for analysis
• Extract the service interface
• Annotate the service interface providing undiscovered features or behaviors
• Manage lifecycle, governance and versioning of the service Interfacesinterfaces

The requirements listed above are derived from the following use cases:

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Life Sciences: Service discovery based on a rich metadata and semantics of the underlying data play a critical role in developing research pipelines. Research pipelines are developed by connecting data and analytical services together to achieve a research objective.

Other National Initiativesnational initiatives: All EHR vendors and national initiatives rely on a services paradigm for integration and interoperability. A standardized services metamodel makes it easier for participating organization organizations to discover and reuse services.

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Clinical Data Forms are the primary channel for capturing information in the healthcare and clinical domain. Forms also play a key role in information exchange and are critical to supporting interoperability in healthcare.

A form differs from a document, in that a document is used to capture information, while a form defines skip patterns, validation rules, and other aspects required to capture or render information for a document.

A document in this context is specifically a clinical document which represents information about a clinical activity. The document contains the specific information gained during that clinical activity and supports the broader definitions of a document. Documents can be transformed into human readable forms, and be transferred or transmitted for use across different systems.

Clinical data forms definition and modeling provides the following benefits:

Define data entry forms using robust data representation. Ultimately the data that is captured on a form is used in many ways, but that data must provide a high level of meaningful use to insure the consumer knows how the data was captured and what context it represents. In this Define data entry forms using robust data representation. Ultimately the data that is captured on a form is used in many ways, but that data must provide a high level of meaningful use to insure the consumer knows how the data was capture and what context it represents.  In this way even a simple question on a form may result in a much more complex representation in the data.  As As an example, a Yes or No question on a form may result in a codified representation of an observation.

Reuse of contextual representation. Since Since a given form my may collect data for a context that might be common to many forms, being able to reuse these elements in a way that insures contextual consistency is a must.  Forms Forms created with the form definition tool , must retrieve access from well defined metadata sources that provide common contexts, default values, and coded representations including value set binding.

Reuse of form elements. When defining a form element which is bound to a specific contextual representation, it should be easy to reuse that element with minimal reconfiguration. 

Provide Governance support. Forms and the supporting schemas need to be versioned as well as support the governance workflows.  This insures that documentation follows a consistent and planed  use.

A form differs from a document, in that a document is used to capture information, while a form defines skip patterns, validation rules, and other aspects required to capture or render information for a document.

A document in this context is specifically a clinical document which represents information about a clinical activity. The document contains the specific information gained during that clinical activity and supports the broader definitions of a document. Documents can be transformed into human readable forms, and be transferred or transmitted for use across different systems.

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form elements. When defining a form element which is bound to a specific contextual representation, it should be easy to reuse that element with minimal reconfiguration.

Provide governance support. Forms and the supporting schemas need to be versioned as well as support the governance workflows. This insures that documentation follows a consistent and planed use.

Clinical Data Form Functions

The functions of clinical data forms include the following:

• Define model objects for reuse
• Define form templates
• Bind value set to data element
• Provide default form delivery
• Provide form data transformation
• Manage lifecycle, governance and version of forms and document schemas.

Based on the use cases the key forms requirements include:

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• Electronic Health Records
• ONC and Other external EHR adopters
• Clinical TrailsTrials

Decision Support and Reasoning

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