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The semantic requirements provide a framework for a detailed description of services in the architecture section. This section presents the requirements derived as a result of the requirements analysis of the use cases presented in previous section. The analysis includes tracing of requirements up to the use case and stakeholders and down to service capabilities specified later in this document. Note that the requirements section is not complete and this section is expected to evolve as additional requirements are added.
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Semantic Infrastructure Users and Roles
The semantic infrastructure is expected to address the needs of a broad group of stakeholders. The semantic infrastructure as defined in this section provides foundational specifications and capabilities that address the requirements of the following key users:
- Clinicians
- Model Developers
- Service Developers
- Service Architects
- Service Analysts
- CBIIT Enterprise Architecture Governance
- Vendors
- Platforms, including caGrid 2.0
- BioInformatics Specialists
Functional Requirements
This section provides a description of the following requirement categories:
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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 support for different formats of models, both static and dynamic. Artifact management also includes the ability to manage content and clinical forms. 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.
Static Models
Static models include a variety of models with different representations. Static models include but are not limited to:
- XML Schemas
- UML/HL7 Models, including domain models like BRIDG and LS-DAM
- OWL
- Meta Models
- Transforms
- Model Constraints, like OCL
- Data Types
Behavioral Models
In the context of this paper, 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.
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- HL7 SAIF behavioral model (which provides a formal model and grammar for service contracts)
- Orchestrations and Workflows
- Business Rules
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. Content includes:
- Service specification content, primarily unstructured text
- Images and other representations of static content
Forms
Forms include both ODM and CDA documents. This includes all aspects of the document including the style, definitions and semantics.
- Form Templates
- Form Definitions
Specification Content
To be provided.
Artifact Management Functions
Artifact lifecycle management and metadata requirements include the ability to:
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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.
Service Discovery and Governance
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.
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caGRID 2.0 Platform: The caGRID 2.0 Platform provides a runtime registry for service discovery. This service registry relies on a small subset of information for discovery. The semantic infrastructure provides a mechanism to leverage rich service and artifact metadata to extend this capability.
Case Report Forms Definition and Modeling
Case Report 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.
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- caEHR
- ONC and Other external EHR adopters
- Clinical Trails
Conformance Testing
Services specifications developed by NCI and the community have to be testable to ensure that the implementation conforms to the specification.
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Other National Initiatives: Other national organizations like NIST are adopting a similar approach to conformance testing.
caGRID 2.0 Platform and Terminology Integration
The Semantic Infrastructure has to support seamless integration with the caGRID 2.0 platform. The following are some high-level platform and terminology requirements that are either supported or addressed by the Semantic Infrastructure.
Service Generation
Service generation is the ability to generate services from user defined service metadata. The semantic infrastructure provides this metadata and the platform leverages this metadata for service generation. The constraints and policies specified in the semantic infrastructure are inherited by the platform and are enforced as runtime policies.
Additional platform specific and runtime information is provided by the developer at the time of service generation.
Service Discovery and Utilization
This group of requirements focuses on enabling developers of composite services and applications to discover, compose, and invoke services. This includes the discovery of published services based on service metadata and the generation of client APIs in multiple languages to provide cross-platform access to existing services.
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Link to use case satisfied from caGRID 2.0 Roadmap: all of the data management and access services in the use case are utilized by application developers to build the user interfaces that the clinicians use during the course of patient care.
Service Orchestration and Choreography
Service orchestration and choreography allows both application developers and non-developers to discover service "building blocks" that can be composed dynamically to provide business capabilities. Special cases include the orchestration of multiple services for a distributed query, or for a transactional workflow. Service orchestration and choreography will leverage static and behavioral semantics from the Semantic Infrastructure 2.0.
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Link to use case satisfied from caGRID 2.0 Roadmap: Federated query over the TCGA data and other data sets is performed using a service orchestration.
Policy and Rules Management
Policy and Rules Management allow non-developer secondary users to create policies and rules and apply them to services. The scope of policies includes, but is not limited to, definition and configuration of business processing policy and related rules, compliance policies, quality of service policies, and security policies. Some key functional requirements for managing policies include capabilities to author policies and store policies, and to approve and validate policies and execute policies at runtime.
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Link to use case satisfied from caGRID 2.0 Roadmap: Each institution has different data sharing needs, access control needs, and business rules for processing that are defined and customized. For example, policy at the pathologist's institution may state that the patient is scheduled for a visit when the review is complete.
Event Processing and Notifications
Event Processing and Notifications enables monitoring of services in the ecosystem and provides for asynchronous updates by services, effectively allowing a loose coordination of services that both provide and respond to conditions (possibly defined in business rules).
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Link to use case satisfied from caGRID 2.0 Roadmap: As patient care proceeds, the system notifies the designated clinicians that data (for example, images) are ready for review. Similarly, when notifications are received, event processing logic allows the appropriate parties to assign clinicians for care. In order to facilitate better treatment (a learning healthcare system), as new de-identified glioblastoma data is made available, notifications are sent that could indicate a recommended change in the treatment plan.
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.
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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.
Data Management
Data management includes linking of disparate data sets and updates of data across the ecosystem. Data updates may include updates to multiple data sources, necessitating the need for transactions.
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Link to use case satisfied from caGRID 2.0 Roadmap: the patient has an electronic medical record that spans multiple institutions. The clinical workup data (for example, genomics and proteomics data) is linked to the clinical care record; similarly pathology and radiology findings must be attached to the patient's electronic medical record.
Data Exploration and Query
The wealth of data must be accessible, resulting in the need for exploration of available datasets. This includes the ability to view seamlessly across independent data sets, allowing a secondary user to integrate data from multiple sources. In addition, the query capability must support sophisticated queries such as temporal queries and spatial queries.
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Link to use case satisfied from caGRID 2.0 Roadmap: The oncologist must be able to quickly find glioblastoma data sets, indicating the fields that he is interested in comparing from his clinical data in order to find similar disease conditions and associated treatment plans. Temporal queries allow clinicians to identify changes in patient condition and treatment over time.
Provenance
Provenance encompasses the origin and traceability of data throughout an ecosystem. This is a clear requirement directly from the use case in order to ensure that all steps of patient care and research are clearly linked via the patient record.
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Link to use case satisfied from caGRID 2.0 Roadmap: The origin of data is tied to the data creator, allowing the oncologist performing the match against TCGA data and other datasets to include and exclude data sets based on their origin.
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.
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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.
External Data Repositories
There are numerous data repositories on the web today. These data repositories contain essential information that must be accessible to services in the ecosystem. As a result, caGrid 2.0 must provide capabilities to integrate these external repositories into the grid with the assumption that the remote service cannot be changed.
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