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2.14.5 Structured Data Capture (SDC) - Data Element Exchange Implementation Guide

This implementation guide is a supplement to the base Structured Data Capture (SDC) implementation guide. It defines expectations for Data Element registries, as well as those systems that are responsible for the creation and maintenance of data elements within those registries. This capability is documented as a distinct implementation guide because the expectations for systems creating and maintaining data elements are higher than for those systems that are merely responsible for referencing data elements when creating forms or configuring their systems to support pre-population or auto-population.

The set of expectations described within this implementation guide reflects the consensus view of those stakeholders involved in the Structured Data Capture public consultation group, which included representatives from several large organizations responsible for data element registries, including:

• The US Federal Drug Administration (FDA)
• The US National Cancer Institute (NCI)
• The US National Library of Medicine (NLM)
• The College of American Pathologists (CAP)

This implementation guide is intended to be conformant with the ISO/IEC 11179-3 standard, though it only defines (and requires support for) only a subset of the properties defined in that specification.

This implementation guide was prepared as a U.S. Realm Specification on behalf of the Structured Data Capture project - an effort under the U.S. Office of the National Coordinator (ONC)'s Standards and Infrastructure (S & I) Framework However, much of the content is likely to be useable in other jurisdictions.

2.14.5.1 Background

DataElement instances do not convey patient-specific information. However, because the mappings associated with data elements can influence the data that might be automatically populated into forms and could also influence the security controls around data associated with the DataElement, security precautions should be taken to ensure that data elements are not created or revised by someone without the proper authority. Security practices for systems complying with this implementation guide are the same as those for the primary SDC implementation guide.

Additional information about the Structured Data Capture project can be found on the project's wiki/

2.14.5.2 Specification

The SDC Data Element Exchange FHIR Implementation Guide is based on the HL7 FHIR standard. It defines expectations around the creation and use of the DataElement. It consists of two aspects:

• A single SDC Data Element Exchange Profile which documents constraints and extensions to be supported when creating and maintaining data elements; and

• Two conformance statements that describe the behavior of systems complying with this specification:

  • SDC Data Element Registry - Repository for data elements
  • SDC Data Element Curator - System responsible for creating and updating data elements

Systems supporting the SDC Data Element Registry role SHALL be capable of accepting, persisting and returning all DataElement properties marked as "must support" in the SDC Data Element Exchange profile. Systems supporting the SDC Data Element Curator role SHALL be capable of providing and updating those same properties.