HL7_IG_DS4P_R1_CH1_CONTENT

Approach

This guide was developed by constraining health IT interoperability standards and US-specific implementation guides in accordance to the requirements captured in the Use Cases developed by the Data Segmentation for Privacy (DS4P) S&I Framework Initiative stakeholder community .

Additional technical requirements were identified by pilot projects engaged in validating the implementation guidance developed by the DS4P S&I ) Framework Initiative. The pilot implementations of the DS4P underwent inspection testing and demonstrated support for the user stories; therefore the project was deemed ready for its first Normative ballot in September 2013.

This IG has also addressed the testable criteria summarized in the requirements specified by the DS4P S&I Initiative Project in the Requirements Traceability Matrix (RTM) developed by the Data Segmentation for Privacy S&I (DS4P) Initiative .

In addition to constraints to the C-CDA specification, this implementation guide is also applying constraints on the relevant transport specifications used by the pilot implementation. The associated transport profile constrain the metadata specified by the IHE IT Technical Infrastructure, Nationwide Health Information Network (NwHIN) and DIRECT Project respectively.

In order to make use of a set of generic and reusable constraint, this IG first defines reusable and platform neutral structures as Privacy Annotation Building Blocks:
Confidentiality Code specified as an implementation neutral class that constrains the terminology constraint - value set:
Figure 1. Implementation-neutral of Confidentiality metadata
Purpose of Use Code specified as an implementation neutral class that constrains the terminology constraint - value set:
Figure 2. Implementation-neutral of Purpose of Use metadata
Obligation Policy Code specified as an implementation neutral class that constrains the terminology constraint - value set:
Figure 3. Implementation-neutral of Obligation Policy metadata
Refrain Policy Code specified as an implementation neutral class that constrains the terminology constraint - value set:
Figure 4. Implementation-neutral of Refrain Policy metadata

Applying Privacy Annotations Building Blocks to CDA R2 and C-CDA document

The definition of the Privacy Annotation Building Blocks are applied to Security Observation applied to individual entries in the structure of a document to annotate its protected content with privacy metadata.

Privacy Annotations are represented as a Security Label(leveraging the HL7 HCS concepts referenced) that contains a pre-defined set of Security Observations:
Figure 5. Applying Privacy Building Blocks to Privacy Annotations Template Structure

Applying the Privacy Annotations Building Blocks to Transport Specification

The ebXML structures used to create the IHE IT Document Sharing Metadata (e.g. XDR and XDM metadata) for registering a document, are all based on a common set of classifications and key-value pair slots. The following is an abstract Registry Classification:
Figure 6. Classifications are typically to specify coded privacy metadata.
The following is a diagram illustrating how the ebXML RIM Classification is constrained to specify the Purpose of Use of a specific document transmission:
Figure 7. Classification used to specify Purpose of Use
The following is a diagram illustrating how the ebXML RIM Classification is constrained to specify the Obligation Policy Code of a specific document transmission:
Figure 8. Classification used to specify Obligation Policy Code
The following is a diagram illustrating how the ebXML RIM Classification is constrained to specify the Refrain Policy Code of a specific document transmission:
Figure 9. Classification used to specify Refrain Policy Code

In conclusion, this IG specifies how the privacy-related requires introduced by the DS4P S&I Framework Initiative are encoded in a platform neutral format and using the ebXML metadata used by the NwHIN and DIRECT implementations. This specification specifies the expectation that receiver of the privacy metadata must process, persist, and use it. Other system capabilities beyond interoperability and system responsibilities are not the focus of this IG. .

The implementation-neutral privacy annotation described above may apply to other types of information exchange standards besides CDA R2 and C-CDA: HL7 Version 2.x, DICOM objects, PDF objects, FHIR resrouces, and other content that can be properly described and carried by appropriately constraints transport specifications.