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  ITU-T A.5 justification information for referenced document HL7 CDA IG (2011) in draft H.810
1. Clear description of the referenced document:
Name: HL7 CDA IG (2011)
Title: HL7 Implementation Guide for Clinical Document Architecture, Release 2: Consent Directives, Release 1
2. Status of approval:
HL7 Draft Standard for Trial Use approved on 2011-01.
3. Justification for the specific reference:
This document describes constraints on the Clinical Document Architecture Release 2 (CDA R2) header and body elements used to express Privacy Consent Directive documents, which are used by the Continua Design Guidelines.
4. Current information, if any, about IPR issues:
N/A
5. Other useful information describing the "Quality" of the document:
Publication of this draft standard for trial use and comment has been approved by Health Level Seven International (HL7). This draft standard is not an accredited American National Standard. The comment period for use of this draft standard shall end 18 months from the date of publication. Suggestions for revision should be submitted at http://www.hl7.org/dstucomments/index.cfm. Following this 18 month evaluation period, this draft standard, revised as necessary, will be submitted to a normative ballot in preparation for approval by ANSI as an American National Standard. Implementations of this draft standard shall be viable throughout the normative ballot process and for up to six months after publication of the relevant normative standard.
6. The degree of stability or maturity of the document:
See item 5 above.
7. Relationship with other existing or emerging documents:
Revised version expected after the trial period finishes and received feedback is incorporated in a future version of the standard.
8. Any explicit references within that referenced document should also be listed:
The base standard for this implementation guide is the HL7 Clinical Document Architecture, Release 2.0./
The following list of specifications was used in the creation of this implementation guide:/
• Clinical LOINC® document and section codes/
• Health Information Technology Standards Panel (HITSP) Constructs, Transaction Package (TP30) - Manage Consent Directives/
• HL7 Clinical Document Architecture, Release 2 Normative Edition 2005,/
• Integrating the Healthcare Enterprise (IHE) Profiles, including the content profiles within Cross-Enterprise Sharing Document (XDS) Sharing Scanned Documents Integration Profile (XDS-SD) and Basic Patient Privacy Consents (BPPC) that is based on it/
• HL7 Version 3 Domain Analysis Model: Medical Records; Composite Privacy Consent Directive, DSTU Release 2 (CPCD DAM) – http://www.hl7.org/dstucomments//
• Sample privacy consent authorization forms provided by the state and federal agencies (e.g., SAMHSA, SSA ,VHA, Sate of New York, State of California, British Columbia)
9. Qualification of HL7:
Health Level 7 meets the qualifying criteria for normative referencing as per Recommendation ITU-T A.5.
10. Other (for any supplementary information):
N/A
Note: This form is based on Recommendation ITU-T A.5