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The following sections provide the history of changes made to this document.
This document is now Released for Implementation.
Removed footnote regarding informative nature of C36 as that construct is now complete
Removed references to HITSP/C45 - Acknowledgements, this construct is no longer required; the topic is covered in the referenced HL7 Implementation Guide that is used in HITSP/C36 - Lab Result Message Component
Upon approval by the HITSP Panel on December 13, 2007, this document is now Released for Implementation.
This document has been updated to include the HITSP Security and Privacy constructs and has been updated to reflect the new template.
Updated document with additional design details and UML diagrams, and inclusion of Security and Privacy constructs
Completed conformance to new template
Mapped Business Actors to Technical Actors and Transactions (Table 3-7)
Enumerated General Laboratory and Microbiology subsets previously implied, but without introducing new requirements
Provided clarifications, updates, and additional implementation details throughout the document with updates to text, UML diagrams, and additional tables
Interoperability Specification Document Map now only shows the constructs used by the Interoperability Specification. To see the specific standards that are used by each construct, refer to the construct specification (see Section 1.2)
Updated the list of Technical Actors used by the Interoperability Specification to include those Technical Actors used by the Security and Privacy constructs
Addition of Security and Privacy requirements and constructs (see Section 1.2 for full list of constructs to Interoperability Specification). The list of Selected Standards now includes the associated Security and Privacy standards (see Section 4.1.2)
There are now 2 standards tables used to provide the standards that are used by the Interoperability Specification:
- Regulatory and Guidance Standards which are the legal or other authoritative declarations that HITSP must abide by. HIPAA and CLIA are now cited in this section (see Section 4.1.1)
- Selected Standards which are those standards that are selected within the context of the specific Use Case requirements, and are required to be implemented as part of the Interoperability Specification (see Section 4.1.2)
Changes were made to the Selected Standards table for clarifications, additions and deletions. These updates do not represent new technical requirements to the Interoperability Specification
- Clarifications: The following standard references were updated to provide version updates, and more specific references (see Table 4-2):
Integrating the Healthcare Enterprise (IHE) IT Infrastructure Technical Framework (ITI-TF) Revision 4.0, Section 10 Cross-Enterprise Document Sharing (XDS.a) updated name of standard
Internet Engineering Task Force (IETF) Hypertext Transfer Protocol (HTTP) over Transport Layer Security (TLS) (RFC) #2818 replaced HTTPS port information with correct standard name
Integrating the Healthcare Enterprise (IHE) Laboratory Technical Framework Volume 3 - updated version of standard
Integrating the Healthcare Enterprise (IHE) IT Infrastructure Technical Framework (ITI-TF) Supplement ITI-25 Notification of Document Availability (NAV) updated name of standard
Integrating the Healthcare Enterprise (IHE) IT Infrastructure Technical Framework (ITI-TF) Revision 4.0 - Registry Stored Query Transaction for XDS Profile additional supplement to standard name, added [ITI-18] for additional clarity
- Deletion: The following standard reference was listed as selected in the previous version of the Interoperability Specification; however, due to the fact that this standard is referenced indirectly through the IHE Laboratory Technical Framework Volume 3, this standard is now being removed from the selected standards list. This does not remove nor introduce any new requirements for the Interoperability Specification
Health Level Seven (HL7) Version 3.0 Clinical Document Architecture (CDA) R2
- Additions: The following standard references are used by the underlying constructs, however, they had previously not been listed in the Interoperability Specification. These are existing technical requirements in the Interoperability Specification and do not represent new requirements for the Interoperability Specification:
Health Level Seven (HL7) U.S. Realm Interoperability Specification: Lab Result Message to EHR (ORU^R01) (HL7 Version 2.5.1)
Integrating the Healthcare Enterprise (IHE) IT Infrastructure Technical Framework (ITI-TF) Volume 2 Supplement 2007 2008 Cross-Enterprise Document Sharing-B (XDS.b)
Updated listed standards gaps and associated resolution plan (see Section 4.2)
Upon approval by the HITSP Panel on May 16, 2008, this document is now Released for Implementation.
This document has been modified to reflect the updated HITSP approach to categorizing standards as Regulatory Guidance, Selected Standards, and Informative References. Please refer to the underlying constructs for specific changes to standards.
Made editorial changes to narrative to provide additional clarity.
Upon approval by the HITSP Panel on August 27, 2008, this document is now Released for Implementation.
[1] HITSP/C37 - Lab Report Document Component references the Integrating the Healthcare Enterprise (IHE) Laboratory Technical Framework Volume 3 (LAB TF-3) Document-based Transactions, Revision 2.0 - For Trial Implementation, August 16, 2007, which provides the guidance for construction of an XML document for Lab Results using HL7 V3.0 Clinical Document Architecture, Release 2.0 (HL7 V3.0 CDA R2).
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