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IHE · Dec 13, 2024 · 01c0842 · 01c0842
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diff --git a/CHANGELOG.md b/CHANGELOG.md
@@ -20,7 +20,10 @@ Each section shall contain a list of action items of the following format: `<bri
 - Clarified intentionality of difference between ad-hoc and managed discovery ([#317](https://github.com/IHE/DEV.SDPi/issues/317))
 - Clarified FHIR Gateway support for multiple paradigms ([#264](https://github.com/IHE/DEV.SDPi/issues/264))
 - Clarified that the SES sections are not comprehensive for risk management ([#271](https://github.com/IHE/DEV.SDPi/issues/271))
-- Added SDPi FHIR Gateway ([#252](https://github.com/IHE/DEV.SDPi/issues/252))
+- Bibliography note added indicating the rationale for the subcategories ([#266](https://github.com/IHE/DEV.SDPi/issues/266))
+- SDPi Use Case Approach explanatory text added to start of supplement ([#263](https://github.com/IHE/DEV.SDPi/issues/263))
+
+- Enhanced explanation of SOA aspects of the SDC/SDPi specification (HL7 Ballot) ([#276](https://github.com/IHE/DEV.SDPi/issues/276))
 
 ### Editorial Fixes
 - Added deprecation notice for three requirements due to expected impact of BICEPS standard corrigendum ([#334](https://github.com/IHE/DEV.SDPi/issues/334))
@@ -30,6 +33,8 @@ Each section shall contain a list of action items of the following format: `<bri
 - Commented out concept sections 1:10.4.1.3 thru 1:10.4.1.10 and minimized referencing to years for improving readability ([#268](https://github.com/IHE/DEV.SDPi/issues/268))
 - Removed TBD statements from Table A-1 ([#273](https://github.com/IHE/DEV.SDPi/issues/273))
 
+### Added
+- Added SDPi FHIR Gateway ([#252](https://github.com/IHE/DEV.SDPi/issues/252))
 
 ## [1.4.1] - 2024-10-04
 

diff --git a/asciidoc/sdpi-supplement-intro.adoc b/asciidoc/sdpi-supplement-intro.adoc
@@ -71,6 +71,18 @@ To that end, the supplement includes updates to all (3) IHE DEV TF volumes, incl
 
 * New content covering the application of ISO/IEEE 11073 SDC semantic standards to device content modules, with a primary focus on specifications related to the ISO/IEEE 11073-10207 BICEPS standard.
 
+[#supplement_clause_mapping_clinical_scenarios_to_profile_requirements]
+=== Use Cases:  Mapping Clinical Scenarios to Profile Requirements
+IHE technical framework integration profile specifications include use case sections to ensure that the technical solutions are rooted in real-world application requirements.
+These sections typically include a basic description of use case scenarios, identify the key systems that exchange information, application-level detail of the information exchanged, and perhaps even some sequence diagrams.
+This information may also be used to drive the test cases that are used for conformity assessment, ensuring that the resulting specification implementation meets the intended needs.
+
+This supplement includes this same organization; however, it also defines a set of general, non-profile-specific clinical use cases that provide requirements, which may be mapped to multiple SDPi integration profiles.
+Section <<vol1_appendix_c_dpi_use_cases>> provides a collection of these high-level clinical use cases.
+
+FOR READERS OF THIS SUPPLEMENT, a good strategy might be to first review the use cases in the Volume 1 appendix (e.g., <<vol1_clause_appendix_c_use_case_sicdmp>> ), and then review the specific profiles to which the clinical scenario requiremets have been mapped.
+Reviewing the use case specifications in this order will provide the needed context to understand what is presented in each profile.
+
 [#supplement_clause_joint_ihe_hl7_gemini_ses_mdi_project_development]
 === Joint IHE-HL7 Gemini SES+MDI Project Development
 This supplement is the result of a joint https://confluence.hl7.org/x/Xzf9Aw[IHE-HL7 Gemini Device Interoperability program] which began early 2020.

diff --git a/asciidoc/volume1/tf1-ch-10-sdpi-p.adoc b/asciidoc/volume1/tf1-ch-10-sdpi-p.adoc
@@ -797,7 +797,12 @@ This generalized model includes (3) system roles:
 * #same system can support both roles; all systems mush support participant#
 ////
 
-NOTE:  A detailed overview of <<acronym_soa>> concepts is beyond the scope of this specification.  See <<vol1_appendix_b_references>> for additional background materials.
+As SOA concepts and implementations have evolved, many different approaches have been defined, building upon some of the basic principles (as listed above) and adding detail appropriate for their specific application use.
+A detailed overview of <<acronym_soa>> concepts is beyond the scope of this specification; however, a number of foundational references related to how SOA has been leveraged for medical device interoperability have been provided in <<vol1_appendix_b_references>>, including:
+
+. <<ref_paper_connecting_clinical_it_to_soa_arch_of_medical_devices>>
+. <<ref_ornet_soa_for_safe_dynamic_medical_device_interoperability>>
+. <<ref_paper_design_pattern_for_soa_integration_of_medical_devices>>
 
 The <<acronym_sdc>> <<acronym_biceps>> standard, which SDPi-P profiles, consists of (3) core components, as illustrated in <<figure_sdc_biceps_components_model>>:
 

diff --git a/asciidoc/volume1/tf1-ch-b-ref-standards-conformance.adoc b/asciidoc/volume1/tf1-ch-b-ref-standards-conformance.adoc
@@ -122,15 +122,21 @@ include::conformance-statements/tf1-ch-c-conformance-statement-ieee-11073-10207-
 
 In addition to Referenced Standards, which include normative requirements and capabilities that this technical framework utilizes, there are other standards, specifications, publications, presentations, materials, etc. that have proven valuable in both developing and understanding the framework's content.  This list identifies those items, including many of which are referenced throughout the specifications.
 
+NOTE: The subcategories for the following sections are solely intended to provide organization to the list of entries, facilitating the use of this section.
+
 [bibliography]
 ==== Media (non-standards) References
 
+The following bibliographic references include graphics, "infographic", and similar media.
+
 * [[[ref_iso_81001_temple,ISO 81001-1 "The Temple"]]], ISO/IEC 81001-1 Figure 1 "The Temple" Diagram, Copyright &#169; 2019 NHS Digital, licensed via Wikimedia Commons, http://www.nationalarchives.gov.uk/doc/open-government-licence/version/3[Greg Wye, NHS Digital, OGL 3], available at https://81001.org/page/Framework[81001.org Framework].
 
 
 [bibliography]
 ==== Standards & Publications
 
+The following bibliographic references include standards that are related to this specification but do not contain normative requirements, as well as papers that are useful in understanding related concepts.
+
 * [[[ref_ihe_pcd_sdpi_use_cases_compendium_2019,IHE PCD SDPi Use Cases Compendium:2019]]] IHE Patient Care Devices (PCD) Compendium of Medical Device Oriented Use Cases, Companion to the "Service-oriented Device Point-of-Care Interoperability (SDPi)" White Paper, Revision 1.1, November 1, 2019.  Available at https://profiles.ihe.net/DEV/[profiles.ihe.net/DEV/].
 
 * [[[ref_ihe_pcd_sdpi_white_paper_2019,IHE PCD SDPi White Paper:2019]]] IHE Patient Care Devices (PCD) Service-oriented Device Point-of-Care Interoperability (SDPi) White Paper, Revision 1.1, November 1, 2019.  Available at https://profiles.ihe.net/DEV/[profiles.ihe.net/DEV/].
@@ -141,12 +147,20 @@ metalanguage - Extended BNF, 15 December 1996, available at https://standards.is
 * [[[ref_omg_sysml_2_0_intro_graphical_model,OMG SysML ^&#174;^ Intro-Graphical Notation 2.0]]]  OMG Systems Modeling Language&#8482;  (SysML^&#174;^), Version 2.0, Introduction to the Graphical Model, Object Management Group (OMG) standard.  Available at https://github.com/Systems-Modeling/SysML-v2-Release/tree/master/doc[github.com/Systems-Modeling/SysML-v2-Release/doc/]
 
 * [[[ref_omg_sysml_2_0_spec,OMG SysML ^&#174;^ 2.0]]]  OMG Systems Modeling Language &#8482; (SysML^&#174;^), Version 2.0, Object Management Group (OMG) specification.  Available at https://github.com/Systems-Modeling/SysML-v2-Release/tree/master/doc[github.com/Systems-Modeling/SysML-v2-Release/doc/]
+
 * [[[ref_gender_harmony_project, HL7-GENDER]]] HL7 gender harmony project, available at https://confluence.hl7.org/display/VOC/The+Gender+Harmony+Project
 
+* [[[ref_paper_connecting_clinical_it_to_soa_arch_of_medical_devices, Connecting the clinical IT infrastructure to a service-oriented architecture of medical devices]]] Paper reviewing use of SOA architecture to integrate medical devices into clinical IT infrastructure, available at https://pubmed.ncbi.nlm.nih.gov/29272252/
+
+* [[[ref_ornet_soa_for_safe_dynamic_medical_device_interoperability, OR.NET: a service-oriented architecture for safe and dynamic medical device intoperability]]] Paper reviewing use of SOA architecture to enable an interoperable and safe ecosystem of medical devices, available at https://pubmed.ncbi.nlm.nih.gov/29346114/
+
+* [[[ref_paper_design_pattern_for_soa_integration_of_medical_devices,Standardized Device Services - A Design Pattern for Service Oriented Integration of Medical Devices]]]  C. Mauro, A. Sunyaev, J. M. Leimeister, and H. Krcmar, 2010 43rd Hawaii International Conference on System Sciences, Honolulu, HI, USA: IEEE, Jan. 2010, pp. 1–10. doi: 10.1109/HICSS.2010.347.
 
 [bibliography]
 ==== Presentations
 
+The following bibliographic references include slide decks and recordings that are helpful in understanding these specifications.
+
 * [[[ref_ihe_eu_experience_2021_presentation_cooper_schlichting,IHE EU Experience-2021 IHE CA for MedTech Solutions]]], "IHE & IHE Catalyst: Advancing Interoperable MedTec Solutions with "Regulatory Submission Ready" Conformity Assessment", presentation by Todd Cooper and Dr. Stefan Schlichting, available at https://connectathon.ihe-europe.net/experience-sessions-2021-presentations[IHE Europe Experience 2021 Presentations web page].