Initial resolution proposal for #294 (#301)

* Initial resolution proposal for #294 * Updates to support 1.4 release notes including referenced standard maturity Updated intro text to include a NOTE that referenced standards may be in development or in revision and that when that is the case, a clear indication will be made in the references section. Added some labels to support linking from intro text. Updated release 1.3 note to reflect 1.4 content. * Fixed Bogus Reference Syntax {} instead of <<>> --------- Co-authored-by: Todd "AFC!" Cooper <[email protected]>
IHE · Sep 12, 2024 · 3526a0e · 3526a0e
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diff --git a/.ci/asciidoc-converter/build_document.bat b/.ci/asciidoc-converter/build_document.bat
@@ -0,0 +1 @@
+start gradlew.bat run --args="--input-file ../../asciidoc/sdpi-supplement.adoc --output-folder ../../sdpi-supplement --backend html"
diff --git a/asciidoc/sdpi-supplement-intro.adoc b/asciidoc/sdpi-supplement-intro.adoc
@@ -7,21 +7,30 @@
 [%autowidth]
 [cols="1"]
 |===
-a| *SDPi 1.3 Supplement -- _STU / TI Version_ -- Note*:
+a| *SDPi 1.4 Supplement -- _STU / TI Version_ -- Note*:
 
-This release of the SDPi 1.3 Standard for Trial Use (HL7 STU) / Trial Implementation (IHE TI) supplement is the first release that integrates resolutions from an HL7 ballot cycle (January 2024). This process implements links from HL7 ballot Jira tickets to IHE DEV.SDPi Github Issues that then enable tracking of the comment resolution implementation in this specification.
+This version of the SDPi 1.4 Standard for Trial Use (HL7 STU) / Trial Implementation (IHE TI) supplement is the 3rd release in 2024, continuing the objective to provide three to four releases each year that include both _incremental_ updates (e.g., editorial "fixes"), ballot comment resolutions (e.g., from HL7 ballot cycles), and additional capability enhancements.
+For this release, key additions include:
 
-Note:  The 1.3.1 release provides a few minor editorial corrections that were overlooked in the first release of 1.3.0.
+1. SDPi-P Managed Discovery Option
+2. TF-1A enhanced description of requirements modeling and metadata
 
-Release 1.3 provides only a few _incremental_ updates to release 1.2; however, it continues the objective of quarterly _minor version_ releases and continues to advance support for prototyping and testing of device-to-device plug-and-trust interoperability.
-It is recognized, though, that this release is incomplete with work continuing for 1.4 and subsequent versions.
-These known limitations include:
+All changes incorporated in a release are managed through Github Issues and reviewed Pull Requests.
+For a list of those related to this release, see <<sdpi_issue_management>> below.
+For HL7 ballot comment resolution, links are made from HL7 ballot Jira tickets to IHE DEV.SDPi Github Issues that then enable tracking of the comment resolution implementation in a specific release.
 
 
+NOTE: This supplement also includes both normative and informative references to other specifications (see <<vol1_appendix_b_references>>), some of which are finalized and published and others that are either being developed or in revision.
+For example, the IEEE 11073-10702 PKP standard is in development with balloting expected late 2024 and publication mid-2025; however, some requirements from that pre-standard may be included in this SDPi specification, providing a pathway to early experience and validation.
+When a referenced specification is used that is in development or revision, a note will be provided in the <<vol1_appendix_b_referenced_standards>> clearly indicating its status.
+
+It is recognized that this release is a work-in-progress that will continue to subsequent versions.
+These known limitations and forward-looking content include:
+
 . Releases along with the planned capability additions are managed in the project's https://github.com/orgs/IHE/projects/6[DEV.SDPi "Gemini SDPi Releases" Github project]
 . This supplement includes (4) SDPi Profiles, though the typical IHE supplement is organized for a single profile; as a result, some adjustments have been made, especially in the supplement overview section where there is a general SDPi overview and then basic overviews for each of the Profiles; challenging areas include profile "options" where there are FOUR sections vs. one; it is a work in progress and feedback is appreciated, especially to enhance clarity
 . *Open / Closed Issues tables* -- starting with SDPi 1.1 and subsequent, the approach for the IHE open / closed issues section has been transitioned to utilize https://github.com/IHE/DEV.SDPi/issues[Github Issues] that are related to this release; each release will update the changelog file, detailing what is Added, Changed or Removed
-. *Requirements boxes* (e.g., "R1234") have been added especially in TF-2, with some also part of TF-1 and TF-3; this is an initial approach that *_will be significantly expanded in future versions of the supplement_*; an initial approach is provided in <<vol1_clause_sdpi_requirements_modeling_integration>>, with discussion related to how it will be expanded in future versions of the supplement;
+. *Requirements boxes* (e.g., "R1234") have been added especially in TF-2, with some also part of TF-1 and TF-3; this is an initial approach that *_will be significantly expanded in future versions of the supplement_*; documentation is provided in <<vol1_clause_sdpi_requirements_modeling_integration>>, including discussion related to how it will be expanded in future versions of the supplement;
 . *_<<term_safe_effective_secure>> Sections_* (see <<vol1_clause_appendix_a_ses_considerations_section_template>>) are included in the specification; however, their use and content will be significantly extended in future versions;
 . This supplement is currently rendered as a *"long form"* document -- one single HTML file; however, in subsequent versions the intent is to consider a multi-page / file HTML rendering + addition of a tabbed menu for navigating the sections of the supplement;
 . *{supplement_note}* boxes are provided throughout the document to help guide reviewers and implementers.
@@ -95,7 +104,7 @@ These three objectives may be summarized as follows:
 [none]
 ** Enable CA test reports that are genuinely _"regulatory submission ready"_ (e.g., inclusion in a U.S. FDA 510(k) submission package)
 
-The SDPi 1.3 version of the supplement continues to make small but significant steps toward support of these objectives, especially Requirements Interoperability, as well as the use of AsciiDoc metadata to annotate the document sources for post-processing.
+The SDPi {ihe_supplement_sdpi_revision} version of the supplement continues to make small but significant steps toward support of these objectives, especially Requirements Interoperability, as well as the use of AsciiDoc metadata to annotate the document sources for post-processing.
 Clearly, moving toward <<term_model_centric>> specifications and full integration of <<term_model_based_systems_engineering>> (<<acronym_mbse>>) will take considerable effort and time; however, this supplement represents a humble start in that direction.
 Subsequent supplement versions will build upon these objectives and support a new level of rigor for connectathon and product conformity assessment testing and ultimately test reports that directly impact the challenges around medical product regulatory submissions.
 

diff --git a/asciidoc/sdpi-supplement-issues.adoc b/asciidoc/sdpi-supplement-issues.adoc
@@ -1,5 +1,6 @@
 
 [sdpi_offset=clear]
+[#sdpi_issue_management]
 == SDPi Issue Management
 
 [sdpi_offset=clear]

diff --git a/asciidoc/volume1/tf1-ch-b-ref-standards-conformance.adoc b/asciidoc/volume1/tf1-ch-b-ref-standards-conformance.adoc
@@ -13,10 +13,20 @@ Also, integration of explicit standards' <<term_implementation_conformance_state
 Ultimately, the content of this appendix may be rearranged and even relocated; however, for early versions of the SDPi supplement, it has proven helpful, and even of critical importance and value.
 |===
 
-// Appendix B.x
+// Appendix B
+[#vol1_appendix_b_referenced_standards]
 [bibliography]
 === Referenced Standards
 
+[%noheader]
+[%autowidth]
+[cols="1"]
+|===
+| *{supplement_note}*: The standards listed in this section are predominantly published.
+However, in the current version, three of them are unpublished drafts and are hence subject to requirement changes once they are published: <<ref_hl7_fhir_pocd_ig>>, <<ref_ieee_11073_10702_202x>> and <<ref_ieee_11073_10703_202x>>.
+No content from those three standards - including their requirements -  is normatively used in the current version.
+|===
+
 * [[[ref_aami_2700_1_2019,AAMI 2700-1:2019]]]  AAMI 2700-1:2019  Medical Devices And Medical Systems - Essential Safety And Performance Requirements For Equipment Comprising The Patient-Centric Integrated Clinical Environment (ICE) - Part 1: General Requirements And Conceptual Model, available at https://webstore.ansi.org/Standards/AAMI/ansiaami27002019[ANSI/AAMI web store].
 
 * [[[ref_hl7_fhir,HL7 FHIR]]]  HL7^&#174;^ Fast Healthcare Interoperability Resources (FHIR^&#174;^), available at http://hl7.org/fhir/[hl7.org/fhir/].
@@ -27,7 +37,7 @@ Ultimately, the content of this appendix may be rearranged and even relocated; h
 
 * [[[ref_iec_60601_1_8_2020,IEC 60601-1-8:2020]]], IEC 60601-1-8:2006/AMD2:2020, Medical electrical equipment — Part 1-8: General requirements for basic safety and essential performance — Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems; Amendment 1:2020, and Amendment 2:2020. available at https://webstore.iec.ch/publication/59648[IEC Webstore] and the https://www.iso.org/standard/41986.html[ISO standards store].
 
-* [[[ref_ieee_11073_10101_2020,IEEE 11073-10101:2020]]] IEEE 11073-10101™ International Standard - Health informatics--Device interoperability--Part 10101:Point-of-care medical device communication--Nomenclature.  Available at hhttps://standards.ieee.org/ieee/11073-10101/10343/[IEEE online standards store].
+* [[[ref_ieee_11073_10101_2020,IEEE 11073-10101:2020]]] IEEE 11073-10101™ International Standard - Health informatics--Device interoperability--Part 10101:Point-of-care medical device communication--Nomenclature.  Available at https://standards.ieee.org/ieee/11073-10101/10343/[IEEE online standards store].
 
 * [[[ref_ieee_11073_10201_2004,IEEE 11073-10201:2004]]] IEEE 11073-10201™ International Standard - Health informatics--Device interoperability--Part 10201:Point-of-care medical device communication--Domain information model.  Note this was updated in 2020.  Available at https://standards.ieee.org/ieee/11073-10201/10263/[IEEE online standards store].