diff --git a/.ci/asciidoc-converter/build_document.bat b/.ci/asciidoc-converter/build_document.bat index 1a35a615..5343e3d9 100644 --- a/.ci/asciidoc-converter/build_document.bat +++ b/.ci/asciidoc-converter/build_document.bat @@ -1 +1 @@ -gradlew.bat run --args="--input-file ../../asciidoc/sdpi-supplement.adoc --output-folder ../../sdpi-supplement --backend html" +gradlew.bat run --args="--input-file ../../asciidoc/sdpi-standard.adoc --output-folder ../../sdpi-standard --backend html" diff --git a/.ci/asciidoc-converter/build_document_pdf.bat b/.ci/asciidoc-converter/build_document_pdf.bat index d245d581..c46cca96 100644 --- a/.ci/asciidoc-converter/build_document_pdf.bat +++ b/.ci/asciidoc-converter/build_document_pdf.bat @@ -1,3 +1,3 @@ -gradlew.bat run --args="--input-file ../../asciidoc/sdpi-supplement.adoc --output-folder ../../sdpi-supplement --backend pdf" +gradlew.bat run --args="--input-file ../../asciidoc/sdpi-standard.adoc --output-folder ../../sdpi-standard --backend pdf" diff --git a/.ci/asciidoc-converter/publish_assets.bat b/.ci/asciidoc-converter/publish_assets.bat index 78adf896..f97a62bd 100644 --- a/.ci/asciidoc-converter/publish_assets.bat +++ b/.ci/asciidoc-converter/publish_assets.bat @@ -1,5 +1,5 @@ -xcopy ..\..\asciidoc\css\*.* ..\..\sdpi-supplement\css /I /R /Y -xcopy ..\..\asciidoc\fonts\*.* ..\..\sdpi-supplement\fonts /I /R /Y -xcopy ..\..\asciidoc\images\*.* ..\..\sdpi-supplement\images /I /R /Y -xcopy ..\..\asciidoc\js\*.* ..\..\sdpi-supplement\js /I /R /Y -xcopy images\*.* ..\..\sdpi-supplement\images /I /R /Y \ No newline at end of file +xcopy ..\..\asciidoc\css\*.* ..\..\sdpi-standard\css /I /R /Y +xcopy ..\..\asciidoc\fonts\*.* ..\..\sdpi-standard\fonts /I /R /Y +xcopy ..\..\asciidoc\images\*.* ..\..\sdpi-standard\images /I /R /Y +xcopy ..\..\asciidoc\js\*.* ..\..\sdpi-standard\js /I /R /Y +xcopy images\*.* ..\..\sdpi-standard\images /I /R /Y \ No newline at end of file diff --git a/.github/prepare_artifacts.sh b/.github/prepare_artifacts.sh index 2934818b..f91d9878 100755 --- a/.github/prepare_artifacts.sh +++ b/.github/prepare_artifacts.sh @@ -5,15 +5,28 @@ gem install asciidoctor-diagram gem install asciidoctor-diagram-plantuml asciidoctor -V cd asciidoc || exit -asciidoctor -r asciidoctor-diagram -D ../ sdpi-supplement.adoc + +mkdir sdpi-documents + +asciidoctor -r asciidoctor-diagram -D ../sdpi-documents sdpi-standard.adoc +asciidoctor -r asciidoctor-diagram -D ../sdpi-documents sdpi-supplement.adoc cd .. -mkdir sdpi-supplement -cp -R asciidoc/images sdpi-supplement/images -cp -R asciidoc/js sdpi-supplement/js -cp -R asciidoc/css sdpi-supplement/css -cp -R asciidoc/fonts sdpi-supplement/fonts -rm -rf sdpi-supplement/.asciidoctor -rm -rf sdpi-supplement/readme.md + +mkdir sdpi-documents/sdpi-standard +cp -R asciidoc/images sdpi-documents/sdpi-standard/images +cp -R asciidoc/js sdpi-documents/sdpi-standard/js +cp -R asciidoc/css sdpi-documents/sdpi-standard/css +cp -R asciidoc/fonts sdpi-documents/sdpi-standard/fonts +rm -rf sdpi-documents/sdpi-standard/.asciidoctor +rm -rf sdpi-documents/sdpi-standard/readme.md + +mkdir sdpi-documents/sdpi-supplement +cp -R asciidoc/images sdpi-documents/sdpi-supplement/images +cp -R asciidoc/js sdpi-documents/sdpi-supplement/js +cp -R asciidoc/css sdpi-documents/sdpi-supplement/css +cp -R asciidoc/fonts sdpi-documents/sdpi-supplement/fonts +rm -rf sdpi-documents/sdpi-supplement/.asciidoctor +rm -rf sdpi-documents/sdpi-supplement/readme.md sudo apt-get install zip gzip tar -zip -r "sdpi-supplement-$1.zip" sdpi-supplement \ No newline at end of file +zip -r "sdpi-documents-$1.zip" sdpi-documents \ No newline at end of file diff --git a/.github/workflows/feature-review-build.yml b/.github/workflows/feature-review-build.yml index f49ae801..bbecfa38 100755 --- a/.github/workflows/feature-review-build.yml +++ b/.github/workflows/feature-review-build.yml @@ -4,7 +4,7 @@ on: [push, pull_request] env: CI: true - + jobs: build: @@ -16,7 +16,7 @@ jobs: steps: - name: Checkout branch uses: actions/checkout@v4 - + - name: Set up JDK 17 uses: actions/setup-java@v4 with: @@ -30,25 +30,34 @@ jobs: with: ruby-version: '3.0' # Not needed with a .ruby-version file bundler-cache: true # runs 'bundle install' and caches installed gems automatically - + - name: Setup gradle uses: gradle/actions/setup-gradle@v4 - - name: Create HTML with Gradle - run: ./gradlew run --args="--input-file ../../asciidoc/sdpi-supplement.adoc --output-folder ../../sdpi-supplement --github-token '${{ secrets.SDPI_API_ACCESS_TOKEN_SECRET }}' --backend html" + - name: Create folders + run: | + mkdir -p sdpi-documents/sdpi-standard + mkdir -p sdpi-documents/sdpi-supplement + + - name: Create SDPi Standard HTML with Gradle + run: ./gradlew run --args="--input-file ../../asciidoc/sdpi-standard.adoc --output-folder ../../sdpi-documents/sdpi-standard --github-token '${{ secrets.SDPI_API_ACCESS_TOKEN_SECRET }}' --backend html" working-directory: .ci/asciidoc-converter - - name: Generate PlantUML diagrams and static files + - name: Create SDPi Supplement HTML with Gradle + run: ./gradlew run --args="--input-file ../../asciidoc/sdpi-supplement.adoc --output-folder ../../sdpi-documents/sdpi-supplement --github-token '${{ secrets.SDPI_API_ACCESS_TOKEN_SECRET }}' --backend html" + working-directory: .ci/asciidoc-converter + + - name: Generate SDPi Standard and Supplement PlantUML diagrams and static files run: .github/prepare_artifacts.sh "x.x.x" - + - name: Extract branch name shell: bash run: echo "branch=$(echo ${GITHUB_REF#refs/heads/})" | tr '/' '-' >> $GITHUB_OUTPUT id: extract_branch - + - name: Upload artifact # if: success() && github.ref == 'refs/heads/master' uses: actions/upload-artifact@v4 with: - name: sdpi-supplement-${{ steps.extract_branch.outputs.branch }} - path: sdpi-supplement + name: sdpi-documents-${{ steps.extract_branch.outputs.branch }} + path: sdpi-documents diff --git a/.github/workflows/latest-master-build.yml b/.github/workflows/latest-master-build.yml index aed213f6..9ff66809 100755 --- a/.github/workflows/latest-master-build.yml +++ b/.github/workflows/latest-master-build.yml @@ -38,7 +38,7 @@ jobs: uses: gradle/actions/setup-gradle@v4 - name: Create HTML with Gradle - run: ./gradlew run --args="--input-file ../../asciidoc/sdpi-supplement.adoc --output-folder ../../sdpi-supplement --github-token ${{ secrets.SDPI_API_ACCESS_TOKEN_SECRET }} --backend html" + run: ./gradlew run --args="--input-file ../../asciidoc/sdpi-standard.adoc --output-folder ../../sdpi-standard --github-token ${{ secrets.SDPI_API_ACCESS_TOKEN_SECRET }} --backend html" working-directory: .ci/asciidoc-converter - name: Generate PlantUML diagrams and copy static files @@ -48,5 +48,5 @@ jobs: # if: success() && github.ref == 'refs/heads/master' uses: actions/upload-artifact@v4 with: - name: sdpi-supplement - path: sdpi-supplement + name: sdpi-standard + path: sdpi-standard diff --git a/.github/workflows/release-build.yml b/.github/workflows/release-build.yml index 9499fc73..91bff5fa 100644 --- a/.github/workflows/release-build.yml +++ b/.github/workflows/release-build.yml @@ -38,7 +38,7 @@ jobs: uses: gradle/actions/setup-gradle@v4 - name: Create HTML with Gradle - run: ./gradlew run --args="--input-file ../../asciidoc/sdpi-supplement.adoc --output-folder ../../sdpi-supplement --github-token ${{ secrets.SDPI_API_ACCESS_TOKEN_SECRET }} --backend html" + run: ./gradlew run --args="--input-file ../../asciidoc/sdpi-standard.adoc --output-folder ../../sdpi-standard --github-token ${{ secrets.SDPI_API_ACCESS_TOKEN_SECRET }} --backend html" working-directory: .ci/asciidoc-converter - name: Generate PlantUML diagrams and static files @@ -48,8 +48,8 @@ jobs: # if: success() && github.ref == 'refs/heads/master' uses: actions/upload-artifact@v4 with: - name: sdpi-supplement - path: sdpi-supplement + name: sdpi-standard + path: sdpi-standard - name: Create release page uses: ncipollo/release-action@v1 @@ -57,5 +57,5 @@ jobs: name: "Release of ${{ github.ref_name }} for TI" makeLatest: true body: "[đź“‹Please click here for a detailed changelog](https://github.com/IHE/DEV.SDPi/blob/${{ github.ref_name }}/CHANGELOG.md)" - artifacts: "sdpi-supplement-${{ github.ref_name }}.zip" + artifacts: "sdpi-standard-${{ github.ref_name }}.zip" diff --git a/CHANGELOG.md b/CHANGELOG.md index db0033ef..401e40d5 100644 --- a/CHANGELOG.md +++ b/CHANGELOG.md @@ -18,9 +18,10 @@ Each section shall contain a list of action items of the following format: `> 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 <>), 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 mature development stage; however, some requirements from that pre-standard may be included (non-normatively) 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 <> 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/IHE/DEV.SDPi/milestones[DEV.SDPi milestones]; +. This supplement includes four 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 was transitioned to utilize https://github.com/IHE/DEV.SDPi/issues[Github Issues] that are related to specific releases; each release updates the changelog file, detailing what is Added, Changed or Removed; +. *Requirements boxes* (e.g., "R1234") are included 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 <>, including discussion related to how it will be expanded in future versions of the supplement; +. *_<> Sections_* (see <>) 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. + +|=== + +// Forward declarations of common labels & acronyms & variables +include::document-declarations.adoc[] + +// Define oids for referenced standards +include::std-oid-definitions.adoc[] + +[#supplement_clause_sdpi_supplement_overview] +== SDPi Standard Overview + +[#supplement_clause_sdpi_supplement_organization] +=== SDPi Organization + +This IHE Devices Technical Framework standard introduces a new _family of interoperability profiles_, Service-oriented Device Point-of-care Interoperability (SDPi), that comprise four separate profiles: + +* SDPi-Plug-and-trust (*SDPi-P*) Profile +* SDPi-Reporting (*SDPi-R*) Profile +* SDPi-Alerting (*SDPi-A*) Profile +* SDPi-external Control (*SDPi-xC*) Profile + +To that end, the supplement includes updates to all three IHE DEV TF volumes, including: + +*TF-1 Profiles* + +* General overview of the SDPi architectural approach and integrated set of profiles +* Profile-specific sections +* Related appendices, for example the integration of this family of SDPi Profiles with other sources of requirements - use cases or reference standards + +*TF-2 Transactions* + +* Extensive new set of transactions based on IEEE 11073 Service-oriented Device Connectivity (SDC) medical device interoperability standards. +* Related appendices, for example the specialized use of web services messaging for device communication and gateways to other protocols or profiles + +*TF-3 Content Modules* + +* New content covering the application of IEEE 11073 SDC semantic standards to device content modules, with a primary focus on specifications related to the IEEE 11073-10207 BICEPS standard. + +NOTE: As explained in the https://profiles.ihe.net/GeneralIntro/ch-7.html#7.5[IHE Technical Framework Document Conventions], the acronym TF stands for Technical Framework, whereas the number immediately behind the hyphen in the "TF-X" notation stands for the volume number within a Technical Framework. + +[#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 <> 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., <> ), and then review the specific profiles to which the clinical scenario requirements 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. +Extensive notes and discussion materials are provided on the project's HL7 Confluence site, including a https://confluence.hl7.org/pages/viewpage.action?pageId=113674346#LibrarywithEVERYTHINGyoueverwantedtoknow...-GeneralUpdate&BriefingPresentations[Library with extensive presentations and other materials]. +This Library also includes *_briefings (slides and recordings) to provide background for those reviewing the specification_*. + +The joint IHE-HL7 devices team leveraged tools from both organizations, as well as participated jointly throughout the project's multi-year efforts. + +The methods currently employed are provided in the wiki article: https://github.com/IHE/DEV.SDPi/wiki/Program-Coordination-Co-Working-Spaces#program-coordination--co-working-spaces[Program Coordination & Co-Working Spaces]. + +[#supplement_clause_supplement_support_for_ri_mc_rr_using_asciidoc] +=== Supplement Support for RI+MC+RR using AsciiDoc +In addition to the supplement's technical specification content, a development approach has been advanced that represents added value to adopters and implementers over the traditional document oriented approach. +These are referred to as: + +[none] +. *_Requirements Interoperability + Model Centric + Regulatory Ready_* + +Or *RI+MC+RR* for short. + +These three objectives may be summarized as follows: + +[none] +* *Requirements Interoperability (RI)* +[none] +** Ability to integrate and automate requirements and capabilities from component specifications and standards to enable traceability and coverage at <> (<>) of the component product interface +* *Model Centric (MC)* +[none] +** Transition from a document-centric to a _computable model-based "single source of truth"_ specification from which the Technical Framework becomes a view of the model +* *Regulatory Ready (RR)* +[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 {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 <> specifications and full integration of <> 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. + +Additional discussion is provided in <>, and on the https://confluence.hl7.org/pages/viewpage.action?pageId=82906664#ConformityAssessment&Tooling-RI+MC+RRforMedTechSpecificationsInitiative[Gemini project's Confluence pages]. +See also related discussions on the Gemini Project's https://confluence.hl7.org/x/XhPUB[Pathway to an Ecosystem of Plug-and-Trust Products]. + + +[#supplement_clause_requirements_glossary] +=== Requirements Glossary + + +[%noheader] +[%autowidth] +[cols="1"] +|=== +a| *Editor's Note*: + +This "glossary" provides a defined set of requirements terminology and meta data is required in order to ensure consistency and processing / automation of requirements throughout the specification. + +It is differentiated from the IHE TF-0 Glossary in that it is specifically created to support the integration of formal requirements interoperability specification content; whereas, the IHE glossary provides general terminology more at the application level that is used throughout all IHE technical frameworks and profile specifications. + +|=== + diff --git a/asciidoc/sdpi-standard-issues.adoc b/asciidoc/sdpi-standard-issues.adoc new file mode 100644 index 00000000..f9cfdde1 --- /dev/null +++ b/asciidoc/sdpi-standard-issues.adoc @@ -0,0 +1,38 @@ + +[sdpi_offset=clear] +[#sdpi_issue_management] +== SDPi Issue Management + +[sdpi_offset=clear] +=== SDPi Issue Management + +*Standalone SDPi:* _Consider how this might change from STU/TI to Normative/FT, and organize it accordingly._ + +All SDPi standard issues are tracked in the https://github.com/IHE/DEV.SDPi/issues[IHE Github DEV.SDPi repository Issues section]. +Filter the issues on their "state" to see them. + + +* To see the full list of OPEN issues, go to https://github.com/IHE/DEV.SDPi/issues?q=is%3Aissue+is%3Aopen +* To see the full list of CLOSED issues, go to https://github.com/IHE/DEV.SDPi/issues?q=is%3Aissue+is%3Aclosed + +For more detailed information on how the Gemini SES+MDI program manages issues from identification to resolution to incorporation into this supplement, see the https://github.com/IHE/DEV.SDPi/wiki[_IHE SDPi wiki_]. + +[sdpi_offset=clear] +=== Open Issues + +The issues listed in this section or in https://github.com/IHE/DEV.SDPi/issues?q=is%3Aissue+is%3Aopen are open, and hence not yet ready for inclusion in the IHE DEV Technical Framework and not subject to comment or review. + +//==== Open Issues + +// open issues are inserted here + +//==== Topic of Interests + +// toi issues are inserted here + +[sdpi_offset=clear] +=== Closed Issues + +The issues listed in this section or in https://github.com/IHE/DEV.SDPi/issues?q=is%3Aissue+is%3Aclosed are closed. + +// closed issues are inserted here + diff --git a/asciidoc/sdpi-standard.adoc b/asciidoc/sdpi-standard.adoc new file mode 100644 index 00000000..0e9c803e --- /dev/null +++ b/asciidoc/sdpi-standard.adoc @@ -0,0 +1,161 @@ += Service-oriented Device Point-of-care Interoperability (SDPi) Technical Framework +:doctype: book +// CAUTION: do not change the xrefstyle attribute as otherwise numbering will be broken +:xrefstyle: short +:stylesdir: css +:!webfonts: +:!iconfont-remote: +:toc-title: Contents +:toc: left +:toclevels: 3 +:multipage-level: 2 +:sectnums: +:icons: font +:icon-set: fas +:imagesoutdir: images/ +:imagesdir: images/ +:docinfo: shared +:source-highlighter: highlight.js +:highlightjsdir: js/highlight + +// STANDALONE SDPi: Deferred is the refactoring of all "supplement" to "standard" language + +// Set the document attribute to automatically generate +// actor transactions table from semantic markup. Unset +// to use manual tables. +// https://docs.asciidoctor.org/asciidoc/latest/attributes/unset-attributes/ +:markup-actor-transactions-table: + +:sdpi_milestone_publication: SDPi 2.3 Publication +:sdpi_milestone_review: SDPi 2.3 Review + +:sdpi_version_major: 2 +:sdpi_version_minor: 4 +:sdpi_version_revision: 0 +// STANDALONE SDPi: QUESTION: Do we rework these to gemini_standard +:ihe_supplement_sdpi_revision: {sdpi_version_major}.{sdpi_version_minor}.{sdpi_version_revision} +:ihe_supplement_sdpi_revision_short: {sdpi_version_major}.{sdpi_version_minor} +:ihe_supplement_sdpi_revision_date: {localdatetime} +:ihe_supplement_sdpi_revision_label: Standard for Trial Use +:ihe_supplement_sdpi_publication_month: December 19, 2025 +:ihe_supplement_sdpi_public_comment_submission_deadline: N/A + +// Oid, assigned by IHE-DEV, for the SDPi specification +// https://wiki.ihe.net/index.php/PCD_OID_Management +:sdpi-parent-oid: 1.3.6.1.4.1.19376.1.6.2.10 + +{empty} + +ifeval::["{backend}" == "html5"] +++++ + +++++ + +[subs=attributes] +++++ +
+
+ + +
+
A Joint HL7-IHE Gemini Device Interoperability Project
+
+

Gemini

+ +

Technical Framework Standard

+ +

Service-oriented Device Point-of-care

+ +

Interoperability (SDPi)

+ +

Revision {ihe_supplement_sdpi_revision} — {ihe_supplement_sdpi_revision_label}

+ +

("Standalone" SDPi Standard - For Review)

+++++ +endif::[] +{empty} + + +[%noheader] +[cols="1,4"] +[frame=none,grid=none] +|=== +| *Publication Date:* +| {ihe_supplement_sdpi_publication_month} + +| *Build Date:* +| {ihe_supplement_sdpi_revision_date} + +| *Author:* +| Gemini Medical Device Interoperability Program Team (Joint HL7 & IHE Devices Working Groups) + +// STANDALONE SDPi: Should this field be included? What address? Or one for IHE and one for HL7? +| *Email:* +| DEV@ihe.net + +*Standalone SDPi:* _Should this email contact be included? If so, what address(es)? One for IHE and one for HL7?_ +|=== + +{empty} + + +*Published versions of this standard are available from both IHE and HL7:* + +* For HL7 publications: Search for "SDPi" on the https://www.hl7.org/implement/standards/product_matrix.cfm[HL7 Standards-based Product Grid] + +* For IHE publications: https://profiles.ihe.net/DEV/[*HERE*] for STU/Trial Implementation and Final Text versions and https://profiles.ihe.net/DEV/#1.2[*HERE*] for Public Comment versions. + +ifeval::["{backend}" == "html5"] +//A PDF version of the specification is available upon request. +endif::[] + +[#supplement_clause_foreword,sdpi_offset=clear] += Foreword + +This Gemini standard is a joint development effort between Health Level Seven International (HL7) and Integrating the Healthcare Enterprise (IHE) devices working groups. +Its development and publication adheres to the consensus standards processes of both HL7, an ANSI accredited standards development organization, and IHE. +The title of this document, "Technical Framework *_Standard_*", reflects its unique status as a Gemini specification, utilizing the IHE Technical Framework organization and elements (e.g., integration profiles, actors, transactions, content modules), but processed as an HL7 specification that will be published as a "standalone" standard and will persist even when its status transitions to normative standard (HL7) or Final Text (IHE). + +To facilitate integration with the companion IHE Devices Technical Framework (final text) specification, a companion to this standard will be created for each edition: SDPi "Technical Framework Supplement", which will be organized according to IHE style guidelines, but it will be in major section outline only, with each section including a note indicating where the content is located in the published Gemini Technical Framework ("standalone") Standard document. +Given its alignment with the companion IHE specification, some section numbers are skipped in this document to facilitate its intended integration into the above-mentioned "supplement". +Skipped section numbers are already present in the Devices Technical Framework and will not require changes due to the incorporation of the supplement once it transitions to normative standard / final text status. + +Additionally, some content that may otherwise be only referenced by a "supplement" document and defined elsewhere in the existing technical framework, will be incorporated in this specification to ensure that it is internally cohesive and does not force the reader to unnecessarily consult other documents. + +Publication as a Standard for *Trial* Use (HL7) or *Trial* Implementation (IHE) reflects the continuous cycle of development, balloting and publication of the specification, to address addition of new capabilities as well as identified safety, effectiveness and security issues and enhancements. +Product developers are encouraged to use the standard, recognizing the potential impact of this continuous development cycle and its status as a _"trial use"_ standard. + + +This supplement is published on {ihe_supplement_sdpi_publication_month} for Trial Implementation and may be available for testing at subsequent IHE or HL7 testing events, such as an IHE Connectathon. +The standard may be amended based on the results of testing. +Following successful testing and implementation maturity, it will transition to a normative standard, and the companion IHE supplement will be incorporated into the Devices Technical Framework. +Comments are invited and can be submitted at https://www.ihe.net/DEV_Public_Comments/[Devices Public Comments] or by submitting a https://github.com/IHE/DEV.SDPi/issues/new/choose[GitHub Issue]. + +General information about IHE can be found at http://www.ihe.net/[IHE.net], and about HL7 can be found at https://www.hl7.org/index.cfm[HL7.org]. + +General information about the HL7 Devices Working Group can be found at https://www.hl7.org/Special/committees/healthcaredevices/index.cfm[HL7.org/healthcaredevices], and the IHE Devices domain can be found at https://www.ihe.net/ihe_domains/[IHE Domains]. + +Information about the organization of IHE Technical Frameworks and Supplements and the process used to create them can be found at https://www.ihe.net/resources/profiles/[Profiles] and https://www.ihe.net/about_ihe/ihe_process/[IHE Processes]. + +The current version of the IHE Devices Technical Framework can be found at https://profiles.ihe.net/DEV/[DEV Technical Framework]. + +include::sdpi-standard-intro.adoc[] + +include::sdpi-standard-issues.adoc[] + +// = Volume 0 -- IHE Technical Frameworks General Introduction + +include::volume0/tf0-main.adoc[] + +// = Volume 1 -- Profiles + +include::volume1/tf1-main.adoc[] + +// = Volume 2 -- Transactions + +include::volume2/tf2-main.adoc[] + +// = Volume 3 -- Content Modules + +include::volume3/tf3-main.adoc[] + diff --git a/asciidoc/sdpi-supplement.adoc b/asciidoc/sdpi-supplement.adoc index 175d739e..7e8eb63d 100644 --- a/asciidoc/sdpi-supplement.adoc +++ b/asciidoc/sdpi-supplement.adoc @@ -1,153 +1,202 @@ -= Service-oriented Device Point-of-care Interoperability (SDPi) Technical Framework -:doctype: book -// CAUTION: do not change the xrefstyle attribute as otherwise numbering will be broken -:xrefstyle: short -:stylesdir: css -:!webfonts: -:!iconfont-remote: -:toc-title: Contents -:toc: left -:toclevels: 3 -:multipage-level: 2 -:sectnums: -:icons: font -:icon-set: fas -:imagesoutdir: images/ -:imagesdir: images/ -:docinfo: shared -:source-highlighter: highlight.js -:highlightjsdir: js/highlight - -// Set the document attribute to automatically generate -// actor transactions table from semantic markup. Unset -// to use manual tables. -// https://docs.asciidoctor.org/asciidoc/latest/attributes/unset-attributes/ -:markup-actor-transactions-table: - -:sdpi_milestone_publication: SDPi 2.3 Publication -:sdpi_milestone_review: SDPi 2.3 Review - -:sdpi_version_major: 2 -:sdpi_version_minor: 4 -:sdpi_version_revision: 0 -:ihe_supplement_sdpi_revision: {sdpi_version_major}.{sdpi_version_minor}.{sdpi_version_revision} -:ihe_supplement_sdpi_revision_short: {sdpi_version_major}.{sdpi_version_minor} -:ihe_supplement_sdpi_revision_date: {localdatetime} -:ihe_supplement_sdpi_revision_label: Standard for Trial Use / Implementation -:ihe_supplement_sdpi_publication_month: December 19, 2025 -:ihe_supplement_sdpi_public_comment_submission_deadline: N/A - -// Oid, assigned by IHE-DEV, for the SDPi specification -// https://wiki.ihe.net/index.php/PCD_OID_Management -:sdpi-parent-oid: 1.3.6.1.4.1.19376.1.6.2.10 - -{empty} + -ifeval::["{backend}" == "html5"] -++++ - -++++ - -[subs=attributes] -++++ -
-
- - -
-
A Joint HL7-IHE Gemini Device Interoperability Project
-
-

IHE Devices

- -

Technical Framework Supplement

- -

Service-oriented Device Point-of-care

- -

Interoperability (SDPi)

- -

Revision {ihe_supplement_sdpi_revision} — {ihe_supplement_sdpi_revision_label}

-++++ -endif::[] -{empty} + - -[%noheader] -[cols="1,4"] -[frame=none,grid=none] -|=== -| *Publication Date:* -| {ihe_supplement_sdpi_publication_month} - -| *Build Date:* -| {ihe_supplement_sdpi_revision_date} - -| *Author:* -| HL7 Devices Working Group & IHE Devices Technical Committee - -| *Email:* -| DEV@ihe.net -|=== - -{empty} + - -*Please verify you have the most recent version of this document.* -See https://profiles.ihe.net/DEV/[*HERE*] for STU/Trial Implementation and Final Text versions and https://profiles.ihe.net/DEV/#1.2[*HERE*] for Public Comment versions. - -ifeval::["{backend}" == "html5"] -//A PDF version of the specification is available upon request. -endif::[] - -[#supplement_clause_foreword,sdpi_offset=clear] -= Foreword - -This Gemini standard is a joint development effort between Health Level Seven International (HL7) and Integrating the Healthcare Enterprise (IHE) devices working groups. -Its development and publication adheres to the consensus standards processes of both HL7, an ANSI accredited standards development organization, and IHE. -Publication as a Standard for Trial Use (HL7) or Trial Implementation (IHE) reflects the continuous cycle of development, balloting and publication of the specification, to address addition of new capabilities as well as identified safety, effectiveness and security issues and enhancements. -Product developers are encouraged to use the standard, recognizing the potential impact of this continuous development cycle. - -This is a supplement to the IHE Devices Technical Framework. Each supplement undergoes a process of public comment and trial implementation before being incorporated into the volumes of the Technical Frameworks. - -This supplement is published on {ihe_supplement_sdpi_publication_month} for Trial Implementation and may be available for testing at subsequent IHE Connectathons. The supplement may be amended based on the results of testing. Following successful testing it will be incorporated into the Devices Technical Framework. Comments are invited and can be submitted at https://www.ihe.net/DEV_Public_Comments/[Devices Public Comments] or by submitting a https://github.com/IHE/DEV.SDPi/issues/new/choose[GitHub Issue]. - -Some section numbers are skipped in this supplement because it is designed for later incorporation into the Devices Technical Framework. Skipped section numbers are present in the Devices Technical Framework, and will not require changes due to the incorporation of this supplement. - -This supplement describes changes to the existing technical framework documents. - -“Boxed” instructions like the sample below indicate to the Volume Editor how to integrate the relevant section(s) into the relevant Technical Framework volume. -|=== -|__Amend section W.X by the following:__ -|=== - -Where the amendment adds text, make the added text +++bold underline+++. -Where the amendment removes text, make the removed text +++bold strikethrough+++. -When entire new sections are added, introduce with editor’s instructions to “add new text” or similar, which for readability are not bolded or underlined. - -General information about IHE can be found at http://www.ihe.net/[IHE.net]. - -Information about the IHE Devices domain can be found at https://www.ihe.net/ihe_domains/[IHE Domains]. - -Information about the organization of IHE Technical Frameworks and Supplements and the process used to create them can be found at https://www.ihe.net/resources/profiles/[Profiles] and https://www.ihe.net/about_ihe/ihe_process/[IHE Processes]. - -The current version of the IHE Devices Technical Framework can be found at https://profiles.ihe.net/DEV/[DEV Technical Framework]. - -include::sdpi-supplement-intro.adoc[] - -include::sdpi-supplement-issues.adoc[] - -// = Volume 0 -- IHE Technical Frameworks General Introduction - -include::volume0/tf0-main.adoc[] - -// = Volume 1 -- Profiles - -include::volume1/tf1-main.adoc[] - -// = Volume 2 -- Transactions - -include::volume2/tf2-main.adoc[] - -// = Volume 3 -- Content Modules - -include::volume3/tf3-main.adoc[] - += Service-oriented Device Point-of-care Interoperability (SDPi) Technical Framework +:doctype: book +// CAUTION: do not change the xrefstyle attribute as otherwise numbering will be broken +:xrefstyle: short +:stylesdir: css +:!webfonts: +:!iconfont-remote: +:toc-title: Contents +:toc: left +:toclevels: 3 +:multipage-level: 2 +:sectnums: +:icons: font +:icon-set: fas +:imagesoutdir: images/ +:imagesdir: images/ +:docinfo: shared +:source-highlighter: highlight.js +:highlightjsdir: js/highlight + +// Set the document attribute to automatically generate +// actor transactions table from semantic markup. Unset +// to use manual tables. +// https://docs.asciidoctor.org/asciidoc/latest/attributes/unset-attributes/ +:markup-actor-transactions-table: + +:sdpi_milestone_publication: SDPi 2.3 Publication +:sdpi_milestone_review: SDPi 2.3 Review + +:sdpi_version_major: 2 +:sdpi_version_minor: 4 +:sdpi_version_revision: 0 +:ihe_supplement_sdpi_revision: {sdpi_version_major}.{sdpi_version_minor}.{sdpi_version_revision} +:ihe_supplement_sdpi_revision_short: {sdpi_version_major}.{sdpi_version_minor} +:ihe_supplement_sdpi_revision_date: {localdatetime} +:ihe_supplement_sdpi_revision_label: Standard for Trial Use / Implementation +:ihe_supplement_sdpi_publication_month: December 19, 2025 +:ihe_supplement_sdpi_public_comment_submission_deadline: N/A + +// Oid, assigned by IHE-DEV, for the SDPi specification +// https://wiki.ihe.net/index.php/PCD_OID_Management +// STANDALONE SDPi: Disabled the following line ... we may eventually need something in this supplement for OIDs but breaking it now makes sure that this is a SLIM document to start with! +// :sdpi-parent-oid: 1.3.6.1.4.1.19376.1.6.2.10 + +{empty} + +ifeval::["{backend}" == "html5"] +++++ + +++++ + +[subs=attributes] +++++ +
+
+ + +
+
A Joint HL7-IHE Gemini Device Interoperability Project
+
+

IHE Devices

+ +

Technical Framework Supplement

+ +

Service-oriented Device Point-of-care

+ +

Interoperability (SDPi)

+ +

Revision {ihe_supplement_sdpi_revision} — {ihe_supplement_sdpi_revision_label}

+++++ +endif::[] +{empty} + + +[%noheader] +[cols="1,4"] +[frame=none,grid=none] +|=== +| *Publication Date:* +| {ihe_supplement_sdpi_publication_month} + +| *Build Date:* +| {ihe_supplement_sdpi_revision_date} + +| *Author:* +| HL7 Devices Working Group & IHE Devices Technical Committee + +| *Email:* +| DEV@ihe.net +|=== + +{empty} + + +*Please verify you have the most recent version of this document.* +See https://profiles.ihe.net/DEV/[*HERE*] for STU/Trial Implementation and Final Text versions and https://profiles.ihe.net/DEV/#1.2[*HERE*] for Public Comment versions. + +ifeval::["{backend}" == "html5"] +//A PDF version of the specification is available upon request. +endif::[] + +[#supplement_clause_foreword,sdpi_offset=clear] += Foreword + +This Gemini standard is a joint development effort between Health Level Seven International (HL7) and Integrating the Healthcare Enterprise (IHE) devices working groups. +Its development and publication adheres to the consensus standards processes of both HL7, an ANSI accredited standards development organization, and IHE. +Publication as a Standard for Trial Use (HL7) or Trial Implementation (IHE) reflects the continuous cycle of development, balloting and publication of the specification, to address addition of new capabilities as well as identified safety, effectiveness and security issues and enhancements. +Product developers are encouraged to use the standard, recognizing the potential impact of this continuous development cycle. + +This is a supplement to the IHE Devices Technical Framework. Each supplement undergoes a process of public comment and trial implementation before being incorporated into the volumes of the Technical Frameworks. + +This supplement is published on {ihe_supplement_sdpi_publication_month} for Trial Implementation and may be available for testing at subsequent IHE Connectathons. The supplement may be amended based on the results of testing. Following successful testing it will be incorporated into the Devices Technical Framework. Comments are invited and can be submitted at https://www.ihe.net/DEV_Public_Comments/[Devices Public Comments] or by submitting a https://github.com/IHE/DEV.SDPi/issues/new/choose[GitHub Issue]. + +Some section numbers are skipped in this supplement because it is designed for later incorporation into the Devices Technical Framework. Skipped section numbers are present in the Devices Technical Framework, and will not require changes due to the incorporation of this supplement. + +This supplement describes changes to the existing technical framework documents. + +“Boxed” instructions like the sample below indicate to the Volume Editor how to integrate the relevant section(s) into the relevant Technical Framework volume. +|=== +|__Amend section W.X by the following:__ +|=== + +Where the amendment adds text, make the added text +++bold underline+++. +Where the amendment removes text, make the removed text +++bold strikethrough+++. +When entire new sections are added, introduce with editor’s instructions to “add new text” or similar, which for readability are not bolded or underlined. + +General information about IHE can be found at http://www.ihe.net/[IHE.net]. + +Information about the IHE Devices domain can be found at https://www.ihe.net/ihe_domains/[IHE Domains]. + +Information about the organization of IHE Technical Frameworks and Supplements and the process used to create them can be found at https://www.ihe.net/resources/profiles/[Profiles] and https://www.ihe.net/about_ihe/ihe_process/[IHE Processes]. + +The current version of the IHE Devices Technical Framework can be found at https://profiles.ihe.net/DEV/[DEV Technical Framework]. + +// STANDALONE SDPi: 1st refactoring, moved copies of these files into the supplement/ directory +// include::supplement/sdpi-supplement-intro.adoc[] + +// include::supplement/sdpi-standard-issues.adoc[] + +// = Volume 0 -- IHE Technical Frameworks General Introduction + +// STANDALONE SDPi: 1st refactoring, simply COMMENTED OUT the 3 volumes +//include::volume0/tf0-main.adoc[] + +// +// = Volume 1 -- Profiles +// +//include::volume1/tf1-main.adoc[] + +// Appendix A +//// +[appendix#vol1_appendix_a_requirements_management_for_p_n_t_interperability,sdpi_offset=A] +== Requirements Management for Plug-and-Trust Interoperability + +[#vol1_clause_sdpi_requirements_modeling_integration] +=== SDPi Requirements Modeling & Integration + +[#vol1_clause_appendix_a_ses_considerations_section_template] +=== SES Considerations Section Template + +// Appendix B +[appendix#vol1_appendix_b_references,sdpi_offset=B] +== References + +[%noheader] +[%autowidth] +[cols="1"] +|=== +| *{supplement_note}*: +IHE Supplement TF-1:B References Appendix content is provided in *Gemini Standard TF-1:B*. +|=== + + +[bibliography#vol1_appendix_b_referenced_standards] +=== Referenced Standards + +[%noheader] +[%autowidth] +[cols="1"] +|=== +| *{supplement_note}*: +IHE Supplement TF-1:B.1 Referenced Standards content is provided in *Gemini Standard TF-1:B.1 Referenced Standards*. +|=== + +// Appendix C + +[appendix#vol1_appendix_c_dpi_use_cases,sdpi_offset=C] +== Device Point-of-care Interoperability (DPI) Use Cases + +[#vol1_clause_appendix_c_use_case_sicdmp,sdpi_offset=4] +=== Use Case Feature {var_use_case_id}: <> (<>) + +// +// = Volume 2 -- Transactions +// +//include::volume2/tf2-main.adoc[] +// +// = Volume 3 -- Content Modules +// +//include::volume3/tf3-main.adoc[] + +//// diff --git a/asciidoc/sdpi-supplement-intro.adoc b/asciidoc/supplement/sdpi-supplement-intro.adoc similarity index 100% rename from asciidoc/sdpi-supplement-intro.adoc rename to asciidoc/supplement/sdpi-supplement-intro.adoc diff --git a/asciidoc/sdpi-supplement-issues.adoc b/asciidoc/supplement/sdpi-supplement-issues.adoc similarity index 100% rename from asciidoc/sdpi-supplement-issues.adoc rename to asciidoc/supplement/sdpi-supplement-issues.adoc