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* Prepare release 1.2.0

* Updated 1.1 version notes for 1.2

Reviewed and updated all the 1.1 version notes for 1.2
Reviewed and updated all 2023 references for 2024.

* Updated a few straggling 1.1 references

All 1.1 references now updated to 1.2

* Addressed the 5 editorial comments by Mary in #247

* Prepare release 1.2.0; update changelog

* Prepare release 1.2.0; update changelog (fix)

---------

Co-authored-by: Todd "AFC!" Cooper <[email protected]>
Co-authored-by: JavierEspina <[email protected]>
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1 change: 1 addition & 0 deletions CHANGELOG.md
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### Editorial Fixes

- Moved reference content in glossary table between columns ([#166](https://github.com/IHE/DEV.SDPi/issues/166)).
- Apply several editorial fixes ([#247](https://github.com/IHE/DEV.SDPi/issues/247))

## [1.1.0] - 2023-07-21

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15 changes: 8 additions & 7 deletions asciidoc/sdpi-supplement-intro.adoc
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|===
a| *SDPi 1.1 Supplement -- _Trial Implementation Version_ -- Note*:
a| *SDPi 1.2 Supplement -- _STU / TI Version_ -- Note*:

This release of the SDPi 1.1 Trial Implementation supplement establishes a quarterly update cadence, enabling prototyping and testing of device-to-device plug-and-trust interoperability.
It is recognized, though, that this is an *incremental* 1.1 release and in that sense is understandably incomplete with work continuing for 1.2 and subsequent versions.
This release of the SDPi 1.2 Standard for Trial Use (HL7 STU) / Trial Implementation (IHE TI) supplement is the first release that is intended for both an HL7 ballot cycle (January 2024), as well as the same IHE Devices release and review process, which was used for the first 3 releases of this supplement.
Release 1.2 provides only a few _incremental_ updates to release 1.1; 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 1.3 and subsequent versions.
These known limitations include:


. The content is scoped per the *_SDPi 1.1 version capabilities specification_* (see https://github.com/IHE/DEV.SDPi/wiki/SDPi-Editorial-Planning-and-Versions#sdpi-version-11-detail---[wiki article "SDPi Version 1.1 (Detail)"]), though future capabilities may be included in a Version Note
. 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* -- for SDPi 1.1 the approach for the open / closed issues section has been integrated with the Github Issues that are related to this release; it is expected that this automation will continue to evolve in subsequent releases;
. *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;
. *_<<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 SDPi 1.x and subsequent 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;
. *"SDPi 1.1 Supplement Note"* boxes are provided throughout the document to help guide reviewers and implementers.
. *"SDPi 1.2 Supplement Note"* boxes are provided throughout the document to help guide reviewers and implementers.

|===

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[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 1.1 version of the supplement has *_begun to take small 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 1.2 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.

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12 changes: 6 additions & 6 deletions asciidoc/sdpi-supplement.adoc
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:source-highlighter: highlight.js
:highlightjsdir: js/highlight

:sdpi_milestone_publication: SDPi 1.1 Publication
:sdpi_milestone_review: SDPi 1.1 Review
:sdpi_milestone_publication: SDPi 1.2 Publication
:sdpi_milestone_review: SDPi 1.2 Review

:ihe_supplement_sdpi_revision: 1.1.0
:ihe_supplement_sdpi_revision: 1.2.0
:ihe_supplement_sdpi_revision_date: {localdatetime}
:ihe_supplement_sdpi_revision_label: Standard for Trial Use / Implementation
:ihe_supplement_sdpi_publication_month: July 21, 2023
:ihe_supplement_sdpi_publication_month: December 8, 2023
:ihe_supplement_sdpi_public_comment_submission_deadline: N/A

{empty} +
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|__Amend section W.X by the following:__
|===

Where the amendment adds text, make the added text +++<u><b>some text bold underline</b></u>+++.
Where the amendment adds text, make the added text +++<u><b>bold underline</b></u>+++.
Where the amendment removes text, make the removed text +++<b><s>bold strikethrough</s></b>+++.
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].
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].

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10 changes: 4 additions & 6 deletions asciidoc/volume1/tf1-ch-10-sdpi-p.adoc
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|===
a| *SDPi Supplement Version Note*: For SDPi 1.1 some actors and transactions have been deferred to a subsequent version, but are included here for completeness.
a| *SDPi Supplement Version Note*: For SDPi 1.2 some actors and transactions have been deferred to a subsequent version, but are included here for completeness.
Specifically: SOMDS FHIR Gateway, SOMDS Sensor Gateway & SOMDS Smart App Platform, have been deferred.

Deferred transactions have been so indicated in the transactions table.

|===

This section defines the actors, transactions, and/or content modules in this specification.
General definitions of actors are given in the https://profiles.ihe.net/GeneralIntro/ch-A.html[_Technical Frameworks General Introduction Appendix A_].

IHE Transactions can be found in the https://profiles.ihe.net/GeneralIntro/ch-B.html[_Technical Frameworks General Introduction Appendix B_].
General definitions of actors are given in the https://profiles.ihe.net/GeneralIntro/ch-A.html[_Technical Frameworks General Introduction Appendix A_]. IHE Transactions can be found in the https://profiles.ihe.net/GeneralIntro/ch-B.html[_Technical Frameworks General Introduction Appendix B_].
Both appendices are located at https://profiles.ihe.net/GeneralIntro/[_profiles.ihe.net/GeneralIntro_].

<<vol1_figure_sdpi_p_actor_diagram>> shows the actors directly involved in the SDPi-P Profile.
The relevant transactions between them are detailed in the subsequent <<vol1_table_sdpi_p_actors_transactions>>.
Abstract actors (i.e., those that provide common specifications that are utilized in other “concrete” or implementation actors) are indicated by stereotype names in italics (e.g., "<< _SOMDS_Participant_ >>". The actors that inherit their capabilities include the stereotype at the top of their actor box.
Alternatively, in accordance with traditional IHE style, the Abstract actor's name can be in italics with "{_abstract_}" (e.g., see _SOMDS Connector_ in <<vol1_figure_sdpi_p_actor_diagram>>).
Actor groupings, including abstract with concrete are detailed in <<vol1_clause_sdpi_p_required_actor_groupings>>.
Actor groupings, including abstract with concrete, are detailed in <<vol1_clause_sdpi_p_required_actor_groupings>>.

[#vol1_figure_sdpi_p_actor_diagram]
.SDPi-P Actor Diagram
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|===
a| *SDPi Supplement Version Note*: For SDPi 1.1, the TF-3 SDC/BICEPS Mapping of SOMDS Connector Content Modules section is out-of-scope., but included above for completeness of this actor overview.
a| *SDPi Supplement Version Note*: For SDPi 1.2, the TF-3 SDC/BICEPS Mapping of SOMDS Connector Content Modules section is out-of-scope., but included above for completeness of this actor overview.
|===

Although the SDPi-P Profile _<<vol1_spec_sdpi_p_actor_somds_connector>>_ provides for non-SOMDS _protocol-specific_ adaptors, they establish the foundation for specifying system and application-specific interfaces such as for EHR or decision support systems (e.g., sepsis determination). See <<vol1_clause_sdpi_p_ensuring_time_synchronization>>, and <<vol1_clause_sdpi_p_aggregators_proxies_sensors>> for additional perspectives and concepts on how SOMDS Connectors may be implemented.
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8 changes: 4 additions & 4 deletions asciidoc/volume1/tf1-ch-11-sdpi-r.adoc
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a| *SDPi Supplement Version 1.1 Note*: This version of the <<acronym_sdpi_r>> Profile is built upon the foundational <<acronym_sdpi_p>> Profile but does not provide substantially more capabilities.
a| *SDPi Supplement Version 1.2 Note*: This version of the <<acronym_sdpi_r>> Profile is built upon the foundational <<acronym_sdpi_p>> Profile but does not provide substantially more capabilities.
This is due to the fact that the primary purpose of this <<acronym_sdpi_r>> Profile, namely communication of medical data to accomplish intended medical purposes, requires the completion and integration of two emerging ISO/IEEE standards: <<ref_ieee_11073_10700_2022>> and <<ref_ieee_11073_10701_2022>>.
When these are published *_in 2023_*, their requirements will be integrated into this supplement, with their <<term_implementation_conformance_statement>> added to <<vol1_appendix_b_referenced_standards_conformance>> below.
When these are published *_in 2023 / 2024_*, their requirements will be integrated into this supplement, with their <<term_implementation_conformance_statement>> added to <<vol1_appendix_b_referenced_standards_conformance>> below.
Many of those requirements will be mapped to the actors and transactions and other elements in this supplement, including this <<acronym_sdpi_r>> Profile.

Additionally, though the <<actor_somds_dec_gateway>> is defined below and fully specified in <<vol2_clause_appendix_sdpi_dec_gateway>>, the implementation guide for mapping from <<acronym_biceps>> to <<acronym_hl7>> <<acronym_fhir>> remains in development, pushing the specification of the <<vol1_spec_sdpi_r_actor_somds_fhir_medical_data_gateway>> to a later version of this supplement.
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<<vol1_figure_sdpi_r_actor_diagram>> shows the actors directly involved in the SDPi-R Profile.
The relevant transactions between them are detailed in the subsequent <<vol1_table_sdpi_r_actors_transactions>>.
actor groupings, including abstract with concrete are detailed in <<vol1_clause_sdpi_r_required_actor_groupings>>.
actor groupings, including abstract with concrete, are detailed in <<vol1_clause_sdpi_r_required_actor_groupings>>.

[#vol1_figure_sdpi_r_actor_diagram]
.SDPi-R Actor Diagram
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a| *SDPi Supplement Version 1.1 Note*: The <<ref_ieee_11073_10700_2022>> and <<ref_ieee_11073_10701_2022>> standards are currently being published by the IEEE.
a| *SDPi Supplement Version 1.2 Note*: The <<ref_ieee_11073_10700_2022>> and <<ref_ieee_11073_10701_2022>> standards are currently being published by the IEEE.
Once published, their requirements will be integrated into this supplement, with many of them being mapped to elements in this <<acronym_sdpi_r>> Profile.

|===
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6 changes: 3 additions & 3 deletions asciidoc/volume1/tf1-ch-12-sdpi-a.adoc
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a| *SDPi Supplement Version 1.1 Note*: This initial version of the <<acronym_sdpi_a>> Profile is built upon the foundational <<acronym_sdpi_p>> Profile but adds services specialized for the communication and management of medical device alerting.
a| *SDPi Supplement Version 1.2 Note*: This initial version of the <<acronym_sdpi_a>> Profile is built upon the foundational <<acronym_sdpi_p>> Profile but adds services specialized for the communication and management of medical device alerting.
Additionally, since the primary purpose of this specification is the communication of medical alert information to accomplish intended medical purposes, it will require the completion and integration of the emerging ISO/IEEE 11073 Alert <<acronym_pkp>> standard <<ref_ieee_11073_10702_202x>>.
When this new standard is published *_in late 2023 or early 2024_*, its requirements will be integrated into this supplement, with its <<term_implementation_conformance_statement>> added to <<vol1_appendix_b_referenced_standards_conformance>>.
When this new standard is published *_in 2024_*, its requirements will be integrated into this supplement, with its <<term_implementation_conformance_statement>> added to <<vol1_appendix_b_referenced_standards_conformance>>.
Many of those requirements will be mapped to the actors, transactions and other specifications in this specification.

Two of the transactions identified below, [DEV-41] and [DEV-42] are related to Medical Alert Delegation; however, at this stage there is considerable standards development activity to update the current <<acronym_sdc>> standards, particularly in association with completing the Alert <<acronym_pkp>> standard <<ref_ieee_11073_10702_202x>>.
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<<vol1_figure_sdpi_a_actor_diagram>> shows the actors directly involved in the SDPi-A Profile.
The relevant transactions between them are detailed in the subsequent <<vol1_table_sdpi_a_actors_transactions>>.
Actor groupings, including abstract with concrete are detailed in <<vol1_clause_sdpi_a_required_actor_groupings>>.
Actor groupings, including abstract with concrete, are detailed in <<vol1_clause_sdpi_a_required_actor_groupings>>.

[#vol1_figure_sdpi_a_actor_diagram]
.SDPi-A Actor Diagram
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a| *SDPi Supplement Version Note*: This SDPi-xC (External Control) Profile Section is generally out-of-scope for the SDPi 1.1 version (see https://github.com/IHE/DEV.SDPi/wiki/SDPi-Editorial-Planning-and-Versions#sdpi-version-11-detail---[wiki article "SDPi Version 1.1 (Detail)"]); however, it is provided here to indicate the intended direction of the SDPi Profiles, with details being added in subsequent versions. Depending on capabilities, some very basic controls may need to be provided in 2023 as part of the 1.x or 2.0 versions, especially around external adjustment of settings (e.g., alert limits or to trigger a blood-pressure reading).
a| *SDPi Supplement Version Note*: This SDPi-xC (External Control) Profile Section is generally out-of-scope for the SDPi 1.2 version (see https://github.com/orgs/IHE/projects/6/views/1["Gemini SDPi Releases" Github project]); however, it is provided here to indicate the intended direction of the SDPi Profiles, with details being added in subsequent versions. Depending on capabilities, some very basic controls may need to be provided in 2024 as part of the 1.x or 2.0 versions, especially around external adjustment of settings (e.g., alert limits or to trigger a blood-pressure reading).

|===

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<<vol1_figure_sdpi_xc_actor_diagram>> shows the actors directly involved in the SDPi-xC profile.
The relevant transactions between them are detailed in the subsequent <<vol1_table_sdpi_xc_actors_transactions>>.
actor groupings, including abstract with concrete are detailed in <<vol1_clause_sdpi_xc_required_actor_groupings>>.
actor groupings, including abstract with concrete, are detailed in <<vol1_clause_sdpi_xc_required_actor_groupings>>.

[#vol1_figure_sdpi_xc_actor_diagram]
.SDPi-xC Actor Diagram
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a| *SDPi Supplement Version Note*: For *_SDPi 1.1_*, no use cases have been included that provide functional requirements for device external control. These will be added to a future version of the SDPi supplement.
a| *SDPi Supplement Version Note*: For *_SDPi 1.2_*, no use cases have been included that provide functional requirements for device external control. These will be added to a future version of the SDPi supplement.
Therefore, with this release of the SDPi specification, this section remains incomplete.
|===

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