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Changed 1.2 to 1.3 throughout specification
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Addressed #282 changes.
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ToddCooper committed Apr 4, 2024
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4 changes: 2 additions & 2 deletions CHANGELOG.md
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Expand Up @@ -13,9 +13,9 @@ The SDPi changelog shall not contain the following sections

Each section shall contain a list of action items of the following format: `<brief one-sentence description of what has been done> (#<issue number & URL>).`

## Unreleased
## [Unreleased]

## [1.3.0] - 2024-03-29
- Remove / Update "1.2" comments from release 1.3.0 ([#282](https://github.com/IHE/DEV.SDPi/issues/282))

### Added

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15 changes: 9 additions & 6 deletions asciidoc/sdpi-supplement-intro.adoc
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|===
a| *SDPi 1.2 Supplement -- _STU / TI Version_ -- Note*:
a| *SDPi 1.3 Supplement -- _STU / TI Version_ -- Note*:

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.
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.

Note: The 1.3.1 release provides a few minor editorial corrections that were overlooked in the first release of 1.3.0.

Release 1.3 provides only a few _incremental_ updates to release 1.3; 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:


Expand All @@ -20,7 +23,7 @@ These known limitations include:
. *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 1.2 Supplement Note"* boxes are provided throughout the document to help guide reviewers and implementers.
. *"SDPi 1.3 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 1.2 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.
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.
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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2 changes: 1 addition & 1 deletion asciidoc/sdpi-supplement.adoc
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{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.
See https://profiles.ihe.net/DEV/[*HERE*] for STU/Trial Implementation and Final Text versions and https://profiles.ihe.net/DEV/#1.3[*HERE*] for Public Comment versions.

A PDF version of the specification is available upon request.

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|===
| *SDPi Supplement Version Note*: This section is provided as a placeholder for the <<acronym_ics>> table specification that will be added in the subsequent SDPi 1.2 supplement version.
| *SDPi Supplement Version Note*: This section is provided as a placeholder for the <<acronym_ics>> table specification that will be added in the subsequent SDPi 1.3 supplement version.
The tables will have an additional SDPi column added to the right side that indicates *if* and TBD *where* the requirement is satisfied.
Requirement Definition (this table's rows) will be referenced where they are satisfied; however, these tables may also include forward references, at least in general, to what capabilities / requirements satisfy the referenced standard requirement.

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4 changes: 2 additions & 2 deletions asciidoc/volume1/tf1-ch-10-sdpi-p.adoc
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Expand Up @@ -26,7 +26,7 @@ For example, Operating Room / Surgery Point-of-Care Integration, ICU Point-of-Ca
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|===
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.
a| *SDPi Supplement Version Note*: For SDPi 1.3 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.
Expand Down Expand Up @@ -434,7 +434,7 @@ See related discussion at <<vol3_clause_biceps_mapping_using_somds_connector_con
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|===
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.
a| *SDPi Supplement Version Note*: For SDPi 1.3, 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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4 changes: 2 additions & 2 deletions asciidoc/volume1/tf1-ch-11-sdpi-r.adoc
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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.
a| *SDPi Supplement Version 1.3 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 / 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.
Expand Down Expand Up @@ -309,7 +309,7 @@ A primary source of safety requirements for this <<acronym_sdpi_r>> Profile come
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|===
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.
a| *SDPi Supplement Version 1.3 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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2 changes: 1 addition & 1 deletion asciidoc/volume1/tf1-ch-12-sdpi-a.adoc
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|===
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.
a| *SDPi Supplement Version 1.3 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 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.
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4 changes: 2 additions & 2 deletions asciidoc/volume1/tf1-ch-13-sdpi-xc.adoc
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a| *SDPi Supplement Version Note*: This SDPi-xC (External Control) Profile Section is generally out-of-scope for the SDPi 1.2 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).
a| *SDPi Supplement Version Note*: This SDPi-xC (External Control) Profile Section is generally out-of-scope for the SDPi 1.3 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).

|===

Expand Down Expand Up @@ -168,7 +168,7 @@ Note that this specification extends the concepts established in the base <<vol1
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|===
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.
a| *SDPi Supplement Version Note*: For *_SDPi 1.3_*, 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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4 changes: 2 additions & 2 deletions asciidoc/volume1/tf1-ch-2-overview.adoc
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Expand Up @@ -163,8 +163,8 @@ Profile options are provided for additional capabilities that may be required to
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|===
a| *SDPi Supplement Version Note*: For SDPi 1.2, the SDPi-xC Profile is provided for completeness and to show the general direction of the family of SDPi Profiles.
It is *_not part of the capabilities specified for 1.2_* and even basic controls will not be added until SDPi 2.0 or later.
a| *SDPi Supplement Version Note*: For SDPi 1.3, the SDPi-xC Profile is provided for completeness and to show the general direction of the family of SDPi Profiles.
It is *_not part of the capabilities specified for 1.3_* and even basic controls will not be added until SDPi 2.0 or later.
|===

The SDPi External Control Profile builds on the basic <<acronym_pnt>> capabilities of the <<acronym_sdpi_p>> Profile, but adds support for *_medical device external control capabilities_*.
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6 changes: 3 additions & 3 deletions asciidoc/volume1/tf1-ch-a-requirements-interoperability.adoc
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Expand Up @@ -10,7 +10,7 @@
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|===
a| *SDPi Supplement Version Note*: This appendix provides informative (vs. normative) information related to the unique way in which this supplement integrates requirements, both from referenced foundational standards and within this specification.
*For SDPi 1.2*, given its non-normative nature, full detailing of the concepts and specifications is deferred to a subsequent revision of the specification.
*For SDPi 1.3*, given its non-normative nature, full detailing of the concepts and specifications is deferred to a subsequent revision of the specification.
So, please excuse the incomplete sections with "placeholder" version notes!
There is value, though, in giving the existing content a quick review and providing feedback that would inform subsequent revisions of the specification.

Expand Down Expand Up @@ -107,8 +107,8 @@ How does this address the "interoperability trust gap"? By integrating SES dire
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|===
a| *SDPi Supplement Version Note*: For SDPi 1.2, the inclusion of SES Considerations sections is early and will be significantly extended in subsequent versions of the specification.
Especially when requirements from the <<acronym_pkp>> standards are included in SDPi 1.2 and following.
a| *SDPi Supplement Version Note*: For SDPi 1.3, the inclusion of SES Considerations sections is early and will be significantly extended in subsequent versions of the specification.
Especially when requirements from the <<acronym_pkp>> standards are included in SDPi 1.3 and following.

Note: When the <<acronym_pkp>> standards are integrated into this specification, then specific requirements will be directly linked to these <<acronym_ses>> Considerations sections.
|===
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2 changes: 1 addition & 1 deletion asciidoc/volume1/use-cases/tf1-ch-c-60601-1-8.adoc
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Expand Up @@ -8,7 +8,7 @@
The following is a quick guide to the functionality of DIS, CDIS, DAS and CDAS systems and how we have used and interpreted them for the purpose of this IHE Profile Supplement.
Please refer to the next section on Definitions from <<ref_iec_60601_1_8_2020>> for normative definitions for these terms.

NOTE: Note that the 1.2 version of the SDPi Profile only supports the Distributed Information System (DIS) model detailed below.
NOTE: Note that the 1.3 version of the SDPi Profile only supports the Distributed Information System (DIS) model detailed below.
The other models are anticipated for subsequent versions.


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2 changes: 1 addition & 1 deletion asciidoc/volume3/tf3-ch-8.3.2-biceps-content.adoc
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Expand Up @@ -58,7 +58,7 @@ a| *SDPi Supplement Version Note*: This version of the supplement does not fully
* Service Control Object (SCO) and Operations
* Battery objects

Additionally, only limited support for the *_AlertSystem_* (and related objects), and for the *_SystemContext_* types are provided in SDPi 1.2.
Additionally, only limited support for the *_AlertSystem_* (and related objects), and for the *_SystemContext_* types are provided in SDPi 1.3.
Subsequent versions of the specification will address complete functionality.
|===

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2 changes: 1 addition & 1 deletion asciidoc/volume3/tf3-ch-8.7.1-infusion-pump.adoc
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Expand Up @@ -23,7 +23,7 @@
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|===
a| *SDPi Supplement Version Note*: Content for this section will be extended in SDPi 1.x and subsequent versions.
The initial content will reflect what is provided in SDPi 1.2 <<vol3_clause_device_physiological_monitor>>.
The initial content will reflect what is provided in SDPi 1.3 <<vol3_clause_device_physiological_monitor>>.
|===


2 changes: 1 addition & 1 deletion asciidoc/volume3/tf3-ch-8.7.2-ventilator.adoc
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|===
a| *SDPi Supplement Version Note*: Content for this section will be extended in SDPi 1.x and subsequent versions.
The initial content will reflect what is provided in SDPi 1.2 <<vol3_clause_device_physiological_monitor>>.
The initial content will reflect what is provided in SDPi 1.3 <<vol3_clause_device_physiological_monitor>>.
|===
2 changes: 1 addition & 1 deletion asciidoc/volume3/tf3-ch-8.7.4-surgical.adoc
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|===
a| *SDPi Supplement Version Note*: Content for this section will be extended in SDPi 1.x and subsequent versions.
The initial content will reflect what is provided in SDPi 1.2 <<vol3_clause_device_physiological_monitor>>.
The initial content will reflect what is provided in SDPi 1.3 <<vol3_clause_device_physiological_monitor>>.
|===
14 changes: 7 additions & 7 deletions asciidoc/volume3/tf3-main.adoc
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Expand Up @@ -30,7 +30,7 @@ For the existing TF-3 content in the <<ref_ihe_pcd_tf_3_2019>>, especially Secti

*_Updating the existing IHE DEV Technical Framework content will be either deferred to a later version of this SDPi supplement or will be accomplished through a specific Change Proposal (CP) to the published IHE DEV TF-3._*

Additionally, for this version of SDPi 1.2, it isn't clear how best to address a similar division of the device specialization sections (e.g., infusion pump or ventilator).
Additionally, for this version of SDPi 1.3, it isn't clear how best to address a similar division of the device specialization sections (e.g., infusion pump or ventilator).
Version note boxes (like this one) have therefore been added to the specializations section and a single BICEPS subsection has been added.
Subsequent versions of the specification may address this more comprehensively.

Expand All @@ -45,7 +45,7 @@ Subsequent versions of the specification may address this more comprehensively.
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|===
| Move IHE PCD 2019 TF-3 Section 3 (text immediately after the section header) to this SDPi 1.2 TF-3 Section 8.1
| Move IHE PCD 2019 TF-3 Section 3 (text immediately after the section header) to this SDPi 1.3 TF-3 Section 8.1
|===

////
Expand All @@ -58,7 +58,7 @@ Subsequent versions of the specification may address this more comprehensively.
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|===
| Move IHE PCD 2019 TF-3 sections 3.1 to this SDPi 1.2 TF-3 Section 8.2
| Move IHE PCD 2019 TF-3 sections 3.1 to this SDPi 1.3 TF-3 Section 8.2
|===

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Expand All @@ -80,7 +80,7 @@ a| *SDPi Supplement Version Note*: The content in the IHE PCD 2019 TF-3 3.1 Sect
[%noheader]
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|===
| Move IHE PCD 2019 TF-3 sections 3.2 to 3.7 to this SDPi 1.2 TF-3 Section 8.3.1.2 TO 8.3.1..7
| Move IHE PCD 2019 TF-3 sections 3.2 to 3.7 to this SDPi 1.3 TF-3 Section 8.3.1.2 TO 8.3.1..7

A new 8.3.1.1 Section should be added to the Classic DIM content section that addresses basic reporting.
This content would be extracted from the existing (2019) Section 3.1, where that content is specific to the Classi DIM (see related note above).
Expand Down Expand Up @@ -112,23 +112,23 @@ Though there are no PHD requirements in this supplement, there are PHD profiles
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|===
| Move IHE PCD 2019 TF-3 Section 4 Reserved to this SDPi 1.2 TF-3 Section 8.4
| Move IHE PCD 2019 TF-3 Section 4 Reserved to this SDPi 1.3 TF-3 Section 8.4
|===

=== RESERVED

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|===
| Move IHE PCD 2019 TF-3 Section 5 Reserved to this SDPi 1.2 TF-3 Section 8.5
| Move IHE PCD 2019 TF-3 Section 5 Reserved to this SDPi 1.3 TF-3 Section 8.5
|===

=== RESERVED

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|===
| Move IHE PCD 2019 TF-3 Section 6 Reserved to this SDPi 1.2 TF-3 Section 8.6
| Move IHE PCD 2019 TF-3 Section 6 Reserved to this SDPi 1.3 TF-3 Section 8.6
|===

// 8.7
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