Skip to content

Commit

Permalink
Changes according to resolution of #272
Browse files Browse the repository at this point in the history
  • Loading branch information
JavierEspina committed Apr 16, 2024
1 parent 3dbc03a commit 8a501c6
Show file tree
Hide file tree
Showing 11 changed files with 21 additions and 21 deletions.
2 changes: 1 addition & 1 deletion asciidoc/volume1/tf1-ch-10-sdpi-p.adoc
Original file line number Diff line number Diff line change
Expand Up @@ -902,7 +902,7 @@ Specific capabilities supporting the <<acronym_aars>> use case include:


[#vol1_clause_sdpi_p_ses_considerations]
=== SDPi-P Safety, Effectiveness, Security Considerations and Requirements
=== SDPi-P Safety, Effectiveness and Security - Requirements and Considerations

==== SES General Considerations
Requirements from the <<ref_iso_81001_1_2021>>, <<ref_iec_80001_1_2021>>, and related standards should be fully applied to this technical framework element.
Expand Down
2 changes: 1 addition & 1 deletion asciidoc/volume1/tf1-ch-11-sdpi-r.adoc
Original file line number Diff line number Diff line change
Expand Up @@ -298,7 +298,7 @@ Specific capabilities supporting the <<acronym_ddes>> use case include:
////

[#vol1_clause_sdpi_r_ses_considerations]
=== SDPi-R Safety, Effectiveness, Security Considerations and Requirements
=== SDPi-R Safety, Effectiveness and Security - Requirements and Considerations

==== SES General Considerations
Requirements from the <<ref_iso_81001_1_2021>>, <<ref_iec_80001_1_2021>>, and related standards should be fully applied to this technical framework element.
Expand Down
2 changes: 1 addition & 1 deletion asciidoc/volume1/tf1-ch-12-sdpi-a.adoc
Original file line number Diff line number Diff line change
Expand Up @@ -416,7 +416,7 @@ Specific capabilities supporting the <<acronym_aars>> use case include:


[#vol1_clause_sdpi_a_ses_considerations]
=== SDPi-A Safety, Effectiveness, Security Considerations and Requirements
=== SDPi-A Safety, Effectiveness and Security - Requirements and Considerations

==== SES General Considerations
Requirements from the <<ref_iso_81001_1_2021>>, <<ref_iec_80001_1_2021>>, and related standards should be fully applied to this technical framework element.
Expand Down
2 changes: 1 addition & 1 deletion asciidoc/volume1/tf1-ch-13-sdpi-xc.adoc
Original file line number Diff line number Diff line change
Expand Up @@ -177,7 +177,7 @@ Therefore, with this release of the SDPi specification, this section remains inc
////

[#vol1_clause_sdpi_xc_ses_considerations]
=== SDPi-xC Safety, Effectiveness, Security Considerations and Requirements
=== SDPi-xC Safety, Effectiveness and Security - Requirements and Considerations

==== SES General Considerations
Requirements from the <<ref_iso_81001_1_2021>>, <<ref_iec_80001_1_2021>>, and related standards should be fully applied to this technical framework element.
Expand Down
8 changes: 4 additions & 4 deletions asciidoc/volume1/tf1-ch-2-overview.adoc
Original file line number Diff line number Diff line change
Expand Up @@ -22,17 +22,17 @@ These general concepts will help the technical framework reader understand the b

// 2.2
[#vol1_clause_ses_considerations_requirements,sdpi_offset=2]
=== Safety, Effectiveness & Security Considerations and Requirements
=== Safety, Effectiveness and Security - Requirements and Considerations
IHE specifications often include sections for "Security Considerations" and "Safety Considerations", capturing both general and specific guidance and requirements for system implementers.
This supplement extends these two concepts to include a third: Effectiveness.
The sections are termed: <<term_safe_effective_secure>> Considerations.
The sections are titled "Safety, Effectiveness and Security - Requirements and Considerations" and make use of the underlying term <<term_safe_effective_secure>>.

The background for <<acronym_ses>> is discussed in detail in <<vol1_appendix_a_integrating_ses>>; however, in general "<<acronym_ses>>" is used as a reference to the standards encompassed (directly and indirectly by reference) in <<term_joint_working_group_7>>, including <<ref_iso_81001_1_2021>> and <<ref_iec_80001_1_2021>>.
These standards are primarily, though not exclusively, focused on *_risk management of health software_* (including <<acronym_samd>>) *_and medical devices that are deployed on various kinds of infrastructure_*, with a focus to managing three key properties: *Safety, Effectiveness and Security*.
Thus the "<<acronym_ses>> Considerations" sections in this supplement are intended to reflect the results of that risk management and to guide those who are tasked with deploying and managing these interoperable solutions during use.
Thus the "Safety, Effectiveness and Security - Requirements and Considerations" sections in this supplement are intended to reflect the results of that risk management and to guide those who are tasked with deploying and managing these interoperable solutions during use.

Note that specific requirements from the above mentioned standards, may also be captured in <<vol1_appendix_b_referenced_standards_conformance>>.
Generally, requirements from these standards would be mapped to the appropriate <<acronym_ses>> Considerations sections throughout the specification.
Generally, requirements from these standards would be mapped to the appropriate "Safety, Effectiveness and Security - Requirements and Considerations" sections throughout the specification.

// 2.3
[#vol1_clause_integration_profiles_overview]
Expand Down
8 changes: 4 additions & 4 deletions asciidoc/volume1/tf1-ch-a-requirements-interoperability.adoc
Original file line number Diff line number Diff line change
Expand Up @@ -67,7 +67,7 @@ NOTE: The implementation of this framework will be extended as the specificatio

// A.2
[#vol1_appendix_a_integrating_ses]
=== Integrating Safety, Effectiveness & Security Requirements & Considerations
=== Integrating Safety, Effectiveness and Security Requirements and Considerations

In 2007, a joint effort between ISO/TC 215 and IEC/SC 62A was launched -- Joint Working Group 7 (JWG7) -- to focus on how to apply risk management to medical devices and health information systems and software that needed to interoperate on shared (hospital owned & managed) networking infrastructure.
The resulting standard, <<ref_iec_80001_1_2021>>, with a first edition published in 2010 and revised in 2021, not only provided a process for performing coordinated multi-stakeholder risk management for these technologies, but recognized the three *key properties* that would be the focus of that risk management: *_Safety, Effectiveness & Security (SES)_* footnote:ses_definitions[For definitions of these and other related terms, consult the https://81001.org[NHS 81001.org web page.] Last accessed 2022.10.04.].
Expand All @@ -89,11 +89,11 @@ To address this <<acronym_ses>> implementation problem, the SDPi Profiles:

. Leverage the ISO/IEEE 11073-1070x <<term_participant_key_purposes>> standards, which represent a consensus standard for risk management of technologies that are implemented in that left-right gap on the Temple model;
. <<term_implementation_conformance_statement>> tables from each of these <<acronym_pkp>> standards is included in <<vol1_appendix_b_references>> of this specification, with indication as to whether, how and where each requirement is addressed;
. "Safety, Effectiveness, Security Considerations and Requirements" sections are integrated throughout the profile specifications to link from the <<acronym_pkp>> <<acronym_ics>> table requirements to the satisfying capabilities.
. "Safety, Effectiveness and Security - Requirements and Considerations" sections are integrated throughout the profile specifications to link from the <<acronym_pkp>> <<acronym_ics>> table requirements to the satisfying capabilities.
[none]
.. Additional non-PKP risk management will also be performed by subject matter experts and formalized in these <<acronym_ses>> Considerations sections, where appropriate.

These <<acronym_ses>> Considerations sections grew out of the _IHE "Security Considerations"_ sections + the IHE Devices _"Safety Considerations"_ sections, but are now consolidated into a single SES Considerations section that integrates the 3rd risk management property, Effectiveness.
These "Safety, Effectiveness and Security - Requirements and Considerations" sections grew out of the _IHE "Security Considerations"_ sections + the IHE Devices _"Safety Considerations"_ sections, but are now consolidated into a single SES section that integrates the 3rd risk management property, Effectiveness.
Whenever possible, each of these considerations should be associated with the requirements of specific standards (e.g, <<ref_ieee_11073_10700_2022>>).

NOTE: The moniker *_<<acronym_ses_mdi>>_* is shorthand to refer to the integration of the technical medical device interoperability (MDI) specifications with the application of quality / risk management SES standards and processes.
Expand Down Expand Up @@ -125,7 +125,7 @@ The content in the following sections should be included and then specialized as
////

[#vol1_clause_appendix_a_ses_considerations_and_requirements]
=== Safety, Effectiveness, Security Considerations and Requirements
=== Safety, Effectiveness and Security - Requirements and Considerations

==== SES General Considerations
NOTE: This section includes guidance and requirements that are not further specialized for specific <<acronym_ses>> properties.
Expand Down
10 changes: 5 additions & 5 deletions asciidoc/volume1/use-cases/tf1-ch-c-use-case-stad.adoc
Original file line number Diff line number Diff line change
Expand Up @@ -34,7 +34,7 @@ image::../images/vol1-diagram-use-case-stad-tech-view.svg[align=center]

*Then* The device will synchronize its time with the <<acronym_ts_service>>

====== Safety, Effectiveness & Security Considerations and Requirements
====== Safety, Effectiveness and Security - Requirements and Considerations

.R1520
[sdpi_requirement#r1520,sdpi_req_level=shall]
Expand Down Expand Up @@ -62,7 +62,7 @@ NOTE: The 50ms target accuracy is suitable for highly demanding use cases like r

*Then* The device will disable the ability to change its time manually

====== Safety, Effectiveness & Security Considerations and Requirements
====== Safety, Effectiveness and Security - Requirements and Considerations

.R1510
[sdpi_requirement#r1510,sdpi_req_level=shall]
Expand All @@ -84,7 +84,7 @@ NOTE: Since manual time adjustments of the device's internal clock would lead to

*Then* The device will not participate on the <<acronym_md_lan>> network until it detects and connects to a <<acronym_ts_service>>

====== Safety, Effectiveness & Security Considerations and Requirements
====== Safety, Effectiveness and Security - Requirements and Considerations

.R1540
[sdpi_requirement#r1540,sdpi_req_level=shall]
Expand Down Expand Up @@ -123,7 +123,7 @@ NOTE: By using the device's clock accuracy, a consumer can decide if received da

NOTE: A <<term_manufacturer>> may decide to limit user notification of technical issues to certain user groups (e.g., biomed).

====== Safety, Effectiveness & Security Considerations and Requirements
====== Safety, Effectiveness and Security - Requirements and Considerations

.R1530
[sdpi_requirement#r1530,sdpi_req_level=shall]
Expand Down Expand Up @@ -196,7 +196,7 @@ If a <<vol1_spec_sdpi_p_actor_somds_participant>> cannot reach the <<acronym_ts_

NOTE: It is the <<vol1_spec_sdpi_p_actor_somds_consumer>>'s responsibility to decide if timestamps are accurate enough to execute its <<term_system_function_contribution>>.

====== Safety, Effectiveness & Security Considerations and Requirements
====== Safety, Effectiveness and Security - Requirements and Considerations

.R1500
[sdpi_requirement#r1500,sdpi_req_level=shall]
Expand Down
2 changes: 1 addition & 1 deletion asciidoc/volume2/dev-x-default-ses-secured-mode.adoc
Original file line number Diff line number Diff line change
@@ -1,4 +1,4 @@
==== Safety, Effectiveness, Security Considerations and Requirements
==== Safety, Effectiveness and Security - Requirements and Considerations

===== SES General Considerations
Requirements from the <<ref_iso_81001_1_2021>>, <<ref_iec_80001_1_2021>>, and related standards should be fully applied to this technical framework element.
Expand Down
2 changes: 1 addition & 1 deletion asciidoc/volume2/dev-x-default-ses-unsecured-mode.adoc
Original file line number Diff line number Diff line change
@@ -1,4 +1,4 @@
==== Safety, Effectiveness, Security Considerations and Requirements
==== Safety, Effectiveness and Security - Requirements and Considerations

===== SES General Considerations
Requirements from the <<ref_iso_81001_1_2021>>, <<ref_iec_80001_1_2021>>, and related standards should be fully applied to this technical framework element.
Expand Down
2 changes: 1 addition & 1 deletion asciidoc/volume2/tf2-ch-a-mdpws.adoc
Original file line number Diff line number Diff line change
Expand Up @@ -68,7 +68,7 @@ A <<vol1_spec_sdpi_p_actor_somds_participant>> shall use HTTPS with mutual authe
.Notes
[%collapsible]
====
NOTE: Each section that specifies a transaction indicates security requirements in the __Security Requirements & Considerations__ subsection beneath the __Safety, Effectiveness, Security Considerations and Requirements__ of each transaction.
NOTE: Each section that specifies a transaction indicates security requirements in the __Security Requirements & Considerations__ subsection beneath the __Safety, Effectiveness and Security - Requirements and Considerations__ of each transaction.
NOTE: Essentially, this specification asks for secured transmission of data except when ad-hoc discovery is performed.
====
Expand Down
2 changes: 1 addition & 1 deletion asciidoc/volume3/tf3-ch-8.3.2-biceps-content.adoc
Original file line number Diff line number Diff line change
Expand Up @@ -197,7 +197,7 @@ NOTE: This includes OIDs for private codes as detailed in <<ref_ieee_11073_10101
****

[#vol3_clause_biceps_ses_content_requirements_considerations]
===== Safety, Effectiveness, Security Content Requirements & Considerations
===== Safety, Effectiveness and Security - Requirements and Considerations

[%noheader]
[%autowidth]
Expand Down

0 comments on commit 8a501c6

Please sign in to comment.