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HL7 2024-Jan: SES Section Clarification as Non-Comprehensive #271

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ToddCooper opened this issue Mar 6, 2024 · 1 comment · Fixed by #351
Closed

HL7 2024-Jan: SES Section Clarification as Non-Comprehensive #271

ToddCooper opened this issue Mar 6, 2024 · 1 comment · Fixed by #351
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@ToddCooper @kenjfuchs
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Comment Review Comment of some sort from somewhere sometime HL7 Ballot Issue is related to an HL7 Ballot comment resolution
Milestone
SDPi 2.0 Review

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@ToddCooper
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Section Number

1:2.2 Safety, Effectiveness & Security Considerations and Requirements

Priority

  • Medium: Significant issue or clarification. Requires discussion, but should not lead to long debate.

Issue

HL7 JAN2024 Ballot Comment: OTHER-2769 "Point out SES section is incomplete".

Add comment to SES discussion that the framework only calls out some SES considerations and that manufacturers and integrators need to perform their own analysis.

Proposed Change

Include a statement to indicate that the SES sections in the document are not intended to be comprehensive, and that any implementers must perform appropriate risk management processes.
@ToddCooper ToddCooper added Comment Review Comment of some sort from somewhere sometime Comment NEW A submitted comment waiting to be reviewed and dispositioned HL7 Ballot Issue is related to an HL7 Ballot comment resolution labels Mar 6, 2024
@ToddCooper ToddCooper removed the Comment NEW A submitted comment waiting to be reviewed and dispositioned label Apr 12, 2024
@ToddCooper ToddCooper added this to the SDPi 1.4 review milestone Apr 12, 2024
@JavierEspina
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SDPi Developers Workshop #4 -

Add proposed statement to end of 2nd paragraph in 1:2.2

@ToddCooper ToddCooper self-assigned this Dec 6, 2024
@ToddCooper ToddCooper linked a pull request Dec 6, 2024 that will close this issue
SES Non-Comprehensive Note Added #351
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@github-project-automation github-project-automation bot moved this from New issues to Done in Gemini SDPi Releases Dec 9, 2024
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@ToddCooper ToddCooper

@kenjfuchs kenjfuchs

Labels
Comment Review Comment of some sort from somewhere sometime HL7 Ballot Issue is related to an HL7 Ballot comment resolution
Projects
Gemini SDPi Releases
Status: Done
Milestone
SDPi 2.0 Review
Development

Successfully merging a pull request may close this issue.

SES Non-Comprehensive Note Added IHE/DEV.SDPi
3 participants
@ToddCooper @JavierEspina @kenjfuchs