diff --git a/CHANGELOG.md b/CHANGELOG.md index d9af5c3..a89fdf0 100644 --- a/CHANGELOG.md +++ b/CHANGELOG.md @@ -19,6 +19,8 @@ Each section shall contain a list of action items of the following format: `> 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 requiremets 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. diff --git a/asciidoc/volume1/tf1-ch-2-overview.adoc b/asciidoc/volume1/tf1-ch-2-overview.adoc index 069f4c2..77441ef 100644 --- a/asciidoc/volume1/tf1-ch-2-overview.adoc +++ b/asciidoc/volume1/tf1-ch-2-overview.adoc @@ -32,6 +32,9 @@ Thus the "Safety, Effectiveness and Security - Requirements and Considerations" Note that specific requirements from the above mentioned standards, may also be captured in <>. Generally, requirements from these standards would be mapped to the appropriate "Safety, Effectiveness and Security - Requirements and Considerations" sections throughout the specification. +NOTE: The *_SES sections in this document are not intended to be comprehensive_*, but provide helpful guidance to risk managers. +Implementers must ensure that all appropriate risk management processes have been performed. + // 2.3 [#vol1_clause_integration_profiles_overview] === Integration Profiles Overview