Tools for implementation & testing are not only fundamental to the adoption & success of SDPi+FHIR but ...


The sections below identify tooling-related resources and discussion topics.   

For additional content and community exchanges, see also the Community Engagement & Stacks of Useful Stuff pages

Updates Pending for this Page (2021.04.15)

  1. General update since last ... a long time ago!
  2. Include intros and links to all subpages (incl. FDA ASCA, MBSE/SysML, ...)
  3. Create a subpage for ReqIF use (per the -10700 journey slides)

What Lays Below ...

From Narratives to Requirements to Plug-and-Trust - Tooling for a New Level of Testability & Rigor

The intent of the Gemini SDPi+FHIR program is to establish a new level of requirements detail and traceability from user narratives to use cases to requirements that are expressed in a clear, concise and TESTABLE ASSERTION form that can be mapped and traced through all the way to the interoperable "plug-n-trust" interface that is tested.  Establishing a set of specification formats and supporting tool chain is the challenge.  

This  discussion slide deck details the approach being developed for this program:

Note:  Updated 2020-07-06A

See Narratives to Plug-n-Trust: Capture & Traceability & V&V & CA for a more detailed discussion.

RI+MC+RR for MedTech Specifications Initiative

During the January 2021 review of areas that should be advanced in this Gemini SES MDI program, three linked areas were identified as key opportunities for the work, as initially indicated in the 2021 Year 3 Update presentation:

RIRequirements Interoperability –  Ability to integrate & automate requirements and capabilities from component specifications & standards to enable traceability & coverage at CA of the component product interface

MC Model Centric – Transition from a document-centric to a computable model-based "single source of truth" specification from which the Technical Framework becomes a view of the model

RR Regulatory Ready – Enable CA test reports that are genuinely "regulatory submission ready" (e.g., inclusion in a U.S. FDA 510(k) submission package)

A set of confluence sandbox discussion pages have been created to support discussions and short-fuse pilot projects for these interlinked areas, including

Conclusions from these short term pilots - anticipated for end of "Summer" 2021 (Northern Hemisphere!) will directly impact the SDPi Supplement (1.0) specification as well as the processes and tooling utilized within the Gemini SES MDI program in general.

SDPi+FHIR Specification Tooling

<add tooling stuff from above "inspiring narratives" discussion slide deck>

Reference Implementation / Open Source Resources

<add from white paper and subsequent discussions>

Test Tooling Resources

<add from white paper & subsequent discussions>

Roadmap & Team Collaboration

CA & Tooling Support Roadmap

  1. Develop an SDC / SDPi Conformity Assessment & Tool Chain Strategy
  2. Roadmap pathway to IHE EU CAT '20 & IHE NA CAT '21 
  3. Roadmap pathway to IHE CA of SDC/SDPi products 

Development Status

  1. <include general updates per roadmap above>

Team Participants

The following individuals have requested to be included in the CA & Tooling Team:

NOTE:  Team participants who are also registered HL7 Confluence users  be able to comment and add content.

Team Discussion Notes

Older CA & Tooling meeting notes are available at Gemini CA Meeting Notes Archive

NOTE:  Add most recent discussions first.

Gemini CA 2022-02-17 Meeting

Gemini CA 2022-02-03 Meeting

NOTE:  2022.01.06 & 2022.01.20 Meetings CANCELED due to holidays & WGMs

Gemini CA 2021-12-16 Meeting

NOTE:  2021.12.02 Meeting CANCELED due to meeting conflicts including PAT #6!!!

Gemini CA 2021-11-18 Meeting

Other related web meeting discussion notes are captured on the SDPi+FHIR Meeting Logs & Notes page.

DescriptionDue dateAssigneeTask appears on
  • ( Todd Cooper  ) Craft overview slides for the SDPi 1.0 Requirements to TA to Test Cases to Test Results for the   meeting discussion
15 Dec 2022Todd CooperGemini CA 2022-12-01 Meeting
  • ( Todd Cooper ) Refactor outstanding CA action items per the current milestones and proposed January summit
Todd CooperGemini CA 2023-08-17 Meeting
Todd CooperGemini CA 2023-03-02 Meeting
  • ( Todd Cooper ) Propose test assertion approach for linking test scenarios to specification requirements 
Todd CooperGemini CA 2023-03-02 Meeting
Todd CooperGemini CA 2023-02-02 Meeting
  • ( David Gregorczyk  ) Discuss tooling transition plan from PAT to CAT events - what would that look like to do transactional testing?  What tooling?
David GregorczykGemini CA 2023-02-02 Meeting
  • ( Todd Cooper ) Todd will find a general Assurance Case overview presentation to distribute to the group
Todd CooperGemini CA 2022-08-04 Meeting
Todd CooperGemini CA 2022-04-07 Meeting
Todd CooperGemini CA 2021-11-18 Meeting
  • Todd Cooper ) identify SysML / UML construct intended for this purpose 
Todd CooperGemini CA Meeting Notes Archive
  • Todd Cooper) Update PAT#1 SDPi Intro & Overview slides for PAT#3, specifically updating with work advanced since the 2021.10 version
Todd CooperGemini CA Meeting Notes Archive
Todd CooperGemini CA Meeting Notes Archive
  • Todd Cooper John Donnelly Engage IHE T&T and IHE Catalyst regarding the path forward for SDC / SDPi+FHIR CA especially at Gazelle integration 
Todd CooperGemini CA Meeting Notes Archive
Todd CooperGemini CA Meeting Notes Archive
Todd CooperGemini CA Meeting Notes Archive
  • Todd Cooper Sync with John J. Garguilo re. future development and use of the above tool to add an SDC connector and support SDPi+FHIR integration & SDPi & XDS etc.
Todd CooperGemini CA Meeting Notes Archive
  • Todd Cooper Engage AAMI re. participation in Gemini SDPi+FHIR & Isolation Bed use case & 2021-01 FHIR CAT & etc. 
Todd CooperGemini CA Meeting Notes Archive
  • Todd Cooper Engage ACCE & IFMBE / CED around the use case
Todd CooperGemini CA Meeting Notes Archive
Todd CooperGemini CA Meeting Notes Archive
  • Todd CooperPost Michael F's Ghirkin for SDPi presentation
Todd CooperGemini CA Meeting Notes Archive


  1. Todd, can you add me to the CA and Tooling team?  Thx

    1. Added you to the Google Group + two monthly WebEx invites - you should see invitations for all.