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Agenda (proposed)

  1. General Updates
    1. IHE Catalyst Engagement Update
    2. ...
  2. PAT #6 Planning
  3. SDC Test Tooling Update
  4. Advancing MBSE/SysML 2.0 use NOW vs. Gherkin / ReqIF 
  5. IHE CA and SDPi leveraging:
    1. Gazelle Master Model documentation and tooling
    2. Assertion Manager documentation and tool
  6. Gazelle Challenges / Improvements (update from John Donnelly  from Stella evaluation days past!)
  7. Test Case Authorizing & formalization and linkages to SDPi requirements (incl. traceability) - what does that look like now?
  8. Additional Topics


Todd Cooper   David Gregorczyk    Michael Faughn   John J. Garguilo   John Rhoads   John Donnelly 

Discussion Notes

NOTE: Todd's computer keyboard was malfunctioning during the meeting; so the discussion notes below are from hand written (pen & paper!).  Comprehensiveness may be ... compromised

  1. General Updates
    1. IHE Catalyst Engagement Update
      1. Gemini Study project continues to progress; target is to conclude before the December Gemini CA meeting; more details then!
    2. PAT Testing Update
      1. PAT #6 (early December, fully virtual has as it's primary goal to get ALL GREEN!!! on the interoperability testing matrix - a great way to end 2022!
      2. AND there will be a new company participating, Vector Informatics (an OR.NET member), which is looking to provide SDC services and is working with the pySDC library 
      3. SO maybe not ALL green but we'll give Vector a "buy" this first time around
      4. PAT #7 is penciled in for the first week in February 2022; the goal for that event will be to transition from the core SDC transaction testing to a more "use case" based approach
    3. SDC Test Tooling Update
      1. Work progresses, with an additional tool developer brought on board (at Dräger) to work on the reference implementation and possibly support tooling later as well
      2. Note:  Todd is working to get access to the Gazelle API specification so as to be able to determine the level of effort needed to integrate the SDC test tool with that platform
    4. Advancing MBSE/SysML 2.0 use NOW vs. Gherkin / ReqIF 
      1. After reviewing the soon-to-be-published SysML 2.0 specification, it has become clear that many of the challenges that drove using Gherkin & ReqIF are now fully supported in the 2.0 specification
      2. For example:
        1. Specification now has (in Volume 1) a foundational language representation (Kernel Modeling Language - KerML) that provides Extended BNF and JSON representations as well as the graphic elements (seel slide below); 
        2. Requirements modeling is greatly enhanced - making the need for ReqIF practically (if not fully?) eliminated
        3. Volume 3 defines a services API that makes tool independence a reality!
          1. NOTE:  That 3DS and INCOSE (think MBSE) are both core developers for 2.0 (see the slide below)
          2. This means that tool support for 2.0 is and will increasingly be provided (especially once the specific
        4. Capabilities are greatly enhanced supporting even digital twinning! 
      3. An early slide of some of the specification pages should help:
      4. Question:  What does it mean "SysML 2.0 now vs. Gherkin & ReqIF"
        1. Since we already have the Gherkin logic for Appendix C, we will keep that for now BUT in the future we may replace it or map it to SysML 2.0 constructs
        2. Creating Gherkin Feature files is probably no longer of value 
        3. For basic RI in the SDPi Supplement Word document, we will use a combination of styles, references / links and bookmarks.  These will require unique names (e.g., for each bookmark) and we will probably use a 2.0 fully qualified name, that is linked now or later to a SysML model element.  
    5. Ecosystem Pathway Group Update
      1. The "SES/Regulatory" group that was proposed in the September '21 WGM, has had a "formation" group discussing purpose / scope / what / when / where / why etc.  and is now ready to start focused meetings
      2. Participants should primarily be quality, regulatory affairs, product risk management experts - those who are responsible for shepherding a product to market & use, including regulatory pathways.  
      3. A home confluence page has also been created:  Pathway to an Ecosystem of Plug-and-Trust Products
      4. Obviously, part of that "ecosystem pathway" involves conformity assessment, as well as, related efforts like the FDA ASCA pilot & IHE CA discussion 
        1. ACTION( Todd Cooper ) Move the ASCA discussion pages under this page, since this is where the primary discussions will occur 
      5. It was noted that during the most recent Ecosystem Pathway (EP) discussion (see 2021.11.18 notes), foundational standards were mentioned but not profiles - which are crucial to both productization as well as CA and market creation; this should be included in the EP discussions
        1. ACTION( Todd Cooper ) will add that to the EP notes
    6. NIST CA for IHE and for FDA ASCA - Clarification
      1. John J. Garguilo mentioned that NIST's Warren Merkle created a document that helps tease apart various terms including conformity testing vs. certification
      2. See:  NIST Special Pubs AP2000-1 & -2, ABCs of Conformity Assessment (2018) & Conformity Assessment Resources for Federal Agencies (2018)
  2. IHE CA and SDPi leveraging:
    1. In discussions with the Catalyst Study project two tools have come to the fore:
      1. Gazelle Master Model documentation and tooling
      2. Assertion Manager documentation and tool
    2. Use of these tools answers questions like, "How do we get our profile information and test cases into Gazelle?"  or "How can we formalize test assertions for our profiles?"
    3. Of course, there are also challenges that come with the these tools, such as the limitation of not being able to do a "bulk" upload or continuous integration with Gazelle of test case content
    4. Questions start with what file format we should use for formalized SDPi test cases (that support RI as well):
      1. John J. Garguilo  mentioned that the IGAMT / TCAMT tools for V2 have a test case file format that might be leveraged
  3. Gazelle Challenges / Improvements 
    1. John Donnelly  discussed some of the issues that were associated with previous efforts, such as the Stella project or Interoperability Test Tool (ITT) ... will try to locate specific details
    2. For FHIR based profile testing, NIST is working on an Asbestos tool that may have application to SDC/SDPi testing with FHIR connectivity - stay tuned
    3. General Discussion though about TOOL DEVELOPMENT COORDINATION & GOVERNANCE, the lack thereof (e.g., Inferno vs. Asbestos etc.) and the need to move in that direction in the future
    4. Todd reiterated that the focus on MBSE / SysML 2.0 provides all the pieces that are needed; however, integrating those artifacts with test platforms like Gazelle is a whole different question
  4. Test Case Authorizing & formalization and linkages to SDPi requirements (incl. traceability) - what does that look like now? - deferred to later discussion
  5. Additional Topics
    1. No additional topics

Action Items / Tasks