Agenda (proposed)

  1. General Updates
  2. Action Items
  3. RI+MC+RR General Update
    1. CA for Multi-Schemes / Owners
  4. SDPi Testing / Tooling Update
  5. EP Coordination
  6. Any Other Business

Participants

Todd Cooper   John J. Garguilo   John Rhoads   Martin Kasparick  Marlene Gebhard   Jan Rizzuto  Tom Kowalczyk   Amy Phelps  

Regrets:  David Gregorczyk   John Donnelly  

Discussion Notes

  1. General Updates
    1. Transition to AsciiDoc platform / development
      1. Per the SDPi Supplement Publication presentation action items for transitioning from Word and markdown to AsciiDoc-based content, the focus the last week+ has been on actioning that transition 
      2. Todd reviewed wiki content https://github.com/IHE/sdpi-fhir/wiki  that was added for the first time
      3. Add CA & Tooling articles linked from Home wiki page; articles can include:  Formalization of Test Assertions, Test Artifact formalization / AsciiDoc use?, workflow for SDPi CA & Tooling, ... 
        1. ACTION( Todd Cooper  ) Add CA & Tooling article place holders to the sdpi-fhir wiki pages
    2. ISO/IEC JWG7 Project:  81001-2-1 Assurance Case Standard Underway 
      1. Familiarity or background with AC's?  Not so much ...
        1. ACTION( Todd Cooper ) Todd will find a general Assurance Case overview presentation to distribute to the group
      2. Note:  Assurance Cases are now part of the recent editions of ISO/IEC 80001-1 & 81001-1 , + the focused project ISO/IEC 81001-2-1 Assurance Case Guidance; so it is a topic that shouldn't be ignored and should be integrated; also, for 15+ (question) years now, the NHS has required an assurance case for all non-regulated connected health technologies, assuming that regulated medical devices are by definition reviewed and assured as "safe", though not SES
  2. Action Items
    1. Gemini CA 2022-07-21 Meeting   
      1. Proposal for how / who / when / where to instantiate a Single Source of Truth (SST) database - target a proposal to the group by for review (during the HL7 WGM)
  3. RI+MC+RR General Update
    1. CA for Multi-Schemes / Owners - Discussions continue / no specific updates
    2. A related CA strategy workshop is being considered after the HL7 September WGM (Baltimore) to be held at NIST (Gaithersburg) to finalize the Gemini CA strategy with SMEs from NIST, FDA and the Gemini community
    3. Note:  As indicated above, the transition to AsciiDoc will fully support requirements interoperability metadata now (today), and will also be the basis for formalization of the Gemini program test artifacts
  4. SDPi Testing / Tooling Update - No update provided
  5. EP Coordination
    1. See EC/EU discussions from Gemini 2022-08-02 EP Web Meeting  -
      1. Reviewed updated MDR EC Ecosystem model from Michael Bothe ... ( HERE is the diagram posted on the above linked page ...)
      2. Discussion:
        1. Amy clarified that there is a significant difference between the FDA's 510(k) process and the FDA's ASCA pilot program (which will hopefully be continued once U.S. congressional budgets are finalized)
          1. For the 510(k) process, there is no formal requirements for a manufacturer to conform to specific standards  - that is voluntary - and product submitters can choose to include a Suppliers Declaration of Conformity (SDoC) to meet the 510(k) requirements for their particular class of product 
        2. The FDA perspective on Michael Bothe's EU model, to be considered by Isabel Tejero  , may include existing 510(k) process today and / or the ASCA provisions, or whatever helps this group understand the general approaches that need to be navigated for SDC/SDPi+FHIR compliant products submitted to the FDA for clearance
        3. Todd pointed out the objective that ultimately, the Gemini SES+MDI program needs to advance an international CA strategy that will meet the needs of various jurisdictions, starting with the EU and US, as well as the various interrelated standards that are likely to be identified in product regulatory submissions.  Clarity on this provides a significant value back to implementing organizations + all stakeholders.
      3. ACTION( Amy Phelps ) Provide a general overview of CA for both the CA & Tooling + EP groups, especially to get the concepts and terminology correct
      4. ACTION( Todd Cooper ) Create a confluence home page for a Gemini SES+MDI White Paper / Technical Report to capture the topics and discussions and eventually the approach and strategy to be taken
    2. Topic: SES Standards Landscape  - Reviewed the current contents of the topic page; once completed by the EP group, this page will help provide the scope for what has to be supported by the CA & Tooling group
  6. Any Other Business
    1. Next CA & Tooling August meeting canceled
    2. September meetings?
      1. ACTION( Todd Cooper ) Schedule as normal   &  


Action Items / Tasks

  • ( Todd Cooper ) Todd will find a general Assurance Case overview presentation to distribute to the group
  • ( Amy Phelps ) Provide a general overview of CA for both the CA & Tooling + EP groups, especially to get the concepts and terminology correct
  • ( Todd Cooper ) Create a confluence home page for a Gemini SES+MDI Technical Report to capture the topics and discussions and eventually the approach and strategy to be taken
  • ( Todd Cooper ) Schedule as normal   &