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Agenda (proposed)

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

Participants

Todd Cooper   John Rhoads   David Gregorczyk  Kenneth Fuchs  Thomas Pils  Marlene Gebhard   John J. Garguilo   Peter Kranich 

Pascal Burek (Vector Informatics), Peter Ziegenhein (Vector) 

Discussion Notes

  1. General Updates
    1. PAT #8 4-6.05.2022 
      1. TBD for F2F ability (esp. given vacation time) ;  most likely virtual 
      2. Focus for PAT:  Get Interoperability Metrics All Green + Equipment Label Extension (Topic: Info exchanged during unsecured discovery
    2. IHE Global CAT in September ... & IHE SDPi? 
      1. Consider promoting inclusion of an "SDC/SDPi Plugathon component?"  Yes ...
      2. Hybrid event - Would European vendors participate in person? 
      3. Participation in the Connectathon Conference?  IHE Experience (EU) conference
      4. Note:  CAT September 12-16, Switzerland & (tbd) Baltimore + virtual component
      5. ACTION( Todd Cooper  & John Rhoads  ) Engage Amit T. re. establishing a role / presence for the SDC/SDPi+FHIR Gemini project in the Global CAT
  2. Action Items
    1. (Todd Cooper ) Still working on 2022 "near term" RI+MC+RR CA & Tooling Strategy / Roadmap (see next)
  3. RI+MC+RR General Update
    1. Todd reviewed the current strategy slide deck - with a focus on the use of the NIST Asbestos tool 
      1. ACTION( Todd Cooper  ) Update Glossary & Abbreviations Deobfuscation with acronyms from this slide deck 
      2. Though many questions and issues have been resolved, a few final questions have yet to have final answers determined - which is a prerequisite to finalizing the strategy roadmap for 2022 (milestones and tasks).  Questions include:
        1. What do "test scripts" look like?  (model & format) - Can we leverage FHIR TestScript?
        2. What do "test reports" look like?  (model & format) - Can we leverage FHIR TestReport?
        3. What test "engine" can we re-use to execute the test scripts, validate the tests and generate the test reports? - Can we leverage NIST Asbestos toolkit?
        4. Does the test engine include a Gazelle EVS Client interface (automating metadata exchange)? - Has NIST Asbestos toolkit been interfaced with Gazelle via the EVS Client API?
        5. What do "test assertions" look like?  (model & format) - Can we utilize FHIR TestScript::Assert?
    2. Note:  From discussion of  Topic:  DAS + Smart Alerting Challenges earlier today, the need for "regulatory submission ready" was reiterated recognizing that:  60601-1-8 requirements are met by 11073-10702 Alert PKP which are met by SDPi-Alerting profile which are tested by this infrastructure and end up with test reports that include traceability and coverage back to ... 60601-1-8!  
  4. SDPi Testing / Tooling Update
    1. Note that Vector Informatics gave an update to the SDPi group last Friday (see slides and discussion posted at Gemini 2022-04-01 SDPi Friday )
      1. The group has done a fantastic job adapting their tooling products to support SDC testing, including participation at PAT #6 & #7
      2. Though the testing infrastructure advanced by this Gemini group necessarily needs to exist in the "open" space, there will be a significant need for more robust testing capabilities both within companies, as well as in deployment projects.  
    2. "David G's amazing test tool" (for lack of a better name) is in the SDPi github / Tooling / sdc11073 repository, but it is not actively being developed / maintained – no longer being used at PAT events
    3. CA & Tooling strategy effort above is using the existing test sequences utilized at IHE DE PAT events to determine how they would be formalized in test scripts and reports as part of the IHE SDPi infrastructure;  
      1. Given the current Gemini roadmap objective of supporting public demonstrations of silent ICU early 2023, the testing artifacts should also support "Silent Point-of-Care" Component Testing" 
        1. ACTION( Peter Kranich  Todd Cooper  ) Discuss system scenarios and tests to consider for advancing test scenario development
  5. EP Coordination
    1. General Update on Ecosystem Pathway Discussions, especially Topic: Tracing the FDA Design considerations for interoperable systems to 510(k) submission documents 
      1. Monica da Silva  presented at the   EP biweekly meeting about the work she had done to trace the interoperable systems design considerations (FDA guidance document) to FDA 510(k) submission form fields.
      2. Though the CA & Tooling group is focused on the testing infrastructure and artifacts that will enable us to get to "regulatory submission ready" product CA test reports, the EP group will determine exactly what will be needed (content) in those reports
  6. Any Other Business
    1. No other business identified

Action Items / Tasks