Agenda

1. Reviewed Georg's Slides (from last week's discussion)
2. Reviewed David G's PKP Slides
3. Refviewed Unity / SSch's 
4. Next Steps
   1. See deck slide #2 for editorial plan 
   2. Circulation of pitch to JWG7 for PWI advancement

Participants

Todd Cooper

Discussion Notes

1. Reviewed Georg's Slides (from last week's discussion)
2. Reviewed David G's PKP Slides
3. Refviewed Unity / SSch's 
4. Next Steps
   1. See deck slide #2 for editorial plan 

Action Items / Tasks

<TBD>

Agenda

1. JWG7 Meeting & TC215 Plenary Resolution Update
2. TR Outline & Action Item Review
3. SDPi Supplement TF-1 Appendix A Review - detailed
4. Matters Arising

Participants

Todd Cooper  Kenneth Fuchs Georg Heidenreich Matthias Marzinko

Discussion Notes

1. JWG7 Meeting & TC215 Plenary Resolution Update
   1. 
   2. Note:  There will be no "draft PWI" available by 30 November 2020 - 
      1. Intent is to provide what will be circulated to SC62A to understand the intent of the PWI
      2. Can be a simple presentation slide deck
      3. Can be a reference to this Confluence page with a brief "orientation tour" 
   3. ACTION( Georg & Todd ) Craft a slide deck for circulation to SC62A 25 Nov 2020 
2. TR Outline & Action Item Review 
   1. Brief review of the outline below 
   2. Brief review of the action items 
   3. ACTION( Matthias ) Will craft some slides for the SC62A presentation + for the report / paper "regulatory" section
3. SDPi Supplement TF-1 Appendix A Review - detailed
   1. Section A.2 will be drafted and integrated into this TR
   2. Need a very simple (e.g., not Hanging Gardens models) w/ a simple Example (e.g., Vent Imaging sync) that shows the standards support 
4. Matters Arising
   1. Roadmap Discussion:  2020-2021, Gemini => JWG7
      1. Brief review of the 2021 Roadmap Central page with SDPi Supplement section

Action Items / Tasks

• Georg Heidenreich Craft a simple set of SES MDI PWI slides for SC62A consumption 25 Nov 2020 
• Matthias Marzinko Craft a few slides based on previous work (see notes from 2020.06.16 and earlier below) as well as related content for the regulatory secion of the report

Agenda

• No agenda published in advance ...

Participants

Todd Cooper Georg Heidenreich

Matthias Marzinko

Discussion Notes

1. SES MDI TR PWI - Update for JWG7 
   1. An update on the TR discussions will be provided to ISO/IEC JWG7 during their session October 27, 2020
   2. Question:  What should be the approach for the update?  What should be included vs. omitted?
   3. Background:
      1. The current set of slides and their description are too complicated for "newbie" audiences to easily follow ...
      2. This is due to the inherent lack of background of the SES or MDI communities w.r.t. the other communities
      3. For example, a diagram that shows the Hanging Gardens model (MDI focused) and the Temple Model (SES focused) requires additional introduction to the "other" audience
      4. Standards are necessarily narrowly scoped and contents constrained ... often the experts working on Standard A do not really understand the ramifications of those working on Standard B, even though when they are applied to products (not to say decoupled Systems of Products) they have to be implemented in an integrated manner
   4. Conclusions:
      1. Setting a common VISION of the PWI is key ...
         1. PAST - PRESENT - FUTURE state 
            1. PAST - Include House of 80001-1 (Mankovich) with a Shared SES Vision of all stakeholders as being key 
            2. PRESENT - Implementation challenge because significant Assembly Required (lack of automation)  + document based + few vendor-to-vendor specifications
         2. Objectives for the FUTURE state
            1. Computable integrated cohesive specifications - automatable / validatable / CA'able 
            2. Bridging between Standards (e.g., IEC Systems Committees vs. TC/SC)
            3. All stakeholders supported 
            4. Decoupled System of Products that are SES & MDI 
         3. Resonate with ALL stakeholders, SES & MDI, technology developers / users / implementer-integrators / regulators 
      2. Timeliness of discussion - with TC215, TC62 & TC215 all reviewing / updating Strategic Business Plans (SBPs) 
         1. Establishing a common vision and roadmap to achieve the above can be at least called out in the SBPs
      3. Identify core SES MDI Concepts that should be communcated ... gently & incrementally ...
         1. Realities of Product Development (SES+MDI)
         2. Stakeholds involved ...
         3. standards involved (families / communities)
         4. SES MDI Trust Gap
         5. Computability / automation of standards and standards based solution specification, validation analytics & CA
         6. IEC Systems Committees "BRIDGING" SDOs and standards 
         7. IHE Use Case driven as the approach for "bridging" 
         8. "App for Regulatory Compliance" (Georg)
         9. Integration of Assurance CAses
         10. ...
2. No additional topics pursued

Action Items / Tasks

• Todd Cooper craft TR PWI update slides for JWG7 for review by this group by 23 Oct 2020 

Agenda

1. General Updates 
   1. TC215 AHG4 CA Discussions
   2. PKP Paper / EU Notified Bodies Engagement
   3. ISO/IEC JWG7 TR Update 10/27
2. Review Key TR Sections / Topic
3. Additional Topics

Participants

Todd Cooper

Matthias Marzinko

Discussion Notes

1. General Updates 
   1. TC215 AHG4 CA Discussions
      1. ISO/TC 215 created an Ad Hoc Group to develop a report on Conformity Assessment, current state of "assessability" of 215's standards portfolio, recommendations on what 215 should do in current and future projects to support CA activities
      2. Focus is on leveraging ISO 17000 family of standards (especially ISO 17007 CA guidance for standards development)
      3. Note:  ISO/IEEE 11073 SDC standards (incl. PKP standards, profiles like SDPi+FHIR) and this SES MDI TR) will end up in 215, thus the relevance of the AHG4's work
      4. The SES MDI approach to CA that is "regulatory ready" and integrates other work in IHE and JWG7 (e.g., assurance cases) will be represented to the AHG4.
   2. PKP Paper / EU Notified Bodies Engagement
      1. OR.NET meeting today (10/13) with (3) German notified bodies to introduce the "SDC Conformance Principles" and subsequent work 
      2. Challenge is how to help notified bodies to understand (contempentence) to understand what is being advanced 
      3. Discussions also included assessment, testability, test houses, etc.
      4. Note:  discussions included mention of assurance cases 
   3. ISO/IEC JWG7 TR Update 10/27
      1. This TR PWI is being transferred from ISO/TC 215 WG2 to ISO/IEC JWG7
      2. TR Briefing to ISO/IEC JWG7 is scheduled for October 27
      3. This briefing will include the broad concepts and approach for SES MDI using SDC / SDPI+fhir
      4. A draft presentation should be ready for initial review in next week's meeting 
   4. IEC/TC 62 Considerations for Integration of MDI into 60601 Series
      1. Medical Electrical Applications in Healthcare (including software) - proposed area of focused work
      2. TC62 evaluating committee feedback on how best to address SES MDI esp. software and AI-based technologies 
      3. Proposals include integration across 60601 standards family, updated TC Scope & biz plan, possibly even a 
2. Review Key TR Sections / Topic
   1. Deferred to next week due to the lack of participants
   2. Todd Cooper will "remind" TR team participants of their areas of deliverables
3. Additional Topics
   1. No additional topics

Action Items / Tasks

No new action items

Agenda

1. General Updates 
2. SES Requirements & Hanging Gardens Model integration

Participants

Todd Cooper Kenneth Fuchs Georg Heidenreich

Meeting Notes

1. General Updates
   1. ISO/TC215 CAG2 considered a proposal to move the SES MDI Technical Report PWI from WG2 to JWG7; expect a resolution during the upcoming November meetings
      1. ACTION( Georg ) To work with JWG7 leadership to add an update discussion to an October JWG7 plenary meeting agenda and to review / approve the formal resolution to move the Preliminary Work Item (PWI) from WG2 to JWG7. 
   2. Noted that primary focus has been on advancing the SDPi Supplement + tooling / testing etc.  vs. detailing out this TR content; 
   3. The SES MDI Overview & Framework slide deck is still in process and will be the next milestone for this group's review.  Expected for presentation the week of the HL7/IEEE WGM September 21st 
   4. The related IEEE 11073-10700 Base Participant Key Purposes (BPKP) draft standard began pre-ballot expert review last week. (see discussion below)
2. SES MDI - Standards Requirements Coordination per the Hanging Gardens Model
   1. Given that the IEEE 11073-10700 BPKP standard is out for pre-balloting review, this begs the question of the relationship of this standard to the SDPi profiles + SES MDI hanging gardens model etc.
   2. As indicated on the Gemini SDPi+FHIR Hanging Gardens model:
      1. The ISO/IEEE 11073 SDC standards are highly cohesive and integrated, and are therefore represented with a dashed blue line around the published and in development SDC standards
      2. The PKP layer provide detailed specifications that specify what an SDC implementation device or PARTICIPANT system must do to be "safe"  (the first "S" in SES); but it also includes security
      3. The Key Interoperability Properties (KIP) layer defines general requirements to achieve Plug-and-Trust SES at the "MDI Trust Gap" between technology suppliers, implementers, users, and regulators.  
         1. This will include formally (e.g., via ReqIF specifications) capturing requirements from 80001-1, 81001-1, 14971, 60601-xyz (when appropriate) etc. 
         2. These general requirements can then be mapped to the specific SDC PKP provisions (as well as other technologies)
      4. Taken together, the requirements from the SES MDI layer would be mapped to the provisions of the SDC/PKP standards, which are in turn mapped to the specific provisions implemented in a compliant SDC PARTICIPANT system, and tested at the network connection interface.
      5. NOTE:  This TR will endeavor to paint this picture clearly and recommend a roadmap to achieve its realization
      6. In addition to ReqIF representation & mapping, the JWG7 Assurance Case work item can be leveraged to define an SES MDI Assurance Case template (or composable assurance cases).
3. Other Discussion Topics
   1. General observation about continuing the work of the IEEE SDC / IHE SDPi profiling to include imaging-related use cases
      1. The PoCSpeC project is focused on Endoscopy and includes device specializations such as an Endoscopy Camera 
      2. The SDPi Supplement TF-3 includes a section (carve out) for Surgery Devices, that is intended to include items such as Endoscopy Cameras and other related. 
      3. Mention was made of the ICE (AAMI 2700-1) use case for ventilator-imaging device synchronization, where the ventilator is "paused" and sync'd so the imaging device can take the picture
         1. Note:  This is a long standing use case that represents a potential application of SDC/SDPi-based SES MDI

Action Items / Tasks

• Georg HeidenreichWork with JWG7 & Joe Lewelling (Secretary) to add an agenda item to a JWG7 October plenary meeting to update on the SES MDI TR work + the resolution to move from WG2 to JWG7

Agenda

1. General Updates & Review
2. Updated Hanging Gardens Model Review
3. SES MDI Slide Deck Review
4. IHE SDPi Supplement - TF-1 Appendix on SES MDI integration
5. Action Items / Tasks List Review + Roadmap
6. Other Topics

Participants

Todd Cooper Kenneth Fuchs David Gregorczyk Georg Heidenreich

Meeting Notes

1. General Updates / Discussion
   1. SES MDI report at TC/215 being moved to JWG7 as a Preliminary Work Item (PWI) 
      1. NOTE:  Many IoMT vendors do not have a general appreciation for the challenges of SES / Med Tech vendor challenges ... 
      2. ACTION (Todd) Ensure that IoT / IoMT / IEEE Clinical IoT is included 
   2. FDA Releases Final Guidance on "Multiple Function Device Products"
2. Hanging Gardens Model Update
   1. Reviewed recently updated SDPi Hanging Gardens model 
   2. NOTE:  This report "lives" in the light green KIP SES layer
3. SES MDI Slide Deck Review
   1. Reviewed current draft of the SDPi Slide Deck (for content for SES MDI WP)
4. IHE SDPi Supplement / TF-1 Appendix on SES MDI Integration
   1. Reviewed draft content of DEV TF-1 Appendix A that points to this SES MDI report
   2. Note specific SES sections added to the TF sections to capture general and detailed requirements + the TF-1 Appendices for requirements mapping (incl. from standards such as 80001-1 2nd edition) and the ISO/IEEE 11073 SDC Implementation Conformance Statement (ICS) tables.
5. Roadmap + Action Items / Tasks Review
   1. Brief review of the Technical Report drafting from this point out - intent is to get the slide deck updated in August and an initial draft ready in September
   2. JWG7 Leadership can be updated using the slide deck - though per Georg Heidenreich"less is more" and perhaps a focused straight-forward slide presentation would be more ... "consumable"!  
6. Other Topics

Action Items / Tasks

• Todd Cooper07 Aug 2020 Include IoT / IoMT / IEEE Clinical IoT in the report outline

Related discussion during the CA & Testing web call including:  Todd Cooper Michael Faughn David Gregorczyk & Anna Feiler 

Action items for the SES MDI report included:

• Todd Cooper  Update report outline with Definitions section that includes concepts around product decoupling / coupling, to be proposed for addition to 81001-1 + review 81001-1 definitions sections for relevance / mapping / utilization within the SES MDI SDC/SDPi application context
• David Gregorczyk Include current set of concepts and working definitions to be included
• Todd Cooper  Add section to WP for the Hanging Gardens model & the SES KIP section & artifacts (note, these will be where the primary JWG7 development subjects show up, like an assurance case template, models for various standards (e.g., 80001-1) that will then be mapped to ReqIF, etc. etc. etc. 
• Todd Cooper  Add to recommendations section, the proposed 81001-x sections for this work

Agenda

1. General Updates on report Development & Standards Coordination &  Community Engagement
2. (All) Review SES MDI report Tasks
3. WP Document Content Review / Discussion:
4. New Business

Participants

Todd Cooper Kenneth Fuchs Stuart Harrison

Georg Heidenreich, Stuart Harrison

Meeting Notes

1. General Updates / Review
   1. ISO/TC 215 PWI Approved

      1. ISO/PWI TR 5605 Safe, Effective & Secure Medical Device Interoperability using Service-oriented Device Connectivity / Service-oriented Device Point-of-care Interoperability + HL7 Fast Healthcare Interoperability Resources

      2. Preliminary = clock not running yet - intent to fast track document once published at IHE - HL7 Gemini
      3. To be discussed at ISO/TC 215 CAG 2 July 30 meeting re. WG2 or JWG7 (per request from Canada)
   2. GitHub Home for report
   3. Publication example - IHE PCC "Health Story" report (joint HL7-IHE example)
   4. OR.NET PoCSpeC Project (11073-1072x standards) - promotion
2. Review related SDPi Supplement "SES" sections
   1. Reviewed the draft SDPi Supplement (on IHE GitHub sdpi-fhir repository)
   2. SES sections added to IHE DEV TF SDPi Supplement Volume 1 & 2 
   3. TF-1 Appendix A includes SES and core of this report's content as it applies to integration with MDI
3. Review report outline
   1. Added new section page SES-MDI: Leveraging Assurance Cases 
   2. ACTION (Todd) Pretty up the page with an initial set of sections
   3. ACTION (Stuart) Update with content per broader discussions, especially in JWG7
4. Review outstanding tasks

Action Items / Task Lists

• Todd CooperUpdate / pretty up SES-MDI: Leveraging Assurance Cases
• Stuart Harrison Update with content per broader discussions, especially in JWG7

Agenda

1. General Updates on Technical Report Development & Standards Coordination &  Community Engagement
2. (Todd) Review Confluence page content, including outline, subsections / pages, etc.
3. WP Document Content Review / Discussion:
   1. (Todd Cooper) general review of outline / target content  + core SES MDI sections
   2. (Matthias) Review Regulatory Approach "introduction" content
   3. (Stefan Schlichting ) Update on new V-model diagrams
   4. (David Gregorczyk) Update on PKP section 
4. New Business

Participants

Todd Cooper Kenneth Fuchs John Rhoads Konstantinos Makrodimitris

Stuart Harrison, Anton Keller, Matthias Marzinko

Meeting Notes

1. General Updates
   1. General SES MDI report status update
      1. ACTION:  (Todd) Create subpages w/ "Gemini-SES-MDI" label 
   2. Intro:  Stuart!  
   3. Reviewed general status of related Quiet Hospital / Silent Hospital narrative
   4. At ISO/TC 215 - PWIs for report are in ballot; at ISO/IEC JWG7 PWI is under consideration 
2. Quality / Regulatory Perspective (Matthias)
   1. Updated on the approach to explain a non-device-centric approach to SES stakeholders
   2. Labeling requirements starting point ...
      1. Reviewed standard:  "ISO 20417:2020 Medical devices — Information to be supplied by the manufacturer"  (ISO/TC 210)  
      2. Section "6.6.4 * Requirements for technical description"
         1. For example:  c) For a medical device with a wireless or wired electronic interface, the technical description shall include at least all of the following, as appropriate:
      3. ACTION:  Create a graphic based on the above how to interlink standards 
   3. CENELEC meeting 
      1. CEN CENELEC Standards Writing webinar:
         1. What: This webinar will show the attendees the requirements for normative references from the Internal Regulations 3. It will also explain how to write normative references for XML. Additional coverage of writing in-text citations of:
            - Clause references
            - Specific standards (dated and undated)
            - References to figures, tables and annexes
   4.  Inter-linkage  from  labeling to 60601-2-x to architecture / MDI requirements should be supported by CENELECT 
      
      1. Promotes use of ReqIF for this capture of these requirements
      2. NOTE:  This is what is being considered for requirements capture and mapping in SDPi+FHIR + used for 11073-1070x PKP standards 
3. Assurance Case Perspective
   1. linkage to the proposed JWG7 - submitted to JWG7 for consideration last week 
      1. ACTION:  Provide general scope for this group
   2. consider linkage between SES MDI Assurance Case template w/ the ReqIF used in the SDPi+FHIR & related standards above 
4. Topic:  UL/AAMI 20800 Discussions (Ken)
   1. Developing a Technical Report that maps UL 2800 to MDR requirements 
   2. Question:  Does the MDR include interoperability requirements?  Explicitly or implicitly?  
      1. NOTE:  Is primary focus on electrical / mechanical safety etc. vs. "interoperability"
      2. MDR:  New Systems chapters & other related content
      3. MDR utilizes international / European standards (ISO, IEC, JTC1, CEN) 
   3. ACTION:  Ken to share draft doc to this group for review 
   4. ACTION:  Include report carve out for 2800 & note re this topic
   5. NOTE:  (Matthias) also a challenge of correlating the structure of UL 2800 to SDC/SDPi 

Action Items / Task Lists

• Todd CooperCreate subpages for report sections + expand current content (from proposal slides) + label w/ "gemini-ses-mdi" 
• (Matthias) Add Regulatory Concept Model / Approach "introduction" content to Regulatory subpage (per presentation  slides on 2020.05.29 discussion)
• (Matthias) Provide graphic per the CENELEC & device standards requirement integration discussed above
• Stefan Schlichting Provide updated V-model diagrams per Unity presentation
• David Gregorczyk Provide Key Purposes rationale section content (PKP, Conformance Principles, etc.)
• Kenneth Fuchs Distribute draft 2800 Technical Report re. MDR mapping to SES MDI group for review & comment
• Todd Cooper Include 2800 standards section with carve out for MDR topic ... 
• (Stuart) Provide JWG7 Assurance Case project proposal general info for this group & inclusion in WP (e.g., title & scope from Form 4) 

Agenda

1. General Updates on Technical Report Development & Standards Coordination &  Community Engagement
2. (Todd) Review Confluence page content, including outline, subsections / pages, etc.
3. (Matthias) Review Regulatory Approach "introduction" content
4. (Stefan) Update on new V-model diagrams
5. New Business

Participants

Todd Cooper Kenneth Fuchs

Meeting Notes

1. General Discussion / Updates
   1. ISO/IEC JWG7 - SES MDI WP PWI proposal was presented to the plenary group and was well received;  JWG7 leadership (co-chairs & Secretary) are determining the best path forward to ensure a Call for Participation to JWG7 membership & those interested in the parent committees
2. Discussed follow-up topics from earlier Quiet Hospital / Silent Hospital discussions
   1. Of particular importance / relevance to this report is the role of "alerting" as an SES risk control measure and integrated both at the point-of-care (SDC-SDPi) and enterprise (PCD ACM & FHIR)
3. ACTION:  (Todd) Transition to IHE DEV WebEx service
4. (Ken) Updated on related AAMI/UL 2800 Discussions
   1. DECISION:  As previously planned, need to add a topic to the SES MDI WP to include consideration of 2800 topics; this includes definitions such as SSEPO (Safety, Security & Essential Performance Objectives)
5. ...

Agenda

1. Reviewed status of SES MDI technical report project approval and development 
2. Plan for content development
3. Discuss specific new sections 

Participants

Todd Cooper (OR.NET), Kenneth Fuchs (Dräger), Stefan Schlichting, Matthias Marzinko

Meeting Notes

1. General Status Review & Backgrounder (Todd)
   1. Review of technical report project approvals (IHE & HL7 & TC215)
2. Technical Report Team Building & Engagement (All)
   1. Question:  How to best engage the Quality / Regulatory / Legal (QRL) community in reviewing & contributing to the Technical Report's content?
   2. Consensus:  "Build it and they will come" is the best approach ... as more content forms, QRL community interest will increase;  but don't wait!  
   3. ACTION ITEMS (Todd): 
      1. (Todd) Reach out to Georg & Nicholas (JWG7 Co-Conveners) to advance the PWI or at least engage that community (via general call for participation announcement ... though that may not be appropriate / allowed); - DONE
      2. (Todd) Add Kosta from FDA to the team - DONE
3. Regulatory Approach "Introduction" (Matthias)
   1. Reviewed regulatory conceptual approach slides that may be used for a similar section of the technical report
   2. ACTION ITEMS: 
      1. (Matthias) Develop the conceptual approach into some content that could be included in the technical report
      2. (Todd) send Matthias one of Prof. Bernt Blobel's Interoperability Reference Architecture Technical Reports (utilizes a cube model) - DONE
      3. (Todd) create a subsection page under this for Regulatory Concept Model (or similar .... name TBD)
4. Updated V-model Graphics (Stefan)
   1. Reviewed a series of updated V-model slides being developed for a systems engineering conference
   2. ACTION ITEMS:
      1. (Todd) add the current SDC V-model diagram to a sub-page for CA / V-Model 
      2. (Stefan) provide content for this updated section, when available

Action Items