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The SES MDI Interoperability Trust Gap

The Problem

Medical device interoperability (MDI) standards & Medical Technology Safety, Effectiveness & Security (SES) standards exist in parallel universes BUT products allowed for patient use must meet both the informatics interoperability technology requirements + quality, regulatory, and legal requirements.

The Question

Can a framework be created to enable
          Trusted Interoperable Product Decoupling
Using
          ISO/IEEE 11073 SDC, IHE SDPi & HL7 FHIR Interoperability Standards
    +
          ISO/IEC JWG7 Safety, Effectiveness & Security Standards?

Detailed background and considerations are provided in this proposal slide deck:



What Lays Below ...

SES MDI Trust Gap?


What trust gap?  As illustrated in the following graphic (from the proposal presentation above), though the MDI and SES standards families have focused for decades on advancing medical technology interoperability along with quality standards for establishing interoperability trust across the technology lifecycle, an SES MDI (Safety Effectiveness & Security ... Medical Device Interoperability) "trust gap" remains between those who develop and "productize" medical technology and those who implement and use them in real-world applications and environments.




See also Hanging Gardens Framework for more background on this graphic, as well as the From Narratives to Requirements to Plug-n-Trust discussion.

Genesis of ISO/IEC 80001-1

<breaking the regulatory mode - in the face of real-world market changes - 

SES Standards Family

<review primary JWG7 and related standards>

MDI Standards Family

<left part of the model above ... and more>

Closing the Gap:  Worlds Collide!  


<products have to bring both of these parallel universes into focus to get to market>

<implementation "gap" requires getting away from the huge "some assembly required" heavy lifting that continues to hamper closing the left / right divide>


Trusted Interoperable Product Decoupling

<flesh out the related content in the slide deck above>

Concept:  Trusted

<SES w/ assurance cases => basis for confidence at Plug-n-Trust>

Concept:  Interoperable

<reference white paper models>

Concept:  Products

<abstract vs. concrete; functional vs. non-functional; markets / customers vs. academic / R&D

Concept:  Decoupling 


<moving from the "accessory" model>

<can discover and establish "trust" at moment of interconnection>

Enabling an SES MDI Plug-n-Trust Product Ecosystem

<addressing the TIPD problem>


Content Considerations

<issues / topics / questions to be considered ... leads into the white paper section below>

<from pitch deck above:

  • Consider the Plug-n-Trust “pathway” through the SES Temple + MDI Layers
  • Identify and discuss the application of standards to be considered …
    • Including coordination with and normative references to/from related standards …
    • ISO/IEEE 11073 SDC, HL7 FHIR, JWG7 81001-1, 80001-1/-2X, 82304-X, 62304,…)
    • In the parent committees (e.g., 60601-2-x & 11073 family)
    • Other ISO/IEC committees (e.g., JTC1, ISO TC210)
  • SES MDI computable assurance case concept, aligned with related JWG7 work
  • Address the use of OMG ReqIF to represent both MDI and SES requirements
  • Consider how to integrate ReqIF specifications + Plug-n-Trust SFC CA results into computable assurance cases
  • Strategy and roadmap recommendations for addressing standards gaps, implementation and test tooling, and multi-stakeholder collaboration & coordination, etc., necessary to address the …

>

<Scope>


Roadmap & Team Collaboration

White Paper Roadmap

  1. Develop a joint HL7-IHE Gemini White Paper 
    • Balloted white paper that is approved and jointly published in both organizations
    • Home working groups:  IHE Devices (DPI) and HL7 Devices (DoF)
    • Supporting working groups:  IHE DEV (PCH & PCD);  HL7 mHealth; IEEE 11073 SDC
    • TARGET:  Ballot 2020 Q3
  2. ISO/TC 215 Coordination
    • Add a preliminary work item (PWI) to the WG2 and JWG7 program;  update TC215 CAG2 appropriately
    • Invite international expert participation in the Gemini white paper development 
    • Once the white paper is completed in the HL7-IHE Gemini Project, it will be submitted for "fast track" processing via the IHE International Liaison A track to ISO/TC 215.  
    • Since the white paper may include recommendations for further work in WG2 and JWG7, ensure that it is a topic to be included in the WG2 & JWG7 meetings later in 2020
    • TARGET:  PWIs by 2020 July; participation invitations starting 2020 May; white paper fast track before end 2020

Development Status

  1. IHE Devices
  2. HL7 Devices
    • PSS Proposal to be submitted by Friday, 2020.05.22 
    • NOTE:  Plan is a single PSS for all three Gemini SDPi+FHIR white paper proposals, followed by a single PSS Form
  3. ISO/TC 215 
    • WG2 PWI approved in virtual meeting 2020.05.18; TC confirmation of resolution anticipated in June / early July
    • JWG7 PWI proposed in virtual meeting 2020.06.03 - Co-chairs and Secretary discussing best path for ensuring engagement of JWG7 membership & parent committees
    • Note:  CAG2 will review and determine best "home" for the work (i.e., WG2 or JWG7); JWG7 would require confirmation from the other parent committee IEC/SC 62A, 
  4. Gemini Project Coordination
    • Paper included in the original set of work products approved at the 2020.04.21 Steering Committee Meeting
    • TBD process & IP details on how and where to jointly publish a Gemini white paper

Paper Team Participants

The following individuals have requested to be included in the Quiet Hospital Team:

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

SES MDI Team Discussion Notes


 Gemini SDPi+FHIR SES MDI White Paper Team Discussion Notes
 2020-05-29 Friday Web Meeting

Agenda

  1. Reviewed stastus of SES MDI white paper 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 white paper project approvals (IHE & HL7 & TC215)
  2. Paper Team Building & Engagement (All)
    1. Question:  How to best engage the Quality / Regulatory / Legal (QRL) community in reviewing & contributing to the paper'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 white paper
    2. ACTION ITEMS: 
      1. (Matthias) Develop the conceptual approach into some content that could be included in the white paper
      2. (Todd) send Matthias one of Prof. Bernt Blobel's Interoperability Reference Architecture papers (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


 2020-06-09 Tuesday Web Meeting

Agenda

  1. General Updates on White Paper 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 white paper 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. ...


 2020-06-16 Tuesday Web Meeting

Agenda

  1. General Updates on White Paper 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 white paper 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 white paper 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 paper 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 white paper 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 white paper 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 paper 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) 


 2020-07-07 Tuesday Web Meeting

Agenda

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

Participants



Meeting Notes

  1. General Updates / Review
    1. ...
  2. ...


Action Items / Task Lists



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


 Gemini SES MDI White Paper Tasks Report

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




"Safe, Effective & Secure Medical Device Interoperability using SDC-SDPi+FHIR" White Paper

This section contains the content of the white paper.  Outline sections can be started here and then linked to subpages as content gets developed.

Title:   

 Safe, Effective & Secure Medical Device Interoperability using SDC-SDPi+FHIR

Subtitle:

Establishing a framework for Trusted Interoperable Product Decoupling
Using ISO/IEEE 11073 SDC / IHE SDPi / HL7 FHIR + ISO/IEC JWG7 SES Standards

or

Strategy for enabling an ecosystem of trusted interoperable decoupled products

Executive Overview

<summarize / bullet anticipated content here>

Scope & Organization

Introduction

<.... sections ...>

<SES MDI>

<Specific standards families & standards - with a focus on their application ... but not the actual application!>

<quality - Updated V-model for SES MDI PnT>

<regulatory - frameworks>

<legal - computable "IFU" / SLA / 80001 RA "stuff">

< framework for establishing - sub-title, model>

<participant key purposes SDC-SDPi >

<assurance case example>

<Recommendations for Further Standardization>

<... annexes ...>

<Bibliography>



2 Comments

  1. Interested in contributing to this effort. LMK at petronp2@gene.com or palm@palmcorp.com

    What areas/topic need work?

    Paul Petronelli


    1. Paul - great!  We're still trying to get this initial set of pages fleshed out ... based on what we already know + get the pieces in place to help everyone start to engage and contribute productively.  

      All to say, hopefully that is done by COB Friday (including this page) ... and I'll add you to the team list - once I have a list to add you to (smile)  

      If the ball gets dropped on my end ... please ping me ... relentlessly!