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.
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:
SES SDC-SDPi Device Interoperability 2020-07-06A.pdf
What Lays Below ...
Table of Contents
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.
An update on the TR discussions will be provided to ISO/IEC JWG7 during their session October 27, 2020
Question: What should be the approach for the update? What should be included vs. omitted?
The current set of slides and their description are too complicated for "newbie" audiences to easily follow ...
This is due to the inherent lack of background of the SES or MDI communities w.r.t. the other communities
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
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
Setting a common VISION of the PWI is key ...
PAST - PRESENT - FUTURE state
PAST - Include House of 80001-1 (Mankovich) with a Shared SES Vision of all stakeholders as being key
PRESENT - Implementation challenge because significant Assembly Required (lack of automation) + document based + few vendor-to-vendor specifications
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
Focus is on leveraging ISO 17000 family of standards (especially ISO 17007 CA guidance for standards development)
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
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.
PKP Paper / EU Notified Bodies Engagement
OR.NET meeting today (10/13) with (3) German notified bodies to introduce the "SDC Conformance Principles" and subsequent work
Challenge is how to help notified bodies to understand (contempentence) to understand what is being advanced
Discussions also included assessment, testability, test houses, etc.
Note: discussions included mention of assurance cases
ISO/IEC JWG7 TR Update 10/27
This TR PWI is being transferred from ISO/TC 215 WG2 to ISO/IEC JWG7
TR Briefing to ISO/IEC JWG7 is scheduled for October 27
This briefing will include the broad concepts and approach for SES MDI using SDC / SDPI+fhir
A draft presentation should be ready for initial review in next week's meeting
IEC/TC 62 Considerations for Integration of MDI into 60601 Series
Medical Electrical Applications in Healthcare (including software) - proposed area of focused work
TC62 evaluating committee feedback on how best to address SES MDI esp. software and AI-based technologies
Proposals include integration across 60601 standards family, updated TC Scope & biz plan, possibly even a
Review Key TR Sections / Topic
Deferred to next week due to the lack of participants
Todd Cooper will "remind" TR team participants of their areas of deliverables
No additional topics
Action Items / Tasks
No new action items
2020-09-08 Tuesday Web Meeting
SES Requirements & Hanging Gardens Model integration
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
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.
Noted that primary focus has been on advancing the SDPi Supplement + tooling / testing etc. vs. detailing out this TR content;
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
The related IEEE 11073-10700 Base Participant Key Purposes (BPKP) draft standard began pre-ballot expert review last week. (see discussion below)
SES MDI - Standards Requirements Coordination per the Hanging Gardens Model
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.
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
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
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.
This will include formally (e.g., via ReqIF specifications) capturing requirements from 80001-1, 81001-1, 14971, 60601-xyz (when appropriate) etc.
These general requirements can then be mapped to the specific SDC PKP provisions (as well as other technologies)
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.
NOTE: This TR will endeavor to paint this picture clearly and recommend a roadmap to achieve its realization
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).
Other Discussion Topics
General observation about continuing the work of the IEEE SDC / IHE SDPi profiling to include imaging-related use cases
The PoCSpeC project is focused on Endoscopy and includes device specializations such as an Endoscopy Camera
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.
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
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
2020.08.04 Tuesday Web Meeting
General Updates & Review
Updated Hanging Gardens Model Review
SES MDI Slide Deck Review
IHE SDPi Supplement - TF-1 Appendix on SES MDI integration
NOTE: This report "lives" in the light green KIP SES layer
SES MDI Slide Deck Review
Reviewed current draft of the SDPi Slide Deck (for content for SES MDI WP)
IHE SDPi Supplement / TF-1 Appendix on SES MDI Integration
Reviewed draft content of DEV TF-1 Appendix A that points to this SES MDI report
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.
Roadmap + Action Items / Tasks Review
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
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"!
Action Items / Tasks
Todd Cooper Include IoT / IoMT / IEEE Clinical IoT in the report outline
2020-07-16 CA & Tooling Web Meeting (Action Items)
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
2020-07-14 Tuesday Web Meeting
General Updates on report Development & Standards Coordination & Community Engagement
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
Inter-linkage from labeling to 60601-2-x to architecture / MDI requirements should be supported by CENELECT
Promotes use of ReqIF for this capture of these requirements
NOTE: This is what is being considered for requirements capture and mapping in SDPi+FHIR + used for 11073-1070x PKP standards
Assurance Case Perspective
linkage to the proposed JWG7 - submitted to JWG7 for consideration last week
ACTION: Provide general scope for this group
consider linkage between SES MDI Assurance Case template w/ the ReqIF used in the SDPi+FHIR & related standards above
Topic: UL/AAMI 20800 Discussions (Ken)
Developing a Technical Report that maps UL 2800 to MDR requirements
Question: Does the MDR include interoperability requirements? Explicitly or implicitly?
NOTE: Is primary focus on electrical / mechanical safety etc. vs. "interoperability"
MDR: New Systems chapters & other related content
MDR utilizes international / European standards (ISO, IEC, JTC1, CEN)
ACTION: Ken to share draft doc to this group for review
ACTION: Include report carve out for 2800 & note re this topic
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
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
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)
ACTION: (Todd) Transition to IHE DEV WebEx service
(Ken) Updated on related AAMI/UL 2800 Discussions
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)
2020-05-29 Friday Web Meeting
Reviewed status of SES MDI technical report project approval and development
Question: How to best engage the Quality / Regulatory / Legal (QRL) community in reviewing & contributing to the Technical Report's content?
Consensus: "Build it and they will come" is the best approach ... as more content forms, QRL community interest will increase; but don't wait!
ACTION ITEMS (Todd):
(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
(Todd) Add Kosta from FDA to the team - DONE
Regulatory Approach "Introduction" (Matthias)
Reviewed regulatory conceptual approach slides that may be used for a similar section of the technical report
(Matthias) Develop the conceptual approach into some content that could be included in the technical report
(Todd) send Matthias one of Prof. Bernt Blobel's Interoperability Reference Architecture Technical Reports (utilizes a cube model) - DONE
(Todd) create a subsection page under this for Regulatory Concept Model (or similar .... name TBD)
Updated V-model Graphics (Stefan)
Reviewed a series of updated V-model slides being developed for a systems engineering conference
(Todd) add the current SDC V-model diagram to a sub-page for CA / V-Model
(Stefan) provide content for this updated section, when available