- (Approved on 05/25/2021) as recorded & presented (motion made by Ken Fuchs, 2nd by John Garguilo; approved 23-0-0); refer to Meeting Minutes (January, 2021, Virtual).
Makrodimitris walked through the IEEE portion of the January 2021 WG PoCD minutes.
Makrodimitris asked attendees for any input/edits/changes. None brought forward.
Motion made by Ken Fuchsto "approve January 2021 IEEE PoCD WG meeting minutes"
Meeting minutes unanimously approved 23-0-0
Goals
Set goals, objectives or some context for this meeting.
Discussion items Agenda and Meeting Minutes (May 2021)
Time
Item
Who
Notes
Time
Item
Who
Notes
Agenda Item
(Note checked box indicates topic discussed at WG meetings)
Tuesday, Q2 & Q3
IEEE EMB 11073 PoCD WG Meeting
(Note checked box indicates topic discussed at WG meetings)
07:00a ET | No sessions until 8:00a ET
08:00a ET | Welcome, Introductions [Stefan]
08:05a ET | [Cooper]
08:15a ET | IEEE Disclosures [Stefan]
Call for Potential Essential Patents Holders. Please contact IEEE WG co-chairs with just name and affiliation.
Makrodimitris walked through the IEEE portion of the January 2021 WG PoCD minutes.
Makrodimitris asked attendees for any input/edits/changes. None brought forward.
Motion made by Ken Fuchs, second by John Garguilo to "approve January 2021 IEEE PoCD WG meeting minutes"
New Members:
Dana Wolff-Hughes
Anil Kochhar, experience MDIB for MDIRA
Alexander Bartschke
Introductions
Each attendee introduced themselves (on virtual meeting)
Attendee intros: Ken Fuchs, Todd Cooper, Bjorn Andersen (Draeger), Dana Wolff-Hughes, David Gregorczyk, Eric Strom (DoD), Fabian Baumeister, Javier Espina, John Garguilo, John Rhoads, Koichiro Matsumoto, Konstantinos Makrodimitris, Kurt, Malcolm, Martin Kasparick, Martin Rosner, Okan Yilmaz, Oyvind HL7 Norway Tech Chair committee, Paul Schluter, Satoshi Kobayashi, Scott Robertson, Steven Dain, Tom Thompson
Review PreviousMinutes from January 2021 (Konstantionos Makrodimitris)
Kosta walked through the IEEE portion of the September 2020 WG PoCD
Kosta asked attendees for any input/edits/changes. None brought forward
Motion made by xxx to "approve January 2021 IEEE PoCD WG Meeting Minutes" second by Ken Fuchs
Made up of two groups: PoCD and PHD (Personal Health Device) WGs
PoCD has two sub groups, one being IDC (implantable Devices)
IEEE liaison with ISO 215 (HIT related standards)
Option of submitting IEEE standards to ISO TC215, and if approved becomes ISO/IEEE standards and kicks off a review process every five years (maintained by standards committee); also provide liaison reports to ISO
IEC 62 - responsible for standards that involve clinical performance (e.g., IEC 60601, )
Ken mentioned there has been a request to liaison
Within ISO, standards are submitted from IEEE (e.g., Cybersecurity -40101, -40102)
Note: one has to be a member of SC to be a voting member, just because you are a member of a Working Group - have to participate in 2 out of 4 last opportunity meetings, or vote on one the ballots.
IEEE-SA members can participate in ballot, any comment must be considered and reviewed by comment resolution group (either SA-ballot process, or working group)
With ISO - if one votes negative, you have to also provide a solution to the problem.
IEEE EMBS and 11073 Standards Committee, and feedback process --> ISO/CEN
11073 Standards Committee, separate from EMBS (much larger than this group) - Ken Fuchs participates as a liaison to be sure all interests are considered and no duplication of work
ISO 215, when standards are review, comments come back to 11073 SC for review and address comments.
09:00a ET | IEEE 11073 PARs, Projects, SDOs and Analytics[Tom, All]
IEEE reports, dates and stats (Tom) 15mins
See Slide Set
P1107301010b-Nomenclature, Amendment, PAR Expiration 12/31/2021
P11073-10103a will be dropped
Malcolm Clarke asked if doing an amendment for 11073-30200 (Transport - Cable) + 11073-30300 (Transport profile - infrared) - answer - leave
See Slides for IEEE PHD WG Updates
Category A Liaisons (ISO/TC 121, ISO/TC 215)
Actual agreement in place to share documents among two groups
IEEE PoCD + PHD to ISO for consideration (assuming passing both ballots)
MOU's have agreements in place - collaboration with groups.
IEEE-SA Governance Group works to form new liaisons
Chair of working group to IEEE-SA
Action item? Liaisons question about TC 121
Determine where exactly the liaison with TC 121 exist…
Reviewed Calendar of Meetings
11073 PoCD Sales and Downloads Tom Thompson showed the following numbers, he did explain these numbers may not be totally representative due to who and how many times the download was requested (e.g. duplicates, someone on web hitting download several times, etc.)
PHD (Marin Rosner/Ray Krasinski)
Spirometry is actively being developed - this could span larger than PHD and into PoCD
Open discussion on the representation of time and time stamps
Goal for improved time stamps to be accepted
Proposed 20601 improved time stamps
Possibly reopening power
Agreement to possibly re-open
Martin Rosner flagged 40101 and 40102 are in the ISO process now to be recognized
Cyber Security standards, FDA is planning to recognize these standards, presently at least partially recognized (until other issue worked out - likely fully approved by fall time frame in Federal Register)
Interested Offer made to provide any information with SDOs
Updates from other SDOs WGs eg AAMI, LOINC, ISO, IEC, SNOMED, IEEE, PHD…(ALL) 15mins
09:45a ET | IEEE 11073 SDC Update[Martin]
See slide set presented by David Gregorczyk
Today's discussion is to the green area above - PKP Standards
Safe and Secure - how to share sensitive data, how to make it safe from a clinical perspective, for at least two participants on a network.
Metrics, Alerts (Alarms and advisory signals), external control (part of 11073)
Device is safe and trustworthy
Blue Boxes (above) are the standards to enable "plug and trust"
Below: Title and Scope re-worded and approved by standards body
For base PKP standards, referring to OIDS for ISO standards (JWG7 OID Discussion)
Use IEEE ARC to avoid maintenance issue/nightmare…
JWG7 - Todd mentioned OID is needed and concrete implementation that idea was straight forward and accepted by JWG7
The solutions to these discussed tickets (above) will likely be in version 4…
Weekly SDC meeting on Tuesdays at 10 am Eastern, ticket resolution…
Timeline to process changes, starting ballot likely for two weeks out (for first few bullets)
Does team only need Standards Committee vote, or working group vote.
Bjorn asked if a vote can be taken today (if just MEC changes) to move forward
Document (latest draft) are in iMeet Central
Martin Kasparick suggested taking vote today.
WG Vote:
Todd Cooper moved, second Ken Fuchs to ask the Standards Committee to vote on 10700 to move to ballot stage. No further discussion. Motion approved (I voted to abstain 17-1-7); Steven Dain voted negative but no reason given
PoCSpec Consortium
See Slide Set
Martin Kasparick, Bjorn Adnerson and Kathrin Riech
Focus on yellow part (specializations) - see slide
10:30a ET |Break
10:45a ET | IEEE 11073 Nomenclature Update[Paul]
See Slide Set
Group 6 (see slides) validated by NIST/Michael Faughn
Paul noted (see slides) for new units in UCUM and MDC units (as a rule all unit standards have a mapping to each other).
Note: Michael Faughn is working with IDCO to get terms into RTMMS (slide above) John G. Motion to "form a P11073-10101b ballot review group". Second by Steven Dain Motion approved 21-0-2
Start Date: The ASCA Pilot launched on September 25, 2020.
Participants: The ASCA Pilot includes participation from accreditation bodies, testing laboratories, device manufacturers and FDA staff.
Fee for participation for accreditation bodies and testing laboratories: The FDA does not charge a fee for accreditation bodies or testing laboratories to participate in the ASCA Pilot.
Fee for participation for manufacturers: Manufacturers have funded the ASCA Pilot program through the MDUFA IV User Fee program. The FDA does not charge an additional fee for manufacturers to participate in the ASCA Pilot.
Contact: After reading this page and the guidance, if you have additional questions, email ASCA@fda.hhs.gov. You may also use this email address to submit documents and applications for the ASCA Pilot as well as to report issues.
12:15p ET | Update RCC-MH/ISOTC215, Mobile Health project(Ken, Gora)
Ken provided update: see slides
Open session at 4 pm on Tuesdays - work on report continues
Accepted to give a presentation at HIMSS21
12:30p ET | Discuss Next 11073/IEEE/SDOs Meetings Logistics (2021-2022) and FDA proposal [Kosta] 12:30p ET | Discuss Next 11073/IEEE/SDOs Meetings Logistics (2021-2022) and FDA proposal [Notes: Garguilo ]
Next Meeting Discussion, again joint w/ HL7 September 20 - 24, 2021
--> Then next year have an in face
FDA Proposal
FDA Sponsor's a panel meeting in fall (November 2021? Virtual likely, following year in person 2022)
Goals:
Coordination of standards activities, understanding domains, public-private partnership data governance
Value: value of standards as it relates to device premarket/post market
Conformity
Idea is to invite many from this WG to various parts of the panel/expertise
Kosta showed the diagram and hopes to have updates to this come this fall meeting…
Todd Cooper mentioned two points 1) "requirements interoperability" and 2)"regulatory ready submissions
01:00p ET | Closing [Stefan]
Motion to adjourn made by Ken Fuchs, Second by John Garguilo, motion fully approved
IEEE PoCD WG meeting adjourned by Chair at 1:05 PM (US EST).
Action Items for Tuesday Q2 & Q3 highlighted inREDabove
Type your task here, using "@" to assign to a user and "//" to select a due date
Ex Wednesday, Q2 & Q3
HL7 Devices (DEV) WG Meeting
Wednesday Q2
Welcome, Introductions, and Agenda Review (HL7 Officers)
Agenda Review(HL7 Officers)
HL7 DEV / Updates & Biz and Work Group documents
Anesthesia
Discuss idea of merging projects version 2 of Intraoperative anesthesia DAM and FHIR Implementation Guide
HL7 PHD and PoCD DoF - focus
Wednesday Q3
Gemini SES MDI - SDC/SDPi+FHIR(Cooper)
Update on project efforts since the January '21 WGM
MDIRA Update
General project update (Griffiths)
IHE MDIRA Profile (confluence page) review (Cooper)
(Scribe: John Garguilo, please review, edit, and update as needed)
Wednesday Q2, HL7 Devices (DEV) WG Meeting
Welcome, Introductions, and Agenda Review (HL7 Officers)
Remembering Jan Wittenber (1954-2021)
Agenda Review(HL7 Officers)
HL7 DEV / Updates & Biz and Work Group documents
John Rhoads provided the patent notice and overview of HL7 legal policy
"Adopt version 5.2 of Decision Making Process" Motion made by John Garguilo, second by Bjorn Anderson
Motion passes 18-0-0.
Anesthesia (Martin Hurrell)
HL7 DEV Working Group Three-year Strategic Plan
See Slide
Discuss idea of merging projects version 2 of (project 1153) Intraoperative/ Intra-Procedureal Anesthesia DAM and FHIR Implementation Guide
Martin asked for advice on elaboration of use cases (adding to the existing) to associate with the use case a clinical note.
Also work on the term binding IOTA/CRG w/ SNOMED to implement about 5K terms; the majority of the terms were already in SNOMED, and Martin H. and team just identified then=m and re-organized them for anesthesia. We did ask for some new terms to be implemented but these were a minority. I think I probably didn't make that clear
Work would involve a project scope statement for version V2 of intraprocedural DAM
Also need to produce a FHIR IG
Q: Martin has no experience in doing FHIR IGs, would it be feasible or sensible to roll into one development of the DAM with the development of the IG
Todd Cooper suggested by pulling things into one project would reduce the administrative work… and work could be done either sequentially or in parallel
Martin Rosner suggested to do the FHIR part under the existing FHIR Devices on FHIR - two IGs one for PHD and one for PoCD, however the scope of the anesthesia FHIR IG might a larger scope…
Todd suggested to have this be one project but intended alignment with other work such as SDPi and Gemini work.
Action: Martin Hurrell is to flush out the work and present on a next call - craft a simple diagram that looks at the connection of this work and provides scope for what is unique and what is connected. Martin H. asked for links to any documentation to inform the process of what is needed… (John Rhoads will help here).
Resolve: (comment from Martin H via chat) BTW, John, I just caught in your notes that it says IOTA/CRG got SNOMED to implement 5K terms. In fact the majority of the terms were already in SNOMED, we just identified then=m and re-organized them for anesthesia. We did ask for some new terms to be implemented but these were a minority. I think I probably didn't make that clear - sorry! Thanks very much.
Next steps - significant new content (outside of what exists) - would there be need for new ballot before going into publication?
artin Rosner indicated there doesn't appear that the steps and checklists asks only when the last ballot, but doesn't seem to have requirements
Bjorn Anderson - mentioned that which
First one
Second was for STU
John Rhoads suggested significant new work (e.g., mapping for SDC semantics is substantive and considerable) - Sept ballot?
Action: Stefan and John Rhoads would champion the new ballot (define the SDPi gateway actor)
Determine timeline and work necessary to get ballot ready.
Still a question to be answered on how to proceed - one PSS or several PSSs?
(Todd Cooper) Or… should we close the existing PSS (from 2016) and create a new one??
(Stefan Karl) Device Alert being available in the core specification - outside our WG control - Stefan suggested waiting for the Alert to be completed…likely over a year out into future…
NIB (notice of intent to ballot) are due in July 4, 2021
(Bjorn Anderson) - is the scope the both IGs… Answer: there is a concept of "project" and no formal "subgroup"
Suggested that the management of three projects (so, proceed with the most lean and efficient content Governance Project)
Suggested having the future agendas show each project - joint HL7 and IEEE
John Rhoads suggested there isn't too much overhead added… moving forward there could be overhead in defining the Device Alert Resource and enabled by the SDC work that would involve substantial new work and enhanced content….
The folks who had to suffer through the in-and-outs should probably be a shared resource, with a lot learning from the folks (such as Stefan Karl and Brian Reinhold)
Todd noted there was value of taking the PSS existing since 2016, declaring success and creating a new PSS - however in the case with Device Alert resource… So would it make more sense to put everything in a DoF or separate PSS for each - and look at separate PSS (craft the language and determine and see how it fits). Presently there are four: 1) PoCD 2) PHD 3) Alerting, and 4) Anesthesia Work. For PHD - ACOM work is a subset of PHD - with time/status being key issue (but not major changes with 20601 as it would remain consistent).
Another issue is that O&O have decided to change the Device Resource - get rid of specializations and change the type (DeviceDefinition)
Thus this group would likely have to launch a maintenance PSS (especially for version 5 of FHIR + UDI)
What we know:
one PSS for DAM revision and maybe one for Anesthesia IG
HL7 International Re-envisioning
Todd referenced HL7 2020 Annual Report
Walter Suarez leading re-envisioning effort: 5 Bold Areas
Remote Connected Health - Mobile Health Technical Paper Update (Datta et al.)
***NEW*** IEEE Industry Connections Program MHA-SLS: Mobile Health Apps: Standards & Laboratory Services (Datta)
Welcome All
HL7 Officers
(Scribe: John Garguilo, please review, edit, and update as needed)
Thursday Q1
Join O & O (Courville)
Join FHIR-I (Rhoads)
Thursday Q2
Welcome, Introductions, and Agenda Review (HL7 Officers)
Agenda Review(HL7 Officers)
Tooling & Testing
Michael Faughn introduced himself and the work he's involved with… Presented the most recent development of RTMMS (V2). Michael demonstrated the system functionality as it stands now.
RTMMS version 2 status update (Faughn)
See Slides
Michael Faughn (on behalf of NIST) also provided an overview of his involvement with V2+
Resource for a V2 Segment definition (can't rely on resource from FHIR) to generate a web publication
MF has to deal with all the parts that IG publisher does not do…
Maintaining integration - is somewhat of a moving target
Todd mentioned within Gemini project there is a pathway to produce HTML document
MF mentioned the tooling has not progressed much from last WG meeting - January 2021
Initial publication of V2+ went through a ballot for comment process in Dec and still going through the resolution of those comments.
MF would need to revisit and likely re-write code and mentioned requirements for V2+ are harder, vs. the requirements we have in DEV are reusable and likely more easy…(like SDPi).
Next week (first week of June, 2021) will be the third "plug-a-thon" - may be a few
Using a "Docker" approach for having a container to start up a virtual environment to test against "golden devices" (so manual install not needed). The Docker container would provide everything to run against a reference in between the plug-a-thons.
This helps participants be more ready for the plug-a-thons (company interop)
Looking at establishing test sequences for bring up a system of SDC participants
Stretch goal of a virtual environment (by end of 2021?)… especially for smaller company participants (who do not much funding for these kinds of virtual connectathons).
FDA ASCA / IHE CA Discussion - Follow-up from Tuesday
Can talk more in tomorrow's (Friday, May 28, 2021) session
OO Report Out (Courville)
The items (below) Chris hoped O&O would get to our items but were not covered
V2-to-FHIR mapping update (esp. for ORU message semantics)
UDI Update (is it actually still ... relevant? Progressing?)
FHIR DeviceDefinition & related device supply chain management discussions
Presentation from BRR side on "Evidence Resource" - no outcome
FHIR-I Report Out (Rhoads/Rosner/Brian Reinhold)
John Rhoads reported out on Resources related to DEV and discussion on Q1 meeting (Thursday morning, May 27, 2021)
Announcements: R5 is pushed out to January 2022
John asked about ?? HL7 Terminology Authority and HL7 Vocab - as soon as consensus is reached (when? Somewhat up in the air)
New resources Discussion
Discussion on DeviceAlert (not much pushback) - and FHIR-I seemed to be good with the old submission for feedback
There is a confluence page (form for resource proposals) for DeviceAlert, bring it to the attention of the FHIR-I after updating it from Gemini
(Brian) Namespace issue - there was some confusion on FHIR-I on the transport IDs, Brian hope that it will get straightened out by UTG. Not clear where the discussion ended (?)… For example Brian was asked why some OIDs defined (historically) and others not… like Bluetooth, which believe in URLs (not OIDs).
Housekeeping: Current Versions of WG documents, for discussion (Rhoads)
Todd mentioned IHE-International 2020 report… engagement of HL7 and vendors
Can leverage be done with the FAANG type companies?
Perhaps re-visioning some of these areas and stakeholders…
Malcolm mentioned work on GHS (Generic Health Sensor) and Bluetooth - "Try to follow GHS in BT MED SIG"
Mention of ACOM (which Malcolm mentioned is rather abstract but provides the glue of commonality of objects and attributes) to translate map into FHIR…
GHS is trying to have one app to plug and play
Martin Rosner mentioned he would follow up with Eric and potentially present to the Mhealth WG (on GHS)
MHealth is working through project scope and work each Monday….check with Gora for details
Listed on Confluence are use case descriptions being addressed…
Kosta proposed bringing a formal contact from FDA on the topic of unique identifier (FDA: Steven Luxemberg, division of systems and oversees UDI development)
This would happen for MHealth WG
(Todd) FWIW - Per Kosta's link above ... for each device class the following language is included: Class II stand-alone software must provide its UDI as required by § 801.50(b).
Topic: Possible connection between JHU/APL MDIRA / Gemini MDIRA Profile & HL7 mHealth Standards? (Cooper / Datta)
Remote Connected Health - Mobile Health Technical Paper Update (Datta et al.)
Many contributors, lead is Kosta, co-leads Gora Datta and Ken Fuchs
See slides
Malcolm noted the work in Turkey and he would contact Gora if a demo is desired.
Closing
(Floyd Eisenberg) "I joined to listen in for 30 minutes - I would be interested in a discussion follow up from CQI call with OO on Monday - about what FHIR resources are appropriate for use cases a bit broader than they have considered - see https://jira.hl7.org/browse/FHIR-32382?filter=-2. Let me know when such a discussion with the Device group could happen.
Todd challenged Floyd per his leadership role in HL7 how to have a home to communicate Devices
Floyd agreed that it's often by an individual not systematic - how do we coordinate? More discussion is welcome
Action items Q1 & Q2 highlited above in RED ...
Type your task here, using "@" to assign to a user and "//" to select a due date
(Scribe: John Garguilo, please review, edit, and update as needed)
Chris Courville's notes:
Friday Q1 OO Meeting:
ServiceRequest parameters: talking through the structure of how to express parameters for an order in ServiceRequest
Issues brought up that this is trying to be way too broadly applicable
It is being stated that this is intended to be basically an order, and that the placer is stating what they 'think' should be done, not that a machine should immediately act on the specific of the request
Mentioned that DeviceRequest is the actual thing to use for what they are trying to modeling
Seems that we’re just trying to give a framework for a generic Doctor Order, and that it is not supposed to be acted on without human intervention
FOLLOW-UP: Would encourage everyone concerned to comment on the Jira (TODD will take this commenting)
V2-to-FHIR mapping update (esp. for ORU message semantics)
Pushing this to the weekly meetings
FOLLOW-UP: John Rhoads will take up getting this discussed (Martin R. will monitor)
UDI Update (is it actually still ... relevant? Progressing?)
Working on a UDI FHIR IG that will address not only FHIR but other standards as well
Brian stated that he’s implemented it, but that PHDs don’t currently electronically have or report UDIs
FOLLOW-UP: Kosta (will follow-up with Marta) and John R will bring this forward, and when ready we will as a group schedule this for an upcoming Wednesday call
FHIR DeviceDefinition & related device supply chain management discussions
Would be snapshot mode of current state, but also expresses differential
Jira has not been applied yet for DeviceDefinition
SupplyChain - Current state is we have a way to say please supply this, and this has been delivered
What we haven’t finished is deciding how this is transported, may need new resource (InventoryStatus or InventoryReport resource in the works)
Ana (Philips), Bas (Philips), Martha V. (FDA) - would be appropriate people to follow-up with.
Device to Normative: They are behind on Jira updates, so Device will change before normative.
Jose is trying to get them all done next week
They did say they would be open to talking through what should stay stable and be normative vs. in flux
We are invited to Monday to talk through a list
FOLLOW-UP: Brian R. to talk to Hans and O&O about getting this meeting scheduled and the issue sorted
(Notes from Garguilo)
Devices on FHIR - Final Updates / Actioning ○ FHIR-I Q1 Report Out (Courville) ○ See above ○ Topic Resolution: ○ Jira Issue: How to store parameters of a procedure in ServiceRequest in a structure way? ○ How to add parameters into service requests (service requests are note intended to make a machine do a "thing", rather for a doctor to give an order of a service to give ○ So, no intension of this going to or altering ANY setting ○ "Request Group" was brought up by Lloyd (which is a new concept to Chris Courville) ○ 31584 JIRA: Todd ○ DEV Monitoring: V2-to-FHIR ...mapping… Who? When? How? ○ Not much time left in the meeting but was pushed out to the weekly meetings… ○ Likely would hear from Hans B. in one of the Monday meetings and reach out ○ John Rhoads will continue to monitor this item ○ UDI Update ○ Working on a UDI FHIR IG that will address not only FHIR but other standards as well ○ Brian stated that he's implemented it, but the PHDs don't currently have or report UDIs ○ Discussion occurred around the huge effort (and number of bits) is a "big" e • Legislation issue • E.g., Amount of bandwidth to report UDI □ Other ways presently done: GUID, Etherenet Address, • Kosta recommended having this be a discussion at FDA Fall meeting ○ Follow up: Kosta will marshal from the FDA group and John Rhoads will bring this forward • Kosta wants to bring Martha V. on this… on a coordinated Wednesday 9 am EST meeting ○ FHIR DeviceDefinition and related device supply chain management discussions ○ Jira has not been applied yet for DeviceDefinition (Jose??) ○ SupplyChain - Current state is we have a way to ○ John Rhoads mentions • Anna K. (Philips) is working with some people working on use cases (related to inventory and request type resources) • Vas Van (Philips) ○ Device to Normative: FHIR-I are behind on Jira updates, so Device will change before normative ○ Did not describe what changes are but are in Jira, so DEV WG needs to find out which Monday meeting this would be discussed ○ They did say they would be open to talking through what should stay stable and be normative vs. in flux. ○ DEV WG are invited to Monday to talk through a list ○ Action: Who from DEV ○ FOLLOW-UP: Brian will continue to monitor as discuss w/ Hans and O&O about getting this meeting scheduled and issue sorted out… What Device Contain…for normative (and left alone) ○ ServiceRequest parameters: talking through the structure of how ○ Zulip Discussion: Device Type vs Kind ○ O&O and many others, appears and many miss the DEV side input • For many cases SNOMED is fine, but it's an example binding, and in our case 11073 is needed. • Brian Reinhold suggested providing examples from the DEV side □ Noted the IEEE 11073 nomenclature should be listed • Add a bullet to in the Summary, Expansion, Content Logical Definition for both "DeviceType" and "DeviceKind" that IEEE 11073 is an alternative to SNOMED. Brian Reinhold will open the Jira issue to explain to implementors that there is SNOMED is not required (. John Rhoads will work with Brian and discuss on Wednesday meetings. • Kosta mentioned mention ISA on ONC site indicates the □ https://www.healthit.gov/isa/sites/isa/files/ISA.html □ This appears to be dated… suggested that Kosta and John Garguilo as Feds look into updating… Todd is happy to work on this as well… History has been that vital signs § Todd, John G. and Kosta look at putting a plan to address this… Zulip discussion - example bindings don't clearly indicate 11073 - thus action item to propose update Device to try to reduce the confusion and better educate… Assigned to John Rhoads?? Zulip post/thread
John Rhoads post on Zulip: This is an area of conspicuous in the specification (and mea culpa, I haven't taken opportunities to speak out about this in Healthcare Products and O&O meetings). @EIIiot Silver (@LIoyd McKenzie, many thanks for drawing attention to this question!) you are right that "Device.type" and "DeviceDefinition.kind" refer to the set of SNOMED concepts. But note that this is only an example binding. The use cases of "Device" and "DeviceDefinition" are quite different.
In the HL7 Devices Work Group, the focus is on devices that communicate with other healthcare IT systems and our IGs are built around reporting and managing specific observations and other data from and going to point-of-care devices (and also personal health devices). We tend to use the IEEE 11073 Medical Devices Communications 11073-10201 Domain Information Model standard and, especially in the "Devices.Type" field, the 11073-10101 Nomenclature standard which is, unlike SNOMED CT, pretty exclusively about the nitty gritty of actual communicating devices.
DeviceDefinition.kind encompasses a lot more more use cases, particularly in the Supply chain realm, including a lot of kinds of devices that don't communicate. This kind of distinction needs to be brought into the FHIR field definitions to give readers some useful help in understanding what is going on!
Gemini SDC/SDPi Work Session (Deferred to first week of June 2021)
(Rescheduled) BICEPS Infusion Pump MBSE/SysML Tour => 03 Jun 2021 during Gemini CA & Tooling Thursday call
(Rescheduled) SDC "Anesthesia Workstation" & related devices / apps research / OR.NET Demo Projects Review => 04 Jun 2021 during SDPi Friday Call (2 hours)
Available Gemini SES MDI Confluence Tours
Topics from the Wednesday Q3 Gemini SES MDI using SDC / SDPi+FHIR update ...
NOTE: Remember these confluence pages are ALL a work-in-progress ... messiness expected!
Todd noted the above (Item 10. Education Pages) on making Tours
Todd noted on the Education Pages a strategy used to curate from Web (translation and curation to YouTube for streaming services, or available for download). The reference page was started by Todd, and he asked that others join the cause!
At this stage, Todd is "scoping out" and described how a similar process was done on an international level (language translation) and referenced a similar activity accomplished and explained by Elliot Sloan
Todd started to test the process for Gemini presentations
Education site is a home to curate - and provide snippet of education on various Device topics…
Kosta noted and mentioned a tentative date for November 18-19 (e.g., 2 days - from 9 am - 2 pm EST)
Idea to have some panels and key notes
Working on an agenda
End with a public report
Question( Malcolm) should cover both Personal and Hospital
e.g., someone to speak about PoCD (such as SDC) and PHD
This could end with laying the foundation for a 2022 in person meeting…
Planning September 20-24 '21 WGM
Feedback from these meetings
Todd Cooper noted a good meeting and meetings worked well - but with meeting being virtual and time zones leads to a labor-focus-involved week (particularly for leadership)
Regarding the overlap of IEEE and HL7 DEV (either covered in both parts of week, or in one but not others
Remote Paper group
Tooling
Some positive about doing meetings virtually
Greater quality of participation and more participants
Cost - obviously much cheaper… considering travel and other
Easier for leadership given home environments (e.g., multiple screens)
Over the past year it has become clear there are benefits of both in person vs. virtual
Virtual could become an organizational issue for generate revenue
ONC business model has changes to revue stream which seem to have increased during virtual period
Topics to schedule in for next meeting (September 2021 - Virtual WG)
Create a copy and move forward for September agenda and meeting notes page… (Confluence)
In between meetings to keep all engaged
Identifiers - Topics include
Why do we need identifiers? -
Separate "People" vs. "Devices" (two very different topics)
This includes going beyond a "field in a message" - much more complicated and gets
SDC / SDPi FHIR Context
E.g., use these for enterprise communication, but both of these have and need Context (e.g., individual patients )
Objectives / Core Topics for September (incl. joint sessions)
Action Items overview in 2021(HL7/IEEE/ISO) and coordination with other SDOs
Action Item Review
HL7 PSS "Action Plan"
Other Action items brought forward:
How to advance within HL7 to the broader community around Device - as presently there is much confusion as the re-envisioning of HL7 (Devices Co-chairs how DEV can do this with others in HL7, e.g., a joint meeting of clinical WGs (and quality WG) - craft and put forward the DEV perspective and how HL7 can address that (lead: Todd)
Within HL7 - Need for Devices and Patient Care to better understand each other due to perhaps many (incorrect?) assumptions
Both political an otherwise
Conclusion - HL7 PSS Action Plan
How to try to finalize the coordination and process - Cochairs (and others interested) to provide contributed thoughts - particularly from the conflicted HL7 tooling and procedures…
Content is often distance to progress and process… both PM and beyond
Co-Chairs to get an action on PSS and push to health completion (e.g., health - go forward or get rid of) - and what we have on books is aligned with plan.
Final May WG Note
Started out with a sad note regarding the passing of Jan Wittenber
Jan was such an instrumental part of many of our lives, RIP - we owe ever so much to Jan Rosanna Danna!!
We will have an opportunity (in mid-summer) for a virtual memorial…
Please send anecdotes to Jan's son and wife (put email addresses here…)
