Saturday 06 May 2023 

FHIR Connectathon - Devices Track

Sunday 07 May 2023 

Monday

08 May 2023 

Meeting Notes from  John J. Garguilo

08 May 2023 

WGM+ Agenda: https://whova.com/portal/webapp/maywg_202305/Agenda/2975504

• Keynote: HL7 and the Policy Landscape / Panel ELT

No DEV Meetings - WGM+ Session:  WGM+ Keynote: HL7 and the Policy Landscape / Panel ELT (Charles Jaffe, Alix Goss, Dan Vreeman, Diego Kaminker, Viet Nguyen

Recorded Attendance: May 2023 HL7 DEVICE WG Attendance 

IEEE POCD Meeting minutes (unapproved) in IMEET-CENTRAL IEEE POCD WEB

• Unofficial MEETING NOTES on HL7 DEV Meeting Minutes page from John J. Garguilo 

IEEE-SA iMeetCentral Folder for: 11073 Point of Care Device Working Group

Monday Q2, May 8, 2023

Start Q2 (11 AM)

IEEE 11073 PoCD Working Group 

11:00 - Call to Order (IEEE 11073 POCD Officers)

11:05 - Introduction and Affiliation Declarations (WG, All) 

1. Establish Quorum - Quorum established

11:15 - Approval of Agenda (WG, All)

11:25 - Approval of Previous Meeting Minutes (WG, All)

11:35 - IEEE Policies (IEEE 11073 POCD Officers) 

1. IEEE SA Call for Patents - call made, no patents (Michael Kipness)
2. IEEE SA Copyright Policy Presentation - No copyrights noted in room or on-line (Michael Kipness)
3. IEEE SA Individual Participation (Michael Kipness read IEEE statement).
1. Participant behavior in IEEE-SA activities is guided by the IEEE Codes of Ethics & Conduct

11:45 - IEEE program manager (updates, PARs, drafts, training, dates)

Michael Kipness - taking over for Tom Thompson

Introduction - New Program Manager - IEEE Liaison (been w/ IEEE since 2005)

Michael also serves as PM for other IEEE standards - approx. 93 PARs

Presentation:

• Michael reminded officers about training and requirements update… within first 90 days there is a :30 minute module (or no later of Dec. 31st of present calendar year).
  • Understanding of IEEE Copyright and Anti-Trust
  • Michael Faughn made comment about martials being rather lengthy - might be much
• Modules are comprehensive about IEEE-SA processes
• IEEE-SA is interested as feedback
• Updates on standards:

PoCD standard updates

Noted: lines 4, and 6-13 are from SDC, mainly because they all started at same date.

Active Standards and expiration dates:

12:15 - SC/IEEE POCD updates 

Ken Fuchs - POCD Chair provided Updates:

Ken noted the number of members in Steering Committee: ~60 Members, 15 Voting Members

SDC: noted companies are holding "Connectathons" - interoperation happens in which companies agree to changes in Biceps…  Some of the changes are non-conformant (e.g., various libraries from Draeger, etc., - in which company is interested in advancement of SDC standard drafts)…

-P2933 Draft 1

Scope:

• 250 in WG, 20-30 Active…number from Industry and Academic
• Comment period has ended, Ken noted they would be happy to receive additional comments
• About 75 Comments - second pass - then go to ballot group
• Over 1200 "Shalls" in document - most in Use Cases (which might not be considered "Shall" from conformance viewpoint
• Started with use cases and scenarios
• Four Use Cases are given as a core to discover the requirements…
1. Connected Monitoring Device
2. Connected Therapy Device
3. Hospital @Home Use Case
4. Home to Hospital Use Case
• The document is accessible P2933/D1

Chat copied:

from Tokyo/Japan. In Tokyo, it is 1:07 AM.\from John Garguilo to everyone:    12:11 PM

Please log attendance at: https://confluence.hl7.org/pages/viewpage.action?pageId=161061968

from Michael Kipness IEEE SA to everyone:    12:53 PM

May 19 is the next PAR submittal deadline

from Javier Espina - Philips to everyone:    1:02 PM

https://ornet.org/en/

from Javier Espina - Philips to everyone:    1:03 PM

Scroll all the way down for the list of members

• Attendees also encouraged to log attendance on HL7 site: Log May 2023 HL7 DEVICE and IEEE 11073 WG Attendance

Noted:

(Official IEEE-SA Folders)

• Draft IEEE POCD Meeting minutes (unapproved) - https://ieee-sa.imeetcentral.com/11073pocd/folder/WzIwLDY2MDkyNDhd/

• IEEE POCD Meeting minutes (Approved) - https://ieee-sa.imeetcentral.com/11073pocd/folder/WzIwLDY2MDkyNjZd

• ACTION John J. Garguilo and IEEE-SA Liaison Michael Kipness to work on potential to expand MOU (report back in future meetings).

12:30 - Lunch break

Monday Q3, May 8, 2023

IEEE 11073 PoCD Working Group 

Technical Presentation(s), Contribution(s) or Discussion(s)        

RTM Subgroup updates (Rosetta Terminology Mapping) - Paul Schluter

Update on 11703-10101b-D3 Ballot and Draft Status

• See slides for detail

• Paul discussed resolution of the 25 "Must be satisfied" (10101b-D2 comments)

• Only 3 remain which are of rejected status…

• One comment was standard appears to make assumption of a containment tree…

• Pre-coordinated… e.g., a dialysis pump has up to six pumps (anything more complicated than a "flow" then they all use same facet… lesson learned to get agreement in a pre-coordinated manner…

• Note: Presently, the new RTMMS does not generate a "containment tree" but might be some additional functionality in the future…

• R1-66: two groups have expertise but different

• Issue on making units normative.

  • Annex J is now normative - slight side effect is that for each MDC member there is an UCUM

  • There may be a case where there are UCUMs without an equivalent unit in MDC

  • Table J.2 is now normative (see note above about diamond character to handle Upper case "liter"

Discussion on when or when not the group may have to accept pre-coordination as a compromise (but not a compromise in safety and effectiveness…  Paul indicated he is ok with this…

Comment made when going from SDC to FHIR

Paul noted he'd like to get the 10101 comments out prior to the IHE-PCD (May 23rd, 1-5 PM)

Ballot group can only see the comments…

Michael Faughn had a comment (not to disparage the quality of work done by Paul) - however, having said that it has been consistent in that we don't have more structure around the ballot group, be invited to join the group to help resolve… would be good to get more structure around the balloting process…

 IDCO Subgroup updates (Implanted Devices Cardiac Observation terminology) Paul Schluter for 

SDC Subgroup updates (Service-oriented Device Connectivity) (Martin Kasparick and Bjorn Anderson)

(Martin Kasparick  & Bjorn Anderson) Berlin, Germany (Booth in OR.NET)

Broad range of Manufactures with near product SDC enabled devices.

HIMSS Demo: (Silent Alarm)

Demo and Talk - Most attended demonstration and presentation at HIMSS Showcase!!!

• Diagram above showed status of SDC work…

• Martin K. noted a technical with

• SDPi 1.0.0 Trial  Implementation published

• Meet every 2-3 months to do plug-a-thons… all welcome - see confluence page

• 13th one starts tomorrow (May 8, 2023)

Biceps

• Progress has advanced from about 30% to more than 50% of work done.

• Kosta noted the effort has supported FDA focus (e.g., 60601-1-8).

Monday Q4, May 8, 2023

IEEE PoCD Working Group

PHD 11073 updates

Philips (Eric Moll) provided demonstration (code available for client and server)

Observation uploaded from Server follow the PHD IG (not coming from IEEE-10101) based on ACOM (if following and IG, it would be simpler and more direct)

 IHE DEV updates (John Rhoads)

• (John Rhoads) - GHS and ACOM - PCH (Personal Connect Health)

• Silent Hospitals work

• WGs working on Alert Communication Management - with extensions

• Location Services - communication about system internals between systems in the context of enterprise systems

• Activity about caring further the rigor of Connectathon Testing.

• PCIM

Standards Coordination/reports (AAMI, ISO, NIST, FDA, LOINC, SNOMED, CSA)

• ISO TC215, WG2 (Interoperability) - IEEE forwarded as ISO standards where ISO will vote on the standards (up or down) - if comments will come back to IEEE PoCD WG (at which point IEEE would have to revise the standard - through next revision).  ISO, if accepted puts a cover on the IEEE standard - ISO has a 5 year cycle, IEEE has a 10 Year cycle.

• TC215 WG4 - (Security)

• NIST - new release of RTMMS

• FDA - AI has become focus…

  • ASCA - system interoperability can be the next pilot - new budget requirements now (e.g., 606xx for test labs)

11073 lifecycles from cases, development to recognition, adoption & value/IoT

Kosta noted the demonstration from Philips

Meeting plan (September 2023, AAMI/FDA/IEEE joint WG meeting POCD-PHD-IHE)

• Kosta noted there have been discussion for over a year, now AAMI is sponsoring and FDA event (three rooms - Sept 26-28th for three working groups: PHD - about 20 people; PoCD - about 30 people; and IHE - about 20 people + some invited guests (e.g., AAMI, FDA - ASCA and standards,

• AAMI is offering a nice joint room and rooms for breakout sessions…

• This meeting is proposed to be in place of IEEE PoCD portion of the usual HL7 WG meeting for IEEE PoCD (September 4 - 8, 2023)

  • First steps would be to define what the WG meeting would look like, with the last day - have a coordinated set of sessions:

  • E.g., Terminology, Lab - using LOINC and SNOMED - how to connect - real mappings…

• Burden of mappings would fall on the Terminology it comes from, non-trivial ; also issue of "equivalency"…

• Paul noted, the mappings would best happen at the containment tree level…

• There will be planning sessions in the next month - for about 10 folks or so…

Other/new business/ideas 

• No new business

Adjournment by Chair

• No motion needed

Monday Q5: Co-Chairs Meeting and Dinner

• Noted: No Co-Chair Meeting Report out needed 

Tuesday

09 May 2023 

MEETING NOTES FROM  John J. Garguilo

Recorded Attendance: May 2023 HL7 DEVICE WG Attendance 

09 May 2023 

Tuesday Q1, 9 AM - 10:30 AM (Central Time - U.S.)

No DEV Meetings - WGM+ Session:  WGM+ Keynote: ONC: Standards Policies for Interoperability / Argonaut Accelerator Overview / Gravity Project Accelerator Overview (Steven Posnack, Brett Marquard, Venessa A Candolera, Corey Smith)

Tuesday Q2, 11 AM - 12:30 PM (Central Time - U.S.)

No DEV Meetings - WGM+ Session:  WGM+ Keynote: TEFCA and the US National Infrastructure on FHIR / FAST Accelerator Overview: Why FHIR Infrastructure Matters (Micky Tripathi, Duncan Weatherston)

Tuesday Q3, 12:45 PM - 3:00 PM (Central Time - U.S.)

• Welcome, Introductions, and Agenda Review (HL7 Officers)

• Welcome and Introductions (to the HL7 DEV portion of WG meetings

  • ANSI Anti-Trust Policy read to attendees (Garguilo): 

    Professional Associations, such as HL7, which bring together competing entities are subject to strict scrutiny under applicable antitrust laws. HL7 recognizes that the antitrust laws were enacted to promote fairness in competition and, as such, supports laws against monopoly and restraints of trade and their enforcement. Each individual participating in HL7 meetings and conferences, regardless of venue, is responsible for knowing the contents of and adhering to the HL7 Antitrust Policy as stated in §05.01 of the Governance and Operations Manual (GOM).

• SHIELD team updates and possible collaborations on terminology and more (Keith E. Campbell  -program director SHIELD and Marti Velezis)

• • Keith presented slides (see slides)
  • Challenges of representing information with different nomenclatures and terminologies

• The two diagrams above illustrate the discrepancies of use of codes/terms

• Challenge is as the cycle repeats (above) the data integrity depletes
• Inconsistencies across the ecosystem

• Different healthcare systems using different healthcare data (underlying codes or data fields)
  • There will data transformations that occur  (mappings) - coupled with IGs
  • For example, if using clinical decision is being done
  • Quality of a standard may not represent quality of cumulative set of standards
  • Is the IG correct?
    • Who is the authority?
    • Need is to integrate in order to fix some of these gaps (e.g., how should it come off the device, how should it be represented in the data communication/transport layer, how should it be stored, and on and on…)
• The SHIELD efforts are working within HL7 to address issues that have been identified in various health care settings around the world.

• How do we reduce ambiguity, work together to gain consistency within the barriers of the ecosystem.

SHIELD is working on bringing this forward, would HL7 DEV be interested in participating…

Key suggestion is shown below:

• HL7 DEV did do a mapping of about 650 LOINC mappings with units ect…
• Comment about doing nomenclature in more of "crowd sourcing" way…
• 11073 is more than device date, also includes things like observations, alerts, etc
• Keith is proposing we facilitate work in this space and using tools, new or existing, then curate in the appropriate space.
• Ultimately, SHIELD wants to be able to represent different standards in one place and build connections between them to ensure that their relationships can be viewed, edited, and changed in one place.
• Martin Rosner noted that this is harmonizing IEEE Terms with BlueTooth.  What is the subset, who is curating, what is the flow…
• Noted to make explicit vs. implicit interdependencies…
• Kosta noted he also can bring back to PM at FDA - this notion of discrepancies SNOMED CT and LOINC

• ACTION Keith Campbell indicated Slides will be shared. (Keith Campbell and Marti Velezis)

• Next steps:  Further discussion w/ LOINC
  • (there was no support SNOMED and IEEE mappings).
  • Establish a discussion with PCD PoCD chairs, and IEEE (Kosta to lead?)
  • Start with Use Cases…
  • Next need requirements…
  • Noted: Agreement between that LOINC will work to create an extension to SNOMED, so that LOINC will work with SNOMED, global CC 4.0 (to take care of license issues) - content would be available to SNOMED and LOINC licenses… may be a big change openness
  • Down the road… IEEE PoCD Leadership - Kosta M., Stefan Schlichting, and Mike Faughn to discuss with Mike Kipness (IEEE-SA Liaison) - from IEEE side?

Tuesday Q4, 3:30 PM - 5:00 PM (Central Time - U.S.)

Wednesday

10 May 2023 

MEETING NOTES FROM John J. Garguilo

Recorded Attendance: May 2023 HL7 DEVICE WG Attendance   

• Welcome and Introductions (new attendees)

• Introductions: 

Garguilo read ANSI Anti-Trust Policy: 

Professional Associations, such as HL7, which bring together competing entities are subject to strict scrutiny under applicable antitrust laws. HL7 recognizes that the antitrust laws were enacted to promote fairness in competition and, as such, supports laws against monopoly and restraints of trade and their enforcement. Each individual participating in HL7 meetings and conferences, regardless of venue, is responsible for knowing the contents of and adhering to the HL7 Antitrust Policy as stated in §05.01 of the Governance and Operations Manual (GOM). 

10 May 2023 Room "TBD"

Wednesday Q1, 9 AM - 10:30 AM (Central Time - U.S.)

NIST Test Tools

RTMMS (Michael Faughn)

Discussion on if APIs and use of getting access to terms

• Txfhir.org

To date:

•  48 registered users…

• MDC Terms: 48,954

• Published

• MDC Units: 65

• Improved Search capabilities

• Fixed Styling issues

• All terms of 10101b ballot

• Michael

  • Paul Schluter noted that this Excel is very helpful for the document centric view of all of this…

• R3/R4 code FHIR resource

• 10101R, 1000 Word pages

• 10101C -

• Excel is nicely formatted - easier to use as formal review for the IEEE-SA documentation process

Plan to sunset earlier version (but it is available should folks not be comfortable with the transition to the new system)

• The above slide

• Michael proved a demo of system (how to get an account, username/password, and the functionality - including search capabilities, downloading…)

Above is screen shot for searching on columns, pagination (e.g., viewing up to 100 results).

• Mapping of UCUM units to MDC Codes: proposed mapping

• Mapping of deprecated term (itself) to unit

• Go to Record capability:

• Flavors of...

Michael noted that there are situations when the terminology has certain characteristics
However, The RTMMS system is not perfect; thus there are times when a user might find they want to see more, so please let NIST know…

System does open new tabs (conscious decision of design)

Question from Elliot Silver: is there list of issues? Or bug tracker…
For example, for IG Publisher - there is a "suggested" change at bottom of each page…
Elliot noted there is a lot of process for JIRA tracking, however if one goes to tracker for IG Publisher - they are very light weight - using GitHub.  There are some requirements on NIST ends.

Note FHIRr3/4 CodeSystem Resource.

Paul Schluter (Terminology Update)

Ballot resolution accepted by IEEE-SA :-)
Draft 3 is now open - 10 day recirculation ballot
Also recognized by ISO once completed through the IEEE process.
Recognized as an ANSI Open Standard.

Ballot members will get a notification from IEEE-SA automated system.

Wednesday Q2, 11 AM - 12:30 PM (Central Time - U.S.)

Anesthesia (incl. Medication Administration + insertion of passive devices)
Martin Hurrell Introduced the topic
• Previously/formally known as IOTA
• About ~5000 terms for Anesthesia 
• X73 Cross references
• Native format was OWL --> now converted to an XLS file
• Martin and Grant Forrest are considering some procedures that are quite complicated, collection of procedures that support other procedures…
    • In particular devices that to introduce and check their positions
    • e.g., guide wires, real time imaging, and other such complex ancillary procedures

The "pink" boxes are in and of their self quite complicated and involve device association, and any number of use cases.

• Gemini Device Interoperability Update -
• SDPi 1.1 & 1.2 ( Todd Cooper )
• PSS-1980 – Projects List 

Martin asked if the above approach seems appropriate and fine?  Group indicated this approach is appropriate…

Martin showed the above - and indicated the fact that we are limited to one body site is problematic…
To extend would effectively break the standard…
Paul Schluter noted OBX-20 allows for multiple body sites… Could record site locations, such as insertion site, the other the tip site (as an array)

Elliot Silver noted the body site resource
Marti V. noted we cannot use Device Usage Resource… we really need to figure the correct resource for the anesthesia resource.
• The gets in the issue of pulling out Device Association from the Device Resource… would first need to look at Device Association.
• Paul mentioned a new resource, like Body Site Pathway (also DICOM might have something similar)… getting such a thing 
• Marti V. believes it would need to be on Device Association… and add to that… so still in time to add/adjust to the Association…
    • Thus - Suggestion is look at Device Association first (Maturity Level 0 at this point)

    • R5 can be changed for R6
    • E.g., instead of bodyStructure - ordered list or just a collection of bodyStuctures (or more than a refernce - a backbone)…
    • Device Usage should perhaps be a codable concept(?)…
However a reference is heavy weight, but a reference

As shown above, as unpacked there quite a number of procedures/sub-procedures - so using the resource in a nested way is likely the way to go forward…

Grant also noted the procedure code 0..1 - there are instances where there are codes from SNOMED and sometimes for LOINC (or both)…
Martin H. noted both codes with be shared…

• Next steps: some really helpful suggested to get past the issues brought forward today… 
• Take the specific use cases (e.g., for CVC) rendering them to get into the details to produce a publish component rendering… which would become a production "job" in FHIR speak…

Gemini Device Interoperability Update -

SDPi 1.1 & 1.2 ( Todd Cooper )

PSS-1980 – Projects List 

Todd Cooper introduced the topic of IHE-HL7 Gemini SES+MDI Program Update .
    • A lot has happened since our last WG meetings in January 2023…
    • After 3 years, we were successful (approved April 10, 2023 by HL7 - Gemini is joint HL7 and IHE (which was already approved).
    • There were a lot of process changes and people change in HL7 - so it was actually created in March 2022… but all resolve down to one thing needed - IEEE Copyright Permissions Letter.
    • HL7 wanted IEEE to include HL7 in permission letter…

• Ask for today: getting a "Project List" in addition to SDPi, such as some of the Integration Statements (ICS tables - 10700 + 10701 - add a column of if SDPi address the conformance statements + references to the statements…) as well as White Papers (e.g., "What is Medical Device"…  Also on the IHE DEV Repo - add to DEV Technical Framework (e.g, this is what a device is and these are device focus areas…

• This Friday Q1/2, Todd has established a SDPi Security Operationalization Workshop
    • Background
    • What is SDPi Security
    • What are the main challenges
        ○ #1 Challenge - Certificates
• Afterwards, July in Lubeck Germany a follow on workshop (and getting at Version 1.2 and 2.0) - Multi MDS and BICEOS  + ensembles + system context profiling
• Todd noted that on the FHIR side of things, we will be able to engage better (as an HL7 advanced project and accelerator…)
• 35 issues tied to 1.1 release; 1.2 use cases (e.g., device coupling - such patient association to multiple device; what we call "device association")
• Article on Major/Minor fixes…
• Version 1.2 publish date is being targeted for fall (~Oct 2023)…
• Alarm management major topic for 2024
• Working on reorganizing the information (story lines are clean and crisp)… from the Gemini page…

• ACTION: Gemini  List of high-level list of projects… to be forwarded on to the Gemini Steering Committee…

Wednesday Q3, 12:45 PM - 3:00 PM (Central Time - U.S.)

(Todd Cooper)
NOTE: Added one more item from prior (closing) Q2 topic (Todd Cooper) on 'Device Interoperability'
    • JSON file of the HL7 / IHE SDPi specification
    • Meta data provide links to other information in JSON representation…
    • This goes along with why the documentation was done using ASCIIDoc - e.g., allows pointing to clauses in use case tables, or to conformance clauses…
    • This helps manufactures who need to have requirements validation tool (automated with however one imports into the manufacturer's tool)…

Gemini DEV.SDPi IHE + HL7 Github Repository "Governance" (Todd Cooper )

• What to do about:  DEV.SDPi ?!
  • Just a policy thing - need to know how to do this…
  • Todd asked Joshua Procious about 
  • One for Device Alerting
  • One for DEV.SDPi
• How should the Github Repo be structured in HL7
• It is known how to do this on IHE side…
• Outcome is to forge ahead until DEV hears otherwise from HL7

DeviceAlert Resource - Advance project materials (from Module page to Resource definitions; see references page)

• DeviceAlert Proposal
• Todd produced a Confluence Page - based on DeviceAssociation (from Marti V. and Hans B.)
• Todd filled in the various categories (borrowed the Zombie page to start work: see

https://confluence.hl7.org/display/FHIR/DeviceAlert+FHIR+Resource+Proposal

• Descriptive test: E.g., The proposal is for DIS, no DAS

Elliot Silver noted he's like to see in and out of scope areas (e.g., references that use flagged
    • How is this different than a "detected issue"?
    • Elliot noted that the Location and Observation of Alert may not be "subject" 
        ○ He suggests that the subject of the alert is the device.
        ○ 
Todd adapted a 'device association' (proposal) to write up an 'alert association'

Questions about if we have multiple Connectathons before R6… (assumed so…) 

DEV JIRA Tickets (See also Thursday Q1 at OO)
Topic Not addressed in Q3 (out of time)

Wednesday Q4, 3:30 PM - 5:00 PM (Central Time - U.S.)

Thursday

11 May 2023 

MEETING NOTES FROM John J. GarguiloWelcome and Introductions (new attendees)

Welcome & Introductions: 

Garguilo read ANSI Anti-Trust Policy: 

Professional Associations, such as HL7, which bring together competing entities are subject to strict scrutiny under applicable antitrust laws. HL7 recognizes that the antitrust laws were enacted to promote fairness in competition and, as such, supports laws against monopoly and restraints of trade and their enforcement. Each individual participating in HL7 meetings and conferences, regardless of venue, is responsible for knowing the contents of and adhering to the HL7 Antitrust Policy as stated in §05.01 of the Governance and Operations Manual (GOM). 

Friday

12 May 2023 

MEETING NOTES FROM Todd Cooper 

• Welcome and Introductions (Cooper)

• Introductions: xx Attendees;  new attendees for Q...

Garguilo read ANSI Anti-Trust Policy: 

Professional Associations, such as HL7, which bring together competing entities are subject to strict scrutiny under applicable antitrust laws. HL7 recognizes that the antitrust laws were enacted to promote fairness in competition and, as such, supports laws against monopoly and restraints of trade and their enforcement. Each individual participating in HL7 meetings and conferences, regardless of venue, is responsible for knowing the contents of and adhering to the HL7 Antitrust Policy as stated in §05.01 of the Governance and Operations Manual (GOM).