Meeting Notes: January 2022 Virtual - IEEE 11073 General Committee / IEEE-PoCD WG / HL7 DEV Devices WG

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

https://ieee-sa.imeetcentral.com/11073pocd/folder/WzIwLDY2MTA4MDNd/

MEETING NOTES FROM John J. Garguilo

08:00a | Welcome, Introductions, and Agenda Review [Steve/Kosta] 

Welcome by Konstantinos Makrodimitris (Kosta) and Steven Dain (Chair Stefan Schlichting regrets for first part of meeting due to travel)

Attendance officially kept by Kosta and IEEE-SA, attendees encouraged to log attendance on HL7 site: Log January 2022 HL7 DEVICE and IEEE 11073 WG Attendance here

(high of 33 attendees) Ken Fuchs, Tom Thompson, Anil Kochhar, Anton ??, Bjorn Anderson, Chris Courville, Craig Reister, David Gregorczyk, Isabel Tejero, Javier Espina, John Garguilo, John Rhoads, Koichiro Matsumoto, Konstantinos Makrodimitris, Malcom Clarke, Martin Kasparick (Univ of Rostock), Michael Faughn, Paul Schluter, Peter Gunter, Peter Karnich, Satoshi Kobayashi, Steven Dain, Sven Kammer, Todd Cooper - others in an out Karen Moniz, James Vollmer, Russ ??, Fabian Baumeister, Andy, S Iverson, Stefan Schlichting, Michael Muzoora

08:10a | IEEE Disclosures [Ken]

Call for Potential Essential Patents Holders. Please contact IEEE WG co-chairs with just name and affiliation. 

IEEE Patent Policy - IEEE Patent Policy

IEEE-SA Copyright Policy - IEEE Copyright Policy

IEEE Meeting Conduct – IEEE Code of Conduct

IEEE Ethics Policy - IEEE Code of Ethics

11073 SC Update [Ken Fuchs]

• Ken mentioned there is a new 10 Day Ballot on P11073-10103 and survey sent out via email requesting participation on the following:

  • The IDCO (Implantable Device) SubGroup has been working on an update to their nomenclature.  Originally they thought this would be in the form of a Supplement (10103a) but have recently decided to just update the current document 11073-10103.

  • This vote will withdraw the PAR for 10103a and update the current PAR for 10103 (which I have attached for your reference).  The PoCD WG has already voted to approve this change.

  • As usual we have prepared a SurveyMonkey to collect your votes.  Here is the link:  https://www.surveymonkey.com/r/N7X9Z85 

  • Please vote before 5:00 PM ET on January 27th.

08:15a | Agenda Review [Kosta] / Review Previous Minutes and New Members[Kosta] 

Kosta made note of membership and showed the membership page from IEEE-SA/11073pocd and mentioned the IEEE iMeet site, that membership uses this site for files folders, etc… Interested individuals need to send leadership a request to get registered.

See IEEE-SA's iMeet site for approved and unapproved Meeting minutes

Motion to approve the meeting minutes from Ken Fuchs, second by Malcolm Clarke, no abstentions, no negative, passes unanimously.

8:30-9:00 am | Update regarding PARs & Standards (Tom Thompson, IEEE-SA Liaison to 11073 PoCD WG) 

IEEE 11073 PARs, Projects, SDOs and Analytics

Tom Thompson, IEEE-SA, provided the 11073 Standards update - please see slide set provided on iMeet Central Site: https://ieee-sa.imeetcentral.com/p/ZgAAAAAA2_vN

• Tom noted there are several projects coming to deadlines in 2023 and suggested members have a look to determine what if anything needs to be done for that project.
• 14 projects, 2 drafts in ballot or recirculation
• Standards Breakdown presented (slide 6)
• PHD side
  • Several active projects due to expire at end of 2022 (see slide 10), extensions may be done if not completed in time…
  • 14 Active PARS, 7 in development, 7 in Ballot or Recirculation
  • Highlights (see slide 13)
• Collaborative Relationships
  • MOUs and Category A's (see slide 19)
• 2022 Standards Association Standards Board (SASB) Meetings shown (slide 20)
• Slide 21 provides Tom's contact information, also in the iMeet Space
• Kosta asked about the "12 Drafts in Development"
  • These are based on the PAR that have not expired…

IEEE reports, dates and stats

• Schedule and upcoming meetings (e.g., NESCOM):

https://standards.ieee.org/content/dam/ieee-standards/standards/web/governance/sasb/2022calendar.pdf

09:00-9:45 am  | Update from SDC SG (Martin Kasparick, Univ of Rostock, Germany)

See slide set: https://ieee-sa.imeetcentral.com/p/ZgAAAAAA2_vN

Martin Kasparick (University of Rostock), subcommittee chair, introduced topic

• PKP SDC Update (by David Gregorczyk)
  • See slide set provided by David Gregorczyk
  • Slide 3 provides the SDC family of standards recap
  • Base PKP initial ballot round 1 completed
  • Base PKP initial ballot round 2 under way, recirculation slated for March 2022 (SourceForge ticket system used - https://sourceforge.net/p/opensdc/p11073-10701
    • Meet every Tuesday at 10 am - contact David G. for details of meetings
    • (Teams Meeting Link) provided in slide set

Reference links for General Project, Issue Tracker, and Draft Document:

• https://sourceforge.net/projects/pocspec/
• https://sourceforge.net/p/pocspec/_list/tickets
• https://sourceforge.net/p/pocspec/drafts/

• MPKP (Metric Provisioning)
• Initial ballot round 1, started and hoping to finish round 1 in March 2022
• Ballot round II ticket status shown (slide 7)
• Date planned for recirculation: March '22
• Todd Cooper asked about procedure for using SourceForge and tracking
• David G. showed SourceForge Ticket System and described process used for vetting and addressing tickets

• Status Report on PoCSpec Project  and Consortium (Martin K)
  • Martin noted the "Git" tab which provides the pdf development standards docs (DRAFT versions, so content can change)
• See Slide Set provided by martin Kasparick (see above)
• End of funding (German Gov't): June 2021
• Currently working on P11073-107xx
• PocSpec Source forge Repository
• Todd Cooper asked about conformity sections, Bjorn noted that improved ICS tables are being considered and planned (Martin noted leveraging and adoption of the improved ICS)

9:45-10:40 am  | Update from the IDCO SG (Craig Reister)

• Craig Reister provided slide set
  • Paul Schluter, John Garguilo, Michael Faughn, and others commented on the importance of where documentation of terms are defined with regards to optionality (e.g., base standard likely not the correct place, vs. IG level (or constraints)).
  • Craig asked for further input to help define such attribution and where 'constrained' information might go…
  • ACTION COMPETED Craig Reiser to meet with Paul Schluter, John Garguilo, Michael Faughn, Malcolm Clarke going forward for more guidance
  • Question of lower/upper case:  Recommended to be added as a "NOTE" for what Craig showed in the spreadsheet provided
  • Sarah Bell, from IHE-DEV, can send notices to folks who ask…
• Focus on P11073-10103R - Implanted Devices Cardiac
• Revision due in 2022
• Kudos to Paul Schluter and Michael Faughn (NIST) for help and expertise on the terminology development
• Craig received input on IEEE process for moving forward, will hook up with Tom Thompson for more details
• ACTION: ACTION COMPLETED Tom Thompson to send Craig Reister IEEE-SA MEC (Modification Editorial Checking) documentation and information on balloting formation and process
• Heart Rhythm Society (HRS) - "Mandatory" / "Optional" / "N/A" -  developed a spreadsheet
• Spreadsheet of RefID that are the to date enumerations
• IDCO meet weekly on Fridays, links in presentation

======

Break 10:40-11 AM, CST

======

11:00 am -12:10 pm | Update from the Nomenclature SG (Paul Schluter)

IEEE 11073 Nomenclature

• Paul provided slide set providing status updates to P11073-10101b
  • "provisional" term groups discussed (Group 1 --> 7)
    • Group 1: 630+ events and alerts covering devices used in the ICU, CCU, OR and ER as well as NMT, rS02 and other parameters.

• • • Group2: IHE PCD infusion pump observations, settings, and events and alerts and MEM-DMC terms. Draft pump containment model has been completed by Brian Witkowski and colleagues.
    • Group3:        Hemodialysis (numeric observations, settings, events and alerts, and containment model) that support the Dialysis Machine Data Standard project.
    • Group4, 5:     Additional terms for Getinge/Maquet Ventilator and Anesthesia (observations, settings, events and alerts, and containment model).
    • Group7:        Terms required for the BPKP (Base Participant Key Purpose) vocabulary for the IEEE P11073-10700 SDC ballot, plus other terms.
    • Group6:        Mapping for Drdger, Getinge and GE ventilator modes to ISO 19223 ventilator mode nomenclature and syntax and to IEEE 11073 REFIDs and numeric codes.

• Amongst focus of this WG meeting: GroupZ, Systematic Names (see slides) + Events and Alerts (see slides) + spreadsheet examples Paul provided
• Paul provide thoughts and an informative diagram on Event and Alert Mapping from a Biomedical and Device Manage, Summary Report, and "Ok/Not OK" points of view demonstrating the varying granularity of Device granularity...
• Paul provided information on Hemodialysis (see slide)
• Question from Martin Hurrell: How can one get a hold of the nomenclature if not an IEEE-SA member? - Paul S. to send to Martin H.
• No Action items identified

12:10-12:30 |  PoCD WG organization, meetings & wrap-up (Kosta)

Kosta introduced Stefan Schlichting, Chair, who was able to join last part of meeting.

Stefan thanked everyone for work and progress and contributions... and looks forward to continuing & advancing the work.

11073 Stories/Pilots and Conformity and Regulatory track: IHE, ASCA, NIST/FDA, IMDRF (Kosta)

No Update provided

Logistics next WG meeting, 

• May Joint IEEE/HL7 WG meetings again to be Virtual
• FDA meeting on March 25, 2022 (by invitation), sessions to include:
• Value Standards
• Conformance of medical device standards
• Purpose of meeting at U.S. FDA: to have and gather an initial meeting leading to a larger, more comprehensive meeting in the future…
• No Additional topics bought forward for this coming Friday morning Q1 meeting (January 21, 2022)

12:30 pm Closing [Stefan/Kosta/Steve]

Motion to end meeting, Kosta, second by Todd Cooper, approved unanimously

• CHAIR: STEFAN SCHLICHTING, PHD
• VICE-CHAIR: STEVEN DAIN, MD
• SECRETARY: KONSTANTINOS MAKRODIMITRIS, PHD

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

  • 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). 

• General updates / announcements 

  • Note:  HL7 International Education on Demand Site for members: https://www.pathlms.com/hl7

    • E.g., "How To" videos on Confluence and Jira

  • HL7 Co-Chair Updates (including new CStdsO / dCImplO, JIRA use, etc.) (Cooper)

    • Chief Standards Development Officer: Dan Vreeman, Deputy Chief: Diego Kaminker
    • Other new TSC members: Jean Duteau (TSC Vice-Chair), Gora Datta, Rich Geimer
  • Other announcements / updates / suggestions from attendees...

    • None

• September 2021 WG Meeting Minutes Review / Approval (Garguilo)

• • https://confluence.hl7.org/pages/viewpage.action?pageId=77369972
  • Garguilo walked through the September 2021 WG Meeting Minutes and Notes
  • No further updates/edits/otherwise brought forward by members
  • Motion made "to approve minutes" by Garguilo, second by John Rhoads
    • Motion passes 15-0-0

• HL7 DEV Working Group 'Health Reports and the Project and Ballot Health Metrics': 2022 January Final Reports (Co-Chairs)

  • See links to current "HL7 WG Health" documents at end of this Agenda

• Housekeeping: Current Versions of WG documents, for discussion (Rhoads)

• HL7 DEV Confluence Page providing mission and relationships: https://confluence.hl7.org/display/HCD
• HL7 Decision making practices (Adopted by TSC Nov 2021 Default_HL7_WG_DMP_V5.3) Review 
  • John Rhoads went over the current version of the HL7 Decision making practices (V5.3 November, 2021)
  • Link on Agendas will be updated going forward
  • Since these are general, HL7 DEV WG has not modified any decision making practices…
  • Motion "to change the default of HL7 DEV WG "Decision-making Practices" accepted by TSC - dated November 2021
    • Motion made by John Rhoads, second by Todd Cooper, motion passes 15-0-0
• 3 Year Plan (2021→2024) Review
  • Martin Hurrell walked HL7 DEV WG through the Anesthesia items with recommending the following:
    • Item 2 - consolidating the  DAM into item 3: (i.e., move item 2. into 3. and expand the description…)
      • Item 2: Consolidate standard definition of intra-procedural anesthetic record (IP-DAM:I2) (Q2:2021 – Q2:2022)
      • Item 3: Impact vendor awareness and adoption of anesthesiology standards. Produce a FHIR implementation guide that will facilitate practical implementation of an electronic intra-procedural anesthesia record. (Q1: 2023 – Q1 – 2024)
    • ACTION: COMPLETED Martin Hurrell Martin Hurrell to make changes (and notify group when subsequent review can occur)
    • Other items have to do with FHIR IGs and SDC standards… which will be talked about during the meetings (Wednesday, Q2)…
    • Malcolm Clarke asked if there is value of including work being done on PHD FHIR IGs?
      • Thought is to add work for good publicity and to benefit general outreach knowledge
      • ACTION: COMPLETED Martin Rosner Martin Rosner will review the PHD FHIR IG and make appropriate edits… send to Martin Hurrell for updates all at once…
• SWOT Analysis (2019-01-17 Document) Review
  • • John Rhoads presented and reviewed document to group (last in 2019)
    • ACTION: COMPLETED John Rhoads John Rhoads to update the SWOT document for the following:
    • Strengths reviewed
      • @John Rhoads to edit based on Suggestion to edit Item 7 into two items: Work with other HL7 WGs and other Standards Bodies
      • @John Rhoads: Add strength of wide international participation
    • Weaknesses reviewed:
      • @John Rhoads: Add for item 1 "International Regulatory Expertise"
      • @John Rhoads: Change item 2. from "bandwidth" to "Work Capacity"
      • @John Rhoads: Add weakness of need for continuity of funding into item 3
      • @John Rhoads: Item 7
    • Opportunities

      • @John Rhoads: Item 4. Add "Cloud, AI, and ML"

    • Threats
      • @John Rhoads: Item 2. note about HL7 cost not consistent with other SDOs meeting fees
      • Suggestion to reverse the items in which item 3 is listed first…
• Download Mission and Charter (2019-01-17 Document) - not reviewed

• DoF Updates 

• PHD FHIR IG - Current Status ... '22 roadmap including final publication & support for PROs, GHS, etc.

  • Brian Reinhold reported on Status
  • Ongoing work over past year+
  • Down to 5 MDC (codes) that are not recognized by FHIR
    • Michael Faughn has a pathway to getting the FHIR Vocab service which is being reconciled (in the short term…)
  • All other items are resolvable - FHIR Publisher continues to change…
  • PHO linking Device with Questionnaires (HL7 Structured Data Capture Group looking into this…)
    • Brian R. Noted a Device is not the source of a "Questionnaire" ; should the device directly feed into Questionnaire and the resources in which the information originated from…  Issue with auto population of information, not ideal for remote monitoring (PHD system)situation… typically done more local as gateway
  • Structure Data Capture WG (led by Lloyd McKenzie) meets Thursday 5 PM EST US - having this at the information resource… presently not handled by PHD FHIR IG… more to come…  Brian believes this will require an update to PHD FHIR IG due to the Version 5 changes… as well as updates to text in PHD FHIR Guide (e.g., ACOM description…). 
    •  Noted that changes to the FHIR Resources have consequences to other work - changes are often not backward compatible…
      • Maturity Level is currently 2, so "use at your own risk" is understood…
    • Noted that O&O "owns" Devices Resource" as Device covers much more than what HL7 DEV typically addresses (much more sophisticated - and tied to IEEE standard of what a "Device" is..)
    • John R. noted similarly on Device Alerts, participation is needed to see what HL7 DEV can do to progress in ways needed by HL7 DEV…
  • Martin Hurrell suggested perhaps proposing three levels of Devices
    • Level 1: Complex Devices, e.g., Patient Monitor, Ventilator
    • Level 2: Compound Device - Beyond simple, but not as complex as most PoCD Devices
    • Level 3: Simple Device - Very simple, like a tongue depressor, band aid, etc..
    • Malcolm Clarke noted there are "descriptions" of devices vs. the "observations" - the communication of Device Data and about the deivce settings  - it appears that both are squeezed into one definition of the Device Resource
    • Paul Schluter mentioned perhaps it could be broken down by uni- or bi-directional…
  • Michael Faughn asked about a statement of what the current "Device" Resource can't do…?
    • A writeup of what presently the Device is incapable of…
  • Perhaps a conscious decision to not define a plethora of Devices
  • Suggested to give very clear recommendations to O&O regarding the device resource and attribution
  • Chris Courville noted DEV needs a concrete proposal to O&O, otherwise traction would not be as it has been… more than statements.
  • ACTION: COMPLETED (Brian Reinhold BrianRienhold, others?) Model a "communicating" Device Resource -
    Define a Communicating Device vs. Non-Communicating Device (perhaps this would overcome the knowledge Gap of what a group like HL7 DEV needs for communication).   Modeling a communication resource, owned by DEV
    • Can DEV quantify changes made by O&O on Device Resource - that have had consequences on DEV's view of Devices
      • Healthcare Products group?
      • One such example is to add the Specialization element (valid in R4), then updated in R5 (specializations element is removed 0:M)
      • John Rhoads suggested having an email dialogue with O&O leadership on this subject
    • Provide detailed information for both PoCD (full level hierarchy) + PHD?
  • Noted that R5 involves element by element will be normative, not the whole Device Resource…
  • (John Rhoads) Because of all the different directions the Device Resource is being pulled into, there is a different way for proceeding depending on the wide varying use cases… different ideas & philosophies being applied pulling the Device Resource in many directions… where does one draw the lines? How do you reconcile the different philosophies?
  • ACTION: (completed 1/20/22) All these (bullets directly above) are Topics for Friday's O&O meeting… and will be put on the O&O Agenda for Q1 Friday
  • (Todd Cooper) Mentioned that another issue is how hard it is to get FHIR IG published (not to mentioned balloted)
    • FHIR Governance should be a key part of Dan Vreeman new view as TSC member on Standards Officer
      • ACTION: COMPLETED Todd Cooper Todd C. mentioned he would bring this topic (discuss with) to Dan Vreeman, new CSDO.
    • Challenge of proliferation of Guides tied to changes of Devices
      • Utilizing FHIR-based which is more stable as we move forward… other work is being done along these lines for various reasons…
      • These need to be addressed to have a "workable plan".
      • IHE-opportunity to have a more stable Profile approach…

• PoCD FHIR IG:  Current & next PSS's

  • 1. What will it take to get the PoCD FHIR IG Published? 

    2. How will Maturity Level #2 be achieved for the IG and the DeviceMetric resource? 

    3. What (3+) independent implementations might be "encouraged"? 

    4. What testing events in addition to the May FHIR CAT be used to achieve the needed testing?

    5. How will we support device alerting in FHIR IGs?  2nd edition of the PoCD FHIR IG?  A focused PoCD Alerting FHIR IG?

  • John Rhoads recognized fine work led by Stefan Karl and others
  • January Balloting round - still some work on JIRA items - and reach out to negative voters (HL7 Canada made helpful suggestions, negative ballot)
  • 51 comments were meant for PHD IG, and misapplied to PoCD, so passed to PHD JIRA for consideration
  • Some text needs to be made more clear, and put into scope
  • Main item which stopped September 2021 Ballot is the requirement that the resources being used have to be Maturity Level (ML) 2 or above (e.g., Device Metric (owned by HL7 DEV WG) - which has not had much prototyping and use - required to get above ML 2). 
  • Need to advance the IG: to get some testing done, thus need prototype code which uses such resources/IGs…  need three communicating entities…John R. called for coders to reach the threshold to advance the IG.
  • (Todd Cooper) At this juncture, DEV needs stronger motivation from participants to move the PoCD IG … there is a lot of work going on, so this is not hopeless, there is a lot of business pull within a FHIR technology context…
  • PoCD work continues on... work continues on describing how to represent Alerts (passed along to an EMR, an archiving system, an archiving system used for analytics… using FHIR format data for these kinds of activities… useful, for example, the history of alerts…
    • Reminder of Weekly Monday meetings 9 AM EST U.S.

• Adjourn IHE-DEV Wednesday 

  • Meeting Adjourned at 12:30 PM CST

Welcome and Introductions (new attendees)

• New: Grant Forest, Thanh-Thien Nguyen, Laurie Whitsel, Sean Rocke

• Recording Attendance:

  See: January 2022 Thursday Q1 HL7 DEVICE Attendance

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). 

Anesthesia WG Topic

PSS - Review & Approve 

• • Martin Hurrell introduced topic and proposed walking through Jira Project PSS-1936 (referenced May 2020 DAM) to get DEV member input.

Review general project scope & INTERSECTION with other DEV areas (incl. DoF IGs & Gemini SES MD)

FHIR IG for Intra-procedural Anesthesia Record  based on PSS-1936 DAM

• Martin Hurrell worked directly from the rendered JIRA page for PSS-1936 and walked through draft document
• Noted that there are many manual entries made (by clinical professionals) within the anesthesia event…
• Comment made by Malcolm Clarke that description of data set - e.g., a containment tree of what's to be recorded… data model ties to PoCD IG across the scope of data collection… Is intent to report device data, and if so, the PSS might need to split out data for procedural, device, etc…
  • One could certainly have a series of observations, and use a common term from 11073 (e.g., HR, Value, Time Stamp)
  • Martin's intent is to provide to categories
  • Martin noted that some of the data is beyond what's provided by (or not typical) by PoCD -
  • Brian Rhine. noted there were prior discussions on how one knows the various devices are running and which resource is associated or linked - someway to structure the "whole anesthesia event" which subsequently can be mapped (to whatever). 
  • Noted that the DAM gives a good source for determining which FHIR resources would be needed…
  • Martin showed use cases, as part of the DAM document ("2020_MAY_HL7_DAM_aNESTH_R1_I5.docx")
  • There is a lot going on which are not necessarily device oriented (perhaps more procedural) which is a gap between device info and all the other information needed…
  • Martin asked if perhaps it best to note there is a LOT of information that is not device-related (communication of device data)
  • Anesthetic record would include a few 10s of parameters, perhaps a bit less, and the rate would be of the order of every :30 seconds, so volume is not that huge…

    • One could certainly have a series of observations, and use a common term from 11073 (e.g., HR, Value, Time Stamp)

• Anesthesia WG produced the DAM, now working towards production of FHIR IG for Anesthesia Record... Thus to reduce the administrative load - the two efforts can be leveraged (previous DAM and FHIR IG).  So perhaps note DAM in description.
• Suggested to identify the camps/categories: 1) Clinical type data, 2) manual reports, 3) PoCD communicating device data...
• The kinds of data needs to be identified...
• Perhaps a Venn Diagram of the kinds of data (from the categories above)...
• Question asked how such data would be communicated via FHIR?  Response is (regarding FHIR) in a variety of ways such as: data could be linked as procedure, or link individual resources tied to patient, etc.
  • Martin Hurrell noted the PSS should be a comprehensive document (similar to something like a CDA document)
• Martin continued to walk through the document… including the description section of PSS-1936
  • Paul Schluter noted that V2 of standard is still very much used, and a mapping might be needed to FHIR (as V2 is the dominant way of doing this communication of data).
  • Martin noted that the artifact of the FHIR IG is indeed FHIR… John Rhoads noted that it's a matter of routing that mapping tables would be involved (including from V2).
• Project Need section of PSS reviewed

• Potential Co-Sponsor: at minimum Pharmacy WG
• No vote today, 
• Todd Cooper that added to SDC specifications that a PAR could be added for anesthesia workstation…
• Given the comments, around the description and scope, a vote today not likely…but if document can be updated, perhaps revised document put to a vote in near future (perhaps on the Wednesday 9 AM EST call?)..

ACTION: COMPLETED Martin Hurrell Completed (Apr 2022) Martin Hurrell to make changes (and notify group when subsequent review can occur) leading to a vote.

• Recording Attendance:

  See: January 2022 Thursday Q1 HL7 DEVICE Attendance

(NIST) Tooling & Testing (Faughn, Garguilo)

• RTMMS version 2 status update (Faughn)

• V2+ Project / Tooling Update (Faughn)

• Tooling update
  • Over the past several months, Individual terms quality improved (via vetting process)
  • 10101b terms have been entered
  • 54,230 terms (with about +350 extra on "tokens"), Michael provided an explanation of where this total number is dervied...
  • Noted, in the published standards are base terms with associated discriminators (a set that are not explicitly in the standard but are non-the-less vetted IEEE-SA 11073 terms).  Examples of this are within units "MDC_X_G_PER_G" which expands out to slots for SI  prefixes for grams, MDC_DEV_REGUL_FLOW_AWAY_VENT (0) to _MDS (1), _VMD (2),  _CHAN(3), etc…
  • Search function enhanced
    • Each Column now searchable (in the Advance Search / enhanced mode)
  • New functionality built in to scroll (and setting how many records (lines) per page)
  • Michael asked group for to please provide feedback on any and all User Interface input for functionality likes and not-likes…
  • Michael showed downloaded search .XLS (Spreadsheet) and content
    • Columns shown including Status, AutoExpanded, RefID, Partition Code, CF_CODE10, etc.…
  • Question about formatting (similarly to what Paul Schluter provides) - Michael is still working on this with a goal to retaining the formatting…
    • E.g., superscripts and subscripts (won't be shown in .xls but the HTML should come with that…)…
  • Hope is to deploy on .nist.gov server by summer 2022, as NIST continues to vet terms with subject matter experts
  • 10101R may have a description with the relationship with IEEE-SA and the Royalty Free Agreement with NIST/RTMSS (See section "H.3" of 10101R, reference provided by Malcolm Clarke)
  • LOINC Terms that are mapped to MDC Terms, each term can be drilled down for more information about the Code(s), including co-constraints (which for most terms will not be found in IEEE Standard) - value added but WELL vetted.
  • "Advanced Information Page" link --> maps the term to the way that tables are laid out in the Standard, e.g., Notes, RefID, Term Codes, Discriminators, Definition, Units, Enums, Body Sites, etc.…  Useful for SDO type users.
  • Download CSV Files (functionality)
    • Terms
    • Expanded Term Set (creates a zip folder with files for: deprecated, partitions, synonyms ,withdrawn terms)
  • "Check Term" - give me a CSV file and include a column that provides (partition, code) validation that the RefIDs and partitions and codes (e.g., warns not to use a term that is deprecated, or withdrawn…

V2+ Project / Tooling Update (Faughn)

• • Transition of V2 being a non-computable standard to a computable standard
  • Michael is serving as the "tool smith" to help this effort…
  • Michael rendered the V2Plus.hl7.org pages

UML --> V2+ Tool

• • • From there the V2 Chapters, via scripts, an a publication module to add to web site
    • HL7 UTG (Unified Terminology Governance) - being vetted through UTG for HTML publications
    • Going forward, folks may want a serializable  V2 publication 
      • HL7 Publisher was considered and arrived at not using this (for various reasons)
      • Uses Serializers --> includes IGAMT, FHIR-Like, JSON
      • FHIR ITS Module:  uses the FHIR syntax to push messages around… similar to V2 message but carried via FHIR
        • This is not mapping from a V2 segment --> FHIR… instead taking the exact structure and package within a FHIR message…

• Joint with Mobile Health WG (Matt Graham/Gora Datta/Nathan Botts/Frank Ploeg - Mobile Health Co-Chairs)

  • Welcome & Introductions (Mobile Health WG Agenda), Mobile Health Co-Chairs Matt Graham and Frank Ploeg Joined DEV

  • Slide Set provided and presented by Matt Graham

  • Updates provide on cMHAFF, MH-ADE, SHIFT, and UMHAI
    • • Consumer Mobile Healthcare Application Functional Framework (cMHAFF)
        • Working toward SU2 version is more HER aligned, next thing is to profile it for further assessment (more constrained to specific use cases)
        • IEC 82304-2  CEN/ISO Health & Wellness Apps --> bringing this back to cMHAFF
        • See slide set
      • Mobile Health App Data Exchange (MH-ADE)
        • Todd Cooper asked about OHDSI (slide 17)
        • See Slide set
      • School Healthcare Information Framework utilizing Technology (SHIFT)
        • See Slide Set
      • Unique Mobile Health App Identifier (UMHAI)
        • PSS-1867
        • See Slide Set
      • Projects and weekly meetings shown on slide 28
    • Todd Cooper: TC215 WG 11, when looking at a pure SAMD and the relevance with UMHAI, how is the traction with participants in this space?
      • • (Matt Graham) Starting to pick up, Gora Datta is getting more exposure/presence with conformance groups, and travels to Asia and Europe (noted that Germany is already using Mobile Health for prescriptions).
    • Malcolm Clarke asked about the granularity - e.g. per user/usage - which would be a VERY large number…
      • Noted that UDI would be blown out of identifiers with potential billions of users… how would it be implemented?
      • Matt G. reinterred this is a key issue, and added that UDI is fairly static...
        • Strong need for micro device as software as health act…

• Noted that Q1 tomorrow (Friday) that DEV Co-chairs will join O&O meeting to discuss Device FHIR-related resource(s)

• Note: Members welcomed to join Joint O&O WG Session in Q1

Welcome and Daily Agenda Review (Cooper)

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). 

Update on TC215 & JWG7 Related Projects (PHN-A & DTx & SES MDI) (Todd Cooper)

• See Slide Set from and presented by Todd Cooper
• Gemini SES MDI Update

• Roadmap update

  • 3-Year Roadmap - Workstreams (see slide)
  • Use Case Capabilities sub-setted for each subsequent version (e.g., one for 1.0, 2.0, etc)
  • What are and how do we leverage the Standards…
  • What are the targets…
  • Key focus is get Version 1.0 completed…
  • Conformity Assessment (CA) & Tooling
    • (Monthly) Connectathons have been instrumental in moving work forward, learning, revising, and advancing.  Also real diversity of applications and platforms addressed…
    • IHE Catalyst Study
• Incl. MDIRA Update

• Ecosystem Pathway update

  • Also have similar table for MDIRA
  • And a 3rd EP Tol Table
  • https://confluence.hl7.org/x/0yPxB
  • see slides
  • Gemini SES MDI - SES Ecosystem Pathway
  • Announced a new Gemini SES MDI Group: Ecosystem Pathway: "Pathway to an Ecosystem of Plug-and-Trust Products"
  • Bi-weekly meetings, Tuesdays at 10 am U.S. EST, calling all SES experts!
  • See slide for Topics of Interest x 3, which show a table of Topics, with attributes including Priority, Date Leads, Synoposis, Status and where in the SDPi+FHIR document(s)

• RI+MC-RR Update (incl. MBSE / SysML 2.0)

  • Center of RI will be in SDPi TF-1 Appendix B (ICS - conformance statement tables with links to profiles)  & C (Use Cases, functional requirements)
  • How do we move from a document to model centric approach and produce "Regulatory ready"
  • Refinement process has continued…
  • RI (Requirements Interoperability) - Near Term approach will continue to be Word (
  • MC (Model Centric) - Recommend using SysML 2.0 (see slide for reference to link providing documents on-line (Github)
  • RR (Regulatory Ready) - formation of the Ecosystem Pathway group + IHE Catalyst Sutdy

 ISO/IEEE 11073 "MDC" 2.0 - Update discussion (Cooper/Faughn)

• Perspective from Michael Faughn
• Michael prefaced conversation that he is NOT an implementer, and "these are only his observations"...
• See Slide Set
• What does Publication encompass?
  • Rosetta?
  • This is not suggesting in any way removing the need for expert human KNOWLEDGE
  • This is planning for the day when we have turnover and there are computers/processes managing data and information.
  • Integration with other tools / resources, e.g., tx.fhir.org
  • Integration with testing tools
  • Dichotomy between what is part of the RFA and what isn't creates significant overhead for development
  • Lack of standardization, computable serialization formats
  • Special cases… "special cases are the devil"
  • Positive approach to IEEE-SA for a potential expansion to the existing NIST-IEEE Royalty Free Agreement
  • Integration device data with HL7 Terminology Governance
  • Speed of getting terms used vs. approved by IEEE-SA
    • Is this a pathway to improving interoperability and...
    • Should Co-constraints be balloted? (Maybe not at SDO level, maybe only at RTMMS level)…
    • Same with Tokens
    • E.g., HL7 FHIR has a consensus model
  • Is there some way to turn RTMMS in a more authoritative source
  • E.g., can there be work done prior
  • Annex H, "approved" status (jumping from provisional --> Balloted), can we make better use of "approved"?
  • An example of this is the co-constraints, and push that into a validation engine - and they are not part of the standard.  In other words, what's the authority of co-constraints…
  • Use of blocks should be considered very carefully
  • Generally, tilt towards interoperability / machine process-ability in favor of human readability when crafting
• Goal of discussion is strictly to get thoughts out and not to solve issues today
• IEEE Publication content (what's in, what's out)
• RTMMS Content
• RTMMS features and functionality
• Facilitating nomenclature development
• Minimizing the need for expert human management
• What does this encompass?
• Headaches
• Discussion
• Consumable data vs. development data
• More to come…

• Case Study: Data exchange between resource constrained Devices (David Gregorczyk)

• See David Gregorczyk's slide set
• protoSDC
• Motivation is that MDPWS based on outdated standards, cumbersome, based on XML (not efficient communication technology for SOAs/ROAs)
• protoSDC leverages protocol buffers over gRPC and HTTP 2.0 (
• Compatible with BICEPS
• Slide presented on "How Does it work?"
• Performance test done between MDPWS and protoSDC

• Working on a Web site for PtotoSDC - good place for those interested to get started…

• (For Reference:) Gemini SDC/SDPi Confluence Pages Review ("upon request") (Cooper)
  

  • •  Gemini SES MDI Confluence Pages of Interest

      Topics regarding Gemini SES MDI using SDC / SDPi+FHIR update ...

      1. Library with EVERYTHING you ever wanted to know ... (https://confluence.hl7.org/x/aojGBg)
      2. RI-TF-CA Coordinated Focus (https://confluence.hl7.org/x/KA7xB)
         1. Requirements Interoperability Pilot (… https://confluence.hl7.org/x/oJGHBg)
         2. MBSE / SysML / Cameo Pilot (https://confluence.hl7.org/x/YAZxBg)
         3. FDA ASCA & IHE CA Pilot (https://confluence.hl7.org/x/VouHBg)
      3. Topics of Interest continue to expand (https://confluence.hl7.org/x/0yPxB)
      4. Device Specializations home (https://confluence.hl7.org/x/wZqfBg)
      5. IHE SDC/SDPi PAT events (https://confluence.hl7.org/x/09R7BQ) 
         1. Python Reference Provider Test PAT #4
         2. Reference Provider/Consumer Specification 
      6. HL7 FHIR CAT “Isolation PoC” events (https://confluence.hl7.org/x/m2PPBQ)
      7. MDIRA Profile home (https://confluence.hl7.org/x/4Y_HBg)

      NOTE:  Remember these confluence pages are ALL a work-in-progress ... messiness expected!

      
      

Break 10:45 - 11:05 AM

DEV Report Out from Joint Meeting with O&O and DEV in Q1, Friday (Rhoads, Courville) 

Chris Courville summarized the following:

• Chris Courville, John Rhoads, Javier Espina, Brian Reinhard (others?) from DEV attended
• Communicating devices span a wide set of domains that utilize FHIR for interoperability needs
• Proposal brought up that middle ground solution…
  • Software protocol information that can be referenced from the Device Resource
    • Perhaps a separate resource be introduced for communicating device
  • Agreement was that much more discussion and analysis
  • More discussion with focused meetings between DEV and OO (beyond the small percentage of time spent on the weekly OO Monday calls in which DEV members attend
• Other topics brought up regarding JIRA issues (from  Device space)
• John Rhoads sent an email regarding potential for improving device resource to address the different concerns
• Take away is agreement that more discussion needed
  • Likely cadence and time would be Wednesday morning (9am EST) weekly DEV FHIR meetings…
• There are a list of JIRA items still on the "backlog" to be considered…
• May 2022 meeting with O&O WG (host)  suggested to be Tuesday Q1…
• Marty Velezis (whom often hosts - along with Hans B. - the Monday Healthcare Products meetings) agreed to attend the DEV Wed. 9am calls…
• the following is reproduced from O&O meeting minutes regarding this topic (from Q1 Friday, January 21, 2022)

• --Begin Reproduced OO Meeting Minutes--
• Device (DEV) 
  • Type 0..* was not previously accepted and specialization was created – that is all reversed now
  • Property 0..*  was changed?
  • Issues around BDP intersects are not fully understood by DEV group and implications on Devices 
  • This is in an effort to deal with the boundary products that may not be definitely the same across jurisdications
  • Also to align across the healthcare products – product pattern (to be discussed at Q3 Friday)
  • Communication between the groups has been an issue
  • There needs to be additional work on communication between the groups (utilizing meetings, listserves and/or zulip)
  • Major changes should be communicated between the group – if the changes are not acceptable then we need to evaluate options; we can minimize breaking changes but may not be able to completely avoid them.  
  • There are breaking changes with PHD IG and they want to update with R5, and would like to address the breaking changes currently introduced
  • Rob noted that this has been done for some other use cases - e.g., Immunization separate from medications
  • Several participants indicated that it may not be desirable to separate out communicating devices from all of the other devices.
  • Several suggestions for how to approach this issue around the changes that have been made to Device that are breaking for the PHD IG
    • Conduct analysis of the options and discuss across the groups
    • HOLD all of the JIRA issues related to the changes (e.g., Device.type, Device.property.type and other narrative descriptions to Device.  Will revisit after the analysis and consensus on the accepted strategy for handing communicating devices.
      • Scope and boundary sections for Device and DeviceDefinition
      • Device.type expand example value set with software/hardware context
      • Concerns with changes to Device/DeviceDefinition
    • HCP topics related to software (IEEE)
    • FHIR-32567
  • A "communication protocol" resource could be created and referenced from Device to carve out the communication related elements/attributes
  • To revert some of the items (e.g., specialization) to their previous state
  • Next steps:
• DEV group is concerned about
• DEV wants to create an additional resource for Communicating Device
• May WGM Joint meeting with DEV will remain on Q1

Device

• HCP Topics on Device R5 Normative candidate, DeviceDefinition / DeviceMetric
  • OO HCP - Normative Device Analysis (Related JIRAs: FHIR-32274, FHIR-32275, FHIR-32374)
  • FHIR-32560 - Mark non-exercised device elements as STU - Note - anything not Normative will need to be marked STU
  • We could already vote on this as that is our approach.
  • Definition/Scope/Boundary
  • Device Scope-Boundary-Relationships  ---- HOLD for progress on other topics.
  • FHIR-32382 - Device Resource Scope and Usage and Boundaries and Relationships Clarification
  • FHIR-32277 - Update Boundaries and Relationship section prior to considering the content Normative
  • FHIR-32276 - Update the Device Scope and Usage text
  • FHIR-32408 - DeviceMetric resource listed as device related resource, but the Device resource does not reference it
  • FHIR-32681- Improve Device documentation for software use case
  •  
• Device and Device Definition Mappings
• Should Device go Normative, and if so, which fields (TO BE DONE AFTER THE REST HAS BEEN RESOLVED).
• Critical to Normative

Image ModifiedFHIR-31750 - Complement Valueset-identifier-type for Device identifiers 

• Friday Q3 - need to address with other discussion topic for identifiers

• Device.parent
  • FHIR-34310 - Device.parent should be (again) for hierarchical relation only  [Waiting for Change and QA]
• Device.status [Discussed 01/21/22 (Q1) still pending resolution, see below]
  • FHIR-32557 -Is there a requirement that records be inactivated for devices that are disposed/destroyed/etc?
    • Refined the proposal.
    • Update: 11/01/21 - comment from Lloyd: Is it possible to have device records that are 'draft' - i.e. the record is at least partially in place but the device isn't ready for use yet?  I'm not clear that "not current" clearly covers that case.
    • Update: 01/21/
• --End Reproduced OO Meeting Minutes--

• Open Discussion / Topics Arising from this week... (Co-Chairs)

  • IEEE POCD 11073 additional topics

    • None 

• FDA Meeting Notice (Konstantinos Makrodimitris)
  • 25 March from around 8 AM - 1 PM, 3 tracks/sessions, fully virtual
    • Kosta - conformity assessment
    • Isabelle - Value track
    • Sandy Weininger - Coordination with SDO
  • Kosta noted several folks from IEEE-SA PoCD/PHD and HL7 DEV WG will be invited to speak and attend

• FDA has a relationship with ONC
  • How is coordination done with ONC with regard to interoperability
    • Perhaps one from IEEE-SA PoCD/PHD one member from HL7 DEV
      • Have preparation prior to May Meeting and assign leads for this item..
      • ACTION: COMPLETED Konstantinos Makrodimitris Schedule a conversation around this (originally with  Co-Chairs)
    • Fall 2022 updates should include representation from DEV groups
  • ACTION: COMPLETED John J. Garguilo Kosta mentioned having a session and Agenda in May WGs (to be scheduled on HL7 DEV May 2022 Agenda)
    • This would provide more up to date information as traction continues to ONC

• Javier Espina had a comment/question with regard to discussion with O&O
  • Asked if there could be a joint meeting between DEV and O&O in May WG meeting week...
  • Discussion focused on and dedicated to the Device Resource and related definition(s)
  • Make Title explicit - tied to Device to get the right O&O folks involved
    • E.g., "Communicating Device Resource"
  • Designate a Q3… Invite OO on the May WG Meetings for Wednesday or Thursday Q3 to HL7 DEV
    • ACTION: COMPLETED John J. Garguilo John G. to make request with O&O when setting up meetings for May '22

• Planning May 9-13 '22 WGM (Co-Chairs)

  • HL7 announced it will again be Virtual

  • Feedback from these/Sept '21 meetings

  • Objectives / Core Topics requested from DEV WG members for May '22 (incl. joint sessions)

  • HL7 (Virtual) Room Reservation for May 2021 Meetings (Garguilo)

• Action Items overview going forward from January 2022(HL7/IEEE/ISO) and coordination with other SDOs

  • Action Item Reviewed from this week (Garguilo)

• Meeting Adjournment (Co-Chairs)

  • Many Thanks to our wonderful presenters, attendees, and a VERY Informative work of week!

  • Be well and thanks for your attendance and work as we move DEV forward :-)

  • Motion made by John Garguilo to "Adjourn January 2022 HL7-DEV WG meetings", second by Konstantinos Makrodimitris

  • Motion passes 13-0-0, meeting adjourned 12:05 PM U.S. CST