DEV Domain F2F Apr 21-24, 2020 Webex

PCD Home

Please NOTE: Agenda created March 16 - still being edited.

Paul Sherman, PCD TPM

Meeting Objectives

These face-to-face meetings have a number of objectives depending on the committees involved:

• Planning Committee: Review, plan and initiate PCD activities; contribute to planning of the HIMSS Interoperability Showcase and other Showcases and events; recruit vendors and users.
• Technical Committee: Review and adopt brief profile proposals; contribute to Connectathon test tools, tests, and procedures.

Location & General Schedule

Location:

- Virtual via Webex

Dates

- To assist European participants, all meetings will be morning meetings, with a meeting on Friday.

the times will be 9AM EDT - 1PM EDT

Tuesday April 21: Pump Working Group

Wednesday April 22: Joint PCD/PCHA meeting, PCD Planning Committee, PCH Meeting

Thursday, April 23: PCD Planning and Technical Committees, PCH Meeting

Friday, April 24: PCD Technical Committee

The schedule is proposed; actual meeting times may change during the week.

Daily Schedule - All times Eastern Daylight Time (US)

• 09:00 - 11:15 Session #1

• 11:30 - 14:00 Session #2

Agenda Suggestions

Please submit suggestions for agenda topics here or through emails to the committee co-chairs.

From the PC Action Items PCD Planning Committee Action Items:

172 DEV Domain Implementation

173 Update TF for DEV Domain

From the TC Action Items: PCD Technical Committee Action Items:

196 Add PCD specific values to HL7 table 78

200 MDS and VMD Requirements

201 Pump utilization - publicizing

202 MEMDMC CP to make PID and PV1 segments optional

Webex Support

Because of COVID-19, these meetings will be held via Webex. The links will are provided below.

Reminders: the IP agreement is in force, and participation counts toward voting rights.

Please note: the log in and phone number for each meeting is the same as for our WG meetings. The password is included in the email sent to participants. These are not provided here for security reasons (this is a public Wiki page).

The HIMSS Webex page is [HIMSS Webex]

PCD Meetings

- Tuesday, April 21: Pump WG: Meeting Number: 922 682 629

- Wednesday April 22: DEV joint and PC: Meeting Number: 922 036 096

- Thursday April 23: Joint PC&TC and TC: Meeting Number: 921 597 565

- Friday, April 24: TC: Meeting Number: 929 476 319

PCH Meetings:

- Wednesday morning, April 22: Meeting Number:

- Thursday morning April 23: Meeting Number:

- Friday morning, April 24: Meeting Number:

Attachments / Materials

Documents related to the meeting when available will be found at the [ftp site] unless otherwise noted. Documents are available without a password.

Schedule/Deadlines: Patient Care Device and Domain Milestones

PCD PC Action Items PCD Planning Committee Action Items. Significant changes, other than dates, will be in bold.

PCD TC Action Items PCD Technical Committee Action Items. Significant changes, other than dates, will be in bold.

Detailed Schedule & Agenda

Tuesday, April 21 (Pump Workgroup)

Date	Hours	Committees	Topics
Tuesday	09:00 - 2:00	Pump workgroup	Morning (09:00-2:00) Introductions - Kurt Agenda review - Kurt IHE IP Management Process - Kurt 9:15 MEMDMC terms for pumps - 30 min 2020-02-24.DMC.1d.2020-03-30T16.IPv4-IPv6.xls https://drive.google.com/open?id=1DTGH766Q5dOoeL2kM3JRjbjkH9KE9Gup MEMDMC Battery status - 30 min 2020-02-24.DMC.1d.2020-03-30T16.IPv4-IPv6.xls https://drive.google.com/open?id=1DTGH766Q5dOoeL2kM3JRjbjkH9KE9Gup Bolus from existing Infusion - 30 min Break (10:55-11:05) Pump Terms containment model update - 1.5hr Break (12:10-12:30) Pump alert/alarm events - 30 min ACM state changes - 30 min Mapping of detailed pump events to broader 11073 terms - 30 min 2:00 > Meeting Adjournment

Wednesday April 22, 2020

Date	Hours	Committees	Topics
Wednesday Pt. 1	09:00 - 11:15	Joint IHE Devices Meeting	09:00 > IHE IP Management Process (Kurt) 09:05 > Introductions and Agenda Review (Kurt and Thom) 09:20 > Welcome (15 minutes) 10:35 > Subdomain Reports (20 minutes each) PCD PCH DPI 10:35 > DEV Domain Guidance and AOB (15 minutes) Feedback from Kevin O'Donnell IEEE P2733 Overview Move future DEV meeting to end of F2F? 10:50 > Next steps and wrap up 11:00 > Adjourn Joint DEV Meeting
Break	11:00 - 11:15 AM
Wednesday Pt. 2	11:15 AM - 2:00 PM	PCD Planning Committee (PC)	11:15 > Start PC meeting Introduction - IHE IP Management Process (5 minutes)(Kurt) - Review & Approve PC Agenda (Kurt) General PCD Work Program Review (statuses, plans only, details during TC sessions): - ACM (Rob W for Monroe P) - MEM DMC (Rob W for Monroe P) - MEM LS (Rob W for Monroe P) - WCM (Paul Schluter) - IDCO (Paul Schluter) - RTM (Paul Schluter) - Vent (Paul Schluter) - PIV (Jeff R) - Pump (Kurt, Jeff R.) - IPEC (Kurt) - PCIM (John R) - Physio monitor (John R) - DEC General update PCD TF) (John R) DEC OPTION: FHIR (Todd C) - EC (John R) - DCM Pulse Oximetry Currently waiting for someone to take it to FT. - Review current Action Item: PCD Planning Committee Action Items: 172 DEV Domain Implementation 173 Update TF for DEV Domain 2:00 > Adjourn Planning Committee meeting

Thursday April 23, 2020

Quarter	Time	Lead	Agenda Items
Thursday Pt. 1	09:00 - 11:15 AM		09:00 > Joint PC/TC meeting Introduction - IHE IP Management Process (5 minutes)(Kurt) - Review & Approve Joint PC&TC Agenda (Kurt) IHE International Board - Update & Feedback (Todd) Review 2020 Milestones - [1] Five year plan No current plan - 2017 Roadmap - and 2011 Plan Notes Cochair Action item - 106 - Activities Promoting PCD. Location, Dates of the DEV PCD 2020 Fall F2F Adjourn Joint PC&TC meeting.
Break	11:15 - 11:30 AM
Thursday Pt. 2	11:30 AM - 2:00 PM	PCD Technical Committee (TC)	11:30 > Open PCD Technical Committee (TC) TC Welcome and Agenda Review (Tom Kowalczyk) Announcement – Decision Making meeting (TC Co-Chairs) Proposals - PCD Program review: ACM (Rob W for Monroe P) MEM DMC (Rob W for Monroe P) MEM LS (Rob W for Monroe P) DEC (John R) EC (John R) IPEC (Al E, Jeff R) PIV (Al E) Pump (Al E, Jeff R.) DPI (John R) Physio monitor (John R) PCIM (John R) Vent (Paul Schluter) IDCO (Paul Schluter) RTM (Paul Schluter) Quiet Hospital - Standards Coordination IEEE 11073 SC & PARs & EMBS SC (mobile, IoT, AI/ML) HL7 Devices on FHIR

Friday, April 24, 2020

Quarter	Time	Lead	Agenda Items
Friday Pt. 1	09:00 - 11:15 AM		09:00 > Continue TC Meeting TC Action item review [TC Action items] 196 Add PCD specific values to HL7 table 78 200 MDS and VMD Requirements 201 Pump utilization - publicizing 202 MEMDMC CP to make PID and PV1 segments optional 09:45 > RTM and IEEE P11073-10101b draft standard (Paul Schluter) Overview of where we are and process to begin “ballot group formation” for IEEE P11073-10101b 10:45 > Containment modeling (Paul Schluter) Key items needed for more rigorous message definition and validation, focusing on containment trees and essential next steps to improve IHE PCD DEC HL7 V2 message conformance testing.
Break	11:15 - 11:30 AM
Friday, Pt. 2	11:30 AM - 2:00 PM	PCD Technical Committee (TC)	11:30 > Continued topic discussions RTMMS update given by NIST contractor Michael Faughn F2F Action Review (from this week) PC PC&TC Proposed agendas for Fall F2F - If Virtual Tuesday AM Pump WG Wed AM PC and Joint PC/TC Thurs AM TC Friday AM Joint DEV - If Live Tuesday Pump WG Wed AM PC and Joint PC/TC Wed PM and Thurs AM TC Thurs PM Joint DEV TC > TC Meeting Wrap up and Adjournment (Kowalczyk)

Note: Time slot TBD: IDCO

Participants

Tuesday, April 21

Kurt Elliason(Smiths Medical), Al Engelbert (BBraun), Andrea Robertson (Smiths Medical), Bill Haralson(Smiths Medical), Brian Witkowski (BBraun), Christophe Fournier (Fresenius), Jeff Rinda (ICU Medical), Marufur Rahmen (ICU), Nathan Berg (Smiths Medical), Paul Schluter (CMI), Tom Kowalczyk (BBraun), Michael Faughn(Prometheus), Dalibor Pokrajac(GuardRFID), John Krupka

Wednesday, April 22

Thursday, April 23

Friday, April 24

Discussion

Discussion Summaries do not require formal approval, while minutes of meetings where votes are taken do. Participants are encouraged to review and bring up significant issues with discussion summaries of previous meetings. Votes will be taken to approve meetings where votes took place; these may be email ballots.

Tuesday Pump WG Meeting

Item	Topic	Discussion
1	Introductions & Agenda Review - Chair	Status/Discussion: Reviewed IHE IP Management Process Decisions/Issues: Agenda approved Action(s):
2	MEMDMC terms for pumps and MEMDMC Battery status	Status/Discussion: Added MDS terms to VMD as optional if there multiple modules. MDC_ATTR_ID_SOFT term needs to be checked. Looked in 10201 for definition. From 10201 "Soft-Id. MDC_ATTR_ID_SOFT. OCTET STRING. Settable, e.g., hospital inventory number." Discussion of battery terms, Dalibor expressed need for Low battery indication. We have terms for Battery charge level and time remaining. Also have events for battery low and depleted that could be used.
3	Bolus from existing Infusion	Status/Discussion: Given Clinician Bolus (CH) Need clarification on whether the ‘O’ on Bolus from existing infusion table should really be ‘X’ Should be 'O', since some EMR vendors always send TQ1. Confirm: MDCX_INFUSION_PROGRAM_TYPE to be used to signify type, while RXG-15/16, TQ1, and MDC_FLOW_FLUID_PUMP to define values Need clarification on what MDCX_INFUSION_PROGRAM_TYPE “continuous” is expected to be used for -- Need CP Should be OBX-3 with enumeration of "clinician dose" Titration (XO) Remove “not valid for PCA” means not valid for PCA device type, revisit in the future if it should be for PCA Basal rate only. Need input from EMR vendors. Typically a change to a PCA pump would be a new order. Intermittent Bolus Need these segments available for PCD-03 MDC_TIME_PD_DOSE_START_INTERVAL MDCX_TIME_PROG_NEXT_DOSE MDCX_TIME_REMAIN_NEXT_DOSE Need clarification on whether “MDC_TIME_PD_PROG” is needed defer to pump terms discussion later today
4	Pump Terms containment model update	Status/Discussion: Brian working with a MongoDB. Created a pump MDS containment generator supports 01, 10, need to add 03. Could support others could put it on a website so the group can review and comment
5	Pump alert/alarm events and Mapping of detailed pump events to broader 11073 terms	Status/Discussion: Reviewed content of ListParSrcEvt.3o.x3u.2020-04-20T16.P3-expanded-displayText.xls Targeting August to start ballot process Would like description of infusion pump for standard. Dialysis has 8 page description
6	ACM state changes	Status/Discussion: Need to make sure REFIDs work well with state machines Action(s): See above

Wednesday Joint PCD/PCHA Meeting Summary

Item	Topic	Discussion
1	Introductions & Agenda Review - Chair	Status/Discussion: Kurt Elliason reviewed the IHE IP Management Process Introductions and Agenda Review Decisions/Issues: Agenda approved Action(s):
2	Discussion Summary or Approval of Minutes - Chair	Status/Discussion: DEV Domain Mar 25, 2020 DEV Joint 2020-03-25 Webex Decisions/Issues: Action(s):
3	Agenda Items -	Status/Discussion: 08:05 > Introductions and Agenda Review (Kurt and Thom) Subdomain Reports Presentations will be on the ftp site. PCD - - Many products using DEC profile. IPEC moved into FT. Provided summary of Profile’s progress. Discussing sterilizer Profile. 10101B – terms under review for update and balloting. Working a lot on Quiet Hospital, had planned demos at HIMSS2020. SDPi and Quiet Hospital groups merged, this is going very well. Looking for regulatory and clinical input. Discussed ECRI participation. MEM – looking at remote command/control. Will update our report for DEV – Need to meet and discuss how to proceed PCH - POU TF published, wiki launched. - Paul Sherman and Mary are working on DEV page redirects as needed. - Working on Direct to Cloud operation, lightweight DIM. - Reviewed Direct to Cloud; stack, simplified DIM and prototype protocol stack. Simplified DIM: looking to simplify for personal health devices, could move beyond to D2C and Bluetooth LE. Hope to have best of both worlds. Currently under Board of Directors review. IEEE group discussed this on Monday, will want to review/change model title. Still looking at how to change it in official PAR. Will need to review and discuss further. Mobile Health apps – Not yet launched and working on the charter. Looking to involve new participants (Apple, etc.) - Test and Tools Maintenance release in May, Gazelle integration complete. Some other items pending funding. - Marcom review. Developed common message, feel free to use or share it. Wrote a number of blogs, ID markets, ID’d vendors to represent, collaborate with Global eHealth Consortium.. Discussed comms strategy. Discussed reporting this to Board. DPI - Rebranding HL7 to HL7 Device Workgroup. Balklot closes 4/26. - Launched WP last April, finished Oct. Ken summarized history and flow. Question on using going forward, more of a living document. - Reviewed ISO/IEEE 11073 SDC - Reviewed/highlighted Use Cases. In process is Remote Monitoring during COVID-!9 response. (FDA initiated). - SDPi Supplement – Developing 4 profiles, include TF 1, 2, and 3 material and testing at Korean CN. Profiles are Plug and Play, Repoorting, Alerting, External Control. - Reviewed Supplement Developement. Will build on existing momentum, SDPi 1.0 foundation, work streams/teams, then white papers. - Presented/recorded HIMSS presentation, will share link when it’s available. - Proposed Joint Joint HL7-IHE Gemini Program. Deliverables – SDPi Supplement, HL7 DoF IG, and joint white papers. Goal – Leverage the resources to create deployable products that are regulatory compliant. - Create a set of Collaboration Tooling. - Question about Military/Disaster casualty care. How to decide where to evacuate to? That is part of this process, but not the main focus. Link to [Saner Project] as discussed. DEV Domain Guidance and AOB (15 minutes) Feedback from Kevin O'Donnell - He’s voiced some concerns on how we’re organizing,, but has no specific info on what we’re violating. Todd has asked for specifics, no response. He’ll ask again. Could be sour grapes or fear of change. We should proceed. - Ballot – Create Tiger Team to address remaining items finalizing DEV structure. Passed unanimously. Todd will convene the group IEEE P2733 Overview - View unavailable, Ken reviewing verbally. Slides will be available. Group struggling to find its way forward. Move future DEV meeting to end of F2F? - Some discussion, will bear in mind Next steps and wrap up DEV Tiger Team – Todd will start that. Adjourn Joint DEV Committee (PC) Decisions/Issues: Action(s):

Wednesday PC Meeting Summary

Item	Topic	Discussion
1	Introductions & Agenda Review - Chair	Status/Discussion: Kurt Elliason reviewed the IHE IP Management Process Introductions and Agenda Review Decisions/Issues: Agenda approved Action(s):
2	Discussion Summary or Approval of Minutes - Chair	Status/Discussion: Minutes approved Decisions/Issues: Action(s):
3	Agenda Items -	Status/Discussion: General PCD Work Program Review (statuses, plans only, details during TC sessions): - ACM (Rob W for Monroe P) Current status; In FT, 19 vendors at Connectathon, Showcase cancelled. Quiet Hospital and SPDi merged, 34 members 10 organizations. Lab results and Rad Workflow pushed to 2021 - MEM DMC (Rob W for Monroe P) TI, in Connectatrhons No updates planned this cycle - MEM LS (Rob W for Monroe P) TI, in Connectatrhons No updates planned this cycle - RDC – still out there. Not much work, but white paper is available. - WCM (Paul Schluter) Not a lot of news, vendors have implemented. Nomenclature will be able to support vent info. - IDCO (Paul Schluter) Meeting each Friday and updating. Working with Heart Rhythm Society EMR vendors. Hope to be at Connectathon, will work with Paul Sherman to prep. - RTM (Paul Schluter) Summary, more detail at TC. Significant 10101b update, everything not in gray will have codes. Asked vendors to supply event strings. Three vendors contributed so far, helpful info. Working with Dialysis vendors to get terms into 10101b. Formalized MEM DMC terms. Nurse call and beds are moving along, but not ready to add to the list. 10101b – Talked to IEEE Steering Committee and staff. Hope to have ballot ready late August. Hope we can join and participate. An invitation will go out late summer, please join. - Vent (Paul Schluter) – Keep adding terms, hoping to get more and add them to the terms. - PIV (Kurt, for Jeff R) – Not a lot going on. Have some minor tweaks due. 1 or 2 CPs - Pump (Kurt, Jeff R.) - A lot of MEMDMC terms, most not pump specific. Collecting a lot of alarm events, some specific ones. - IPEC (Kurt) – Final Text, in Technical Framework. Can work on other Profiles. - PCIM (John R) – On hold, limited resources right now. Discussing, possible that HL7 v2 won’t quite address needs. FHIR may be a better fit. Some work by Ioana, but doesn’t quite fit our needs. - Physio monitor (John R) – Continual flow of input capabilities, managed in terminology management. Will want to look at it as we rethink TF organization. May want to enrich physio monitoring terms. - DEC General update PCD TF) (John R) – Pretty stable, new capabilities pretty well covered. Exercised well in Connectathons. DEC OPTION: FHIR (Todd C) – A lot of advances, in good position to leverage that work into FHIR implementation. Planning Korean Connectathon, will work with them for a CP to implement it. Not a lot of work, will be able to claim FHIR implementation across whole Domain. - EC (John R) - ‘Parent’ of IPEC. - DCM Pulse Oximetry Currently waiting for someone to take it to FT. Needs formatting. Developers don’t wish to move it into FT. John is willing to help when he has the time. - Review current Action Item: PCD Planning Committee Action Items: 172 DEV Domain Implementation - Close this and create an Action Item for PCD Coordination with the Tiger Team. Let Todd know of any questions. Report at next DEV meeting. 173 Update TF for DEV Domain - Close this and create an Action Item for PCD Coordination with the Tiger Team. Let Todd know of any questions. Report at next DEV meeting. Further topics Todd) - Virtual Connectathons – Is the PC part of this discussion? We haven’t discussed it. Would be very challenging. Gazelle is the easiest parts. Theoretically could use a 4G router to divorce from corporate IT limitations. Epic has a HIMSS system separate from their own regular systems. - How to officially add a sponsor to an existing Domain. IHE has no process separate from Domain creation. Domain management should have a way to vet sponsors. Make this a Domain Action Item. Adjourn PCD Planning Committee (PC) Decisions/Issues: Action(s): Close existing PC Action items and roll them into a DEV Tiger Team Action Item Create DEV Action Item on creating a process to add a sponsor to a Domain.

Thursday Joint PC&TC Meeting Summary

Action(s):

• Cochair Action item - 106 - Activities Promoting PCD.

Close, refer to Tiger Team and start as a DEV Action Item.

• Fall F2F

DEV decision refer to Tiger Team

Item	Topic	Discussion
1	Introductions & Agenda Review - Chair	Status/Discussion:	IHE IP Management Process Action(s):
2	Discussion Summary - Chair	Status/Discussion:	- Decisions/Issues: Action(s):
3	Agenda Items -	Status/Discussion:	IHE International Board - Update & Feedback (Todd) Good handle on the programs. Unsure is to know how IHE supports member organizations. Membership – about 180, steady and growing a bit. The paid membership seems to be working. Funding – Down a bit. Affects document staff. Global ehealth Consortium – Started in January, expected announcement at HIMSS. Goal is to clarify interoperability. Still very early in the process. Real world impact; For us, pretty clear, outside of IHE, still needs fleshing out. Covid-19 – Have a page and press release stating what we’ve been doing. Global support – WHO deployment, World summit, deployment committees Testing and Tools – Connectathon, Connectathon seal, certification. Also looks at tools, especially looking at virtualizing Connectathons and consistent testing. - Question – See these announcements, but customers may not see value. It takes many years, and they don’t see the long view. How do we keep them interested? Trying to get the message out to those that decide to implement or purchase systems. - Membership Value/Challenges – Transitioned from Steve Moore for CN support to IHE Europe. How to effectively manage virtualization. - Is the message getting out well enough? Generally, so far. Is the Product Registry valuable? Somewhat, but not hugely. Good to point to for reference, But it’s not comprehensive and accurate. Our Commercially Available list is more useful. The Connectathon Results page helps. Don’t know how to increase viability of the Registry. Extensive discussion of how to make it more useful. Where do customers come up with requirements? Unsure. Definite uptick in IHE requirements by customers. (left 8:50 for IDCO help) - (back 9:07) Tiger Team - Reviewed Domain Page, discussed framework and internal operations. Other big pieces for our ‘top 10’ list. Review 2019 Milestones - [2] Ken – Seems compressed. Discussed timelines, resolved concerns. Five year plan No current plan - 2017 Roadmap - and 2011 Plan Notes Architecture – Revamp Vol 1 to reflect new structure of Devices. DEC – Tested PCD-05 at 2020 CN. Add FHIR option (Todd). ACM – add PCD-07 (Tom K). Is PCD-06 affected at all? Anyone remember the ePHI ? Smart Alarms – Leave for now, but is likely will be absorbed into Quiet Hospital. Device Context Management – PCIM will be addressed in Dpi Point of Care – Should this move into DPi? Likely, will need to triage. Quality – Will be a proposal coming soon from DPi White Paper this cycle. SESMDI – Safe, Effective and Secure Medical Device Interoperability. IEC 60601 Cochair Action item - 106 - Activities Promoting PCD. Close, refer to Tiger Team and start as a DEV Action Item. Location, Dates of the DEV PCD 2020 Fall F2F Unlikely to get to a hospital by the next meeting. Hotels may be desperate for our business. Dates – Oct 6, Sept 29, Sept 16 HIMSS event Sept 16-19 in San Francisco. Could set up close to a provider at a hotel. September may be challenging for international members. Bring up with Tiger Team. We have enough to start. Adjourn Joint PC&TC meeting. Joint PC&TC Meeting Adjourned Decisions/Issues:

Friday TC Meeting Summary

Action(s):

Item	Topic	Discussion
1	Introductions & Agenda Review - Chair	Status/Discussion:	Decisions/Issues: Agenda approved IHE IP Management Process Announcements – - Decision Making meeting (TC Co-Chairs) Action(s):
2	Discussion Summary - Chair	Status/Discussion:	- Decisions/Issues: Action(s):
3	Agenda Items -	Status/Discussion:	> TC Meeting Wrap up and Adjournment (Kowalczyk) TC Meeting Adjourned Decisions/Issues:

Action Items - PC

The Action Items that follow and approved in subsequent committee meetings will be added to the committee Action Item page.

Action Items - TC and WGs

The Action Items that follow and approved in subsequent committee meetings will be added to the committee Action Item page.

Next Meetings

Technical Committee: PCD TC 2020-05-06 Webex

Planning Committee: PCD PC 2020-05-13 Webex

Joint Planning and Technical Committee: PCD PC&TC 2020-05-29 Webex