DEV Domain F2F Sep 2025 FDA: Difference between revisions
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'''Agenda Dates''': Sept 9-11, 2025 | '''Agenda Dates''': Sept 9-11, 2025 | ||
== ''' | == '''Final Agenda ''' == | ||
== Meeting Objectives == | == Meeting Objectives == | ||
| Line 21: | Line 20: | ||
: '''Meeting Location''': | : '''Meeting Location''': | ||
:FDA Headquarters Address: | :FDA Headquarters Address: [https://sagroups.ieee.org/11073/venue/fda-white-oak-campus-silver-spring-md-usa/ FDA White Oak Campus] | ||
::Special access information: | ::10903 New Hampshire Avenue, Silver Spring, MD 20993 | ||
::Special access information: All foreign visitors without a green card must provide information to Isabel Tejero and Kostas Makrodimitris to submit 10 days prior to the meeting, the information is linked to the IEEE agenda. [https://www.fda.gov/about-fda/visitor-information Visitor Information] | |||
:: | :: | ||
::Directions to FDA | ::Directions to FDA -[https://www.google.com/maps/place/Building+1,+10903+New+Hampshire+Ave,+Silver+Spring,+MD+20903/@39.035399,-76.9856606,802m/data=!3m2!1e3!4b1!4m6!3m5!1s0x89b7c5a314822b7b:0xecc525c0d92b818d!8m2!3d39.035399!4d-76.9830857!16s%2Fg%2F1q62bkxb_?hl=en&entry=ttu&g_ep=EgoyMDI1MDYyMy4yIKXMDSoASAFQAw%3D%3D Google map] | ||
::: | ::: | ||
::[https://www.google.com/maps/dir/Residence+Inn+Silver+Spring,+Plum+Orchard+Drive,+Silver+Spring,+MD,+USA/39.0384822,-76.9858131/@39.039855,-76.9960243,1565m/data=!3m1!1e3!4m14!4m13!1m10!1m1!1s0x89b7c4e543e3fbc5:0x56102590e8c14e14!2m2!1d-76.9536307!2d39.0517184!3m4!1m2!1d-76.9898614!2d39.0378835!3s0x89b7c598e3fa73af:0xb41de13b03281292!1m0!3e0!5m1!1e2?entry=ttu&g_ep=EgoyMDI1MDgyNC4wIKXMDSoASAFQAw%3D%3D the route to the visitor's parking from hotel] | |||
::Plan about 30 min to get to FDA from hotel , visitor parking is near security building, about a 5 min walk from there to building 1. | |||
::Need to be at building 1 security by 7:45 to allow time to get to meeting rooms. | |||
::: | ::: | ||
: | : | ||
: '''Suggested Hotels''' | : '''Suggested Hotels''' | ||
::Hotel information for the Joint PoCD/PHD Meeting that will be in held at FDA Headquarters in | ::Hotel information for the Joint PoCD/PHD Meeting that will be in held at FDA Headquarters in | ||
::*Hotel Name: | ::*Hotel Name: Residence Inn Silver Spring | ||
::*Hotel Website: | ::*Hotel Website: https://www.marriott.com/en-us/hotels/waslv-residence-inn-silver-spring/overview/ | ||
::*Hotel Address: | ::*Hotel Address: 12000 Plum Orchard Drive, Silver Spring, Maryland, USA, 20904 | ||
::*Room Rate: | ::*Room Rate: | ||
:: | :: | ||
| Line 42: | Line 45: | ||
: '''Meeting Dates''' | : '''Meeting Dates''' | ||
::* Tuesday, Sept 9: IHE Session 1: Point-of-Care Identity Management - IHE Session 2: Pump Meeting | ::* Tuesday, Sept 9: IHE Session 1: Point-of-Care Identity Management - IHE Session 2: Pump Meeting (FDA Building 2 – Room 2053) | ||
::* Tuesday, Sept 9: PHD Session 1: | ::* Tuesday, Sept 9: PHD Session 1: | ||
::* Tuesday, Sept 9: POCD Session 1: | ::* Tuesday, Sept 9: POCD Session 1: | ||
::* Wednesday, Sept 10 : IHE Session 1: PCD Planning Committee & PCD Technical Committee IHE Session 2: Joint DEV Domain meeting (PCD+DPi+PCH) | ::* Wednesday, Sept 10 : IHE Session 1: PCD Planning Committee & PCD Technical Committee IHE Session 2: Joint DEV Domain meeting (PCD+DPi+PCH) (FDA Building 2 – Room 2053) | ||
::* Wednesday, Sept 10 : PHD Session 1: | ::* Wednesday, Sept 10 : PHD Session 1: | ||
::* Wednesday, Sept 10 : POCD Session 1: | ::* Wednesday, Sept 10 : POCD Session 1: | ||
::* Thursday, Sept 11 : Plenary | ::* Thursday, Sept 11 : Plenary (FDA Room 2047 -Auditorium) | ||
:: The schedule is proposed; actual meeting times may change during the week. | :: The schedule is proposed; actual meeting times may change during the week. | ||
| Line 61: | Line 64: | ||
Please submit suggestions for agenda topics here or through emails to the committee co-chairs. | Please submit suggestions for agenda topics here or through emails to the committee co-chairs. | ||
== Teams Information == | == Teams Meeting Information == | ||
Topic: IHE DEV Domain Sept 2025 F2F - '''Tuesday, Sept 9''' | Topic: IHE DEV Domain Sept 2025 F2F - '''Tuesday, Sept 9''' | ||
:All times are in US Eastern Time | :All times are in US Eastern Time | ||
: 8:00am – | : 8:00am – 12:00am: PCIM Workgroup | ||
: | : 1:30pm – 5:00pm: Pump Workgroup | ||
:[https://teams.microsoft.com/l/meetup-join/19% | :[https://teams.microsoft.com/l/meetup-join/19%3ameeting_ODZhYzlkNjYtZDgzZi00OGE4LWI3ZDktMTE3MzZmZmUyODhi%40thread.v2/0?context=%7b%22Tid%22%3a%227d2fdb41-339c-4257-87f2-a665730b31fc%22%2c%22Oid%22%3a%22c093ba8a-f397-41dc-a795-54e1fcb11f90%22%7d Join Teams meeting] | ||
:Meeting ID: | :Meeting ID: 292 339 385 743 8 | ||
:Passcode: | :Passcode: qF2VQ6DW | ||
Topic: IHE DEV Domain Sept 2025 F2F - '''Wednesday, Sept 10''' | Topic: IHE DEV Domain Sept 2025 F2F - '''Wednesday, Sept 10''' | ||
:All times are in US Eastern Time | :All times are in US Eastern Time | ||
:8:00am – 12:00pm: PCD Technical & Planning Committees | :8:00am – 12:00pm: PCD/DEV Technical & Planning Committees | ||
: | :[https://teams.microsoft.com/l/meetup-join/19%3ameeting_ODZhYzlkNjYtZDgzZi00OGE4LWI3ZDktMTE3MzZmZmUyODhi%40thread.v2/0?context=%7b%22Tid%22%3a%227d2fdb41-339c-4257-87f2-a665730b31fc%22%2c%22Oid%22%3a%22c093ba8a-f397-41dc-a795-54e1fcb11f90%22%7d Join Teams meeting] | ||
:Meeting ID: 292 339 385 743 8 | |||
:Passcode: qF2VQ6DW | |||
:[https:// | :1:30pm – 5:00pm: IHE Devices/IEEE Joint Meeting | ||
:[https://sagroups.ieee.org/11073/meeting/annual-joint-ieee11073-phd-and-pocd-with-ihe-devices-in-person-meeting-fdawhiteoaksilverspringusa/ IEEE agenda and meeting links] | |||
Topic: IEEE | Topic: IEEE/IHE Plenary Sept 2025 F2F - '''Thursday, Sept 11''' | ||
:[https:// | :[https://sagroups.ieee.org/11073/meeting/annual-joint-ieee11073-phd-and-pocd-with-ihe-devices-in-person-meeting-fdawhiteoaksilverspringusa/ IEEE agenda and meeting links] | ||
== Attachments / Materials == | == Attachments / Materials == | ||
| Line 100: | Line 104: | ||
:PCD Work Program Co-Chairs: | :PCD Work Program Co-Chairs: | ||
::* DEV Planning Committee Co-Chair: [mailto:kurt.elliason@icumed.com| Kurt Elliason (ICU Medical)], [Rob Wilder (Spok)] | ::* DEV Planning Committee Co-Chair: [mailto:kurt.elliason@icumed.com| Kurt Elliason (ICU Medical)], [Rob Wilder (Spok)] | ||
::* DEV Technical Committee Co-chair [Tom Kowalczyk, (BBraun Medical | ::* DEV Technical Committee Co-chair [Tom Kowalczyk, (BBraun Medical)] | ||
:PCH Work Program Co-Chairs: | :PCH Work Program Co-Chairs: | ||
| Line 121: | Line 125: | ||
:::Onsite: | :::Onsite: | ||
::: | ::::Al Engelbert (B. Braun Medical), Amy Rowe (B. Braun Medical), Brendan Burke (B. Braun Medical Inc.), David Eguren (FDA), Eldon Metz (InnoVision Medical Technologies), Kurt Elliason (ICU Medical), Tom Kowalczyk (B. Braun Medical) | ||
:::Remote: | |||
::::Brian Witkowski (Baxter), Debaditya Ghosh(GE Healthcare), Jeff Gaetano (BD), Jacob Braschler(Epic), Michael Workman (BD), Monroe Pattillo (Practical Health Interoperability LLC), Tim Chant (Connexall) | |||
:'''PCD Pump WG ''' | :'''PCD Pump WG ''' | ||
| Line 129: | Line 136: | ||
:'''Participants:''' | :'''Participants:''' | ||
:::Onsite: | :::Onsite: | ||
::: | ::::Al Engelbert (B. Braun Medical), Amy Rowe (B. Braun Medical), Brendan Burke (B. Braun Medical Inc.), David Eguren (FDA), Eldon Metz (InnoVision Medical Technologies), Paul Schluter (Paul Schluter Consulting), Tom Kowalczyk (B. Braun Medical), | ||
:::Remote: | |||
::::Brian Sullivan (BD), Brian Witkowski (Baxter), Debaditya Ghosh(GE Healthcare), Jeff Gaetano (BD), Michael Workman (BD), Tim Chant (Connexall), Shawntanu (BD) | |||
| Line 141: | Line 150: | ||
:'''Participants:''' | :'''Participants:''' | ||
:::Onsite: | :::Onsite: | ||
::: | ::::Al Engelbert (B. Braun Medical), Amy Rowe (B. Braun Medical), Brendan Burke (B. Braun Medical Inc.), David Eguren (FDA), Eldon Metz (InnoVision Medical Technologies), Javier Espina (Philips), Ken Fuchs (Red*Fox Consulting), Michael Faughn (NIST), Todd AFC! Cooper (OR.NET), Tom Kowalczyk (B. Braun Medical), | ||
:::Remote: | |||
::::Brian Witkowski (Baxter), Jeff Gaetano (BD), Michael Workman (BD), Monroe Pattillo (Practical Health Interoperability LLC), Rob Wilder (Spok), Tim Chant (Connexall) | |||
== Meeting notes == | == Meeting notes == | ||
| Line 160: | Line 170: | ||
|- | |- | ||
| align="center" | '''Tuesday Pt. 1''' | | align="center" | '''Tuesday Pt. 1''' | ||
| align="center" | 08:00 - | | align="center" | 08:00 - 10:00 | ||
| align="center" | PCIMWG Meeting | | align="center" | PCIMWG Meeting | ||
| | | | ||
| Line 197: | Line 207: | ||
::* [[Patent_Disclosure_Process | IHE IP Management Process]] - Kurt | ::* [[Patent_Disclosure_Process | IHE IP Management Process]] - Kurt | ||
:: | :: | ||
::* pcd-15 containment for pumps - 30 min | |||
::* pcd-03 error codes - 30 min | |||
::* pcd-03 for PCA pumps - 30 min | |||
:::[https://docs.google.com/document/d/1i3tv1NlBnkEAwW7tZxsIWdE-aolCvEPF/edit?usp=sharing&ouid=108127959796856836161&rtpof=true&sd=true Multiple delivery types, multiple RXG examples] | |||
::* Break - 15 min | |||
::* Review TF vol2 Table M.1.2.1-4 Clinical Scenarios - 30 min | |||
::: switching from a library based infusion to non library pg. 262 | |||
::* Review comments in [https://docs.google.com/document/d/1kbFbmYOjYphtXxW6MySFcfTviy2qwYNS/edit?usp=sharing&ouid=108127959796856836161&rtpof=true&sd=true Standardized Identification Whitepaper] - 30 min | |||
::* - 30 min | |||
|- | |||
| align="center" | '''Tuesday Pt. 4''' | |||
| align="center" | 5:00 PM - 5:30 PM | |||
| align="center" | Group Dinner | |||
| | |||
|- | |- | ||
|- | |- | ||
| Line 204: | Line 229: | ||
|} | |} | ||
=== Tuesday Sept 9, 2024 (IEEE 11073 PHD WG | === Tuesday Sept 9, 2024 (IEEE 11073 PHD and POCD WG Sessions) === | ||
https://sagroups.ieee.org/11073/meeting/joint- | https://sagroups.ieee.org/11073/meeting/annual-joint-ieee11073-phd-and-pocd-with-ihe-devices-in-person-meeting-fdawhiteoaksilverspringusa/ | ||
:The draft minutes of the Sep 9, 2025 meeting are at https://ieee-sa.imeetcentral.com/p/aQAAAAAFL6L-. | |||
:Presented materials on that day are stored at https://ieee-sa.imeetcentral.com/p/ZgAAAAABJ4tK and linked from the minutes. | |||
https:// | |||
=== Wednesday Sept 10, 2024 (IHE PCD Work Program committee and DEV Domain Committee) === | === Wednesday Sept 10, 2024 (IHE PCD Work Program committee and DEV Domain Committee) === | ||
| Line 229: | Line 253: | ||
::: - Introductions and Agenda Review (Kurt) | ::: - Introductions and Agenda Review (Kurt) | ||
::: - Welcome | ::: - Welcome | ||
::::If you are interested in receiving Domain updates, Ballot invitations and meeting notices etc. for the Devices Domain please click this link to join the [https://groups.google.com/g/devpc-tc DevPC-TC] Google group. | |||
:* 8:05 IHE International Board - DEV Town Hall (Kurt/Ken) | :* 8:05 IHE International Board - DEV Town Hall (Kurt/Ken) | ||
: | ::'' - All IHE meetings have switched over to use IHE Google Meet account instead of HIMSS Teams account. | ||
:: | ::'' - Elections | ||
:: | :::''Treasurer | ||
:: | :::''Board Co-chair B | ||
:* | :::''General Membership voting in process for (though Sept 15) | ||
:: Oct. 5-9 | ::::''Board Member At-large C&D | ||
::::''Emeritus Domain Co-chair B | |||
::::''MarComm Chair | |||
::'' - Acknowledgment of the IHE "Project Z" | |||
:::''V 1.0 was approved through offline voting | |||
:::''working on formal name and public launch | |||
:::''Pilot project in EU'' | |||
:* 8:15 [https://www.iheusa.org/ihe-north-america-connectathon-week-2025 NA Connectathon 2026 ''link to be updated] | |||
:: IHE-NA Early Oct. (5-9?) | |||
:: Location: TBD | :: Location: TBD | ||
:::[https://docs.google.com/spreadsheets/d/1UYaXPOt1iVKjYUcxZn72lycNZr5Yw_PthKXRhS7F6Ws/edit?gid=761685478#gid=761685478 Planned profiles to test] | :::''[https://docs.google.com/spreadsheets/d/1UYaXPOt1iVKjYUcxZn72lycNZr5Yw_PthKXRhS7F6Ws/edit?gid=761685478#gid=761685478 Planned profiles to test] | ||
::'' IHE-EU: March 23 - 26, 2026, Brussels Belgium | |||
:: | :: | ||
:* | :* HIMSS'26 Showcase | ||
:: March 9-12 | :: March 9-12 | ||
:: Location: Las Vegas | :: Location: Las Vegas | ||
:: | :: | ||
:* | :* 8:25 Marketing/Recruitment of DEV Globally | ||
::The IHE Marketing and Communications Committee has been working to revamp the IHE Newsletter; one area of focus has been to highlight important milestones within IHE Domains. | ::The IHE Marketing and Communications Committee has been working to revamp the IHE Newsletter; one area of focus has been to highlight important milestones within IHE Domains. | ||
:- IHE Newsletter [https://ihe.us1.list-manage.com/subscribe?u=a75e449ea24da34a9a89ed37a&id=fd5b4c628e Signup] | :: - IHE Newsletter [https://ihe.us1.list-manage.com/subscribe?u=a75e449ea24da34a9a89ed37a&id=fd5b4c628e Signup] | ||
:: - [https://infocentral.infoway-inforoute.ca/en/news-events/event-calendar/icalrepeat.detail/2025/09/18/36512/167/ihe-canada-webinar-tbd IHE Canada Webinar: Sept 18,2025] | |||
:: | :: | ||
:* | :* 8:30 Program Summary Reports (15 minutes each) | ||
::: | ::* DPI (8:35) | ||
::* PCD (8:40) [https://drive.google.com/file/d/1njs7Cgl4V_Edbk3cwG75_b3Dh0m-v9vT/view?usp=sharing PCD-update] | |||
: | ::* PCH (8:45) | ||
:: | :* 9:00 IHE DEV OID extensions | ||
:: | ::'' https://wiki.ihe.net/index.php/PCD_OID_Management | ||
::'' SDPi-specific discussion that Todd just mentioned, listing the missing "OID categories": https://github.com/IHE/DEV.SDPi/issues/449 | |||
::''Add OIDs · Issue #449 · IHE/DEV.SDPi | |||
:: | :: | ||
:* 9: | :* 9:30 [[Complete DEV Domain Action Items]] | ||
:* 9:40 GitHub/AsciiDoc publishing update | |||
::''Considerations | |||
:::'' Start with all three volumes or just Vol2 or the smaller v1 and 3? | |||
:::''Use one repo for TF, IHE\DEV? | |||
:::''Separate Repo for tools\code | |||
:::''extensions in Java, Javascript, Ruby? | |||
:::''Tools: IntelliJ, VS Code, other | |||
:::''Consider shared CSS for consistency across DEV publications | |||
:* Adjourn Joint DEV Meeting Archive 2025 | :* Adjourn Joint DEV Meeting Archive 2025 | ||
|- | |- | ||
| align="center" | '''Wednesday Pt. 2''' | | align="center" | '''Wednesday Pt. 2''' | ||
| align="center" | 10: | | align="center" | 10:30 - 12:00 | ||
| PCD Program Planning and Technical Committee (PC&TC) | | PCD Program Planning and Technical Committee (PC&TC) | ||
| | | | ||
| Line 268: | Line 313: | ||
:* '''General PCD Work Program Review''' (statuses, plans, and technical discussion): | :* '''General PCD Work Program Review''' (statuses, plans, and technical discussion): | ||
::- ACM (Rob W) | ::- ACM (Rob W) [https://drive.google.com/file/d/1aHRnt4amb1uERpUFYUPgrCQizSxnxr_C/view?usp=sharing ACM+MEM] | ||
::: | ::- PCMC (Point of Care Monitored Communication) | ||
::: New profile proposal (Peter K) | |||
::- MEM DMC (Monroe P) | ::- MEM DMC (Monroe P) | ||
::- MEM LS (Monroe P) | ::- MEM LS (Monroe P) | ||
::- Pump (Kurt) [https://docs.google.com/presentation/d/ | ::- Pump (Kurt) [https://docs.google.com/presentation/d/1DbYiZa8ff2K-XRczzRYG3hHum9nC_wwr/edit?usp=drive_link&ouid=108127959796856836161&rtpof=true&sd=true (Pump WG update presentation)] | ||
:::- IPEC (Kurt) | :::- IPEC (Kurt) | ||
:::- PIV (Kurt) | :::- PIV (Kurt) | ||
::- PCIM (Eldon /Tom) [https://docs.google.com/presentation/d/ | ::- PCIM (Eldon /Tom) [https://docs.google.com/presentation/d/1DbYiZa8ff2K-XRczzRYG3hHum9nC_wwr/edit?usp=sharing&ouid=108127959796856836161&rtpof=true&sd=true (PCIM update presentation)] | ||
::- Physio monitor () | ::- Physio monitor () | ||
::: No updates, not active at this time | ::: No updates, not active at this time | ||
| Line 286: | Line 332: | ||
:::Co-chairs reviewing last update, plan to have a 2024 update complete for publication by end of the year. | :::Co-chairs reviewing last update, plan to have a 2024 update complete for publication by end of the year. | ||
: | : | ||
:* Standards Coordination -5min | :* Standards Coordination - 5min (Summary only, details to be covered in joint afternoon session) | ||
: *[https://docs.google.com/spreadsheets/d/1snjYMDmv5TKuBLzvWPNgG33o0mE16_zx/edit?usp=drive_link 2024 DEV Domain Roster] cleanup/update | |||
: | :::Please review the roster and update for your organization. List of member organizations is available [https://www.ihe.net/about_ihe/member_organizations/ here ] | ||
:: | |||
:* Proposed Location, Dates of the DEV Spring 2026 F2F | |||
:: HIMSS in March, HL7/IEEE meetings in May. Will plan a time in April. | |||
:: West coast option at ?, East coast possibly ? | |||
: | : | ||
:* PC&TC Meeting Wrap up and Adjournment (Kurt & Tom) | :* PC&TC Meeting Wrap up and Adjournment (Kurt & Tom) | ||
| Line 301: | Line 349: | ||
| | | | ||
|- | |- | ||
| align="center" | '''Wednesday | | align="center" | '''Wednesday afternoon''' | ||
| align="center" | 1:30 PM - | | align="center" | 1:30 PM - 5:00 PM | ||
| Joint | | Joint PoCD/PHD/IHE DEV meeting | ||
| | | | ||
:* | :*[https://sagroups.ieee.org/11073/meeting/annual-joint-ieee11073-phd-and-pocd-with-ihe-devices-in-person-meeting-fdawhiteoaksilverspringusa/ IHE/PoCD/PHD Agenda] | ||
|- | |- | ||
| | | | ||
| Line 317: | Line 360: | ||
|} | |} | ||
=== Wednesday Sept 10, 2025 (IEEE 11073 PHD WG | === Wednesday Sept 10, 2025 (IEEE 11073 PHD and POCD WG Sessions) === | ||
https://sagroups.ieee.org/11073/meeting/joint- | https://sagroups.ieee.org/11073/meeting/annual-joint-ieee11073-phd-and-pocd-with-ihe-devices-in-person-meeting-fdawhiteoaksilverspringusa/ | ||
=== Thursday Sept 11, 2025 (IEEE11073/IHE DEVICES JOINT WORKGROUP MEETING ON INTEROPERABILITY STANDARDS) === | === Thursday Sept 11, 2025 (IEEE11073/IHE DEVICES JOINT WORKGROUP MEETING ON INTEROPERABILITY STANDARDS) === | ||
https://sagroups.ieee.org/11073/meeting/annual-joint-ieee11073-phd-and-pocd-with-ihe-devices-in-person-meeting-fdawhiteoaksilverspringusa/ | |||
https://sagroups.ieee.org/11073/meeting/joint- | |||
:Goal: | :Goal: | ||
| Line 351: | Line 389: | ||
[[Category:DEV Meeting Archive 2025]] | [[Category:DEV Meeting Archive 2025]] | ||
[[Category:PCD Meeting Archive 2025]] | [[Category:PCD Meeting Archive 2025]] | ||
Latest revision as of 12:06, 14 January 2026
Meeting Week: Sept 8-12, 2025 Agenda Dates: Sept 9-11, 2025
Final Agenda
Meeting Objectives
- This is a special meeting held in parallel with the IEEE 11073 PoCD and PHD WGs.
- The final day (Thursday 9/11) will be a joint plenary with invited guests.
- These face-to-face meetings have a number of objectives depending on the programs and committees involved:
- DEV Domain level Discussions
- DEV PCD Program Discussion
- DEV PCH Program Discussion
- DEV DPi Program Discussion
- 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
- Meeting Location:
- FDA Headquarters Address: FDA White Oak Campus
- 10903 New Hampshire Avenue, Silver Spring, MD 20993
- Special access information: All foreign visitors without a green card must provide information to Isabel Tejero and Kostas Makrodimitris to submit 10 days prior to the meeting, the information is linked to the IEEE agenda. Visitor Information
- Directions to FDA -Google map
- the route to the visitor's parking from hotel
- Plan about 30 min to get to FDA from hotel , visitor parking is near security building, about a 5 min walk from there to building 1.
- Need to be at building 1 security by 7:45 to allow time to get to meeting rooms.
- Directions to FDA -Google map
- Suggested Hotels
- Hotel information for the Joint PoCD/PHD Meeting that will be in held at FDA Headquarters in
- Hotel Name: Residence Inn Silver Spring
- Hotel Website: https://www.marriott.com/en-us/hotels/waslv-residence-inn-silver-spring/overview/
- Hotel Address: 12000 Plum Orchard Drive, Silver Spring, Maryland, USA, 20904
- Room Rate:
- Hotel information for the Joint PoCD/PHD Meeting that will be in held at FDA Headquarters in
- Meeting Dates
- Tuesday, Sept 9: IHE Session 1: Point-of-Care Identity Management - IHE Session 2: Pump Meeting (FDA Building 2 – Room 2053)
- Tuesday, Sept 9: PHD Session 1:
- Tuesday, Sept 9: POCD Session 1:
- Wednesday, Sept 10 : IHE Session 1: PCD Planning Committee & PCD Technical Committee IHE Session 2: Joint DEV Domain meeting (PCD+DPi+PCH) (FDA Building 2 – Room 2053)
- Wednesday, Sept 10 : PHD Session 1:
- Wednesday, Sept 10 : POCD Session 1:
- Thursday, Sept 11 : Plenary (FDA Room 2047 -Auditorium)
- The schedule is proposed; actual meeting times may change during the week.
- Daily Schedule - All times Eastern Daylight Savings Time
- 08:00 - 12:00 Session #1
- 1:00 - 5:00 Session #2
Agenda Suggestions
Please submit suggestions for agenda topics here or through emails to the committee co-chairs.
Teams Meeting Information
Topic: IHE DEV Domain Sept 2025 F2F - Tuesday, Sept 9
- All times are in US Eastern Time
- 8:00am – 12:00am: PCIM Workgroup
- 1:30pm – 5:00pm: Pump Workgroup
- Join Teams meeting
- Meeting ID: 292 339 385 743 8
- Passcode: qF2VQ6DW
Topic: IHE DEV Domain Sept 2025 F2F - Wednesday, Sept 10
- All times are in US Eastern Time
- 8:00am – 12:00pm: PCD/DEV Technical & Planning Committees
- Join Teams meeting
- Meeting ID: 292 339 385 743 8
- Passcode: qF2VQ6DW
- 1:30pm – 5:00pm: IHE Devices/IEEE Joint Meeting
- IEEE agenda and meeting links
Topic: IEEE/IHE Plenary Sept 2025 F2F - Thursday, Sept 11
Attachments / Materials
Documents related to the meeting when available will be found at the [2025-09 DEV F2F Devices Google Drive] 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.
CoChairs
- PCD Work Program Co-Chairs:
- DEV Planning Committee Co-Chair: Kurt Elliason (ICU Medical), [Rob Wilder (Spok)]
- DEV Technical Committee Co-chair [Tom Kowalczyk, (BBraun Medical)]
- PCH Work Program Co-Chairs:
- DEV Planning Committee Co-Chair: [TBD]
- DEV Technical Committee Co-chair [Javier Espina (Philips)]
- Device Point-of-Care Interoperability Program Co-Chairs:
- DEV Planning Committee Co-Chair: Ken Fuchs
- DEV Technical Committee Co-chair David.Gregorczyk (OR.NET)
Participants
Tuesday, Sept 9
- PCD PCIM WG
- Chair: Eldon Metz
- Participants:
- Onsite:
- Al Engelbert (B. Braun Medical), Amy Rowe (B. Braun Medical), Brendan Burke (B. Braun Medical Inc.), David Eguren (FDA), Eldon Metz (InnoVision Medical Technologies), Kurt Elliason (ICU Medical), Tom Kowalczyk (B. Braun Medical)
- Remote:
- Brian Witkowski (Baxter), Debaditya Ghosh(GE Healthcare), Jeff Gaetano (BD), Jacob Braschler(Epic), Michael Workman (BD), Monroe Pattillo (Practical Health Interoperability LLC), Tim Chant (Connexall)
- Onsite:
- PCD Pump WG
- Chair: Kurt Elliason
- Participants:
- Onsite:
- Al Engelbert (B. Braun Medical), Amy Rowe (B. Braun Medical), Brendan Burke (B. Braun Medical Inc.), David Eguren (FDA), Eldon Metz (InnoVision Medical Technologies), Paul Schluter (Paul Schluter Consulting), Tom Kowalczyk (B. Braun Medical),
- Remote:
- Brian Sullivan (BD), Brian Witkowski (Baxter), Debaditya Ghosh(GE Healthcare), Jeff Gaetano (BD), Michael Workman (BD), Tim Chant (Connexall), Shawntanu (BD)
- Onsite:
Wednesday, Sept 10
- PCD/DEV Planning and Technical
- Chair: Kurt Elliason
- Participants:
- Onsite:
- Al Engelbert (B. Braun Medical), Amy Rowe (B. Braun Medical), Brendan Burke (B. Braun Medical Inc.), David Eguren (FDA), Eldon Metz (InnoVision Medical Technologies), Javier Espina (Philips), Ken Fuchs (Red*Fox Consulting), Michael Faughn (NIST), Todd AFC! Cooper (OR.NET), Tom Kowalczyk (B. Braun Medical),
- Remote:
- Brian Witkowski (Baxter), Jeff Gaetano (BD), Michael Workman (BD), Monroe Pattillo (Practical Health Interoperability LLC), Rob Wilder (Spok), Tim Chant (Connexall)
- Onsite:
Meeting notes
Tuesday, Sept 9, 2024 (IHE Pump & PCIM Workgroups)
Date Hours Committees Agenda Items Tuesday Pt. 1 08:00 - 10:00 PCIMWG Meeting - Introductions - Eldon/Tom
- Agenda review - Eldon/Tom
- IHE IP Management Process - Eldon/Tom
-
Tuesday Pt. 2 10:15 - 12:00 PCIMWG Meeting
Lunch 12:00 - 1:30 PM Tuesday Pt. 3 1:30 PM - 5:00 PM Pump WG Meeting - Introductions - Kurt
- Agenda review - Kurt
- IHE IP Management Process - Kurt
-
- pcd-15 containment for pumps - 30 min
- pcd-03 error codes - 30 min
- pcd-03 for PCA pumps - 30 min
- Break - 15 min
- Review TF vol2 Table M.1.2.1-4 Clinical Scenarios - 30 min
- switching from a library based infusion to non library pg. 262
- Review comments in Standardized Identification Whitepaper - 30 min
- - 30 min
Tuesday Pt. 4 5:00 PM - 5:30 PM Group Dinner
Tuesday Sept 9, 2024 (IEEE 11073 PHD and POCD WG Sessions)
- The draft minutes of the Sep 9, 2025 meeting are at https://ieee-sa.imeetcentral.com/p/aQAAAAAFL6L-.
- Presented materials on that day are stored at https://ieee-sa.imeetcentral.com/p/ZgAAAAABJ4tK and linked from the minutes.
Wednesday Sept 10, 2024 (IHE PCD Work Program committee and DEV Domain Committee)
Date Hours Committees Agenda Items
Wednesday Pt. 1 8:00 AM - 10:00 AM DEV Planning and Technical Committee - 8:00 > IHE IP Management Process (Kurt)
- - Introductions and Agenda Review (Kurt)
- - Welcome
- If you are interested in receiving Domain updates, Ballot invitations and meeting notices etc. for the Devices Domain please click this link to join the DevPC-TC Google group.
- 8:05 IHE International Board - DEV Town Hall (Kurt/Ken)
- - All IHE meetings have switched over to use IHE Google Meet account instead of HIMSS Teams account.
- - Elections
- Treasurer
- Board Co-chair B
- General Membership voting in process for (though Sept 15)
- Board Member At-large C&D
- Emeritus Domain Co-chair B
- MarComm Chair
- - Acknowledgment of the IHE "Project Z"
- V 1.0 was approved through offline voting
- working on formal name and public launch
- Pilot project in EU
- IHE-NA Early Oct. (5-9?)
- Location: TBD
- IHE-EU: March 23 - 26, 2026, Brussels Belgium
- HIMSS'26 Showcase
- March 9-12
- Location: Las Vegas
- 8:25 Marketing/Recruitment of DEV Globally
- The IHE Marketing and Communications Committee has been working to revamp the IHE Newsletter; one area of focus has been to highlight important milestones within IHE Domains.
- - IHE Newsletter Signup
- - IHE Canada Webinar: Sept 18,2025
- 8:30 Program Summary Reports (15 minutes each)
- DPI (8:35)
- PCD (8:40) PCD-update
- PCH (8:45)
- 9:00 IHE DEV OID extensions
- https://wiki.ihe.net/index.php/PCD_OID_Management
- SDPi-specific discussion that Todd just mentioned, listing the missing "OID categories": https://github.com/IHE/DEV.SDPi/issues/449
- Add OIDs · Issue #449 · IHE/DEV.SDPi
- 9:30 Complete DEV Domain Action Items
- 9:40 GitHub/AsciiDoc publishing update
- Considerations
- Start with all three volumes or just Vol2 or the smaller v1 and 3?
- Use one repo for TF, IHE\DEV?
- Separate Repo for tools\code
- extensions in Java, Javascript, Ruby?
- Tools: IntelliJ, VS Code, other
- Consider shared CSS for consistency across DEV publications
- Adjourn Joint DEV Meeting Archive 2025
Wednesday Pt. 2 10:30 - 12:00 PCD Program Planning and Technical Committee (PC&TC) - Introduction
- - IHE IP Management Process (5 minutes)(Kurt)
- - Review & Approve PCD Agenda (Kurt)
- General PCD Work Program Review (statuses, plans, and technical discussion):
- - ACM (Rob W) ACM+MEM
- - PCMC (Point of Care Monitored Communication)
- New profile proposal (Peter K)
- - MEM DMC (Monroe P)
- - MEM LS (Monroe P)
- - Pump (Kurt) (Pump WG update presentation)
- - IPEC (Kurt)
- - PIV (Kurt)
- - PCIM (Eldon /Tom) (PCIM update presentation)
- - Physio monitor ()
- No updates, not active at this time
- - DEC
- - DCM Pulse Oximetry
- No updates, currently waiting for someone to take it to FT.
- - WCM (Paul Schluter)
- - Vent (Paul Schluter)
- - General update PCD TF (Co-Chairs)
- Co-chairs reviewing last update, plan to have a 2024 update complete for publication by end of the year.
-
- Standards Coordination - 5min (Summary only, details to be covered in joint afternoon session)
- *2024 DEV Domain Roster cleanup/update
- Please review the roster and update for your organization. List of member organizations is available here
- Proposed Location, Dates of the DEV Spring 2026 F2F
- HIMSS in March, HL7/IEEE meetings in May. Will plan a time in April.
- West coast option at ?, East coast possibly ?
-
- PC&TC Meeting Wrap up and Adjournment (Kurt & Tom)
- PC&TC Action item review
Lunch 12:00 - 1:30 PM Wednesday afternoon 1:30 PM - 5:00 PM Joint PoCD/PHD/IHE DEV meeting
Wednesday Sept 10, 2025 (IEEE 11073 PHD and POCD WG Sessions)
Thursday Sept 11, 2025 (IEEE11073/IHE DEVICES JOINT WORKGROUP MEETING ON INTEROPERABILITY STANDARDS)
- Goal:
- Facilitate the standard development lifecycle of interoperability standards, profiles and use cases of the three Workgroups (IEEE11073/POCD/PHD and IHE/DEV).
- Coordinate interoperability standards, profiles and use cases, understand domains amongst workgroups and other in the interoperability space, collaborate on promotion of standards, optimize :standards for regulatory purposes, plan for conformity assessment, evaluate the adoption of standards and harmonize these standards globally.
Action Items - PC
The Action Items that follow and approved in subsequent committee meetings will be added to the committee Action Item page.
Next Meetings
Technical Committee:
Planning Committee:
- - Next DEV Joint Meeting DEV Joint 2025-09-24
- - Next PCD TC-PC Meeting PCD TC-PC 2025-10-08