DEV Joint 2021-03-24 Webex

DEVices Domain

Meeting Purpose

Joint DEV Domain Meeting (PCD, PCH, DPi): At the Regularly Scheduled Meeting Time

WebEx Information

Topic: Joint DEV Domain Meeting

Regularly Scheduled Meeting Time

- Time: 11:00 am, Eastern Time (New York)

- Duration: 60 Minutes

Proposed Agenda

1. Agenda Approval

2. Review Discussion Summary: DEV Joint 2021-02-24 Webex

3. Standards Coordination

4. Ballots 

- Ballot 1 for DPi MDIRA Detailed Profile Proposal

5. Marketing DEV, IHE

6. Calendar http://wiki.ihe.net/index.php?title=Domain_Milestone_Dates

- Status of Adopted Work item Proposals DEV_Proposals: Cycle 16

7. DEV Action Item Review 

- Link to Action Items: https://wiki.ihe.net/index.php/DEV_Planning_Committee_Action_Items#Action_Items_001-009

- Link to DEV Google Drive: https://drive.google.com/drive/folders/1bASbQ802YbXVr--1kCiAGeyKCk6Om6Tv

8. Programs activities 

- PCD

- PCH

- DPi

9.  Other Business

- Virtual DEV F2F April DEV Domain F2F Apr 2021 Webex

10. Next and Recent Meetings 

- DEV Cochairs March 23rd, 2021, DEV Cochairs 2021-03-23 Webex

- DEV Domain (Joint) March 24th, 2021 DEV Joint 2021-03-24 Webex

Action Items from Previous Meetings

None currently

See DEV Planning Committee Action Items and DEV Technical Committee Action Items

Significant changes, other than dates, will be in bold.

References

• Published and Draft Versions of the TF, Supplements, Other Documents:

- The PCD ftp site has draft versions.

- Published (and possibly in the process of being replaced with new versions):

o http://ihe.net/Technical_Framework/index.cfm#pcd

• Not Yet Published:

o ftp://ftp.ihe.net/Patient_Care_Devices/Profiles/

Participants

Cochairs: Kurt Elliason, Thom Erickson, Javier Espina, Todd Cooper, Rob Wilder, Lisa Diggett

Ken chaired today's meeting.

Attendees: Monroe Pattillo, Brian Witkowski, Rob Wilder, John Rhoads, Martin Rosner, John Garguilo, Dan Kernan, Monroe Pattillo, Michael J. Kirwan, Rob Wilder, Thom Erickson, John Donnelly, Ken Fuchs, Javier Espina, Paul Schluter, Martin Rosner and Tom Kowalczyk.

Technical Project Manager: Michael J. Kirwan

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.

Item	Topic	Discussion
1	Introductions & Agenda Review - Chair	Status/Discussion: Decisions/Issues: Agenda approved Action(s):
2	Discussion Summary or Approval of Minutes - Chair	Status/Discussion: - Accepted Decisions/Issues: Action(s):
3	Agenda Items - Standards Coordination	Status/Discussion: :3. Standards Coordination - Ken noted two new IEEE 11073 PHD Cybersecurity standards which were approved by the IEEE in January are now going to ISO. He also noted that the 11073 POCD group has a vote going out on their SDC scope. Additionally, the P2933 group hosted a webinar with Kevin Fu who created Archimedes architecture group and is now acting director for Cybersecurity at the FDA. If you are an IEEE member you have access to his presentation here: https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/virtual-public-meeting-patient-generated-health-data-throughout-total-product-life-cycle-medical?utm_source=FDALinkedin :4. Ballots - MDIRA Detailed Proposal has passed (March 9th). Ken notes that the work at Johns Hopkins is awaiting funding. - PCD TC Cochair election ballot: Currently one candidate, Lisa Diggett, where most have approved (only a few abstains). Discussion on her background during the call. Michael will be talking with her this week and will report-out to the ballot group. :5. Marketing DEV, IHE - Rob noted that nothing has really started yet regarding the HIMSS Interoperability Showcase. Michael added that he is one of the PM's for the Vignettes and this won't start till mid-May timeframe. He will report out on this later. Also, the EU Connectathon planning also on-going. Thom noted that PCHAlliance is contributing to the EU Connectathon and building content on why people should care about DEV POU. - Ken noted that they've submitted and application for a Remote Connected Care and Mobile Health project for HIMSS. They've completed a TR which has been submitted to HIMSS and accepted. They are awaiting further word from HIMSS on this TR. It will be related to IHE's DEVices. :6. Calendar http://wiki.ihe.net/index.php?title=Domain_Milestone_Dates - Reviewed the calendar. Michael now attending the DCC calls so can report-out going forward on this. - We are now in Cycle 16, so after a Connectathon we rev the cycle, so now from 15 to 16. :7. DEV Action Item Review - Number 2 in-work. Numbers 6, 7 & 8 are open and due in April, ahead of F2F. - Regarding the Board Report, we may need to regroup on this going forward as a couple of Programs have submitted 2020 updates yet the Board Report hasn't been submitted. :8. Programs activities - PCD - Kurt noted that they are working on how pumps can go into slots and that the PCIM group has been resurected, now having good discussions their Monday calls. He's hopeful that they'll have something for 2022. - PCH - Thom presented slides on spec development, test tools and they're work at the Connectathon Acceleration Track. This was a great program. - Ballot for -10206 ACOM going into ballot this week. - Generic Health Sensor at the Bluetooth SIG is moving along. This will be modeled from -10206 ACOM over BLE. - Direct to Cloud Constrained moving along with another Chair so a slight delay. Working toward next draft by end of April. Taking another look at D2C binary model, as it may not be necessary. - Testing and tools: looking further at this but awaiting funding. - Javier questioned status on ACOM (-10206). He believes that the review would start at the end of April. Thom believes it may be earlier. - Dpi - SDPi Supplement. Not yet sure of timeframe for review but likely in a few months (after editorial). :9. Other Business - Our virtual F2F now set for the week of April 26th. There is a plenary on Friday AM. More to come as the Cochairs build out their vF2F agendas. - JohnG questioned Ken on their remote work (calls with the FDA on Tuesday at 4pm). Ken noted they're building the Technical Report and are making progress every week. Not sure when it will be ready but moving forward with good discussions and questions. John would like to review the document. Ken shared the doc link via chat. It's also on the google drive so can get access. - Michael noted that we'd like to have a farewell thing for Paul Sherman during the vF2F. He would like receive any pictures that anyone in the group has taken of Paul. He will send out an email on this shortly requesting help and ideas. Next Meetings The next meetings are: - DEV Joint vF2F Week of April 21 - 24th, 2021, https://wiki.ihe.net/index.php/DEV_Domain_F2F_Apr_21-24,_2020_Webex - DEV Cochairs May 25th, 2021 DEV Cochairs 2021-05-25 - DEV Joint May 26th, 2021 DEV Joint 2021-05-26 PCD Home