February 19, 2016 UDI Project Meeting
Minutes - Universal Device Identifier Implementation Guidance Project Meeting, February 11, 2016
- Meeting Minutes - Approve February 4, 2016
- Meeting Discussion:
- Meeting Time
- Review Updated Use Case Matrix
- Action Items:
- PSS Status
- Doodle Results
- Next Meeting:
- Patrick Loyd
- Martha Velezis
- Ioana Singureanu
- Greg Staudenmaier
- John Rhoads
- MaryKay McDaniels
- Steve Rosenberg
- Nancy Orvis
- Is ballot Informative or Normative for this conceptual?
- Regarding NIB, will the document be UDI DSS R1 STU R1? Or UDI DSS R1 Informative?
Motion: The NIB for this document is for an Informative Ballot (UDI DAM) and the naming will be finalized after review amongst the co-chairs and project leads before Sunday (to be documented in these minutes). Marti/MaryKay - 7; 0; 0
Meeting Time - Poll wins at Tuesdays, 12-1pm EDT (Patrick action item for conf calls setup)
Participation - For this next week, announcements will include not only UDI listserv but ord, healthcaredevices, and pharmacy as we continue to seek enough participation. MaryKay will specifically copy a number of X12 members who are also HL7 members are informed of our meetings
PSS Status - Approved at SD, now at TSC
Doodle Results - See above meeting time
EHR SFM Analysis for Devices/UDI - There is a set of requirements in the EHRSFM. Patrick to publisch to listserv.
Use Case Review - Updated use case document attached to email distributing the link to these minutes.
- Confirm whether or not the PSS has been approved and submitted to the TSC for approval in time for this Ballot Cycle
- While submitted mid-December, it did not go out for SSD-SD vote until last Friday. Deadline for votes is Feb 8. Then it will go to TSC. It is also in FMG's queue for approval given potential FHIR involvement / impact.
- Final Call for Participation for UDI Implementation Guidance Project
- Done. firstname.lastname@example.org
- Please sign up.
- Confirm that the UDI Implementation Guidance Project will be developing 1) UDI DAM and 2) UDI Implementation Guide (to include harmonization across v2, v3, CDA and FHIR)
- Need to spin off a PSS for the C-CDA to address the individual UDI components (this will be a dependency for IG related work) - Request Paul K. update us on this item
- Not done yet.
- Identify and Reference all previously related content on this topic (as a resource), for example materials from the UDI Implementation Guidance Project
- Available through the PSS.
Are we prioritizing based on regulations?
March 22, deadline for publishing in May ballot
Need to follow-up on submission of Harmonization proposal Need to send out updated use case list
Hans - please take an action item to review the current in-scope use cases are appropriate for the Universal Realm
- Friday, February 19, 2016, 11:00AM ET - 12:00PM ET
- Phone: +1 770-657-9270, Passcode: 398652
- WebEx: https://fda.webex.com/fda/j.php?MTID=md9a88ae42bd560327a990e56e1b44f21