HL7 RCRIM / BRIDG Meeting Minutes
Location: Call (+1 770-657-9270, Participant Code: 7485962) / Date: 2016-11-29
Time: 10:00 – 11:00 am Eastern Time
Facilitator / Ed Helton, Vada Perkins, John Kiser / Note taker(s) / John Kiser, Boris Brodsky
Attendee / Name / Affiliation
X / John Kiser / AbbVie
Norman Gregory / FDA
X / Catherine Hosage Norman / Module 3 Solutions
X / Ulrike Wagner / NCI/FNLCR
X / Glen Marshall
X / Bill Gregory / Pfizer
X / Elaine Ayres / NIH
X / Jose Galvez / NIH
Myron Finseth / Medtronic
X / Lauren Becnel / CDISC
X / Mitra Rocca / FDA
X / Ed Helton / NCI
X / Vada Perkins / Indentifica
Mary Ann Slack / FDA
Smita Hastak / Samvit Solutions
Bill Friggle / Sanofi
Bron Kisler / CDISC
X / Wendy Ver Hoef / Samvit Solutions
Hugh Glover / Blue Wave / Parexel
Julie James / Blue Wave / Parexel
X / Swapna Bhatia / ESAC
Angelique Cortez
X / Boris Brodsky / FDA
X / Julie Evans / Samvit Solutions
X / Brent Marquard
Panagotis Telonis / EMA
X / Mead Walker / Mead inc
X / Jonathan Coleman
Becky Kush / CDISC
Lloyd McKenzie / Gevity
X / Nagesh Bashyam
X / Mike Glickman
J
Quorum Requirements Met: Yes

Agenda Topics

1.  Approve 15 and 22 Nov 2016 WG minutes

2.  DAF PSS and Study Participation FHIR Proposal resolution and vote

3.  BRIDG /RCRIM San Antonio Agenda

4.  Other business


Supporting Documents

Minutes/Conclusions Reached:

  1. Meeting Minutes:
  2. Motion for approval - Lauren Becnel, Mitra Rocca – 2nd, Abstain – 0, Negative – 0, Affirmative – 20: Approved.

2.  DAF PSS and Study Participation FHIR Proposal resolution and vote

a.  PSS presented and reviewed via WebEx

b.  Recapped the previous discussion, agreeing to support the wording with edits proposed by Brett, considering the two resources following the 80/20 rule

a.  Mead Walker and Mike Glickman discussion around PSS being “General and accurate” vs “Specific and wrong” as this is a procedural point to get the PSS in for the ballot cycle. Agreed we are time pressured by the balloting cycle, so “being general and accurate is better than being specific and wrong” Need a resolution now to meet the timeline

b.  Motion to approve PSS Jose Galvez – 1st, Lauren Becnel – 2nd – Abstain – 3 (Mead, Catherine, Norman), Negative - 0, Affirmative - 17 :Approved

3.  BRIDG / RCRIM San Antonio Agenda

a.  Joint meetings Monday Q3 thru Thursday Q4

b.  Rewrite - new charter and mission for combined groups (RCRIM and BRIDG).

c.  1 Qtr – combined with O&O - RCRIM Topics – SPLr8 (IDMP)

i.  SPL r7 can be used to implement food labeling

ii. Not intended as a regulatory standard, guidance only

iii.  Presently, no stakeholder available to implement at the moment, so writing implementation guide may be premature

iv.  Need to discuss a mechanism of communicating this WG recommendations to HL7

d.  4 Qtrs – Balloting HL7, CDISC and ISO – BRIDG 5.0

e.  1 Qtr – Elaine Ayres – FHIR AE Resource – 3rd Qtr Wednesday (Mitra in attendance)

f.  Tuesday morning meeting with CIC

g.  FHIR Management WG

Meeting closed at 10:51 EDT

Actions: Agenda Topics Deferred
1. 
Next Meeting:

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