Location: Call (+1 770-657-9270, Participant Code: 7485962) / Date: 20131119
Time: 10:00 – 11:00 am/pm Eastern Time
Facilitator / Ed Helton / Don Jaccard / Note taker(s) / Don Jaccard
Attendee / Name / Affiliation
X / Ed Helton / NCI
X / Don Jaccard / FDA
X / Mark Gray / FDA
X / Marti Velezis / Sonrisa / FDA Contractor
X / Mead Walker / Mead Walker Consulting
X / Myron Finseth / Medtronic
X / Barry Brown / Mortara Instrument
X / Norman Gregory / FDA
X / Lise Stevens / FDA
X / Armando Oliva / FDA
X / Julie James / Blue Wave Informatics
X / Damien Francois / Beth Israel Medical Center
Quorum Requirements Met: Yes / No
Agenda Topics
1. Annotated ECG Reaffirmation
2. RPS Ballot Reconciliation Status
3. Publishing
4. IDMP Project Scope
5. Other Topics
Supporting Documents
· N/A
Minutes/Conclusions Reached:
1. Agenda agreed to without comment
2. Minutes from the last call were approved.
a. Mead Walker moved to approve the minutes as drafted. Norman Gregory seconded the motion.
i. Vote: Unanimous
3. Discussion on Agenda Topic 1: The group needed to formally vote on the Annotated ECG Reaffirmation to move to ballot in January.
a. Barry Brown moved to approve the reaffirmation ballot. Norman Gregory seconded the motion. There was no further discussion.
i. Vote: Unanimous
b. NB: After the meeting HL7 informed RCRIM the January ballot window had closed and therefore the aECG Reaffirmation will not appear in January. The item will appear in the May 2014 ballot cycle.
4. Discussion on Agenda Topic 2: Mark Grey reports the IG (informative) was approved by the RPS Workgroup on November 5.
a. The RPS (normative) is proving more difficult. Most of the ballot comments have been addressed and properly reconciled, but there are still several challenging comments. The primary hurdles revolve around Compound Documents, Group Submission, and Reviewable Units. The workgroup will continue working through these during scheduled meetings/calls. This item will not be resolved in time for the January 2014 ballot.
b. The group engaged in a lengthy discussion on the HL7 process related to the dependencies between normative standards and their associated informative IG’s. At what point is the IG updated as the standard evolves. Ed Helton took for action to seek HL7 guidance on the proper timing of related ballot materials.
c. RPS does not plan on meeting at the San Antonio WG Meeting (January 2014) and therefore does not require the Wednesday, Q1 session.
5. Discussion on Agenda Item 3: Myron Finseth led a discussion on ballot comment reconciliation. The issue revolves around process of adjudicating negative comments. When a person tenders a negative comment, should they be afforded the opportunity to formally review the amended language or should they accept at face value the respective workgroup adequately addressed the negative comment? What is the proper process for collaboratively gaining consensus on the negative comment so that the comment can be removed and the ballot moved forward?
a. Armando noted the issue being germane to his Study Participation normative ballot process.
b. Ed Helton, Myron Finseth, and Don Jaccard took an action item to clarify this process question with HL7.
6. Discussion on Agenda Item 4: IDMP – Project Scope: Lise Stevens updated the group on the IDMP with a significant change in direction from the recent ISO meeting. ISO will proceed to publish IDMP IG’s one at a time via Workgroup 6 with Substances being first out of the gate. ISO intends to manage this process under ISO cognizance then share with HL7. ISO does not currently consider IDMP a JIC arrangement.
a. Lise will withdraw the PSS request of HL7/RCRIM.
b. IDMP may have a nexus with CMET, but that is unclear at this point.
c. Julie made the point ISO does not do communication standards. Others expressed concerns that HL7 V3 Messaging may be appropriate responsible party.
d. Vada Perkins (FDA) will do the ISO project management work.
e. The group agreed to re-engage on this topic after the first of the year.
7. Discussion on Agenda Item 5:
a. Lynn Lasko (HL7) has requested RCRIM withdraw the CTRR based on a lack of activity. CTRR has been unable to maintain a sustainable sponsor and funding. CTRR can be re-initiated down the road if necessary/appropriate.
i. Julie James moved to support closure of CTRR. Mead Walker seconded the motion. There was no further discussion.
1. Vote: Unanimous
b. Ed Helton noted the Co-Chair term of Ed Tripp ends with the January WG meeting. Ed and the entire group expressed appreciation and respect for Ed T’s leadership and counsel during his tenure.
i. John Kiser of ABBVIE has expressed an interest in running for the open co-chair.
ii. Others who may be interested should contact HL7 to have their names entered into the nomination process.
Adjourned 11:00 AM EDT.
Actions· Ed Helton: Confirm proper Normative / IG routing process with HL7.
· Ed Helton, Myron Finseth, and Don Jaccard: Confirm proper process for adjudicating negative comments and removing the hold on the ballot.
Next Meeting / Preliminary Agenda Items
Tuesday, December 3, 2013, 10:00 – 11:00am EST
a. January Working Group Logistics
b. RPS IG Guidance – Ed/Don/Myron
c. SPL Negatives -- Myron /Ed/ Don
d. Meeting In San Antonio
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