BRIDG WG meeting – Q1 through Q4 Continuous Minutes Wednesday 7 May 2014

Attendees:

NAME AFFILIATION

Mary Ann Slack CDER FDA

Rebecca Kush CDISC

Bob Milius NMDP

John Kiser ABBVIE

AMS HL7 Facilitator

Jean DuTeau HL7 Facilitator

Mead Walker HL7 Facilitator

Leslie Tompkins CDRH FDA

Edward Helton NIH/NCI

Bron Kisler CDISC

Boris Brodsky CDER FDA

Myron Finseth Medtronic

Earlier guidance (prior to this meeting) was that we would need 4 co-chairs. Confirmed 2 co-chairs is sufficient.

·  The group discussed that 2 additional co-chairs representing other stakeholder groups may be beneficial in future.

Ed provided some history on BRIDG & BRIDG oversight. He described the re-instituted BRIDG Advisory Panel, supported by NCI. The Panel subsequently developed a charter and prioritized list of community needs.

BRIDG scope currently encompasses biomedical research and all of life sciences.

The WG must determine the relationship and intersection of activities with BRIDG AP and SCC. We need:

·  Priority-setting governance body (BRIDG AP)

o  sets scope & policy; seeks input from BRIDG WG and SCC, others

·  Body to perform the modeling & harmonization (SCC)

·  Body to establish and maintain BRIDG as an authoritative document (BRIDG WG)

o  receives change requests, interfaces with BRIDG AP on scope changes, finds/facilitates the modeling & harmonization of changes, shepherds BRIDG thru ballots with stakeholder SDOs; addresses (or triages) questions and makes recommendations to AP as necessary; defines criteria for determining what should be balloted and vets changes prior to approving for ballot

·  Body to ensure currency and viability of BRIDG (BRIDG WG); communicate & advocate for harmonization with BRIDG across other WGs and beyond

Risks & constraints:

·  BRIDG AP must be active

·  SCC must be able (or supplemented to be able) to support requests; funding and capacity are historic issues due to over-demand - demand needs to be regulated by BRIDG WG to stay within capacity

·  SCC needs to grow from 1 person to a committee

o  a possibility (to be considered further) would be to make the SCC a subgroup of this one? Potential issues with modeling consistency/integrity? Requires further discussion whether this is a realistic idea.

WG Actions/decisions –

Establish operating processes

  1. Location of artifacts
  2. Model & all releases - bridgmodel.org
  3. Meeting minutes, agendas, project proposals, etc – HL7 wiki

Action – (1) modify product brief (AMS) and (2) project insight on HL7 website (Ed/MA, then review with WG) to reference appropriate model location and appropriate WG and artifacts location, (3) provide information on both websites about the availability of BRIDG and ability to participate in ballots(Mitra to write intro)

2.  Publishing facilitator – Myron Finseth - confirmed

3.  Vocabulary facilitator – Julie James

4.  Modeling facilitator – Hugh Glover

Action – confirm all facilitators above (Ed)

Decision making practices and meeting protocol – developed from RCRIM DMP and approved by WG

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4. 

  1. Anticipated stakeholder WGs – ArB & M&M, RCRIM, CIC, Pt Care, O&O (specimen), CG (4.0), EHR, EC
  2. Joint mtgs with CIC, Pt Care, O&O, CG, EHR, EC

Action – include joint discussions in September agenda (done)

Establish baseline BRIDG

  1. What version of BRIDG to ballot?
  2. NCI needs version with LSDAM; v4.0 is not currently an official release
  3. V3.2 is ready, doesn’t satisfy NCI needs but provides likely early success for WG if this version is balloted
  4. Potential issues – differences in modeling, disconnects with RIM, not enough time to socialize it with other WGs

Decision – (a) ballot 4.0 in January; if in September it is clear that this isn’t possible, adjust and ballot 4.0 in January with Sept ballot comments, and (b) do “ballot for comment only” of 3.2 in Sept, both SDOs. (c) Socialize ballot for comment to make sure it gets attention.

Current 3.2 package for ISO is ready and suffices for HL7 & CDISC

Action – develop roadmap (BRIDG WG/Ed & MA) to convey planned activities and ballots; roadmap to convey balloting of 4.0 in Jan, 3.2 for comments only in Sept

Action – develop one project scope statement (BRIDG WG/Ed & MA) for both and get it approved

  1. Ballot approach –
  2. Still to determine – what kind of ballot to do for 4.0? Informative, normative, or DSTU to normative? (Jean will speak to ArB Thursday for their input)
  3. Ballot in CDISC & HL7
  4. simultaneous but separate ballots
  5. all comments aggregated & dispositioned in this WG