/ HL7 RCRIM WG
FHIR AdverseEvent Resource
CALL MINUTES: Friday, February 10, 2017

Meet online at www.webex.com, meeting number: 196 412 889

Phone +1 770-657-9270, passcode 7485962

Attendees: ##

Present / Name / Email / Affiliation
Behnaz Minaei / / FDA
Brian Peck / / EPIC
Claude Nanjo /
Daniela Vanco / / FDA
David Pettie / Simon Fraser University
Ed Hammond PhD / / Duke
Edward Helton (NIH/NCI) / / NIH
X / Elaine Ayres (NIH/CC/OD) / / NIH
Gary Saner / Reed Technologies
Hojjat Salamasian / / New York Presbyterian
IonaThraen / / VA/Dept of Health Utah
James Swiger / FDA
Jaya Kaja, Ph.D. / IBM Watson Solutions
Jose Costa Teixeira /
Jose Galvez / NIH
Julie Evans / Samvit Solutions
Julie James / / Blue Wave Informatics
Karen Zimmer /
Konstadinos Kidos / / Baxalta
M’Lynda Owens / / Cognosante
Mary Ann Slack / / FDA
Mead Walker / / Mead Walker Consulting
Mitra Rocca / / FDA
Pooja Babbrah / / Point of Care Partners
X / Rashad Hasan / FDA
Raymond Kassekert / / GSK
X / Rik Smithies / / HL7 UK
Robert Moura
X / Sheila Connelly / OPTUM
Smita Hastak / NCI
Stella Stergiopoulos / / Tufts University
Suranjan De / / FDA
Susan Terrillion (AHRQ/CQuIPS) (CTR) / / AHRQ
Ta Jen Chen / Ta Jen / FDA
Thomas Felix / / AMGEN
Terrie Reed / FDA
Tony Schueth / / Point of Care Partners
Wayne Kubick / / CTO HL7
X / William Friggle / / Sanofi
William Gregory / / Pfizer
Finnie Flores
Joe Quinn / OPTUM

Project Wiki

http://wiki.hl7.org/index.php?title=FHIR_Adverse_Event_Resource

References

1)  Search the FDA Acronyms & Abbreviations Database: http://www.fda.gov/AboutFDA/FDAAcronymsAbbreviations/default.htm

2)  FHIR Conformance Rules: http://hl7.org/fhir/conformance-rules.html

a)  See 1.12.2 Cardinality

Agenda

1)  Updates from the San Antonio WG meeting

2)  Changes in the RCRIM WG structure

3)  Discuss the current FHIR AE resource build and next steps

a)  Process for monitoring comments related to a FHIR Resource

4)  Agenda for next meeting on February 24

1. 

Minutes

1.  At the San Antonio WG meeting the decision was made to merge the RCRIM and BRIDG Workgroups into what will be called the Biomedical Research and Regulations WG – BRR. Administrative actions through HL7 will create a new WG will one list-serv and document repository within the HL7 website and wiki.

2.  Elaine reviewed the slides presented on this project at the San Antonio Jan 2017 meeting. Those slides are here:

3.  During the San Antonio meeting, Rik Smithies created the inaugural build of the HL7 FHIR Adverse Event resource – it can be viewed here: http://build.fhir.org/adverseevent.html

4.  There was much discussion at the San Antonio WG meeting on how to represent a reaction. Discussed resolution of Reaction issue in the build. Options include building the entire reaction sequence in the resource similar to how this was done in the Allergy and Intolerance resource, creating a new reaction resource or referencing the Condition resource. Ultimately the decision was made to reference the condition resource for now and see how this meets the needs of those implementing the resource. The minutes of this quarter from the San Antonio WG meeting can be found here:

5.  G-FORGE FHIR Tracker is how comments posted about the FHIR AE resource as well as any future ballot comments will be tracked and resolved. Rules for G-FORGE FHIR are here: http://wiki.hl7.org/index.php?title=FHIR_gForge_Tracker . To date there are no comments or change requests docketed for the FHIR AE resource, however, this will be an activity that will be ongoing now that the resource is built. Here is the link for the G-FORGE site (also there is a link at the bottom of the HL7 homepage): http://gforge.hl7.org/gf/ A log-in and password is required to view content and post comments. The question was asked who will receive notifications when comments or change requests are posted related to the FHIR AE resource. Elaine will check with Lloyd McKenzie on how to establish these notifications.

  1. Note that many FHIR discussions also occur on Zulip – here is the link: https://chat.fhir.org/login/ This is a Google-based chat room so a gmail account is necessary.

6.  The group then discussed specifics of the actual build and questions that Rik had as he actually assembled the resource.

  1. Note the reference to Condition resource to represent a reaction
  2. The group discussed the causality data elements. Rik questioned if Causality should be a backbone item (e.g. a grouper) for all of the causality related items.
  3. The causality data items represent a process – however, is the need actually to represent the outcome, not the process? This point requires some examples to clarify how the various data elements would be represented and the purpose that they serve.

7.  The group then discussed the FHIR rule for workflow resources. The group felt that this particular event item did not meet the criteria and that an exemption be sought.

8.  There are many to-do’s for this new resource – specifically a review of the introductory prose and table 9.2.3.1 Terminology Bindings.

  1. Sheila Connelly will review the introductory prose and present at the next meeting.
  2. Elaine will review potential terminology bindings (MedDRA and SNOMED CT) and will contact

9.  Calls are now every other week to allow for time to do work on the resource between calls.

Agenda for February 24, 2017:

1.  Review minutes from February 10

2.  Review suggestions for FHIR AE prose – Sheila Connelly

3.  Review potential terminology bindings in MedDRA and SNOMED CT – Elaine Ayres and Rob Hausam

4.  Other issues

  1. Tracking issues in G-FORGE and Zulip

5.  Agenda items for Friday, March 10 at 10 AM ET.

HL7 FHIR AdverseEvent Resource, Call Minutes, Friday, February 10, 2017 Page 3