2021 09 WGM Agenda

Unicom

Presentation on Unicom by Robert Stegwee:

Gap Analysis document:

Discussion about resolving some of the gaps that were identified by Unicom WP1.  Strong recommendation that Unicom must actively manage these issues and their resolution.  This is probably by raising a Jira ticket but in extreme cases may require a new HL7 Project.

Medication Definition

Melva ?? Methodological questions

Melva ?? Joint working - has BR&R updated their charter.  Has there been any joint working?  Discussion of extent to which it is monitored - Jean Duteau generally keeps track of the discussion.  BR&R has been swamped by ballot comments. John Hatem suggested a checklist like this: 

Action: BR&R go back to May minutes for actions and make sure they have been done, especially update to charter

Action: HG Produce a confluence page that lists all the issues that are of joint interest 

Canonical resources: Rik explained the issue and that BR&R are taking it to M&M

Agree to meet again next WGM

• FHIR IG based on FDA implementation of SPL
• 5 year FDA project, awarded to IBM
• Primarily for mapping between V3 SPL standard for select use cases and existing FHIR resources
  • Will use profiles and R4B in future work
• More complex mappings will be provided in a separate low-level technical mapping in the future

EBM on FHIR

Wed Q2

Codex

Presentation by Caroline Pottiger.  Community of practice open meeting this Friday .

presentation will be here

link to community of practice meeting

https://mitre.zoomgov.com/meeting/register/vJIsc-Ctrz8jHCYvWBpSzd-TK3RC8iuSo34

Questions:

Q: Have you find that EHR are variable in how they implement data?

A: Mainly working with EPic so not an issue so far.  Have an interim option of getting EHR to send data to CSV that mCode can manage.

Q: Does framework do conversion?

A:  See - EHR Endpoints for Cancer Clinical Trials

Q: Can you comment on structuring criteria to match FHIR resources

A: See the IG: http://hl7.org/fhir/us/mcode/index.html for mappings.  Have had some discussion with Microsoft eligibility criteria project.  There is interest in making the two projects work together.

Q: EBM has mapped ClinicalTrials.gov.  Has Codex thought of using something similar?

A: No, not involved in general mapping

Q: Ballot plans?

A: STU2 probably next Spring

BRIDG

1) Need to finish BRIDG 5.3 publication 

2) ISO asked CDISC want to reaffirm standard, Rhonda Facile is working with ISO to work out the process. Will come back to HL7 when the process is understood.

Mission & Charter

Current version is here: Mission and Charter 2017

Revised version is here: Mission and Charter

Made revisions to "formal relations", added a section on collaboration with Pharmacy on MedicationDefinition  resources.  The scope diagram needs to be updated.

Action: Notify WG and take a vote on our next conference call

Wed  Q3

Follow-up discussion

• Need to see how many real sites/EHRs implement and use FHIR in practice, but hard to get access to this information.
• The need for claims data, assuming the ability to match patients, to get more complete and certain medication information. Need to explore the feasibility.
• An option under discussion of conducting “micro-studies” instead of addressing individual SDTM domains one-at-a-time, e.g. a study medication, conmeds, AEs of interest (from observations or other relevant resource), etc.  This allows a practical way to show the challenge in multiple domains.  
• The mapping of vocabularies (i.e. RxNorm to NDC) was out of scope, but other groups have been working to map them out.
• The primary scope of the track aimed at data that is currently structured and is in FHIR. Expecting a greater challenge with other data in EHRs that is either unstructured or structured in non-standardized ways. 

Vulcan SOA

Hugh Glover provided an update

Vulcan Phenopackets

Melissa Haendel provided an update

Link to slides: https://docs.google.com/presentation/d/1Xf4gqmc_bKFso4LO5sr-Ybj_7TJbKEQ03wp92dhinRQ/edit#slide=id.gf10e5a8a1b_0_16

(summary discussion notes to follow)

Next steps

• The goal of discussing Vulcan projects in the context of BR&R is to facilitate their development toward turning them into HL7 standards. Ideally, all Vulcan projects need to be HL7 projects, eventually balloted.
• Projects can span multiple WGs, with each one co-sponsored by multiple WGs. Need to clarify the process of determining the best groups for an exploratory project.
• For SoA and Phenopackets projects, will dedicate separate calls to determine next steps later in October.

sIRB update and ballot reconciliation

James Topping provided an update

• Help streamline interaction of multiple sites with IRB, using a central site
• Allows PI to use questionnaires centrally, for the individual sites to receive responses, in place of current pdf’s
• Positive response overall, several negatives on the same subject
• Planning to provide review of ballot responses close to the end of October

AE project update and ballot reconciliation

Jean Duteau provided an update

• Mostly positive comments (all negatives about defining URL’s in THO)
• After ballot reconciliation, planning to work toward closer integration with MedMorph, which will enable reporting AE’s to registries. May need to update the PSS

Phenopackets

Slide deck as above for Q3

Q: Which Group is natural home?

A: Genomics seems natural home.

Q: Maria Michaels: MedMorph suggests architecture for information exchange MedMorph Reference Architecture IG: http://build.fhir.org/ig/HL7/fhir-medmorph/index.html also FHIR Clinical Guidelines IG: https://hl7.org/fhir/uv/cpg/ which may be useful maria.michaels@cdc.gov

A: Yes worth a discussion

RWD

Slide deck as above for Q3

Subsequent discussion covered mapping terminologies (esp medication identification) and provision of sample data sets.

SoA

Slide deck as above for Q3

Q: Will the Vulcan server provide terminology services?

A: Yes, it is an important function for the server.  It will only be for development work though, not at production level.