Coordinated Registry Network (CRN) HL7 Implementation Guide (IG) Workgroup (WG)

Meeting Date & Time

Tuesday, August 6, 2019 at 2:00 pm ET

Attendees

Attendees

Present/Absent

Attendees

Present/Absent

Becky Angeles

 

Behnaz  Minaei

 

Nagesh Bashyam (Dragon)

P

JaWanna Henry

 

Gayathri Jayawardena

P

Myron Finseth

P

Richard Ballew

 

Vaishnavi Rao

 

Rob Samples

 

Ioana Singureanu

 

Terrie Reed

 

Marti Velezis

 

Lisa Lang

 

Patrick McLaughlin

 

Abdullah Rafiqi

P

Robin Taylor

P

Christina Nguyen

 

Lindsey Hoggle

 

Craig Newman

 

Vahan Simonyan

 

Yanyan Hu

 

Mike Flanigan

P

Sweta Ladwa

 

Clem McDonald

 

Discussion                                                                    

FHIR Tracker Comments

The group reviewed the remaining tickets to discuss the final disposition.

  • Tracker #20789, 21016 - Adverse Events (AEs)
    • No response was received from the FDA Clinical WG.  Need to aggressively follow up on the following: Does it need to be retained in the CDEs and if so, we need additional details on the data elements to be retained.
  • Tracker #21309 - Specific Questionnaires
    • Example questionnaires will be added to the IG for reference.
  • Tracker#21311 - Increase in provider burden by increasing data collection
    • Provider burden is reduced by using an auto-populatable questionnaire.  Will send this to George to confirm he is satisfied with this resolution.
  • Tracker #21313 - De-personalization of patient data
    • Art and Courtney responded.  The registries that collect the data will have informed consent from patients, thus they do not need to de-identify their own data; however if any other party analyzes the data it will need to be de-identified before being shared.  This is standard practice.
    • Will add this response to the IG.  Will forward this response to commenter to ensure it satisfies their concern.
  • Tracker #21317, 21319 - UDI pattern ballot comments
    • Will attach the Device CRN Profiles provided by Marti to the ticket.
    • Will revise the IG based on this information.
  • Block Vote for BR&R WG
    • Will occur once final approval received on these resolutions.  Support Team will obtain approval by 8/9.
    • Following approval, email should be sent to BR&R WG listserv (on Tuesday).  Email should include a two-column table with the Ticket Number and Commenter, which includes a hyperlink to the ticket. 

 

Next Steps

  • Support Team to follow-up with commenters individually to confirm resolutions discussed on this call are acceptable.
  • Following approval, Support Team will email BR&R WG listserv and request to be added to agenda for next week’s BR&R WG Call.