Wednesday Q3 – Joint meeting with O&O
Attendees:
Elaine Ayres, NIH
Rik Smithies, HL7 UK
Mitra Rocca, FDA
Myron Finseth, MedTronic
Christian Hay, GS1
Lise Stevens, Saturn Services
Panagiotis Telonis, EMA
Juliet Rubini, Mathematica
Annette Vernon, FDA
Ed Helton, NIH/NCI
Ulrike Wagner, FNLCR
Wendy VerHoef, Samvit Solutions
Julie Evans, Samvit Solutions
Anita Walden, University of Arkansas
James Topping, Duke University
Russ Leftwich, Intersystems
Floyd Eisenberg, iParsimony
Bill Gregory, Pfizer
John Kiser, Abbvie
William Goosen, <…>
Mike Glickman, CDISC, ISO-TC215
BronKisler, CDISC
Hugh Glover, BlueWave
Kevin Shekleton, Cerner
Robin Williams, Lantana
Karen Nocera, CBORD
Lindsey Hogle, AND
Amy Nordo, Duke University
Norman Gregory, FDA
William Friggle, Sanofi
J. D. Baker, Sparx Systems
David <…>, Epic
Mary Kramer, Mitre
Jose Galvez, NIH
Mary Ann Slack, FDA
Vada Perkins, Identifica
Joshua Mandel, Childrens Harvard
Wilfred Sonney, HL7
Harold <…>, Mayo
Elaine Ayres chairing
Meeting Notes:
2 topics –AE FHIR resource (facilitated by Elaine), Introduction to PSS coming for IDMP FHIR resource(s) (facilitated by Vada)
AE FHIR resource
The project was conceived from clinicians asking for a way to capture and share adverse event information.
RCRIM has a “blanket” PSS that allows working with the FHIR team to develop FHIR resources for things within RCRIM’s scope (PSS 1240). The AE resource doesn’t have its own project scope statement.
A draft resource has just been completed.
Elaine presented an overview of the project, project composition, progress and key concepts.
The project has quite broad stakeholder participation.
Elaine walked through what the project team has discussed, and facilitated discussion an issue of how to handle Adverse Reaction. She also provided list of resources that have been defined already that could be used for particular purposes in the AE resource (by reference)
Discussion on Adverse Reaction issue – relationship of Adverse Reaction to Allergy Intolerance and Adverse Event.Concern thatAdverse reaction is needed even though all the attributes appear in AllergyIntolerance. Anobserved reaction may or may not be due to allergy, which is very important for clinicians. Important if truly computable semantics is needed, e.g. distinguishing facts from interpretations (one-to-many)
Rik provided a walkthrough of the new AE FHIR resource. This is a first pass.
Elaine described the concept of causality within SuspectEntityand requested input from the group. Lise noted that it’s an assessment based on related data and holds a level of subjectivity to it. A good discussion ensued including different examples to determine if the way it has been constructed will work. No final decision was made.
A question was asked where the response to an event is captured. There are 2 different types of outcomes – patient outcome and action taken. Rik and Elaine noted that they haven’t come to this yet.
Elaine closed by describing that the project can now move into a “continual comments” phase where the resource is made available for comments and anyone can review and provide comments on gforge regarding what’s needed to make it work for them.
Since this is a BR&R (RCRIM) project, it’s important for the BR&R workgroup to elicit engagement by a broader community to make it robust enough to work for a broad set of use cases. The project team will continue to try to address comments as they come in. We can anticipate that comments will plateau over time, at which time the resource is considered mature.