Skip to end of metadata
Go to start of metadata

Meeting Information

Phone Number: +1 563-999-2090
Participant Passcode: 792564
Chair:  Michelle Miller
Scribe:  Michelle Miller



XStephen ChuThe Australian Digital Health Agency (ADHA)

Irina Connelly Georgia Tech Research Institute 
XGeorge Dixon Allscripts 

Evelyn GallegoEMI Advisors LLC

Eric HaasHealth eData Inc

Rob HausamHausam Consulting LLC
XLaura Heermann-LangfordIntermountain Healthcare

Yanyan HuJoint Commission  
XEmma JonesAllscripts
XThom Kuhn 
XRuss LeftwichInterSystems
XTony LittleOptum 360

Jay LyleOckham Information Services LLC, VA

Chris Melo Philips
XMichelle M MillerCerner

Lisa NelsonMax MD
XMike PadulaThe Children's Hospital of Philadelphia

Joe QuinnOptum

Nick Radov United Healthcare 

Stefan RothGeorgia Tech Research Institute  
XCasey Thompson  Clinovation

Jack Wallace Georgia Tech Research Institute  
XChristi Denney 
XHugh Glover  

Wayne Kubick
XAmy Nordo   

John Stamm

Mead Walker 

Barbee Whitaker  
XTom Yosick 
XLynn Perrine
XAndi Maddela
XRobinette Renner

Quorum (chair + 3) met?  Yes


  1. Agenda Review
  2. Approve previous meeting minutes 2019-03-28 Patient Care FHIR Conference Call
    1. Motion:  Emma/Mike
  3. gForge change requests


Stephen updated Adverse Event Topic based on 2019-03-14 Patient Care FHIR Conference Call

Hugh suggested a few AdverseEvent changes, Revisions to FHIR Definition, so we got that logged as GF#20676

AdverseEvent Scope

Per Russ, in clinical trials, adverse reaction or injury are recorded - regardless of workflow or cause.  No near misses.

Hugh said that V3 would specify responsibilities on each side of message, but that is more complex than what FHIR requires.  FHIR doesn't force recording of what isn't needed.  No more conflict between clinical care vs clinical trials since that can be pushed to the implementation guide.

Per Amy, on clinical care side, adverse event is negative, but pharma doesn't always consider it negative.  Amy suggested that EHRs are using forms to capture any change (positive or negative) in the patient for clinical trials.

Russ doesn't think any AdverseEvent is positive.

Stephen has suggested separation between reaction vs incident.  For example, in context of a clinical trial, if patient falls in the middle of the night.  In clinical trial world, it would be an incident.  The fall has a number of consequences.  If patient is not in clinical trial, but patient gets med and has reactions.

Amy agrees an incident is any change to the patient (good or bad).  Does that change meet the criteria of adverse event?  Is it a serious adverse event? Related to study interventions

Russ would like to focus on what AdverseEvent contains.  In clinical care, a clinician (or patient) asserts a cause/effect for a reaction whereas in a clinical trial, it is based on a protocol.  For example, vomiting might be an adverse event in clinical trial, but vomiting wouldn't be an adverse event when patient has stomach flu.  Why do we need to use the same resource for both clinical trial and clinical care?

Stephen asked Amy Nordoto send Stephen Chua summary to add to the  Adverse Event Topic.

Russ asked if we need an AdverseReaction resource?

Hugh countered if we need an Incident resource with two profiles (one that is focused on clinical care and the other is focused on clinical trials).  Russ is concerned that "incident" is a loaded term.  Russ prefers AdverseEvent and AdverseReaction.  Amy doesn't think it is an incident (negative connotation).  Amy thinks it is a change that happened after patient is enrolled in study.  PI needs to determine if related to study drug.  In a trial, a headache is an AdverseEvent (not an incident).  Hugh reminded everyone that only developers see the name of the resource – need to focus on the data items.

Stephen summarized that Amy will send Stephen her feedback.  Offline discussion on the name of the resource.

gForge Discussed

  • GF#20593 Description missing – discussed, no vote.

gForge Backlog

AdverseEvent - April 4

  • GF#20593 Description missing 
  • GF#20537 Change AdverseEvent.identifier cardinality to 0-*
  • GF#20535  Add attribute to indicate if patient or SDM notified of incident/adverse event

  • GF#20534  Add concepts in AdverseEventSeverity value set

  • GF#19310 AdverseEvent.subjectMedicalHistory definition missing 

  • GF#18854 SuspectedEntity doesn't work for "certain" - STU #203 (2018-Sep Core STU)
  • GF#18853 The short description is significantly different in meaning to the Definition. - STU #202 (2018-Sep Core STU)
  • GF#18852 AdverseEvent.resultingCondition - inadequate and inappropriate for documenting adverse reactions associated with AdverseEvent incidents - STU #201 (2018-Sep Core STU)

  • GF#17397 Add ameliorating actions in AdverseEvent
  • GF#17238 Add attribute to capture future strategies/recommendations 

  • GF#17237 Request to add attribute for actions or circumstances that prevented harm 

  • GF#16092 Add contributing factors to AdverseEvent

  • GF#16038 Add interventions required  in AdverseEvent

  • GF#16037 Add attribute to capture likelihood of recurrence - Christi will look into a possible value set / code system to use

  • GF#11021 Increase cardinality of substance and make certainty relation to substance not reaction - 2016-09 core #40


  • GF#20566  Update the value set binding on participant.role


  • GF#20606 highlight that intent is an immutable element. 
  • GF#13903 CarePlan should allow tracking of past activities (i.e. past interventions)
  • GF#11332 - Acknowledge Advance Directives as type of Care Plan - 2016-09 core #490 (2016-Sept Core)
  • GF#11173 CarePlan needs support for reviews - 2016-09 core #327 (2016-Sept Core)
  • GF#10028 Careplan: Provide ability to specify patient and/or provider preferences

SD / SOAP Notes

  • GF#12676 Guidance request for GP SOAP in FHIR
  • GF#14720 Add Guidance for Exchanging Notes - 2018-Jan Core #42


  • GF#20483 Add Encounter.diagnoses elements to Condition

  • GF#17736 Need guidance on representation of Concern
  • GF#14872 Not sufficient support for Concern - 2018-Jan Core #213

Condition/Encounter borderline duplicates

  • GF#16147 Condition.category - can be used to specify granular type code? 2018-May Core - In Person Claude
  • GF#20483 Add Encounter.diagnoses elements to Condition In Person
  • GF#16148 Encounter.reason and Encounter.diagnosis (PA) In Person


  • GF#20190 Deprecate Clinical Impression Resource
  • GF#18859 Definition/description at odds with what clinical impression is - STU #208
  • GF#10635 Michelle Miller logged it and is ok deferring due to ClinicalImpression maturity (2016-Sept Core:2018-Sep Core STU)


  • GF#13047 Add DosageInstructions to Procedure
  • GF#12993 Please Create a NonMedicationAdministration object or an Administration object

Waiting for Input

  • GF#11026 - 2016-Sept Core Ballot - Jay Lyle was thinking about how to decompose - Relationship between Condition and Observation
  • GF#8458 Is a blood transfusion closer to a medication administration or a procedure  or something else?
  • GF#13389 Clarify Communication Scope and Usage
  • GF#13046 Add relevantHistory 0..* Provance to Procedure
  • GF#17592 FHIRPath expression of search parameter "onset" on AllergyIntolerance is wrong
  • GF#17902 Description for Communication resource  may need to be updated 
  • GF#17946 Confusion regarding 'status' and 'outcome' metadata elements of "Procedure" resource - In Person (Floyd)


Adjourned at 6:32pm Eastern

Next Meeting

Preliminary Agenda Items

  1. Agenda Review
  2. Approve previous meeting minutes
  3. gForge change requests

  • No labels