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[[Category:RCRIM]]
 
[[Category:RCRIM]]
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Return to [[Regulated Clinical Research Information Management|RCRIM]] main page
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Return to [[http://wiki.hl7.org/index.php?title=Patient_Care_WG | Patient Care] main page
 +
 
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Return to [[http://wiki.hl7.org/index.php?title=FHIR_Clinical_Resources_-_PCWG | Patient Care FHIR]]
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 +
==FHIR Adverse Event==
 +
 
 +
FHIR Resource: http://hl7.org/fhir/adverseevent.html (STU 3)
  
 
''Project Number'' '''Project Number 1240'''
 
''Project Number'' '''Project Number 1240'''
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''Project Name'' '''FHIR Adverse Event Resource'''  
 
''Project Name'' '''FHIR Adverse Event Resource'''  
  
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''Project Sponsor(s)'' [[Regulated Clinical Research Information Management|RCRIM Work Group]] and [[Patient Care WG]]
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''Project Sponsor(s)'' [[Patient Care WG]]
  
 
==Description==
 
==Description==
  
  
−
[http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?action=edit&ProjectNumber=1240| Project Scope Statement - Project 1240]
+
[http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?action=edit&ProjectNumber=1240 Project Scope Statement - Project 1240]
 +
 
 +
'''Thanks to the efforts of Rik Smithies we have a draft build of the FHIR AE resource!!'''
 +
 
 +
http://build.fhir.org/adverseevent.html
  
 
==Objectives / Deliverables==
 
==Objectives / Deliverables==
Line 19: Line 29:
 
To enhance patient safety, it is noted that many countries have strong needs to exchange product safety information between varieties of stakeholders in the healthcare domain. Currently many regulatory agencies collect safety reports of adverse drug reactions, adverse events, infections, contamination and other incidents from consumers, pharmaceutical companies and healthcare professionals.
 
To enhance patient safety, it is noted that many countries have strong needs to exchange product safety information between varieties of stakeholders in the healthcare domain. Currently many regulatory agencies collect safety reports of adverse drug reactions, adverse events, infections, contamination and other incidents from consumers, pharmaceutical companies and healthcare professionals.
  
−
The adverse event resource will address the exchange of the following types of information:
+
The AdverseEvent resource will address the exchange of the following types of information:
−
1) Individual Case Safety Report (ICSR): framework for data exchange and information sharing by providing a common messaging format for transmission of ICSRs for adverse drug reactions (ADR), adverse events (AE), product problems and consumer complaints that may occur upon the administration or use of one or more products or substances.  The reports can relate to a specific subject or may be used to relay an issue or finding related to a specific substance, product or device.
+
 
−
2) (Not in current standard) – Individual Occurrence Report (IOR): the identification and characterization of exceptional events related to patient care, patient safety, protocol implementation, and service delivery. Examples might be falling out of bed, slipping on a wet floor, inappropriate use of restraints.
+
1) Individual Case Safety Report (ICSR): Framework for data exchange and information sharing by providing a common messaging format for transmission of Individual Case Safety Reports (ICSR) for adverse drug reactions (ADR), adverse events (AE), product problems and consumer complaints that may occur upon the administration or use of one or more products or substances.  The reports can relate to a specific subject or may be used to relay an issue or finding related to a specific substance, product or device.
 +
 
 +
2) (Not in current standard) – Individual Occurrence Report (IOR): The identification and characterization of exceptional events related to patient care, patient safety, protocol implementation, and service delivery. Examples might be falling out of bed, slipping on a wet floor, inappropriate use of restraints.
  
 
==Meeting Details==
 
==Meeting Details==
  
−
Fridays 10 AM to 11 AM Eastern
+
The FHIR Adverse Event resource is discussed during the weekly Patient Care FHIR calls held on Thursdays at 5 PM ET.
 +
 
 +
Agendas: http://wiki.hl7.org/index.php?title=PCWG_FHIR_Conference_Calls_and_Meeting_Minutes
 +
 
 +
AUDIO - HL7 Teleconference Line:
  
−
Conference Call Information:
 
 
Phone Number: +1 770-657-9270
 
Phone Number: +1 770-657-9270
−
Participant Passcode: 7485962
 
  
−
Web Meeting Info (does not include audio connection)
+
Participant Passcode: 943377
 +
 
 +
WEBEX - https://cernermeeting.webex.com/join/michelle.m.miller  |  596 965 698
 +
 
 +
==Meeting Agendas / Minutes / Presentations / Publications==
 +
 
 +
Links are to files. Download, or open in a new Tab or Window.
 +
 
 +
[[Media:FHIR_AdverseEvent_Resource_Agenda_and_Minutes_2017-06-16.pdf | Call 22 > FHIR AdverseEvent Resource Conf Call on 2017-06-16: Agenda and Minutes]]
 +
 
 +
[[Media:FHIR_AdverseEvent_Resource_Agenda_and_Minutes_2017-06-02.pdf | Call 21 > FHIR AdverseEvent Resource Conf Call on 2017-06-02: Agenda and Minutes]]
 +
 
 +
[[Media:Changes_to_Adverse_Event_Resource_2017_04_04.pdf | List of Changes to AdverseEvent Resource 2017-04-04]]
 +
 
 +
[[Media:FHIR_AdverseEvent_Resource_Agenda_and_Minutes_2017-04-07.pdf | Call 20 > FHIR AdverseEvent Resource Conf Call on 2017-04-07: Agenda and Minutes]]
  
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www.webex.com - meeting number 622 569 796
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[[Media:FHIR_AdverseEvent_Resource_Agenda_and_Minutes_2017-03-24.pdf | Call 19 > FHIR AdverseEvent Resource Conf Call on 2017-03-24: Agenda and Minutes]]
−
password - Meeting
 
  
−
Direct Meeting Link:  [https://nih.webex.com/nih/j.php?MTID=m9e24e9564bdfda4090cdb5fe6825f5bd|Meeting Link]
+
[[Media:FHIR_AdverseEvent_Resource_Agenda_and_Minutes_2017-03-10.pdf | Call 18 > FHIR AdverseEvent Resource Conf Call on 2017-03-10: Agenda and Minutes]]
  
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'''Next scheduled meeting''': Friday, June 3, 2016 at 10 AM EDT
+
[[Media:FHIR_AdverseEvent_Resource_Agenda_and_Minutes_2017-2-24.docx | Call 17 > FHIR AdverseEvent Resource Conf Call on 2017-2-24: Agenda and Minutes]]
  
−
==Meeting Agendas/Minutes==
+
[[Media:FHIR_AdverseEvent_Resource_Agenda_and_Minutes_2017-2-10.docx | Call 16 > FHIR AdverseEvent Resource Conf Call on 2017-2-10: Agenda and Minutes]]
  
−
[[FHIR AE Resource Agenda and Minutes 2016 5 20]
+
[[Media:FHIR_AdverseEvent_Resource_Agenda_and_Minutes_2017_1_6.docx | Call 15 > FHIR AdverseEvent Resource Conf Call on 2016-1-06: Agenda and Minutes]]
  
−
[[Media:FHIR_AE_Resource_2015_5_27.docx| FHIR AE Resource Agenda and Minutes 2016 5 27]]
+
[[Media:FHIR_AdverseEvent_Resource_Agenda_and_Minutes_2016_12_09.docx | Call 14 > FHIR AdverseEvent Resource Conf Call on 2016-12-09: Agenda and Minutes]]
  
−
==Project Requirements==
+
[[Media:FHIR_AdverseEvent_Resource_Agenda_and_Minutes_2016_11_18.docx | Call 13 > FHIR AdverseEvent Resource Conf Call on 2016-11-18: Agenda and Minutes]]
  
−
[[Media:DraftAEresource_as_of_2016_5_20.xlsx | FHIR AE Spreadsheet as of 2-16 5 20]]
+
[[Media:FHIR_AdverseEvent_Resource_Agenda_and_Minutes_2016_10_28.docx | Call 12 > FHIR AdverseEvent Resource Conf Call on 2016-10-28: Agenda and Minutes]]
 +
 
 +
[[Media:FHIR_AdverseEvent_Resource_Agenda_and_Minutes_2016_10_21.docx | Call 11 > FHIR AdverseEvent Resource Conf Call on 2016-10-21: Agenda and Minutes]]
 +
 
 +
[[Media:FHIR_AdverseEvent_Resource_Agenda_and_Minutes_2016_10_14.pdf | Call 10 > FHIR AdverseEvent Resource Conf Call on 2016-10-14: Agenda and Minutes]]
 +
 
 +
[[Media:FHIR_AdverseEvent_Resource_Agenda_and_Minutes_2016_09_02.docx | Call 9 > FHIR AdverseEvent Resource Conf Call on 2016-9-02: Agenda and Minutes]]
 +
*See BRIDG Presentation below
 +
 
 +
[[Media:FHIR_AdverseEvent_Resource_Agenda_and_Minutes_2016_08_12.pdf | Call 8 > FHIR AdverseEvent Resource Conf Call on 2016-08-12: Agenda and Minutes]]
 +
 
 +
[[Media:FHIR_AdverseEvent_Resource_Agenda_and_Minutes_2016_07_01.pdf | Call 7 > FHIR AdverseEvent Resource Conf Call on 2016-07-01: Agenda and Minutes - includes links to data sources]]
 +
 
 +
[[Media:FHIR_AdverseEvent_Resource_Agenda_and_Minutes_2016_06_24.pdf | Call 6 > FHIR AdverseEvent Resource Conf Call on 2016-06-24: Agenda and Minutes]]
 +
 
 +
[[Media:FHIR_AdverseEvent_Resource_Agenda_and_Minutes_2016_06_17.pdf | Call 5 > FHIR AdverseEvent Resource Conf Call on 2016-06-17: Agenda and Minutes]]
 +
 
 +
[[Media:FHIR_AdverseEvent_Resource_Agenda_and_Minutes_2016_06_10.pdf | Call 4 > FHIR AdverseEvent Resource Conf Call on 2016-06-10: Agenda and Minutes]]
 +
 
 +
[[Media:FHIR_AdverseEvent_Resource_Agenda_and_Minutes_2016_06_03.pdf | Call 3 > FHIR AdverseEvent Resource Conf Call on 2016-06-03: Agenda and Minutes]]
 +
 
 +
[[Media:FHIR_AdverseEvent_Resource_Agenda_and_Minutes_2016_05-27.pdf | Call 2 > FHIR AdverseEvent Resource Conf Call on 2016-05-27: Agenda and Minutes]]
 +
 
 +
[[Media:FHIR_AdverseEvent_Resource_Agenda_and_Minutes_2016_05_20.pdf | Call 1 > FHIR AdverseEvent Resource Conf Call on 2016-05-20: Agenda and Minutes]]
 +
 
 +
'''PRESENTATIONS'''
 +
 
 +
[[Media:Presentation_BRIDG_Adverse_Event_Sub-domain_Summary_2016_09-02.pptx | Call 9 >  Presentation, BRIDG Adverse Event Sub-domain Summary, Edward Helton, Smita Hastak, Wendy Ver Hoef, Julie Evans, 2016-09-02]]
 +
 
 +
[[Media:Presentation_PoojaBabbrah_BiosimilarResearch_PointofCarePartners_2016_08-12.pdf | Call 8 >  Presentation, Biosimilar Research, Pooja Babbrah, Senior Consultant, Point of Care Partners, 2016-08-12]]
 +
 
 +
[[Media:Presentation_DrMitraRocca_FDA_AdverseEventReporting_2016_06-24.pdf| Call 6 >  Presentation, FDA Adverse Event Reporting, Dr. Mitra Rocca, 2016-06-24]]
 +
 
 +
'''PUBLICATIONS'''
 +
 
 +
Publication by Stella Stergiopoulos et al. from Tufts, "A Survey of Adverse Event Reporting Practices Among US Healthcare Professionals"  http://link.springer.com/article/10.1007/s40264-016-0455-4
 +
 
 +
==Project Requirements and Use Cases==
 +
 
 +
[[Media:Standards_Comparison_of_Data_Elements_2016_10_14.xlsx| FHIR AdverseEvent Resource Data Elements Draft as of 2016-10-14]]
 +
 
 +
[[Media:Adverse_Event_and_Patient_Safety_Use_Cases_for_HL7_FHIR_Adverse_Event_Resource_V2.docx| FHIR AdverseEvent Resource Draft Use Cases V2 2016-10-28]]
 +
 
 +
[[Media:Adverse_Event_and_Patient_Safety_Use_Cases_for_HL7_FHIR_Adverse_Event_Resource_V3.docx| '''FHIR AdverseEvent Resource Draft Use Cases V2 2016-11-17''']]
  
 
==Project References==
 
==Project References==
  
−
Based on TANSI/HL7 V3 ICSRP1, R2-2012 HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report, Part 1: The Framework for Adverse Event Reporting, R2 (revise and partition ANSI/HL7 V3 RRCS, R1-2005)1/31/2012
+
'''FHIR Event Resource Pattern'''
 +
 
 +
Guidance on standard syntax issued by the FHIR team for any Resource that details event information.
 +
 
 +
[[Media:FHIR_Event_Resource_Pattern.pdf | FHIR_Event_Resource_Pattern.pdf, July 5, 2016]]
 +
 
 +
 
 +
'''Based on TANSI/HL7 V3 ICSRP1, R2-2012'''
 +
 
 +
'''HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report'''
 +
 
 +
 
 +
ICSR Part 1: The Framework for Adverse Event Reporting, R2
 +
 
 +
http://www.hl7.org/implement/standards/product_brief.cfm?product_id=266
 +
 
 +
 
 +
ICSR Part 2: Human Pharmaceutical Reporting Requirements for ICSR, R2
 +
 
 +
http://www.hl7.org/implement/standards/product_brief.cfm?product_id=267 (medicinals only)
 +
 
 +
 
 +
AHRQ Patient Safety Common Format Guidelines
 +
 
 +
https://www.psoppc.org/psoppc_web/publicpages/supportingDocsV1.2
  
−
ICSR Part 1 is http://www.hl7.org/implement/standards/product_brief.cfm?product_id=266
 
−
ICSR Part 2 is http://www.hl7.org/implement/standards/product_brief.cfm?product_id=267. (medicinals only)
 
  
−
[https://www.psoppc.org/psoppc_web/publicpages/supportingDocsV1.2|AHRQ Patient Safety Common Format Guidelines]
+
FHIR W5 Guidelines:
 +
http://hl7-fhir.github.io/w5.html

Latest revision as of 19:36, 3 August 2017

Return to [| Patient Care main page

Return to [| Patient Care FHIR]

FHIR Adverse Event

FHIR Resource: http://hl7.org/fhir/adverseevent.html (STU 3)

Project Number Project Number 1240

FHIR Resource Proposal AdverseEvent_FHIR_Resource_Proposal

Project Name FHIR Adverse Event Resource

Project Sponsor(s) Patient Care WG

Description

Project Scope Statement - Project 1240

Thanks to the efforts of Rik Smithies we have a draft build of the FHIR AE resource!!

http://build.fhir.org/adverseevent.html

Objectives / Deliverables

To enhance patient safety, it is noted that many countries have strong needs to exchange product safety information between varieties of stakeholders in the healthcare domain. Currently many regulatory agencies collect safety reports of adverse drug reactions, adverse events, infections, contamination and other incidents from consumers, pharmaceutical companies and healthcare professionals.

The AdverseEvent resource will address the exchange of the following types of information:

1) Individual Case Safety Report (ICSR): Framework for data exchange and information sharing by providing a common messaging format for transmission of Individual Case Safety Reports (ICSR) for adverse drug reactions (ADR), adverse events (AE), product problems and consumer complaints that may occur upon the administration or use of one or more products or substances. The reports can relate to a specific subject or may be used to relay an issue or finding related to a specific substance, product or device.

2) (Not in current standard) – Individual Occurrence Report (IOR): The identification and characterization of exceptional events related to patient care, patient safety, protocol implementation, and service delivery. Examples might be falling out of bed, slipping on a wet floor, inappropriate use of restraints.

Meeting Details

The FHIR Adverse Event resource is discussed during the weekly Patient Care FHIR calls held on Thursdays at 5 PM ET.

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

AUDIO - HL7 Teleconference Line:

Phone Number: +1 770-657-9270

Participant Passcode: 943377

WEBEX - https://cernermeeting.webex.com/join/michelle.m.miller | 596 965 698

Meeting Agendas / Minutes / Presentations / Publications

Links are to files. Download, or open in a new Tab or Window.

Call 22 > FHIR AdverseEvent Resource Conf Call on 2017-06-16: Agenda and Minutes

Call 21 > FHIR AdverseEvent Resource Conf Call on 2017-06-02: Agenda and Minutes

List of Changes to AdverseEvent Resource 2017-04-04

Call 20 > FHIR AdverseEvent Resource Conf Call on 2017-04-07: Agenda and Minutes

Call 19 > FHIR AdverseEvent Resource Conf Call on 2017-03-24: Agenda and Minutes

Call 18 > FHIR AdverseEvent Resource Conf Call on 2017-03-10: Agenda and Minutes

Call 17 > FHIR AdverseEvent Resource Conf Call on 2017-2-24: Agenda and Minutes

Call 16 > FHIR AdverseEvent Resource Conf Call on 2017-2-10: Agenda and Minutes

Call 15 > FHIR AdverseEvent Resource Conf Call on 2016-1-06: Agenda and Minutes

Call 14 > FHIR AdverseEvent Resource Conf Call on 2016-12-09: Agenda and Minutes

Call 13 > FHIR AdverseEvent Resource Conf Call on 2016-11-18: Agenda and Minutes

Call 12 > FHIR AdverseEvent Resource Conf Call on 2016-10-28: Agenda and Minutes

Call 11 > FHIR AdverseEvent Resource Conf Call on 2016-10-21: Agenda and Minutes

Call 10 > FHIR AdverseEvent Resource Conf Call on 2016-10-14: Agenda and Minutes

Call 9 > FHIR AdverseEvent Resource Conf Call on 2016-9-02: Agenda and Minutes

  • See BRIDG Presentation below

Call 8 > FHIR AdverseEvent Resource Conf Call on 2016-08-12: Agenda and Minutes

Call 7 > FHIR AdverseEvent Resource Conf Call on 2016-07-01: Agenda and Minutes - includes links to data sources

Call 6 > FHIR AdverseEvent Resource Conf Call on 2016-06-24: Agenda and Minutes

Call 5 > FHIR AdverseEvent Resource Conf Call on 2016-06-17: Agenda and Minutes

Call 4 > FHIR AdverseEvent Resource Conf Call on 2016-06-10: Agenda and Minutes

Call 3 > FHIR AdverseEvent Resource Conf Call on 2016-06-03: Agenda and Minutes

Call 2 > FHIR AdverseEvent Resource Conf Call on 2016-05-27: Agenda and Minutes

Call 1 > FHIR AdverseEvent Resource Conf Call on 2016-05-20: Agenda and Minutes

PRESENTATIONS

Call 9 > Presentation, BRIDG Adverse Event Sub-domain Summary, Edward Helton, Smita Hastak, Wendy Ver Hoef, Julie Evans, 2016-09-02

Call 8 > Presentation, Biosimilar Research, Pooja Babbrah, Senior Consultant, Point of Care Partners, 2016-08-12

Call 6 > Presentation, FDA Adverse Event Reporting, Dr. Mitra Rocca, 2016-06-24

PUBLICATIONS

Publication by Stella Stergiopoulos et al. from Tufts, "A Survey of Adverse Event Reporting Practices Among US Healthcare Professionals" http://link.springer.com/article/10.1007/s40264-016-0455-4

Project Requirements and Use Cases

FHIR AdverseEvent Resource Data Elements Draft as of 2016-10-14

FHIR AdverseEvent Resource Draft Use Cases V2 2016-10-28

FHIR AdverseEvent Resource Draft Use Cases V2 2016-11-17

Project References

FHIR Event Resource Pattern

Guidance on standard syntax issued by the FHIR team for any Resource that details event information.

FHIR_Event_Resource_Pattern.pdf, July 5, 2016


Based on TANSI/HL7 V3 ICSRP1, R2-2012

HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report


ICSR Part 1: The Framework for Adverse Event Reporting, R2

http://www.hl7.org/implement/standards/product_brief.cfm?product_id=266


ICSR Part 2: Human Pharmaceutical Reporting Requirements for ICSR, R2

http://www.hl7.org/implement/standards/product_brief.cfm?product_id=267 (medicinals only)


AHRQ Patient Safety Common Format Guidelines

https://www.psoppc.org/psoppc_web/publicpages/supportingDocsV1.2


FHIR W5 Guidelines: http://hl7-fhir.github.io/w5.html

Retrieved from "https://wiki.hl7.org/w/index.php?title=FHIR_Adverse_Event_Resource&oldid=143312"