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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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''Project Number'' '''1229'''
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Return to [[http://wiki.hl7.org/index.php?title=FHIR_Clinical_Resources_-_PCWG | Patient Care FHIR]]
  
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''Project Name'' '''Structured Product Labeling for Food and Dietary Supplements (SPL r8)'''
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==FHIR Adverse Event==
  
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''Project Sponsor(s)'' [[Regulated Clinical Research Information Management|RCRIM Work Group]]  
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FHIR Resource: http://hl7.org/fhir/adverseevent.html (STU 3)
 +
 
 +
''Project Number'' '''Project Number 1240'''
 +
 
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''FHIR Resource Proposal''    [[AdverseEvent_FHIR_Resource_Proposal]]
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''Project Name'' '''FHIR Adverse Event Resource'''
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''Project Sponsor(s)'' [[Patient Care WG]]
  
 
==Description==
 
==Description==
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The purpose of this project is to ensure that the structured product label V3 artifact includes all of the necessary data elements for food and dietary supplements. The goal is to allow the electronic transmission of foods, branded food products, dietary supplements and botanicals. The dietary supplements and botanicals are included to encompass those products that are currently not available in the medicinal structured product label standards. The following types of data elements will be included in the V3 DMIM: nutrient composition, ingredients, allergens, product image and GTIN barcode (GS1 standard).
 
  
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[http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?action=edit&ProjectNumber=1229 | Project Scope Statement - Project 1229]
 
  
 +
[http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?action=edit&ProjectNumber=1240 Project Scope Statement - Project 1240]
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 +
'''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==
−
* To develop requirements for data elements and other functional requirements for complete electronic transmission of information contained in a food or dietary supplement label.  Requirements developed will then enable a gap analysis with the current structured product labeling standard for drugs (SPL r7).
+
 
 +
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==
 
==Meeting Details==
  
−
Mondays from 4-5 PM Eastern
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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:
  
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Conference Call Information:
 
 
Phone Number: +1 770-657-9270
 
Phone Number: +1 770-657-9270
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Participant Passcode: 7485962
 
  
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Web Meeting Info (does not include audio connection)
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Participant Passcode: 943377
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[http://www.webex.com|Webex website]  
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−
Meeting  ID 193 128 608 (no password).  
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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]]
 +
 
 +
[[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]]
 +
 
 +
[[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]]
 +
 
 +
[[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]]
 +
 
 +
[[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]]
 +
 
 +
[[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_AdverseEvent_Resource_Agenda_and_Minutes_2016_12_09.docx | Call 14 > FHIR AdverseEvent Resource Conf Call on 2016-12-09: Agenda and Minutes]]
 +
 
 +
[[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]]
  
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Direct Meeting Link:  [https://meetings.webex.com/collabs/#/meetings/detail?uuid=M8B9ZKDZAIIKHBGUAR299G14AE-4MOF&rnd=548277.12942|Meeting Link]
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[[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]]
  
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'''Next scheduled meeting''': Monday, April 25, 2016 at 4 PM EDT
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[[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]]
  
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==Meeting Agendas/Minutes==
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[[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]]
  
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*[[Media: SPLr8_Minutes_2016_2_8.docx |SPL r8 Minutes for 2016-2-8]]
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[[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
  
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*[[Media: SPLr8_Minutes_2016_2_15.docx |SPL r8 Minutes for 2016-2-15]]
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[[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]]
  
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*[[Media: SPLr8_Minutes_2016_2_22.docx |SPL r8 Minutes for 2016-2-22]]
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[[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]]
  
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*[[Media: SPLr8_Minutes_2016_2_29.docx |SPL r8 Minutes for 2016-2-29]]
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[[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]]
  
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*[[Media: SPLr8_Minutes_2016_3_7.docx |SPL r8 Minutes for 2016-3-7]]
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[[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]]
  
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*[[Media: SPLr8_Minutes_2016_3_14.docx |SPL r8 Minutes for 2016-3-14]]
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[[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]]
  
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*[[Media: SPLr8_Minutes_2016_3_28.docx |SPL r8 Minutes for 2016-3-28]]
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[[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]]
  
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*[[Media: SPLr8_Minutes_2016_3_30_AAAAI.docx |SPL r8 Minutes with AAAAI Sub-Group for 2016-3-30]]
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[[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]]
  
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*[[Media: SPLr8_Minutes_2016_4_18_AAAAI.docx  |SPL r8 Minutes with AAAAI Sub-Group for 2016-4-18]]
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[[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]]
  
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*[[Media: SPLr8_Minutes_2016_4_25.docx |SPL r8 Minutes for 2016-4-25]]
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'''PRESENTATIONS'''
  
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==Project Requirements==
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[[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]]
  
−
*Project Requirements Document: *[[Media: Copy_of_Structured_Product_Labeling_for_Food_and_Dietary_Supplements_V_1.0_2016_2_15.xlsx |DRAFT Requirements Spreadsheet 2016-2-15]]
+
[[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]]
  
−
*Project Requirements Document: *[[Media: Structured_Product_Labeling_for_Food_and_Dietary_Supplements_V_1.0_2016_3_1.xlsx |DRAFT Requirements Spreadsheet 2016-3-1]]
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[[Media:Presentation_DrMitraRocca_FDA_AdverseEventReporting_2016_06-24.pdf| Call 6 >  Presentation, FDA Adverse Event Reporting, Dr. Mitra Rocca, 2016-06-24]]
  
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*Project Requirements Document: *[[Media: Structured_Product_Labeling_for_Food_and_Dietary_Supplements_V_1.0_2016_3_13.xlsx |DRAFT Requirements Spreadsheet 2016-3-13]]
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'''PUBLICATIONS'''
  
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*Project Requirements Document: *[[Media: Structured_Product_Labeling_for_Food_and_Dietary_Supplements_V_1.0_2016_3_27.xlsx |DRAFT Requirements Spreadsheet 2016-3-27]]
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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
  
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*Project Requirements Document: *[[Media: Structured_Product_Labeling_for_Food_and_Dietary_Supplements_V_1.0_2016_3_28_(includes_GS1_data_elements).xlsx |DRAFT Requirements Spreadsheet 2016-3-28]]
+
==Project Requirements and Use Cases==
  
−
*Project Requirements Document: *[[Media: Structured_Product_Labeling_for_Food_and_Dietary_Supplements_V_1.0_2016_4_19.xlsx |DRAFT Requirements Spreadsheet 2016-4-19]]
+
[[Media:Standards_Comparison_of_Data_Elements_2016_10_14.xlsx| FHIR AdverseEvent Resource Data Elements Draft as of 2016-10-14]]
  
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* '''Updated''' Project Requirements Document: *[[Media: Structured_Product_Labeling_for_Food_and_Dietary_Supplements_V_1.0_2016_5_9.xlsx |DRAFT Requirements Spreadsheet 2016-5-9]]
+
[[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==
 +
 +
'''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
 +
 +
 +
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"