FHIR Adverse Event Resource

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Project Number Project Number 1240

FHIR Resource Proposal AdverseEvent_FHIR_Resource_Proposal

Project Name FHIR Adverse Event Resource

Project Sponsor(s) RCRIM Work Group and Patient Care WG

Description

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

Next scheduled meeting: Friday, January 6, 2017 at 10 AM TO 11 AM Eastern

WebEx Meeting: http://www.webex.com

Meeting number: 196 412 889

Direct WebEx Meeting Link:

https://meetings.webex.com/collabs/#/meetings/detail?uuid=M0MCNPZF4GHR2C7KYHRW8D7Y5O-4MOF&rnd=603658.56063

AUDIO - HL7 Teleconference Line:

Phone Number: +1 770-657-9270

Participant Passcode: 7485962

Meeting Agendas / Minutes / Presentations / Publications

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

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