EN ISO 27953-1:2011
(Main)Health informatics - Individual case safety reports (ICSRs) in pharmacovigilance - Part 1: Framework for adverse event reporting (ISO 27953-1:2011)
General Information
- Abstract
ISO 27953-1:2011 seeks to establish an international 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 can occur upon the administration or use of one or more products.
The messaging format is based upon the HL7 Reference Information Model (RIM) and can be extended or constrained to accommodate a variety of reporting use cases. ISO 27953-1:2011 will be harmonized over time with other HL7 public health and patient safety reporting standards to help ensure that messaging constructs and vocabulary are harmonized in the HL7 Public Heath and Regulatory Reporting domains.
The data elements used in ISO 27953-1:2011 were identified as consistent across many of the use cases and can be applied to a variety of reporting scenarios. Specific reporting requirements within organizations or regions might vary.
- Status
- Published
- Publication Date
- 30-Nov-2011
- Withdrawal Date
- 29-Jun-2012
- Technical Committee
- CEN/TC 251 - Medical informatics
- Drafting Committee
- CEN/TC 251/WG 1 - Information models
- Current Stage
- 6060 - Definitive text made available (DAV) - Publishing
- Start Date
- 01-Dec-2011
- Completion Date
- 01-Dec-2011
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EN ISO 27953-1:2012 - PAZI: ISO na CD-romu! SIST standard je v PDF-obliki sestavljen samo iz CEN dokumenta in 3 strani ISO dokumenta. ISO/HL7 27953-1:2011 je v elektronski obliki, zip-file (html-oblika). ISO dokument je potrebno dodati na CD-romu. Število strani velja za celoten (skupaj z CEN-3 strani in ISO dokumentom-597 strani)
Overview
EN ISO 27953-1:2011 (ISO/HL7 27953-1:2011) defines an international framework for adverse event reporting focused on Individual Case Safety Reports (ICSRs) in pharmacovigilance. The standard specifies a common messaging format for exchanging ICSRs that document adverse drug reactions (ADRs), adverse events (AEs), product problems and consumer complaints associated with one or more products. The messaging approach is based on the HL7 Reference Information Model (RIM) and is designed to be extensible and constrainable to accommodate diverse reporting scenarios across organizations and regions.
Key topics and technical requirements
- Common messaging format for transmission of ICSRs to support consistent data exchange between health care providers, regulators and pharmacovigilance systems.
- HL7 RIM–based model: ICSR message constructs are derived from the HL7 Reference Information Model to promote semantic interoperability.
- Extensibility and constraints: Message structures can be extended or constrained to meet specific use cases (regional regulations, organizational workflows).
- Harmonization intent: Designed to align over time with other HL7 public health and patient safety reporting standards to ensure consistent constructs and vocabulary across reporting domains.
- Core data elements: Identifies a set of consistent data elements applicable across many use cases (patient, suspect product, event, reporter, outcome); note that exact reporting requirements may vary by authority or organization.
- Scope of reports: Covers ADRs, AEs, product problems and consumer complaints related to product administration/use.
Practical applications
- Exchange of ICSR data between marketing authorization holders (MAHs), national competent authorities and international pharmacovigilance centers.
- Integration of adverse event reporting into electronic health records (EHRs), safety databases and signal-detection systems.
- Standardizing submission pipelines for regulatory reporting and for aggregating safety data from multiple sources.
- Enabling cross-border and multi-vendor interoperability for pharmacovigilance workflows.
- Supporting automated processing and downstream analytics (case triage, signal management, regulatory compliance).
Who should use this standard
- National regulatory authorities and pharmacovigilance centres
- Pharmaceutical companies and MAHs responsible for ICSR submission
- Healthcare IT vendors, EHR integrators and safety database providers
- Software developers building reporting interfaces and message converters
- Public health agencies and organizations involved in patient safety reporting
Related standards and harmonization
- Based on and intended to be harmonized with HL7 public health and patient safety reporting standards and other ISO/HL7 initiatives.
- Original reference: ISO/HL7 27953-1:2011 (adopted as EN ISO 27953-1:2011 / EN ISO 27953-1:2011).
Keywords: individual case safety reports, ICSR, pharmacovigilance, adverse drug reaction, ADR, HL7 RIM, adverse event reporting, ISO 27953-1, messaging format, data exchange, safety reporting.
Relations
- Refers
ISO/HL7 21731:2006 - Health informatics — HL7 version 3 — Reference information model — Release 1 - Effective Date
- 25-Aug-2026
- Effective Date
- 25-Aug-2026
- Effective Date
- 09-Feb-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 12-Feb-2026
Buy Documents
EN ISO 27953-1:2012 - PAZI: ISO na CD-romu! SIST standard je v PDF-obliki sestavljen samo iz CEN dokumenta in 3 strani ISO dokumenta. ISO/HL7 27953-1:2011 je v elektronski obliki, zip-file (html-oblika). ISO dokument je potrebno dodati na CD-romu. Število strani velja za celoten (skupaj z CEN-3 strani in ISO dokumentom-597 strani)
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Frequently Asked Questions
EN ISO 27953-1:2011 is a standard published by the European Committee for Standardization (CEN). Its full title is "Health informatics - Individual case safety reports (ICSRs) in pharmacovigilance - Part 1: Framework for adverse event reporting (ISO 27953-1:2011)". This standard covers: ISO 27953-1:2011 seeks to establish an international 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 can occur upon the administration or use of one or more products. The messaging format is based upon the HL7 Reference Information Model (RIM) and can be extended or constrained to accommodate a variety of reporting use cases. ISO 27953-1:2011 will be harmonized over time with other HL7 public health and patient safety reporting standards to help ensure that messaging constructs and vocabulary are harmonized in the HL7 Public Heath and Regulatory Reporting domains. The data elements used in ISO 27953-1:2011 were identified as consistent across many of the use cases and can be applied to a variety of reporting scenarios. Specific reporting requirements within organizations or regions might vary.
ISO 27953-1:2011 seeks to establish an international 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 can occur upon the administration or use of one or more products. The messaging format is based upon the HL7 Reference Information Model (RIM) and can be extended or constrained to accommodate a variety of reporting use cases. ISO 27953-1:2011 will be harmonized over time with other HL7 public health and patient safety reporting standards to help ensure that messaging constructs and vocabulary are harmonized in the HL7 Public Heath and Regulatory Reporting domains. The data elements used in ISO 27953-1:2011 were identified as consistent across many of the use cases and can be applied to a variety of reporting scenarios. Specific reporting requirements within organizations or regions might vary.
EN ISO 27953-1:2011 is classified under the following ICS (International Classification for Standards) categories: 35.240.80 - IT applications in health care technology. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 27953-1:2011 has the following relationships with other standards: It is inter standard links to ISO/HL7 21731:2006, ISO 21090:2011, ISO/TS 22224:2009, EN 16580:2015, EN 1538:2010/FprA1, ISO/HL7 27953-1:2011. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 27953-1:2011 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-februar-2012
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Health informatics - Individual case safety reports (ICSRs) in pharmacovigilance - Part 1:
Framework for adverse event reporting (ISO 27953-1:2011)
Medizinische Informatik - Pharmakovigilanz - Einzelfallbericht für unerwünschte
Arzneimittelwirkungen - Teil 1: Grundstruktur für Berichte über unerwünschte
Arzneimittelwirkungen (ISO 27953-1:2011)
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Ta slovenski standard je istoveten z: EN ISO 27953-1:2011
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 27953-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2011
ICS 35.240.80
English Version
Health informatics - Individual case safety reports (ICSRs) in
pharmacovigilance - Part 1: Framework for adverse event
reporting (ISO 27953-1:2011)
Informatique de santé - Rapports de sécurité de cas Medizinische Informatik - Pharmakovigilanz -
individuel (ICSRs) en pharmacovigilance - Partie 1: Cadre Einzelfallbericht für unerwünschte Arzneimittelwirkungen -
pour rapporter un événement défavorable (ISO 27953- Teil 1: Grundstruktur für Berichte über unerwünschte
1:2011) Arzneimittelwirkungen (ISO 27953-1:2011)
This European Standard was approved by CEN on 12 November 2011.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
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Contents Page
Foreword .3
Foreword
This document (EN ISO 27953-1:2011) has been prepared by T
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