ISO/HL7 27953-1:2011
(Main)Health informatics - Individual case safety reports (ICSRs) in pharmacovigilance - Part 1: Framework for adverse event reporting
Health informatics - Individual case safety reports (ICSRs) in pharmacovigilance - Part 1: Framework for adverse event reporting
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.
Informatique de santé — Rapports de sécurité de cas individuel (ICSRs) en pharmacovigilance — Partie 1: Cadre pour rapporter un événement défavorable
L'ISO 27953-1:2011 vise à établir un cadre de travail international pour l'échange de données et le partage de l'information en proposant un format de messagerie commun pour la transmission des ICSR relatifs aux effets indésirables des médicaments (EI), aux effets indésirables (EI), aux problèmes liés à un produit et aux plaintes de consommateurs qui peuvent se produire pendant l'administration ou l'utilisation d'un ou plusieurs produits. Le format de messagerie est basé sur le Modèle d'information de référence (RIM) HL7 et peut être étendu ou restreint pour s'adapter à diverses exigences de déclaration de cas d'utilisation, tel que décrit dans la section de scénario du présent scrutin. L'ISO 27953-1:2011 sera harmonisée au fil du temps avec d'autres normes HL7 relatives à la déclaration d'incident de sécurité de santé publique et du patient afin de contribuer à garantir que les concepts de base et le vocabulaire de la messagerie sont harmonisés dans les domaines de Déclaration de santé publique et réglementaires. Les éléments de données utilisés dans l'ISO 27953-1:2011 ont été jugés pertinents dans un grand nombre des cas d'utilisation et peuvent s'appliquer à une variété de scénarios de déclaration. Les exigences spécifiques de déclaration pouvant varier au sein des organismes ou des régions.
General Information
Overview
ISO/HL7 27953-1:2011 - Health informatics: Individual case safety reports (ICSRs) in pharmacovigilance - Part 1: Framework for adverse event reporting defines an international framework for exchanging Individual Case Safety Reports (ICSRs). The standard specifies a common messaging format for transmission of adverse drug reactions (ADR), adverse events (AE), product problems and consumer complaints that may occur during the use of one or more products. The format is built on the HL7 Reference Information Model (RIM) and is designed to be extended or constrained to meet diverse reporting scenarios while supporting harmonization across public health and patient safety domains.
Key topics and technical requirements
- Common messaging format for ICSR transmission based on the HL7 RIM
- Support for reporting of ADRs, AEs, product problems, and consumer complaints
- Extensibility and constraints: message constructs can be adapted to specific use cases or regulatory requirements
- Vocabulary harmonization: alignment over time with other HL7 public health and regulatory reporting standards to ensure consistent semantics and interoperability
- Core data elements: identification of data elements that are consistent across many reporting scenarios (applicable across organizations and regions)
- Recognition that local or organizational reporting requirements may vary, so implementations must allow for regional customization
Applications
ISO/HL7 27953-1:2011 is applied where standardized, interoperable adverse event reporting is required:
- Electronic submission of ICSRs between healthcare providers, manufacturers, and regulatory authorities
- Pharmacovigilance systems for signal detection and safety monitoring
- Integration of patient safety reporting into public health surveillance and regulatory workflows
- Exchange of case reports across national and international pharmacovigilance networks
Who should use this standard
- National and regional regulatory agencies (for receiving and processing ICSRs)
- Pharmaceutical companies and drug safety teams implementing electronic case reporting
- Health IT vendors building pharmacovigilance, EHR, or safety reporting interfaces
- Hospitals, clinics, and healthcare providers participating in adverse event reporting programs
- Public health organizations and researchers involved in post-market surveillance
Related standards
- HL7 Reference Information Model (RIM) - foundational modeling framework used by this standard
- Other HL7 public health and patient safety reporting standards - intended targets for harmonization
ISO/HL7 27953-1:2011 helps organizations achieve interoperable, consistent adverse event reporting by providing a flexible, RIM-based messaging framework for ICSRs, improving data sharing across pharmacovigilance and public health systems.
Frequently Asked Questions
ISO/HL7 27953-1:2011 is a standard published by the International Organization for Standardization (ISO). Its full title is "Health informatics - Individual case safety reports (ICSRs) in pharmacovigilance - Part 1: Framework for adverse event reporting". 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.
ISO/HL7 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.
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Standards Content (Sample)
INTERNATIONAL ISO/HL7
STANDARD 27953-1
First edition
2011-12-01
Corrected version
2012-10-15
Health informatics — Individual case
safety reports (ICSRs) in
pharmacovigilance —
Part 1:
Framework for adverse event reporting
Informatique de santé — Rapports de sécurité de cas individuel
(ICSRs) en pharmacovigilance —
Partie 1: Cadre pour rapporter un événement défavorable
Reference number
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NORME ISO/HL7
INTERNATIONALE 27953-1
Première édition
2011-12-01
Informatique de santé — Rapports de
sécurité de cas individuel (ICSRs) en
pharmacovigilance —
Partie 1:
Cadre pour rapporter un événement
défavorable
Health informatics — Individual case safety reports (ICSRs) in
pharmacovigilance —
Part 1: Framework for adverse event reporting
Numéro de référence
©
ISO/HL7 2011
Le présent CD-ROM contient la publication ISO/HL7 27953-1:2011 au format HTML.
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Fax + 41 22 749 09 47 Fax +1 734 677 66 22
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The article discusses ISO/HL7 27953-1:2011, which aims to establish a global framework for the exchange of data and information related to individual case safety reports (ICSRs) in pharmacovigilance. The standard provides a common messaging format for reporting adverse drug reactions, adverse events, product problems, and consumer complaints. The messaging format is based on the HL7 Reference Information Model and can be adjusted to suit different reporting needs. ISO 27953-1:2011 will align with other HL7 standards in the public health and patient safety domains over time. The standard includes consistent data elements that can be applied to various reporting scenarios, although specific reporting requirements may vary across organizations or regions.
아래 기사를 한국어로 요약하시오: 기사 제목: ISO/HL7 27953-1:2011 - 건강 정보학 - 약물 안전성을 위한 개별 사례 안전 보고서 (ICSR) - 제1부: 부작용 사례 신고를 위한 프레임워크 기사 내용: ISO 27953-1:2011은 약물 안전성에 관련된 개별 사례 안전 보고서(ICSR)에 대한 데이터 교환 및 정보 공유를 위한 국제 표준을 수립하고자 한다. 이를 위해 하나 이상의 제품 투약 또는 사용 시 발생할 수 있는 약물 부작용(ADR), 부작용 사례(AE), 제품 문제 및 소비자 불만 사례에 대한 ICSR의 전송을 위한 공통 메시징 형식을 제공한다. 이러한 메시징 형식은 HL7 참조 정보 모델(RIM)을 기반으로 하며, 다양한 신고 용례를 수용하기 위해 확장 또는 제한될 수 있다. ISO 27953-1:2011은 시간이 지나면서 다른 HL7 공중보건 및 환자 안전 보고 표준과 조화를 이루게 될 것이다. ISO 27953-1:2011에서 사용된 데이터 요소는 다양한 신고 시나리오에 적용될 수 있을 뿐 아니라 많은 사용 용례 간의 일관성이 있는 요소로 확인되었다. 하지만 조직이나 지역마다 특정한 신고 요구 사항은 달라질 수 있다.
ISO/HL7 27953-1:2011 is a standard that establishes a framework for the exchange of data and information related to adverse events in pharmacovigilance, specifically the reporting of individual case safety reports (ICSRs). The standard provides a common messaging format based on the HL7 Reference Information Model (RIM) for transmitting ICSRs related to adverse drug reactions, adverse events, product problems, and consumer complaints. The messaging format can be customized to suit different reporting scenarios. ISO 27953-1:2011 will be aligned with other HL7 public health and patient safety reporting standards to ensure consistency in messaging constructs and vocabulary. While the standard identifies consistent data elements applicable to various reporting scenarios, specific reporting requirements may vary among organizations or regions.
ISO/HL7 27953-1:2011 - 医療情報学 - 薬剤の安全性に関する個別ケースの安全性報告 (ICSRs) - 第1部: 不良事象報告のフレームワーク ISO 27953-1:2011は、薬剤の副作用、不良事象、製品の問題、消費者の苦情に関連する個別ケースの安全性報告書 (ICSRs) の送信に共通のメッセージング形式を提供することにより、データ交換と情報共有のための国際的な枠組みを確立しようとするものです。このメッセージング形式はHL7参照情報モデル(RIM)に基づいており、さまざまな報告ユースケースに合わせて拡張または制約することができます。 ISO 27953-1:2011は、HL7の公衆衛生および患者安全性報告の標準と時間の経過とともに調和され、メッセージング構造と用語がHL7公衆衛生および規制報告のドメインで調和するようにサポートします。 ISO 27953-1:2011で使用されるデータ要素は、多くの使用ユースケースで一貫性があると認識されており、さまざまな報告シナリオに適用することができます。ただし、組織または地域ごとに特定の報告要件が異なる場合があります。
記事を日本語で要約します： 記事のタイトル：ISO/HL7 27953-1:2011 - ヘルスインフォマティクス - 薬物健康監視における個別症例安全報告書（ICSR）- 第1部：不良事象報告のためのフレームワーク 記事の内容：ISO 27953-1:2011は、薬物健康監視の個別症例安全報告書（ICSR）のデータ交換と情報共有のための国際的な枠組みを確立することを目的としています。このために、1つ以上の製品の投与または使用によって発生する薬物副作用（ADR）、不良事象（AE）、製品の問題、消費者の苦情に関するICSRの送信のための共通のメッセージング形式を提供します。このメッセージング形式は、HL7参照情報モデル（RIM）に基づいており、さまざまな報告用途に対応するために拡張または制約することができます。ISO 27953-1:2011は、時間の経過とともにHL7公衆衛生および患者安全報告の他の規格と調和するようになるでしょう。ISO 27953-1:2011で使用されるデータ要素は、多くの使用事例で一貫していることが確認され、さまざまな報告シナリオに適用することができますが、組織や地域ごとに特定の報告要件は異なるかもしれません。
ISO/HL7 27953-1:2011 - 의료 정보학 - 약물 안전성 평가를 위한 개별 증례 안전 보고서 (ICSRs) - 제 1 부 : 이상사건 보고를 위한 프레임워크 ISO 27953-1:2011은 국제적인 데이터 교환 및 정보 공유를 위한 틀을 마련하는데, 하나 이상의 제품 투여 또는 사용 시 발생할 수 있는 약물 반응 (ADR), 이상사건 (AE), 제품 문제 및 소비자 불만에 대한 개별 증례 안전 보고서 (ICSRs)의 전송을 위한 공통 메시징 형식을 제공합니다. 이 메시징 형식은 HL7 참조정보모델 (RIM)을 기반으로 하며, 다양한 보고 사례에 맞게 확장하거나 제한할 수 있습니다. ISO 27953-1:2011은 시간이 지나면서 다른 HL7 공공건강 및 환자 안전 보고 기준들과 조화를 이룰 예정으로, HL7 공식 건강 및 규제 보고 분야에서 메시징 구조와 어휘가 조화를 이뤄질 수 있도록 지원할 것입니다. ISO 27953-1:2011에서 사용된 데이터 요소들은 많은 사용 사례에서 일관적이라고 확인되었으며, 다양한 보고 시나리오에 적용할 수 있습니다. 그러나 조직이나 지역마다 구체적인 보고 요구 사항은 다를 수 있습니다.
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