ISO/TS 20405:2018 PDF

Name: ISO/TS 20405:2018 — Health informatics — Framework of event data and reporting definitions for the safety of health software
SKU: ISO/TS 20405:2018
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Health informatics — Framework of event data and reporting definitions for the safety of health software

Название (английский):

ISO/TS 20405:2018

Health informatics — Framework of event data and reporting definitions for the safety of health software

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 16
Дата публикации:: 18 мая 2018 г.
Издание:: ISO TS 20405 edition 1 version 1
ICS:: 35.240.80

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Описание (английский):

This document provides a model framework for improving the surveillance and reporting of events with respect to the safety of health software. This document defines those data elements needed for identification of particular events including incidents, near-misses and unsafe conditions, as well as outlining good principles, relevant concepts and a process model for the recording, analysis and reporting of event-specific information related to the safety of health software.

Abstract

Похожие стандарты

Упомянутые в описании и другие стандарты ISO

Overview

ISO/TS 20405:2018 - "Health informatics - Framework of event data and reporting definitions for the safety of health software" - defines a consensus-based model to improve surveillance, recording, analysis and reporting of safety-related events involving health software. The technical specification focuses on the data elements, principles and process model needed to describe incidents, near-misses and unsafe conditions where health software contributes to patient safety risk.

Keywords: ISO/TS 20405:2018, health informatics, health software safety, event reporting, patient safety, incident reporting.

Key Topics and Requirements

Scope and purpose: Provides a model framework for consistent identification and documentation of health software safety events to support learning and mitigation.

Core definitions: Clarifies terms such as health software, hazard, hazardous event, incident, near‑miss and unsafe condition (drawing on IEC/ISO terminology).

Principles: Establishes guiding principles including proactivity, objectivity, accountability, transparency, preparedness and comprehensiveness to underpin event surveillance and reporting.

Data concepts: Emphasizes accuracy, timeliness, comparability, usability and relevance of event data to make surveillance actionable.

Process model: Recommends organizational processes for recording, analysing and reporting event-specific information about health software safety.

Patient safety data elements: Specifies the types of data elements to capture-event identification, event date/time, report date, reporter information, and supplementary event details-plus categorization and classification (e.g., input/output errors).

Annex and examples: Provides information on existing national and organizational reporting systems to illustrate implementation approaches.

Applications and Practical Value

Standardizes how organizations collect and share safety data about electronic health records, clinical decision support, medical device software and interoperable health IT.

Enables better surveillance, cross-system comparisons, trend analysis and root-cause investigations.

Supports regulatory reporting, vendor post-market surveillance, hospital safety programs, and academic research into health software-related harm.

Helps design or improve incident management workflows, event databases, and reporting templates to meet patient safety goals.

Related Standards

IEC 82304-1 (health software definition and lifecycle considerations)

ISO/IEC Guide 51 and ISO Guide 73 (risk and terminology foundations)

National reporting frameworks referenced in the specification (e.g., AHRQ common formats, NHS NRLS) as implementation examples

Adopting ISO/TS 20405:2018 helps organizations create consistent, comparable event data and reporting processes that improve the safety and reliability of health software in clinical settings.

ISO/TS 20405:2018 PDF

Abstract

Похожие стандарты

Overview

Key Topics and Requirements

Applications and Practical Value

Who Should Use This Standard

Related Standards

Технические детали

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