SIST EN ISO 13119:2023 PDF

Overview

EN ISO 13119:2022 - Health informatics - Clinical knowledge resources - Metadata defines a standardized set of metadata elements for describing medical knowledge resources. It targets primarily digital documents and web resources (e.g., guideline repositories, journal articles, HTA reports) but is also applicable to paper documents. The metadata support clear, international and unambiguous description of resources’ purpose, issuer, intended audience, legal status and scientific background to make clinical knowledge easier to find, evaluate and process by humans and machines.

Key topics and technical requirements

This standard specifies the structure and content of metadata for clinical knowledge resources. Major topics include:

• Resource form: type, format and language classifications for digital and paper resources.
• Intended use: audience, clinical situation and clinical process stage to indicate who and when the resource applies.
• Subject and scope: subject keywords, descriptions, coverage, inclusion/exclusion criteria and relations to other resources.
• Identification and source: unique identifier, title, creator, creator contact, dates (created, available, issued), status, rights management, publisher, contributors and citation/source fields.
• Quality control metadata: evidence grade, recommendation strength and risk consequence class to annotate the methodological context without prescribing content quality criteria.
• Support for presentation to both health professionals and patients/individuals, and for automatic processing (e.g., search engines filtering by document type or quality indicators).

The document explicitly does not cover metadata for single-patient records (medical records), nor does it attempt to describe detailed medical content or impose content-quality rules.

Applications

EN ISO 13119:2022 is practical for:

• Clinical guideline repositories, knowledge bases and decision support systems that need consistent metadata for search and integration.
• Publishers, HTA agencies and government bodies that publish recommendations, regulations, protocols or review articles.
• EHR and health information system vendors implementing interoperability and discovery services for clinical knowledge resources.
• Medical librarians, informaticians and researchers cataloguing or indexing clinical literature.
• Search engines and content aggregators that want to restrict or rank results by document type, audience or evidence indicators.

Who should use it

• Health informatics teams, clinical knowledge managers, guideline developers, HTA authors, publishers, and standards implementers across healthcare IT and digital health ecosystems.

Related standards

• Developed by ISO/TC 215 (Health informatics) in collaboration with CEN/TC 251.
• Supersedes EN ISO 13119:2012; second edition adds support for Health Technology Assessment document types.

Keywords: EN ISO 13119:2022, health informatics, clinical knowledge resources, metadata, metadata elements, clinical guidelines, digital health, medical literature.