PD ISO TR 12309-2009 PDF

Full title and description

Health informatics — Guidelines for terminology development organizations. This technical report provides guidance on the governance, processes and organizational arrangements that should be exhibited by organizations that develop or maintain healthcare terminologies to support international standardization and interoperability in health informatics.

Abstract

ISO/TR 12309:2009 specifies principles and processes for developers of healthcare terminologies, addressing organizational governance, lifecycle management, quality controls and the services such organizations should provide. It is intended for organizations establishing or reviewing terminology-development activities and for those evaluating related services or products; it complements content-focused standards such as ISO 17115 and ISO 17117.

General information

• Status: Published.
• Publication date: 4 December 2009 (ISO publication: December 2009).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 35.240.80 — Health informatics / health care information technology.
• Edition / version: Technical Report ISO/TR 12309:2009 — Edition 1 (2009).
• Number of pages: 6 pages (official ISO publication length).

Scope

The report establishes recommended principles and processes for organizations that develop, maintain or govern healthcare terminologies intended for international use. It focuses on governance, lifecycle management (creation, review, maintenance, versioning), quality assurance, access and distribution policies, and interactions with other standards bodies. It is aimed at organizations that set up or review terminology-development activities and those evaluating terminology services or products.

Key topics and requirements

• Organizational governance and responsibilities for terminology development and maintenance.
• Lifecycle processes: creation, review, validation, versioning and retirement of terms and concepts.
• Quality management and conformance practices to ensure consistency and reliability of terminologies.
• Metadata, documentation and services (access, licensing, distribution) for terminology products.
• Interoperability considerations and alignment with related ISO health‑informatics standards (for example ISO 17115 and ISO 17117).
• Recommendations for internationalization, stakeholder engagement and evaluation of terminology organizations.

Typical use and users

Used by national and international standards bodies, terminology authorities, clinical informatics teams, health IT vendors, implementers of electronic health record systems, researchers in health informatics, and organizations that evaluate or accredit terminology services. Typical activities include designing governance structures, defining maintenance workflows, documenting metadata and setting distribution/licensing policies for clinical terminologies.

Related standards

Complements and is related to ISO 17115 and ISO 17117 (content and controlled health terminology standards), ISO 1087 (terminology vocabulary), and other ISO health‑informatics deliverables addressing terminology content, coding and conformance practices. Users commonly consult these documents together when establishing or assessing terminology organizations.

Keywords

health informatics; terminology development; terminology governance; clinical terminology; controlled vocabularies; metadata; terminology lifecycle; ISO TR 12309:2009.

FAQ

Q: What is this standard?

A: ISO/TR 12309:2009 is a Technical Report from ISO that provides guidelines for organizations that develop, maintain or govern healthcare terminologies — covering governance, lifecycle management and quality practices.

Q: What does it cover?

A: It covers recommended organizational principles and processes (creation, review, maintenance, versioning, metadata, access and quality assurance) to support international terminology standardization and interoperability in health informatics.

Q: Who typically uses it?

A: Terminology development organizations, national standards bodies, health‑IT vendors, clinical informatics teams, implementers of EHR/health data systems, and auditors or evaluators of terminology services.

Q: Is it current or superseded?

A: ISO/TR 12309 was published in December 2009 (4 December 2009) as ISO/TR 12309:2009. The ISO catalogue lists it as published; there is no public record on the ISO catalogue page indicating it has been formally superseded or withdrawn as of the catalogue entry checked. Users who need the absolute current lifecycle status for procurement or compliance should verify the ISO catalogue or their national standards body immediately before relying on it.

Q: Is it part of a series?

A: It is a Technical Report (ISO/TR) in the health informatics domain and is used in conjunction with related ISO standards on terminology content and terminology work (for example ISO 17115, ISO 17117 and ISO 1087). It is not numbered as a sequential part of a multi‑part standard but sits alongside content standards in the ISO health‑informatics portfolio.

Q: What are the key keywords?

A: Health informatics; terminology development; governance; lifecycle; controlled terminology; metadata; interoperability; ISO/TR 12309:2009.