December 2025: New Standard Defines Characteristics for Health Terminologies

In December 2025, the publishing of EN ISO 17117-1:2025 marks a significant step in the world of health informatics and documentation standards. This newly released international standard defines universal characteristics for health terminological resources, providing a robust framework for clinical concept representation and interoperability across healthcare systems. As digital health expands, precise and standardized terminology resources are increasingly essential for data aggregation, reporting, and quality management. For professionals in healthcare, health IT, quality assurance, and compliance, understanding and implementing this standard is a key foundation for effective and interoperable clinical information systems.

Overview of Health Informatics Terminology Standards

Health informatics is a discipline at the intersection of healthcare, information science, and computer technology. Clear, precise, and interoperable terminologies are at the heart of this field, enabling reliable clinical documentation, research, patient data exchange, and analytics. Without well-defined standards for terminological resources, healthcare organizations risk data fragmentation, miscommunication, and operational inefficiencies. The December 2025 publication of EN ISO 17117-1:2025 directly addresses these challenges by standardizing the characteristics and core functions expected of health sector terminologies. This article explores what the standard covers, how it impacts practice, and why it’s a must-have for anyone responsible for health data systems, compliance, or procurement.

Detailed Standards Coverage

EN ISO 17117-1:2025 – Defining Characteristics for Health Terminological Resources

Full Standard Title: Health informatics – Terminological resources – Part 1: Characteristics (ISO 17117-1:2025)

The newly published EN ISO 17117-1:2025 delivers a clear set of definitions for key characteristics and functions that health terminological resources must meet to be considered fit for clinical concept representation. The standard applies to terminological resources intended primarily for use in healthcare—such as controlled vocabularies and coding systems used to describe diseases, procedures, drugs, and other clinical phenomena. Its structured approach allows organizations and developers to:

• Assess whether a terminology resource supports their specified requirements
• Identify and categorize types of terminological resources by their characteristics and functions
• Lay the groundwork for semantic interoperability within and across health information systems

Scope and Purpose

EN ISO 17117-1:2025 exclusively addresses terminologies meant for clinical concept representation, such as:

• Terminological systems (taxonomies, ontologies, formal concept representation)
• Coding systems (mapping concepts to alphanumeric codes)
• Classification systems (for statistical or reporting purposes)

The standard provides:

• Universal and specialized characteristics (such as concept identifiers, term identifiers, compositionality, and semantic interoperability)
• Criteria for categorizing terminological resources based on their role and structure
• Guidance to help organizations match terminologies to application needs (data entry, aggregation, reporting, interoperability, etc.)

Not covered: evaluations of terminological quality, service requirements, or mapping between different terminological versions or systems.

Key Requirements and Specifications

• Identification Features: Each term and concept must have a unique, consistent identifier. Version control and editorial information are also specified for proper management.
• Concept Representation: Both pre-coordinated (single code for a specific clinical concept) and post-coordinated (combination of codes/attributes for complex concepts) methods are supported.
• Relations Between Concepts: Hierarchical (parent/child, part/whole) and associative relationships are defined, along with explicit semantic links for advanced use cases.
• Extensibility and Maintenance: Characteristics such as context-free identifiers, obsolescence marking, and responsiveness to changes are crucial for effective maintenance and evolution of terminologies.
• Functions Supported: Data capture, aggregation, statistical analysis, presentation, and internal consistency reasoning are all described as core functions enabled by compliant terminological resources.

Who Needs to Comply?

This standard is essential for:

• Healthcare organizations selecting or deploying health information systems
• Developers and maintainers of terminological systems or health coding schemes
• IT and quality professionals integrating clinical data
• Regulators and national standards bodies
• Health data analysts and researchers

Implementing EN ISO 17117-1:2025 helps ensure alignment with global best practices for health terminology management, offering reassurance to regulators, patients, and partners that information is handled consistently and safely.

Practical Implications

Organizations adopting this standard can:

• Systematically evaluate new or existing terminology resources for clinical application fitness
• Support safer interoperability between electronic health records (EHR) and other digital health solutions
• Minimize misunderstandings and enhance consistency across diverse healthcare systems

Notable Changes (from previous specification)

• Extensive revision and technical updates compared with the previous ISO/TS 17117:2002
• Expanded framework for categorization based on characteristics and functions, rather than resource names

Key highlights:

• Clear criteria for evaluating health terminological resources
• Supports both pre- and post-coordination of clinical concepts
• Framework for interoperability in digital health environments

Access the full standard:View EN ISO 17117-1:2025 on iTeh Standards

Industry Impact & Compliance

Adoption of EN ISO 17117-1:2025 strengthens data governance and compliance in healthcare organizations. Key impacts include:

• Consistency: Clear terminology structures reduce errors in patient records, care communications, and statistical reporting.
• Interoperability: Facilitates seamless data exchange within and across organizational boundaries, supporting national and cross-border healthcare initiatives.
• Procurement: Provides a benchmark for selecting third-party terminology systems and tools.
• Compliance Considerations:
  • Organizations should review existing terminological resources for alignment
  • Implementation timelines may depend on internal IT change management processes
  • Early adoption can offer strategic advantages in international collaborations and regulatory reporting
• Benefits:
  • Improved quality and safety of health information
  • Streamlined decision support, analytics, and reporting
  • Easier adaptation to evolving regulatory demands
• Risks of Non-Compliance:
  • Increased likelihood of miscommunication
  • Regulatory scrutiny or financial penalties for systemic errors
  • Missed opportunities in health IT modernization

Technical Insights

Common Technical Requirements

EN ISO 17117-1:2025 emphasizes several recurring themes vital for high-quality health terminological systems:

• Unique Identifiers: Both terms and concepts must be unambiguously represented
• Extensibility: Resource must allow for domain and geographic adaptation
• Semantic Relations: Hierarchies and associations (e.g., "is-a", "part-of", "caused-by") are coded clearly
• Maintenance Features: Versioning, permanence, and historical tracking of terminology are integral
• Presentation/Display: Support for both machine-readable and human-friendly presentations

Best Practices for Implementation

1. Terminology Assessment: Begin by matching system requirements to standard characteristics. Use the framework to benchmark existing terminological resources.
2. Configuration Management: Implement processes for version control, identifier assignment, and change tracking.
3. Integration Testing: Align semantic links and hierarchies with broader data models and interfaces.
4. Staff Training and Awareness: Ensure IT staff, clinicians, and coders understand new structures and processes.
5. Vendor Collaboration: Specify EN ISO 17117-1:2025 compliance in new procurement and RFPs for terminology solutions.

Testing and Certification Considerations

• Consider external certification or validation of critical health terminology systems
• Utilize automated regression and compliance testing, particularly when introducing new mappings or concept versions
• Document evidence of compliance as part of audit preparation

Conclusion / Next Steps

The December 2025 release of EN ISO 17117-1:2025 represents a state-of-the-art foundation for structuring, evaluating, and implementing health sector terminological resources. Strategic adoption will help healthcare organizations ensure data quality, achieve regulatory alignment, and position themselves for future advancements in digital health interoperability and analytics.

Key takeaways:

• This standard is essential for anyone involved in health informatics, terminology development, or compliance
• Organizations should conduct gap analyses and plan for phased implementation
• iTeh Standards offers authoritative access to this and related specifications—review the full text to inform your strategy

Stay ahead:

• Explore EN ISO 17117-1:2025 on iTeh Standards
• Follow future updates in health terminology, documentation, and health informatics
• Incorporate these requirements into your IT governance plans and vendor selection criteria

For detailed implementation guidance and authoritative updates, regularly visit standards.iteh.ai.