Overview
ISO/TS 17251:2023 - "Health informatics - Business requirements for a syntax to exchange structured dose information for medicinal products" defines the business requirements for representing dose instructions in a consistent, computable form. It is technology‑agnostic and focused on the structured or semi‑structured dose instructions that appear in electronic medication orders, EHRs, and patient/caregiver-facing directions. The specification aims to enable precise, unambiguous dose instructions to support safe medication use, dose checking and clinical decision support (CDS).
Key topics and requirements
- Scope and intent: Requirements cover structured content of dose instructions for primary, secondary and tertiary care; emphasis on patient/caregiver comprehension and safety.
- Dose syntax concepts: Defines terms such as dose instruction, dose event, dose syntax, semi‑structured and unstructured information.
- Elements of a dose instruction (Clause 6): business requirements for component parts including:
- Administration amount and choices between unit of measurement vs unit of presentation;
- Administration method and route/site of administration;
- Timing of dose events (frequency, interval, ranges and multi‑term representations);
- Conditional administration and complex instructions (multiple schedules/dose amounts);
- Subject‑of‑care specific information (e.g., optional lab observations, dates/times for characteristics);
- Ancillary information and human‑readable text representation.
- Terminologies & code systems: Requirements address use of coded vocabularies to achieve semantic interoperability while allowing text representation for comprehension.
- Conformance: Systems can claim conformance when they meet Clause 6 requirements; requirements are labelled with identifiers like [DOSESYN‑NNN].
- Relationship to other ISO deliverables: Clarifies linkage with IDMP concepts and related standards (see Related Standards).
Practical applications
- Enables EHRs, pharmacy systems, e‑prescribing, and CDS engines to exchange unambiguous dose instructions for:
- Automated dose checking and allergy/drug interaction screening;
- Safe dispensing and administration workflows;
- Clear patient/caregiver instructions (SIG) derived from structured data;
- Interoperable medication order exchange across care settings.
Who should use this standard
- Software developers building health IT: EHR vendors, e‑prescribing and pharmacy system implementers.
- Clinical informaticians and standards architects designing medication order and CDS integrations.
- Regulatory and healthcare organizations seeking consistent, machine‑readable dose information for safety and reporting.
Related standards