ISO 17523-2016 PDF

Full title and description

Health informatics — Requirements for electronic prescriptions. ISO 17523:2016 defines the required content and core data elements of an electronic prescription (the digital document issued by a prescriber and received by a dispenser), with a focus on medicinal products and the information necessary to legally and safely authorize dispensing and administration of medicines.

Abstract

ISO 17523:2016 specifies requirements that apply to electronic prescriptions (ePrescriptions). It describes generic principles and a list of data elements considered essential for ePrescriptions (depending on jurisdiction and clinical setting). The standard is constrained to the content of the ePrescription itself and does not prescribe message exchange, transport, or nation‑specific workflows such as reimbursement or local validation procedures. The requirements are aimed primarily at medicinal products for human use.

General information

• Status: Withdrawn (superseded by a newer edition).
• Publication date: June 2016 (Edition 1, published 2016-06).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 35.240.80 — IT applications in health care technology.
• Edition / version: Edition 1 (2016).
• Number of pages: 18 pages (original ISO publication).

(Core bibliographic and lifecycle details from the ISO record for ISO 17523:2016.)

Scope

The scope of ISO 17523:2016 is limited to the data content and requirements of the electronic prescription document itself — the information issued by a prescribing healthcare professional and intended for a dispensing healthcare professional. It applies to prescriptions for medicinal products (including pharmacy‑compounded preparations) and lists essential data elements and content rules. It explicitly excludes specifications for message transport, national legal/regulatory workflows (e.g., reimbursement, national validation), and the broader prescribing/administration processes that vary by jurisdiction.

Key topics and requirements

• Definition of the electronic prescription as an information object and the roles of prescriber and dispenser.
• Core data elements that an ePrescription should contain (patient identifiers, prescriber identifiers, medication identity and form, dosage instructions, quantity, directions for use, validity/expiry, authorization and signature/authentication metadata).
• Applicability focused on authorized medicinal products and pharmacy‑compounded preparations; non‑medicinal products are out of primary scope.
• Requirements to support authenticity and clear identification of essential elements (to enable legal dispensing and clinical safety), while leaving transport/exchange and jurisdictional workflow decisions to national implementations.
• Guidance intended to be generic and adaptable to different care settings (community, institutional) and legal frameworks.

Typical use and users

ISO 17523:2016 is intended for standards bodies, national eHealth authorities, healthcare IT vendors, EHR and ePrescribing system implementers, pharmacies, hospital information departments, and regulators who define or adopt ePrescription content requirements. Implementers commonly map the ISO content model to local data models or to exchange frameworks (for example, FHIR profiles or national messaging specifications).

Related standards

Key related or complementary standards and initiatives include the newer ISO 17523:2025 (which revises and republishes the ePrescription requirements), ISO/TC 215 health informatics work, electronic health record communication standards such as ISO 13606, and international/supranational implementation guides and profiles based on HL7 FHIR and IHE for prescription and dispense workflows. Many jurisdictions adopt or adapt ISO content into regional or national implementation guides (for example, EN adoptions and FHIR ePrescription guides).

Keywords

electronic prescription; ePrescription; health informatics; medication data; prescription content; prescriber; dispenser; medication orders; ISO 17523.

FAQ

Q: What is this standard?

A: ISO 17523:2016 is an International Standard that specified the content requirements and core data elements for electronic prescriptions (ePrescriptions).

Q: What does it cover?

A: It covers the required content of the ePrescription document (patient, prescriber, medicinal product identification, dosage and directions, validity, and related metadata). It does not specify message transport, national legal workflows, or broader EHR exchange mechanisms.

Q: Who typically uses it?

A: Standards bodies, national eHealth programs, healthcare IT vendors, EHR/ePrescribing system implementers, pharmacies, hospitals, and regulators use it to define or harmonize the data content of prescriptions.

Q: Is it current or superseded?

A: The 2016 edition has been withdrawn and a revised edition is available as ISO 17523:2025 (published 2025). Implementers should refer to the 2025 edition for the current, published requirements.

Q: Is it part of a series?

A: ISO 17523 sits within the ISO/TC 215 health informatics portfolio (ICS 35.240.80) and is commonly used alongside other EHR and medication-related standards and implementation guides (for example ISO 13606, HL7 FHIR prescription/medication profiles and IHE medication profiles).

Q: What are the key keywords?

A: electronic prescription, ePrescription, medication, prescriber, dispenser, prescription content, health informatics, ISO 17523.