oSIST prEN ISO 13606-1:2026

• Abstract:

  This document specifies a means for communicating part or all of the electronic health record (EHR) of one or more identified subjects of care between EHR systems, or between EHR systems and a centralised EHR data repository.; It can also be used for EHR communication between an EHR system or repository and clinical applications or middleware components (such as decision support components), or personal health applications and devices, that need to access or provide EHR data, or as the representation of EHR data within a distributed (federated) record system.; This document will predominantly be used to support the direct care given to identifiable individuals or self-care by individuals themselves, or to support population monitoring systems such as disease registries and public health surveillance. Uses of health records for other purposes such as teaching, clinical audit, administration and reporting, service management, research and epidemiology, which often require anonymization or aggregation of individual records, are not the focus of this document but such secondary uses might also find the document useful.; This Part 1 of the multipart series is an Information Viewpoint specification as defined by the Open Distributed Processing ? Reference model: Overview (ISO/IEC 10746-1). This document is not intended to specify the internal architecture or database design of EHR systems.

• Status: Not Published
• Public Enquiry End Date: 16-Sep-2026
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ITC - Information technology
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 22-Jul-2026
• Due Date: 09-Dec-2026
• Completion Date: 20-Aug-2026
• Ref Project: prEN ISO 13606-1 - Health informatics - Electronic health record communication - Part 1: Reference model (ISO/DIS 13606-1:2026)

• Revises: SIST EN ISO 13606-1:2019 - Health informatics - Electronic health record communication - Part 1: Reference model (ISO 13606-1:2019)
• Effective Date: 22-Jan-2025

Overview

oSIST prEN ISO 13606-1:2026: Health informatics - Electronic health record communication - Part 1: Reference model establishes a standardized framework for the safe, meaningful, and interoperable exchange of electronic health record (EHR) information. Developed jointly by CEN and ISO, this reference model defines how part or all of a patient’s EHR can be communicated between disparate EHR systems, centralized repositories, clinical applications, personal health devices, and middleware that supports healthcare delivery and public health functions.

The primary purpose of this standard is to facilitate best practices for direct patient care, self-care, and population monitoring activities such as disease registries and public health surveillance. By focusing on semantic consistency, provenance, and confidentiality, oSIST prEN ISO 13606-1:2026 supports interoperability across complex healthcare environments without dictating internal system architecture or database design.

Key Topics

• Reference Model Structure: The standard introduces a hierarchical model describing the main building blocks of EHR information, such as EHR extracts, folders, compositions, sections, entries, and elements. This structure enables consistent organization and communication of clinical data.
• EHR Interoperability: It provides the foundation for semantic and structural interoperability, enabling EHR systems from different vendors and organizations to safely exchange patient health information while preserving clinical meaning and original context.
• Dual Model Approach: The specification distinguishes between a stable, generic reference model and adaptable archetype models. Archetypes are used to constrain and define clinical content for specific healthcare domains, supporting flexible yet standardized communication.
• Roles and Provenance: Key roles in the creation, attestation, and commitment of EHR documentation are defined, supporting traceability, auditability, and legal compliance.
• Confidentiality and Security: The model embeds mechanisms to convey the confidentiality status and handling of personal health information, aligning with global privacy requirements.
• Alignment with Other Standards: The standard is designed to align with related terminologies and interoperable frameworks such as HL7 FHIR and openEHR, facilitating integration within modern healthcare IT environments.

Applications

oSIST prEN ISO 13606-1:2026 offers significant practical value in several scenarios:

• Direct Patient Care: Enables clinicians to access consolidated EHR data about an individual, regardless of where or how the data was originally collected, supporting continuity and quality of care.
• Personal Health Systems: Facilitates secure sharing of health data between personal health devices/applications and centralized or distributed EHR repositories, empowering patient self-care and engagement.
• Population Health and Disease Registries: Supports public health authorities and researchers in gathering consistent, accurate data for population monitoring, disease tracking, and surveillance programs.
• Middleware and Clinical Decision Support: Provides a reliable foundation for middleware components, such as decision support systems and alerting services, to access or update EHR information without compromising semantic integrity.
• Multi-Organization and Multi-National Collaboration: Facilitates cross-institutional, regional, or national health information exchange, including federation or consolidation of patient records across boundaries.

Related Standards

The oSIST prEN ISO 13606-1:2026 reference model is part of a broader family of standards designed to enhance EHR interoperability worldwide. Related standards include:

• ISO 13606-2: Archetype Interchange Specification – for defining and exchanging clinical archetypes.
• ISO 13606-3: Reference Terminology and Constraints – offering guidance on terminology binding for data elements.
• ISO 13606-4: EHR Communication Security – addressing confidentiality, integrity, and security requirements.
• ISO 13606-5: Interface Specification – describing pragmatic approaches for system interfaces.
• HL7 FHIR: A modern, API-driven framework for exchanging healthcare information electronically, with which ISO 13606 aligns structurally.
• openEHR Reference Model: An extensively used, open standard for health data architectures aligned with dual model approaches.
• ISO/IEC 10746 (ODP Reference Model): Underpins the information viewpoint and distributed processing elements of this standard.

In summary, oSIST prEN ISO 13606-1:2026 provides the essential reference model to enable safe, meaningful EHR data exchange across diverse healthcare IT systems, supporting both contemporary and emerging medical informatics applications.

SLOVENSKI STANDARD
01-september-2026
Zdravstvena informatika - Komunikacija z elektronskimi zdravstvenimi zapisi - 1.
del: Referenčni model (ISO/DIS 13606-1:2026)
Health informatics - Electronic health record communication - Part 1: Reference model
(ISO/DIS 13606-1:2026)
Medizinische Informatik - Kommunikation von Patientendaten in elektronischer Form -
Teil 1: Referenzmodell (ISO/DIS 13606-1:2026)
Informatique de santé - Communication du dossier de santé informatisé - Partie 1:
Modèle de référence (ISO/DIS 13606-1:2026)
Ta slovenski standard je istoveten z: prEN ISO 13606-1
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
International
Standard
ISO/DIS 13606-1
ISO/TC 215
Health informatics — Electronic
Secretariat: ANSI
health record communication —
Voting begins on:
Part 1: 2026-06-29
Reference model
Voting terminates on:
2026-09-21
Informatique de santé — Communication du dossier de santé
informatisé —
Partie 1: Modèle de référence
ICS: 35.240.80
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO/DIS 13606-1:2026(en)
DRAFT
ISO/DIS 13606-1:2026(en)
International
Standard
ISO/DIS 13606-1
ISO/TC 215
Health informatics — Electronic
Secretariat: ANSI
health record communication —
Voting begins on:
Part 1:
Reference model
Voting terminates on:
Informatique de santé — Communication du dossier de santé
informatisé —
Partie 1: Modèle de référence
ICS: 35.240.80
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2026
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
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POTENTIAL TO BECOME STANDARDS TO
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or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
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TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
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Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 13606-1:2026(en)
ii
ISO/DIS 13606-1:2026(en)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
3.1 Actors .1
3.2 Concepts and terms .3
3.3 Information management .3
3.4 Privacy and security .5
3.5 Process management .6
4 Abbreviations . 6
5 Overview . 6
5.1 Overview of the reference model .6
5.2 Representing roles and responsibilities within the EHR _EXTRACT .7
5.2.1 General .7
5.2.2 Actors playing a role in the actual healthcare process .7
5.2.3 Actors contributing to the process of documenting care within the EHR .8
5.2.4 Actors confirming the validity of the EHR documentation .8
5.2.5 Subject of care .8
5.2.6 Composer .9
5.2.7 Committer .9
5.2.8 Subject of information .9
5.2.9 Information provider .10
5.3 About the use of datatypes in this document .10
6 Common Properties of Record Components .11
6.1 Base, record and structure components .11
6.1.1 General .11
6.1.2 Base component . 12
6.1.3 Electronic health record component . 13
6.1.4 Structure component . 15
6.2 Attestation .16
6.2.1 General .16
6.2.2 Attestation information .17
6.3 Audit information .18
6.4 Linking record components .21
6.4.1 General .21
6.4.2 Link usages .21
6.4.3 Communicating referenced record components . 23
6.4.4 Link . 23
6.4.5 External link .24
7 Elements and data values .25
7.1 General . 25
7.2 Data value. 26
7.2.1 Boolean .27
7.2.2 Attachment . 28
7.2.3 String . 30
7.2.4 Simple text .31
7.2.5 Coded simple value .31
7.2.6 Coded value .32
7.2.7 Instance identifier . 34
7.2.8 URI.37
7.2.9 Physical quantity . . 38

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ISO/DIS 13606-1:2026(en)
7.2.10 Duration . 39
7.2.11 Real . 39
7.2.12 Integer . 40
7.2.13 Instant .41
7.2.14 Date .42
7.2.15 Time .42
7.2.16 Date time .43
7.2.17 Data value . 44
8 EHR Components .45
8.1 General .45
8.2 Folder . 46
8.2.1 General . 46
8.2.2 Folder .47
8.3 Compositions . . 48
8.3.1 General . 48
8.3.2 Composition . 48
8.4 Content and sections . 50
8.4.1 General . 50
8.4.2 Content . 50
8.4.3 Section .51
8.5 Entries .51
8.5.1 General .51
8.5.2 Entry .52
8.6 Items and clusters . . 53
8.6.1 Item . 53
8.6.2 Cluster . 54
8.7 Element . 55
9 EHR Extract . .56
9.1 General . 56
9.2 EHR extract . 56
9.3 Extracted component set .57
9.4 Demographic extract. 58
10 Demographics .59
10.1 General .59
10.2 Demographic folder . 60
10.3 Demographic entity .61
10.4 Demographic item .61
10.5 Demographic cluster .62
10.6 Demographic element . . 63
11 Conformance .64
[5]
Annex A (informative) About the ISO 21090:2011 profile for datatypes .65
Annex B (informative) Alignment with HL7 FHIR .69
Annex C (informative) Cross-Domain Interoperability .70
Bibliography .75

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ISO/DIS 13606-1:2026(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent
rights identified during the development of the document will be in the Introduction and/or on the ISO list of
patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 215, Health Informatics.
This third edition cancels and replaces previous editions, which have been technically revised
— The scope of all parts remains the same.
— The alignment with HL7 FHIR and with the openEHR Reference Model has been improved, utilising the
[1]
guide published in ISO/PAS 24305 .
— The name attribute has been reinstated in this revision against circumstances to cater better for vendors
and providers who do not intend to use archetypes.
— The structural alignment with the openEHR Reference Model and archetype-based semantics has been
improved. However, the explicitly separate template layer that openEHR uses has not been introduced,
and is an area of consideration for future harmonisation guidance.
A list of all parts in the ISO 13606 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

v
ISO/DIS 13606-1:2026(en)
Introduction
0.1  Preface
The overall goal of this document is to define a rigorous and stable information architecture for exchanging
or archiving part or all of the electronic health record (EHR) of a single subject of care (patient), or for a
group of patients whose information might need to be communicated together (for example, a family). This is
to support the interoperability of systems (see Annex C). and components that need to communicate (access,
transfer, add or modify) EHR data. The information architecture defined in this document is intended to
support safe processing of exchanged EHR data by ensuring that the exchange can:
— preserve the original clinical meaning intended by the author;
— incorporate the necessary provenance metadata to inform the recipient or receiving system about the
context in which the EHR data were obtained and composed;
— observe and communicate the confidentiality of that data as intended by the author and subject of care .
This document considers the EHR to be the persistent longitudinal and potentially multi-organisation or
multi-national record of health and care provision, most often relating to a single subject of care (the patient),
created and stored in one or more physical systems. Its primary purpose is to support future healthcare for
the subject of care and to provide a medico-legal record of care delivered. This corresponds to the definition
[2]
provided in ISO 18308 .
This document is not intended to specify the internal architecture or database design of EHR systems or
components, nor is it intended to prescribe the kinds of clinical applications that might request or contribute
EHR data in particular settings, domains or specialities. For this reason, the information model proposed
here is called the EHR Extract, and might be used to define a message, an XML document or schema, or
an object interface. These might be used to communicate EHR data between two repositories, to update
a centralised regional or national EHR repository, or within a distributed network of EHR components,
systems and services. Whilst an EHR service or system will need to interact with many other services or
systems providing terminology, medical knowledge, guidelines, workflow, security, persons registries,
billing etc. this document has only touched on those areas if some persistent trace of such interactions is
required in the EHR itself, and therefore requires specific features in the reference model to communicate
that trace.
This document may offer a practical and useful contribution to the design of EHR systems but will primarily
be realised as a common set of external interfaces or messages built on otherwise heterogeneous clinical
systems. The components that might support an interface conforming to this document will be not only
electronic health record systems but also other middleware services such as security components, guideline
and workflow systems, alerting and decision support services, personal health systems and applications,
sensors and wearable devices, and medical knowledge management services. This document might also
prove useful for communicating data about individuals between electronic health record systems and
population registries, and also for conducting (approved) research using electronic health records.
This document is part of a five-part standard series, published jointly by CEN and ISO through the Vienna
Agreement.
In this document dependency upon any of the other parts of this series is explicitly stated where it applies.
0.2  Technical approach
This document is the third version of an original standard which was published in 2007 by CEN, and in 2008
[2]
by ISO. It meets the relevant requirements in ISO 18308 .
The revision has taken into account, and aligns as far as possible, with other CEN and ISO Standards and
Technical Specifications with which this document might also be used, with international terminology
standards and with emerging standards from HL7: Fast Healthcare Interoperability Resources (FHIR). The
specifications in this document have drawn from, and align as far as possible with, the reference model
specifications published by the openEHR Foundation, and with the archetype models published by the
openEHR Foundation.
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ISO/DIS 13606-1:2026(en)
The information model in this document is an Information Viewpoint of the ISO Reference Model for Open
[3]
Distributed Processing (ISO/IEC 10746-1 ). In practical terms, this document defines the structure and
semantics of EHR information to be exchanged, rather than prescribing technologies, storage architectures,
or deployment patterns.
Given the diversity of deployed EHR systems, this document permits optionality for many features of EHR
communication. However, a minimum level of prescription is required to ensure that EHR extracts can
be processed safely and consistently by EHR recipient systems. This is reflected in mandatory properties
within the models in Parts 1, 2 and 4 of this series, and through normative term lists (defined in Part 3).
0.3  The Dual Model approach
The challenge for EHR interoperability is to devise a generalised approach to representing every conceivable
kind of health record data structure in a consistent way. This needs to cater for records arising from any
profession, speciality or service, whilst recognising that the healthcare data sets, value sets and other
context-specific clinical content artefacts required by different healthcare domains will be diverse, complex
and will change frequently as clinical practice and medical knowledge advance. This requirement is part of
the widely acknowledged health informatics challenge of semantic interoperability .
The approach adopted by this standard series distinguishes a Reference Model, defined in this document
and used to represent the generic properties of health record information , and Archetypes (conforming
[4]
to an archetype model , defined in ISO 13606-2:2019 ), which are meta-data used to define patterns
for the specific characteristics of the healthcare data that represents the requirements of each particular
profession, speciality or service.
This document adopts a dual model approach based on a stable Reference Model and archetype constraints.
However, readers should note that openEHR operationalises a more explicit multi-level modelling pattern
in which archetypes define reusable domain concepts and templates apply context-specific constraints for
particular use cases, workflows and deployment settings. In this document, such template-level concerns
are not separated with the same degree of formality, and this has implications for granularity, semantic
governance and implementation guidance.
The Reference Model represents the global characteristics of health record components, how they are
aggregated, and the context information required to meet ethical, legal and provenance requirements.
This model defines the set of classes that form the generic building blocks of the EHR. It reflects the stable
characteristics of an electronic health record , and would be embedded in a distributed (federated) EHR
environment as specific messages or interfaces (as specified in Part 5 of this series).
This generic information model needs to be complemented by a formal method of communicating and
sharing the organisational structure of predefined classes of EHR fragment corresponding to sets of record
components made in particular clinical situations. These are effectively pre-coordinated combinations
of named RECORD_COMPONENT hierarchies that are agreed within a community in order to ensure
interoperability, data consistency and data quality.
An Archetype is the formal definition of prescribed combinations of the building-block classes defined in
the Reference Model for particular clinical domains or organisations. An archetype is a formal expression of
a distinct, domain-level concept, expressed in the form of constraints on data whose instances conform to the
reference model. For an EHR_EXTRACT, as defined in this document, an archetype instance specifies (and
effectively constrains) a particular hierarchy of RECORD_COMPONENT sub-classes, defining or constraining
their names and other relevant attribute values, optionality and multiplicity at any point in the hierarchy,
the data types and value ranges that ELEMENT data values may take, and other constraints.
This document recognises that archetypes (or equivalent clinical models) are not always directly
incorporated within the present-day architectures of electronic health record systems. This document
therefore does not mandate that archetypes are used within such systems. It does, however, require that
the clinical information models or equivalents (data items, data item aggregations, data value constraints,
terminology bindings, units of measure etc.) that have been used to generate an EHR_EXTRACT are
themselves created and communicated, or referenced, within each EHR_EXTRACT. These communicated or
referenced archetypes have to conform to Part 2 of this standard series, and maybe communicated through
an interface conforming to part 5 of this Standard series.

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ISO/DIS 13606-1:2026(en)
In this document, archetypes are the primary formal mechanism for expressing domain-level constraints
over the reference model. Where implementers use templates or equivalent contextual artefacts, these are
better understood as implementation-specific assemblies or refinements of archetypal content rather than
as a separately formalised modelling layer.
0.4 Overview of the EHR_EXTRACT record hierarchy
The information in a health record is inherently hierarchical. Clinical observations, reasoning and intentions
can have a simple or a more complex structure. They are generally organised under headings, and contained
in “documents” such as consultation notes, letters and reports. These documents are usually filed in folders,
and a subject of care may have more than one folder within a healthcare enterprise (e.g. medical, nursing,
and obstetric).
The EHR Communications Reference Model needs to reflect this hierarchical structure and organisation,
meeting published requirements in order to be faithful to the original clinical context and to ensure meaning
is preserved when records are communicated between heterogeneous clinical systems. To do this, the model
formally sub-divides the EHR hierarchy into parts that have been found to provide a consistent mapping to
the ways which individual EHRs are organised within heterogeneous EHR systems.
These parts are summarised in Table 1 below.
Table 1 — Main hierarchy components of the EHR Extract Reference Model
EHR HIERARCHY DESCRIPTION EXAMPLES
COMPONENT
EHR_EXTRACT The top-level container of part or all of the (Not applicable)
EHR of a single subject of care or for a group of
subjects of care (such as a family), for communi-
cation between an EHR Provider system and an
EHR Recipient.
FOLDER The high level organisation within an EHR, Diabetes care, Schizophrenia, Cholecys-
dividing it into compartments relating to care tectomy, Paediatrics, St Mungo’s Hospi-
provided to a single subject of care , for a single tal, GP Folder, Episodes 2000-2001.
condition, by a clinical team or institution, or
over a fixed time period such as an episode of
care.
COMPOSITION The set of information committed to one EHR Progress note, Laboratory test result
by one agent, as a result of a single clinical en- form, Radiology report, Referral letter,
counter or record documentation session. Clinic visit, Clinic letter, Discharge sum-
mary, Functional health assessment,
Diabetes review.
SECTION EHR data within a COMPOSITION that belongs Reason for encounter, Past history,
under one clinical heading, usually reflecting Family history, Allergy information
the flow of information gathering during a , Subjective symptoms, Objective
clinical encounter, or structured for the benefit findings, Analysis, Plan, Treatment,
of future human readership. Diet, Posture, Abdominal examination,
Retinal examination.
ENTRY The information recorded in an EHR as a result A symptom, an observation, one test
of one clinical action, one observation, one clin- result, a prescribed drug, an allergy
ical interpretation, or an intention. This is also reaction, a diagnosis, a differential di-
known as a clinical statement. agnosis, a differential white cell count,
blood pressure measurement.
CLUSTER The means of organising nested multi-part data Audiogram results, electro-encephalo-
structures such as time series, and to represent gram interpretation, weighted differen-
the columns of a table. tial diagnoses.
ELEMENT The leaf node of the EHR hierarchy, containing a Systolic blood pressure, heart rate, drug
single data value. name, symptom, body weight.
An EHR_EXTRACT contains EHR data as COMPOSITIONs, organised in a FOLDER hierarchy.
COMPOSITIONs contain ENTRYs, optionally contained within a SECTION hierarchy.

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ISO/DIS 13606-1:2026(en)
ENTRYs contain ELEMENTS, optionally contained within a CLUSTER hierarchy.
Representing participation: The Reference Model in the previous version of this standard provided explicit
classes at certain parts of the Record Component hierarchy through which it was possible to represent the
identity and roles played by actors contributing to healthcare and to its documentation. In this version of the
Reference Model the LINK class is intended to be used to reference demographic entities. The roles played
by these entities can be labelled using extended term lists defined in Part 3 of this standard series. This
updated mechanism offers greater flexibility than the previous version in where the references to such
democratic entities may be represented within the Record Component hierarchy.
Representing context: Any EHR_EXTRACT references any other RECORD_COMPONENTS that are
connected to the communicated content, for example via the RECORD_COMPONENT hierarchy and via LINK
targets. If the EHR exchange service (e.g. as specified in Part 5) permits access to referenced components,
any user would be able to access and review any additional areas of content that were not originally included.
(Archetypes bring together the key elements of immediate documentation context.)
Representing authenticity: Every EHR_EXTRACT may contain attested views: these might be PDF or html
or other renderings that are the authentic view of what was seen and persisted by the original author. The
proof may also optionally be included, which is the evidence of a digital signature .
EHR_EXTRACTS are created for specific purposes, and will not automatically guarantee that these will be fit
for other purposes.
0.5  Relationship of this standard to other relevant standards
[5]
— The data types used in this document are a profile of ISO 21090:2011 .
[6]
— Alignment has especially been undertaken with ISO 13940 . All of the terms and definitions within the
ISO 13606 series have been harmonised across the five parts, with most of the terms being in Part 1. All
[6]
of them have been aligned with ISO 13940 .
— An important 13606 FHIR profile project is in progress within HL7 (see Annex B). No challenges have
been identified with being able to create such a profile.
[7]
— Parts 1 and 4 align with ISO 27789 . Alignment in Part 4 has been maintained with ISO 22600 series .

ix
DRAFT International Standard ISO/DIS 13606-1:2026(en)
Health informatics — Electronic health record
communication —
Part 1:
Reference model
1 Scope
This document specifies a means for communicating, or preserving as an archive, part or all of the electronic
health record (EHR) of one or more identified subjects of care between EHR systems, or between EHR
systems and a centralised EHR data repository .
It can also be used for EHR communication between an EHR system or repository and clinical applications
or middleware components (such as decision support components), or personal health applications and
devices, that need to access or provide EHR data, or as the representation of EHR data within a distributed
(federated) record system.
This document will predominantly be used to support the direct care given to identifiable individuals or
self-care by individuals themselves, or to support population monitoring systems such as disease registries
and public health surveillance, animals, and events such as pollution, poisons, etc. . Uses of health records for
other purposes such as teaching, clinical audit, administration and reporting, service management, research
and epidemiology, which often require anonymization or aggregation of individual records, are not the focus
of this document but such secondary uses might also find the document useful.
[3]
This document is an Information Viewpoint specification as defined ISO/IEC 107
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