prEN ISO 13606-5

• Abstract:

  This document specifies the information architecture required for interoperable communications between systems and services that need or provide EHR data. This document is not intended to specify the internal architecture or database design of such systems.; The subject of the record or record extract to be communicated is an individual person, and the scope of the communication is predominantly with respect to that person's care.; Uses of healthcare records for other purposes such as administration, management, research and epidemiology, which require aggregations of individual people's records, are not the focus of this document but such secondary uses could also find the document useful.; This document defines a set of interfaces to request and provide:; — an EHR_EXTRACT for a given subject of care as defined in ISO 13606-1;; — one or more ARCHETYPE(s) as defined in ISO 13606-2;; — an EHR_AUDIT_LOG_EXTRACT for a given subject of care as defined in ISO 13606-4.; This document defines the set of interactions to request each of these artefacts, and to provide the data to the requesting party or to decline the request. An interface to query an EHR or populations of EHRs, for example for clinical audit or research, are beyond its scope, although provision is made for certain selection criteria to be specified when requesting an EHR_EXTRACT which might also serve for population queries.; This document defines the Computational Viewpoint for each interface, without specifying or restricting particular engineering approaches to implementing these as messages or as service interfaces.; This document effectively defines the payload to be communicated at each interface. It does not specify the particular information that different transport protocols will additionally require, nor the security or authentication procedures that might be agreed between the communicating parties or required by different jurisdictions.

• Status: Not Published
• Publication Date: 02-Apr-2028
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: CEN/TC 251 - Medical informatics
• Drafting Committee: CEN/TC 251/WG 1 - Information models
• Current Stage: 4020 - Submission to enquiry - Enquiry
• Start Date: 08-Oct-2026
• Completion Date: 08-Oct-2026
• Ref Project: oSIST prEN ISO 13606-5:2026 - Health informatics - Electronic health record communication - Part 5: Interface specification (ISO/DIS 13606-5:2026)

• Revises: EN ISO 13606-5:2019 - Health informatics - Electronic health record communication - Part 5: Interface specification (ISO 13606-5:2019)
• Effective Date: 22-Jan-2025

prEN ISO 13606-5 is a CEN and ISO draft standard for health informatics that specifies the interface layer for electronic health record communication. It defines how an EHR requester, an EHR provider and an EHR recipient exchange an EHR_EXTRACT, ARCHETYPEs and an EHR_AUDIT_LOG_EXTRACT for an individual subject of care.

What does prEN ISO 13606-5 specify?

prEN ISO 13606-5 specifies the information architecture for interoperable communication between systems and services that need or provide EHR data. It is focused on communication for a person’s care, not on the internal database design or internal architecture of the systems that use it.

The document is organized into Scope, Normative references, Terms and definitions, Abbreviations, Conformance, Interactions, Interfaces, Term Lists, and Bibliography. Clause 7 contains the three interface definitions that are the core of the standard.

What are the key requirements of prEN ISO 13606-5?

prEN ISO 13606-5 defines three request-and-response interfaces, and each one is built around a requester, a provider and a recipient. In practice, this means implementers need to support a defined payload for the request, a return value for the supplied artefact, and a rejection path when the request cannot be fulfilled.

REQUEST_EHR_EXTRACT

Clause 7.1 defines the request for an EHR_EXTRACT. The request must identify the subject of care and may refine the request with a purpose, record component identifiers, a time period, a maximum sensitivity level, all_versions, multimedia_included, archetype_id, and structure_only.

This matters because the interface is designed to narrow an extract as precisely as needed. For example, structure_only supports a table-of-contents style request for large records, while max_sensitivity and multimedia_included let implementers control what content is returned.

REQUEST_ARCHETYPES

Clause 7.2 defines the request for one or more ARCHETYPEs. The request can identify archetype_ids directly or select them by concept, specialisations, parent_of, terminology_available, or language_available.

This matters for repository and modelling work because the same interface can be used to fetch a known archetype or discover suitable archetypes by content or terminology. The response returns one or more ARCHETYPE instances, or the provider can return a rejection reason.

REQUEST_EHR_AUDIT_LOG_EXTRACT

Clause 7.3 defines the request for an EHR_AUDIT_LOG_EXTRACT. The request identifies the subject of care and can constrain the response by time_period, rc_ids, max_sensitivity, archetype_ids, and using_policies.

This matters when access history needs to be reviewed for a patient record or a specific part of that record. The interface allows audit-log retrieval to be targeted instead of requesting the full record history.

Conformance and implementation

Clause 5 says a conforming message or service interface shall include the mandatory parameters for the chosen interface and shall be able to process the optional ones too. The same clause also allows local extensions, but those extensions are only valid within the agreed jurisdiction or environment.

Clause 6 makes the document explicitly about the Computational Viewpoint. That means it defines the payload and the logical interaction, while leaving transport choices such as SOAP, REST, FHIR, EDIFACT or ebXML to the implementation.

What terms does prEN ISO 13606-5 define?

EHR_requester is the entity or service that initiates the communication request. It is the party that asks for the extract, archetype or audit log.

EHR_provider is the service that holds and can return the requested artefact. In practice, this is the repository or system that answers the request.

EHR_recipient is the entity or service that receives the communicated EHR data. It may be the same party as the requester, but it does not have to be.

EHR_EXTRACT is the part or all of the electronic health record of a subject of care that is being communicated. The document uses it as the main payload for clinical record sharing.

EHR_AUDIT_LOG_EXTRACT is the audit log activity history for part or all of an EHR. It is the payload used when access history or use history is being communicated.

Who uses prEN ISO 13606-5?

prEN ISO 13606-5 is used by healthcare software vendors, EHR system designers, archetype repository services and health IT architects who need to implement record communication interfaces. It also serves clinicians, GPs, nurses, physiotherapists, system administrators, managers, researchers, patients and legal representatives when their systems exchange EHR data.

The standard is relevant in hospitals, general practice, national EHR repositories, decision support, reporting, security and audit systems, and cross-organisation health networks. It is especially useful where systems must request a targeted extract, fetch archetypes, or review audit activity for a named subject of care.

What changed in prEN ISO 13606-5 from the previous edition?

prEN ISO 13606-5 is the third edition and replaces ISO 13606-5:2019. The stated changes are updated lists of applicable web service architecture styles and API schemas to include REST and FHIR, and the addition of the structure_only parameter to REQUEST_EHR_EXTRACT for incremental retrieval of large records and better respect for data protection principles.

Which standards are used with prEN ISO 13606-5?

ISO/TS 14265 provides the default terminology for the purpose field. ISO/DIS 13606-1 supplies the EHR_EXTRACT reference model, ISO 13606-2 supplies the ARCHETYPE model, and ISO 13606-4 supplies the EHR_AUDIT_LOG_EXTRACT model and related security context.

ISO/CD 13606-3 is named for term lists and reference archetypes, while ISO/DIS 18308 is named for the corresponding enterprise viewpoint. The introduction also points to the ISO 12967 series for compatibility and the ISO 22600 series for security and authorization mechanisms.

What does the prEN ISO 13606-5 document contain?

The document contains three interface definitions in Clause 7, each with purpose, description, function list and parameter tables. Tables 1 to 9 define the request, rejection and return-value structures for EHR_EXTRACT, ARCHETYPEs and EHR_AUDIT_LOG_EXTRACTs.

It also contains a term list in Table 10 for rejection reasons and a purpose terminology note tied to ISO/TS 14265. Figure 1 gives the interaction diagram for the requester-provider-recipient relationship, and the bibliography identifies the companion parts of the ISO 13606 series and related standards.

SLOVENSKI STANDARD
01-december-2026
Zdravstvena informatika - Komunikacija z elektronskimi zdravstvenimi zapisi - 5.
del: Specifikacija vmesnika (ISO/DIS 13606-5:2026)
Health informatics - Electronic health record communication - Part 5: Interface
specification (ISO/DIS 13606-5:2026)
Medizinische Informatik - Kommunikation von Patientendaten in elektronischer Form -
Teil 5: Interface-Spezifikation (ISO/DIS 13606-5:2026)
Informatique de santé - Communication du dossier de santé informatisé - Partie 5:
Spécification d'interfaces (ISO/DIS 13606-5:2026)
Ta slovenski standard je istoveten z: prEN ISO 13606-5
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 13606-5
ISO/TC 215
Health informatics — Electronic
Secretariat: ANSI
health record communication —
Voting begins on:
Part 5: 2026-10-05
Interface specification
Voting terminates on:
2026-12-28
Informatique de santé — Communication du dossier de santé
informatisé —
Partie 5: Spécification d'interfaces
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 has not been edited by the ISO Central Secretariat.
IN ADDITION TO THEIR EVALUATION AS
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USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
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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 13606-5:2026(en)
DRAFT
ISO/DIS 13606-5:2026(en)
International
Standard
ISO/DIS 13606-5
ISO/TC 215
Health informatics — Electronic
Secretariat: ANSI
health record communication —
Voting begins on:
Part 5:
Interface specification
Voting terminates on:
Informatique de santé — Communication du dossier de santé
informatisé —
Partie 5: Spécification d'interfaces
ICS:
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 has not been edited by the ISO Central 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
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
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RECIPIENTS OF THIS DRAFT ARE INVITED
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Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 13606-5:2026(en)
ii
ISO/DIS 13606-5:2026(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviations . 2
5 Conformance . 2
6 Interactions . 3
7 Interfaces . 5
7.1 Interface: REQUEST_EHR_EXTRACT .5
7.2 Interface: REQUEST_ARCHETYPES .8
7.3 Interface: REQUEST_EHR_AUDIT_LOG_EXTRACT .9
7.4 Term Lists .11
Bibliography .12

iii
ISO/DIS 13606-5:2026(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 on 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 the following URL:
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 215, Health Informatics.
This third edition cancels and replaces the second edition (ISO 13606-5:2019), which has been technically
revised. The main changes compared to the previous edition are as follows:
— lists of applicable web service architecture styles and API schemas have been updated to include REST
and FHIR .
— the parameter structure_only has been added to the REQUEST_EHR_EXTRACT interface to support
incremental retrieval of large records and to better respect data protection principles.
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.

iv
ISO/DIS 13606-5:2026(en)
Introduction
0.1 General
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  Preface
This document defines the interfaces by which an EHR_EXTRACT, an ARCHETYPE or an EHR_AUDIT_LOG_
EXTRACT may be requested and provided.
The scope of this document has been considered carefully in order to achieve several objectives:
— to specify those interfaces that are unique to the 13606 context, and not to include more generic health
information communication interfaces that might be the scope of other standards and specifications;
— to specify the interfaces in ways that are compatible with the the ISO 12967 series ;
— to specify the interfaces as computational viewpoints, in order to support the wide range of engineering
viewpoints that might be adopted by individual vendors or eHealth programmes; (it should be noted
[1] [2] [3]
that ISO/DIS 13606-1 , ISO 13606-2 and ISO 13606-4 define the corresponding information
[4]
viewpoints, and that ISO/DIS 18308 defines the corresponding enterprise viewpoint);
— to construct these interfaces such that they might easily be implemented as specialisations of standard
interfaces within the commonly used engineering languages such as Java, Visual Basic, dotnet, SOAP ,
ebXML, REST etc.;
— to work through the Joint SDO Initiative and Council on the production of Engineering Viewpoint
Implementation Guides, that will define more specifically how to implement these interfaces, for example
in HL7 version 3 or FHIR ; these guides will be published separately from this document, to enable them
to be maintained and updated more frequently (to reflect implementation experience) than is possible
for a standards document;
— to recognize that EHR communication will be implemented within a healthcare communications
infrastructure, usually nationally, that will define a generalised approach to many other complementary
and necessary services such as patient demographics registries, provider registries, authentication and
authorization policies and services etc.; these are therefore not part of the formal scope of this document
but are referred to as being assumed and necessary complementary services;
— to require an ISO/TS 22600 series compatible architecture or its equivalent will be used for managing
security services, and not to duplicate or conflict with these services in this document;
— to further support the protection of patient privacy by avoiding the need to reveal if any EHR data has
been withheld by the provider when responding to a request;
— to enable each interface and term set to be extended locally to cater for specialised circumstances of EHR
communication, in which additional requirements constraints might apply.
[1]
This document defines a set of interfaces by which the different artefacts defined in ISO/DIS 13606-1 ,
[2] [3]
ISO 13606-2 and ISO 13606-4 may be requested and provided:
[1]
a) ISO/DIS 13606-1 defines a reference model for an EHR_EXTRACT: part or all of the EHR of a subject of
care;
[2]
b) ISO 13606-2 defines an information model for an ARCHETYPE, and optionally a serialised form
represented using Archetype Definition Language;
[3]
c) ISO 13606-4 defines an EHR_AUDIT_LOG_EXTRACT to communicate the audit log activity history
pertaining to part or all of an EHR .

v
ISO/DIS 13606-5:2026(en)
[5]
(ISO/CD 13606-3 defines term lists and reference archetypes, to which a direct interface is not required.
[3]
ISO 13606-4 defines an access policy model to which a direct interface is also not required.)
This document defines three interfaces, one for each of a-c above, as a communication between an EHR_
requester (wishing to and authorising the communication of the artefact), an EHR_provider (a repository
service that contains and can return the requested artefact) and an EHR_recipient who is intended and
authorized to receive the artefact (usually but not always the same as the EHR_requester).
These interfaces are all expressed as Computational Viewpoint specifications and aim to support
implementation through many different Engineering Viewpoint (transport) formalisms, such as message
protocols (e.g. EDIFACT , HL7 version 3, FHIR ) or service protocols (e.g. SOAP, Java RMI , REST). This document
therefore specifies only the “payload” information to be communicated at each interface. Attributes such
as message identifiers, message time-stamping and message version management are normally defined
and handled by each kind of transport protocol in particular ways, and this document therefore does not
define its own duplication of this kind of information. It should be noted that the EHR_EXTRACT defined
[1] [2]
in ISO/DIS 13606-1 , the ARCHETYPE defined in ISO 13606-2 , and the EHR_AUDIT_LOG_EXTRACT
[3]
defined in ISO 13606-4 all include time-stamping, authorship and version management information of the
payload data as part of their information models.
Request acknowledgements and system/communication error messages are routinely handled by most
engineering transport protocols. It is also not appropriate that this document duplicates these. An optional
exception is defined to communicate back to the EHR_requester a reason why a request has been received
but refused, if it is legitimate to reveal this without breaching confidentiality.
The EHR_requester will need to authenticate to the EHR_provider in ways that are to be locally determined,
and will present authorization credentials that are also beyond the scope of this document but are
specified in the ISO 22600 series. It is recognised that there might be times when an EHR_requester wishes
the EHR_provider to “send” the EHR_EXTRACT to a third party. This document may be used within a
delegation architecture, in which an EHR_requester acts on behalf of another party, but the representation
and communication of the hierarchy of authorisations involved in delegation is a matter for the privilege
management and access control architecture and does not directly impact on this document. Alternatively,
local arrangements may be made to securely communicate to a third party a unique reference for any
particular RECORD_COMPONENT (e.g. for a particular letter or discharge summary, via the ehr-id and rc_id
of the COMPOSITION) that the third party is recommended to and has permission to access directly, without
therefore requiring the use of delegation.

vi
DRAFT International Standard ISO/DIS 13606-5:2026(en)
Health informatics — Electronic health record
communication —
Part 5:
Interface specification
1 Scope
This document specifies the information architecture required for interoperable communications between
systems and services that need or provide EHR data. This document is not intended to specify the internal
architecture or database design of such systems.
The subject of the record or record extract to be communicated is an individual person, and the scope of the
communication is predominantly with respect to that person’s care.
Uses of healthcare records for other purposes such as administration, management, research and
epidemiology, which require aggregations of individual people’s records, are not the focus of this document
but such secondary uses could also find the document useful.
This document defines a set of interfaces to request and provide:
[1]
— an EHR_EXTRACT for a given subject of care as defined in ISO/DIS 13606-1 ;
[2]
— one or more ARCHETYPE(s) as defined in ISO 13606-2 ;
[3]
— an EHR_AUDIT_LOG_EXTRACT for a given subject of care as defined in ISO 13606-4 .
This document defines the set of interactions to request each of these artefacts, and to provide the data to
the requesting party or to decline the request. An interface to query an EHR or populations of EHRs, for
example for clinical audit or research, are beyond its scope, although provision is made for certain selection
criteria to be specified when requesting an EHR_EXTRACT which may also serve for population queries.
This document defines the Computational Viewpoint for each interface, without specifying or restricting
particular engineering approaches to implementing these as messages or as service interfaces.
This document effectively defines the payload to be communicated at each interface. It does not specify
the particular information that different transport protocols will additionally require, nor the security or
authentication procedures that may be agreed between the communicating parties or required by different
jurisdictions.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO/TS 14265, Health informatics — Classification of purposes for processing personal health information
3 Terms and definitions
[1] [2]
For the purposes of this document, the terms and definitions given in ISO/DIS 13606-1 , ISO 13606-2 ,
[3]
ISO 13606-4 and the following apply.

ISO/DIS 13606-5:2026(en)
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
electronic health record requester, noun
entity initiating a request for electronic health record communication to take place between an electronic
health record provider and an electronic health record recipient (3.2)
3.2
electronic health record recipient, noun
entity to whom electronic health record data is communicated by an electronic health record provider
4 Abbreviations
For the purposes of this document, the following abbreviations apply.
CORBA Common Object Request Broker Architecture
ebXML Electronic Business XML
EDIFACT Electronic Data Interchange For Administration, Commerce and Transport
EHR Electronic Health Record
FHIR Fast Healthcare Interoperability Resources
GP General Practitioner
HL7 Health Level Seven
ISO International Organization for Standardization
REST Representational State Transfer
RMI Remote Method Invocation
SDO Standards Development Organization
SOAP Simple Object Access Protocol
XML Extensible Mark-up Language
5 Conformance
5.1 A message or service interface that serves to request part or all of the Electronic Health Record (EHR )
of a subject of care shall include all of the information specified as mandatory in 7.1, and shall include any of
the information specified as optional in 7.1. An EHR_provider shall be able to receive and process all of the
mandatory and optional parameters in the request. The provision of an EHR_EXTRACT in response to this
request, or the refusal to do so, shall conform to 7.1.
5.2 A message or service interface that serves to request one or more Archetypes shall include all of the
information specified as mandatory in 7.2, and shall include any of the information specified as optional in
7.2. An EHR_provider shall be able to receive and process all of the mandatory and optional parameters in
the request. The provision of ARCHETYPES in response to this request, or the refusal to do so, shall conform
to 7.2.
ISO/DIS 13606-5:2026(en)
5.3 A message or service interface that serves to request part or all of the Audit Log pertaining to an EHR
of a subject of care shall include all of the information specified as mandatory in 7.3, and shall include any
of the information specified as optional in 7.3. An EHR_provider shall be able to receive and process all of
the mandatory and optional parameters in the request. The provision of an EHR_AUDIT_LOG_EXTRACT in
response to this request, or the refusal to do so, shall conform to 7.3.
5.4 The information specified in 7.1 to 7.3 shall be included as parameters, arguments or message
segments within the communications artefact, as appropriate to the engineering paradigm adopted.
These interfaces can be locally extended to include additional information that is locally relevant, but such
extensions cannot be mandated outside of the jurisdiction in which they have been agreed.
6 Interactions
The five parts of ISO 13606 define the way in which the following may be communicated:
[1]
— part or all of the EHR (an EHR_EXTRACT, as defined in ISO/DIS 13606-1 );
[2]
— an Archetype (an ARCHETYPE, as defined in ISO 13606-2 );
[3]
— an Audit Log (an EHR_AUDIT_LOG_EXTRACT, as defined in ISO 13606-4 ).
[1] [2] [5] [3]
ISO/DIS 13606-1 , ISO 13606-2 , ISO/CD 13606-3 and ISO 13606-4 specify the information models
and terminology that togethe
...