EN ISO 13606-1:2019

Health informatics - Electronic health record communication - Part 1: Reference model (ISO 13606-1:2019)

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.

Medizinische Informatik - Kommunikation von Patientendaten in elektronischer Form - Teil 1: Referenzmodell (ISO 13606-1:2019)

Informatique de santé - Communication du dossier de santé informatisé - Partie 1: Modèle de référence (ISO 13606-1:2019)

Le présent document spécifie un moyen de communication de tout ou partie du dossier de santé informatisé (DSI) d'un seul ou de plusieurs sujets des soins identifiés entre systèmes de DSI, ou entre des systèmes de DSI et un référentiel de données de DSI centralisé.
Il peut également être utilisé pour la communication de DSI entre un système ou référentiel de DSI et des applications médicales ou composants intergiciels (tels que des composants d'aide à la prise de décision) ou des applications et appareils de santé personnels nécessitant d'avoir accès aux ou de fournir des données de DSI, ou pour la représentation des données de DSI dans un système réparti (fédéré).
Le présent document est destiné à être principalement utilisé pour prendre en charge les soins directs dispensés à des personnes identifiables ou les soins auto-administrés par les personnes elles-mêmes, ou les systèmes d'observation de la population tels que les registres de maladies et l'observation de la santé publique. L'utilisation des dossiers de santé pour d'autres finalités telles que l'enseignement, l'évaluation médicale, l'administration et l'établissement de rapports, la gestion des services de santé, la recherche et l'épidémiologie, qui nécessitent l'anonymisation ou l'agrégation de dossiers individuels de personnes physiques ne constitue pas l'objet du présent document; néanmoins, ces applications secondaires sont susceptibles de trouver un intérêt à ce document.
La présente Partie 1 de la série en plusieurs parties est une spécification de point de vue d'information telle que définie par le Traitement réparti ouvert — Modèle de référence: Aperçu général (ISO/IEC 10746-1). Le présent document n'a pas pour vocation de spécifier l'architecture interne ou la conception de la base de données des systèmes de DSI.

Zdravstvena informatika - Komunikacija z elektronskimi zdravstvenimi zapisi - 1. del: Referenčni model (ISO 13606-1:2019)

Ta dokument določa sredstva za posredovanje dela ali celotnega elektronskega zdravstvenega kartona (EHR) enega ali več opredeljenih oseb v zdravstveni oskrbi med sistemi EHR ali med sistemi EHR in centralizirano zbirko podatkov EHR.
Lahko se uporablja tudi za komunikacijo med sistemom EHR, aplikacijami za shranjevanje in kliničnimi aplikacijami oziroma komponentami vmesne programske opreme (kot so podporne komponente odločanja) ali osebne zdravstvene aplikacije in naprave, ki potrebujejo dostop do podatkov EHR ali zagotavljajo podatke EHR, ali za predstavitev podatkov EHR
v okviru porazdeljenega (združenega) sistema evidentiranja.
Ta dokument se uporablja predvsem za omogočanje neposredne nege za prepoznavne posameznike ali samooskrbe posameznikov ali za podporo za sisteme nadzorovanja prebivalstva, kot so arhivi bolezni in nadzor javnega zdravja. Uporaba zdravstvenih arhivov za druge namene, kot so učenje, klinična presoja, upravljanje in poročanje, upravljanje storitev, raziskave ter epidemiologija, ki pogosto zahtevajo anonimizacijo ali združevanje posameznih arhivov, ni osrednji predmet tega dela dokumenta, vendar je ta dokument lahko uporaben tudi za tovrstno sekundarno uporabo.
Ta 1. del večdelne skupine je specifikacija informacijskega vidika, kot je opredeljeno v Odprti porazdeljeni obdelavi – Referenčni model: Pregled (ISO/IEC 10746-1). Namen tega dokumenta ni:
določitev notranje arhitekture ali načrtovanja baz podatkov sistemov EHR.

General Information

• Status: Published
• Publication Date: 02-Jul-2019
• Withdrawal Date: 30-Jan-2020
• 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: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 03-Jul-2019
• Completion Date: 03-Jul-2019
• Ref Project: SIST EN ISO 13606-1:2019 - Health informatics - Electronic health record communication - Part 1: Reference model (ISO 13606-1:2019)

Relations

• Replaces: EN ISO 13606-1:2012 - Health informatics - Electronic health record communication - Part 1: Reference model (ISO 13606-1:2008)
• Effective Date: 08-Jun-2022

Overview

EN ISO 13606-1:2019 - Health informatics - Electronic health record communication - Part 1: Reference model - defines a standardized information viewpoint for exchanging part or all of an electronic health record (EHR) between systems. Published as the Reference Model (ISO 13606-1:2019), it describes how EHR data and metadata should be represented so EHR systems, repositories, clinical applications, middleware and personal health apps can communicate and interoperate. It is an Information Viewpoint specification aligned with the Open Distributed Processing reference model (ISO/IEC 10746-1) and is not intended to prescribe internal system architectures or database designs.

Key Topics and Technical Requirements

The standard specifies structured concepts and requirements for EHR communication, including:

• Actors and roles - definitions for Subject of Care, Composer, Committer and other actors involved in care documentation and data exchange.
• EHR components - a compositional model that includes Folders, Compositions, Sections and Entries to represent clinical record structure.
• Data types and elements - canonical datatypes and element definitions (Boolean, String, Attachment, Coded values, Instance identifiers, Date/Time, Physical quantities, etc.) to ensure consistent data representation.
• Common properties - base, record and structural component properties that apply across EHR fragments.
• Attestation and audit - requirements for documenting authorisation, verification and audit trails to support provenance, accountability and medico-legal traceability.
• Linking and references - mechanisms for linking record components and handling external references between distributed records.
• Privacy/security and information management - terms and constructs to support confidentiality, access control and responsible information handling (conceptual level).

These elements together enable the creation of an interoperable EHR extract suitable for direct care, self‑care and population monitoring.

Practical Applications and Who Uses It

ISO 13606-1 is practical for organizations and professionals focused on EHR interoperability:

• EHR vendors and system architects implementing standardized exchange formats.
• Health IT integrators and interoperability engineers building interfaces between hospital systems, registries and centralized repositories.
• Developers of clinical applications, middleware and decision‑support tools that need to consume or contribute structured EHR data.
• Public health agencies and registry operators enabling population monitoring and surveillance.
• Device and personal health application developers exchanging patient data with clinical systems.
• Standards bodies and implementers who require a formal reference model for semantic and structural consistency.

While oriented to direct care and monitoring, the model also supports secondary uses (audit, research, reporting) when appropriate anonymization or aggregation is applied.

Related Standards

• ISO 13606 multipart series (Reference Model is Part 1)
• Open Distributed Processing - Reference model: Overview (ISO/IEC 10746-1)
• ISO/TC 215 (Health informatics) guidance and related interoperability standards

Keywords: EHR communication, ISO 13606-1, electronic health record, reference model, health informatics, interoperability, EHR extract, audit, attestation, data types.

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2019
Nadomešča:
SIST EN ISO 13606-1:2012
Zdravstvena informatika - Komunikacija z elektronskimi zapisi na področju
zdravstva - 1. del: Referenčni model (ISO 13606-1:2019)
Health informatics - Electronic health record communication - Part 1: Reference model
(ISO 13606-1:2019)
Medizinische Informatik - Kommunikation von Patientendaten in elektronischer Form -
Teil 1: Referenzmodell (ISO 13606-1:2019)
Informatique de santé - Communication du dossier de santé informatisé - Partie 1:
Modèle de référence (ISO 13606-1:2019)
Ta slovenski standard je istoveten z: EN ISO 13606-1:2019
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.

EN ISO 13606-1
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2019
EUROPÄISCHE NORM
ICS 35.240.80 Supersedes EN ISO 13606-1:2012
English Version
Health informatics - Electronic health record
communication - Part 1: Reference model (ISO 13606-
1:2019)
Informatique de santé - Communication du dossier de Medizinische Informatik - Kommunikation von
santé informatisé - Partie 1: Modèle de référence (ISO Patientendaten in elektronischer Form - Teil 1:
13606-1:2019) Referenzmodell (ISO 13606-1:2019)
This European Standard was approved by CEN on 2 July 2019.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 13606-1:2019 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 13606-1:2019) has been prepared by Technical Committee ISO/TC 215 "Health
informatics" in collaboration with Technical Committee CEN/TC 251 “Health informatics” the
secretariat of which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by January 2020, and conflicting national standards shall
be withdrawn at the latest by January 2020.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 13606-1:2012.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 13606-1:2019 has been approved by CEN as EN ISO 13606-1:2019 without any
modification.
INTERNATIONAL ISO
STANDARD 13606-1
Second edition
2019-06
Health informatics — Electronic
health record communication —
Part 1:
Reference model
Informatique de santé — Communication du dossier de santé
informatisé —
Partie 1: Modèle de référence
Reference number
ISO 13606-1:2019(E)
©
ISO 2019
ISO 13606-1:2019(E)
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved

ISO 13606-1:2019(E)
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 . 7
5.1 Overview of the reference model . 7
5.2 Representing roles and responsibilities within the EHR _EXTRACT. 8
5.2.1 General. 8
5.2.2 Actors playing a role in the actual healthcare process . 8
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 . 9
5.2.6 Composer . 9
5.2.7 Committer .10
5.2.8 Subject of information . .10
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 .13
6.1.3 Electronic health record component .14
6.1.4 Structure component .15
6.2 Attestation.16
6.2.1 General.16
6.2.2 Attestation information .18
6.3 Audit information .19
6.4 Linking record components .22
6.4.1 General.22
6.4.2 Link usages .22
6.4.3 Communicating referenced record components .24
6.4.4 Link .24
6.4.5 External link .25
7 Elements and Data Values .26
7.1 General .26
7.2 Data value .27
7.2.1 Boolean .29
7.2.2 Attachment .29
7.2.3 String .32
7.2.4 Simple text .33
7.2.5 Coded simple value .33
7.2.6 Coded value .34
7.2.7 Instance identifier . .37
7.2.8 URI .39
7.2.9 Physical quantity.40
ISO 13606-1:2019(E)
7.2.10 Duration.41
7.2.11 Real .42
7.2.12 Integer .43
7.2.13 Date time .43
7.2.14 Date .44
7.2.15 Time .45
7.2.16 Point in time .45
8 EHR Components .46
8.1 General .46
8.2 Folder .47
8.2.1 General.47
8.2.2 Folder .48
8.3 Compositions .49
8.3.1 General.49
8.3.2 Composition .50
8.4 Content and sections .51
8.4.1 General.51
8.4.2 Content .51
8.4.3 Section.52
8.5 Entries .53
8.5.1 General.53
8.5.2 Entry .53
8.6 Items and clusters .55
8.6.1 Item .55
8.6.2 Cluster .56
8.7 Element.57
9 EHR Extract .57
9.1 General .57
9.2 EHR extract.58
9.3 Extracted component set .59
9.4 Demographic extract .60
10 Demographics .61
10.1 General .61
10.2 Demographic folder .62
10.3 Demographic entity .63
10.4 Demographic item .64
10.5 Demographic cluster .65
10.6 Demographic element .66
11 Conformance .67
Annex A (informative) About the ISO 21090:2011 profile for datatypes .68
Annex B (informative) Alignment with HL7 FHIR .72
Annex C (informative) Cross-Domain Interoperability .73
Bibliography .78
iv © ISO 2019 – All rights reserved

ISO 13606-1:2019(E)
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 second edition cancels and replaces the first edition (ISO 13606-1:2008), which has been technically
revised. The main changes compared to the previous edition are summarised in the Introduction.
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.
ISO 13606-1:2019(E)
Introduction
0.1  Preface
The overall goal of this document is to define a rigorous and stable information architecture for
communicating 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:
— preserving the original clinical meaning intended by the author;
— incorporating the necessary provenance metadata to inform the recipient or receiving system about
the context in which the EHR data were obtained and composed;
— observing and communicating 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 in order to inform each subject’s future
healthcare and to provide a medico-legal record of care that has been provided. This corresponds to the
definition provided in ISO 18308:2011 (Requirements for an Electronic Health Record Architecture).
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 requires specific features in
the reference model to allow their communication.
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 second version of an original standard which was published in 2007 by CEN, and
in 2008 by ISO. This revision has taken into account the experiences gained by EHR system developers
and by large scale eHealth programmes from using the original standard. These were ascertained
through an international survey, a wide range of 1:1 interviews, a review of the academic literature,
and interactions with many experts active in R&D relating to the EHR. It also meets the relevant
requirements in ISO 18308:2011 (Requirements for an Electronic Health Record Architecture). The
vi © ISO 2019 – All rights reserved

ISO 13606-1:2019(E)
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 and by the Clinical Information Modeling Initiative (CIMI).
The information model in this document is an Information Viewpoint of the ISO Reference Model for
Open Distributed Processing (ISO/IEC 10746-1:1998).
Given the diversity of deployed EHR systems, this document has made most features of EHR
communication optional rather than mandatory. However, some degree of prescription is required
to make EHR Extracts safely processable by an EHR recipient system, which is reflected through
mandatory properties within the models in Parts 1, 2, and 4 of this series, and through normative term
lists (defined in Part 3 of this series).
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, templates etc. 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
to an Archetype Model, defined in Part 2 of this series), 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.
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.
ISO 13606-1:2019(E)
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 com-
munication between an EHR Provider system
and an EHR Recipient.
FOLDER The high level organisation within an EHR, Diabetes care, Schizophrenia, Chole-
dividing it into compartments relating to care cystectomy, Paediatrics, St Mungo’s
provided to a single subject of care, for a sin- Hospital, GP Folder, Episodes 2000-
gle condition, by a clinical team or institution, 2001.
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 form, Radiology report, Referral let-
encounter or record documentation session. ter, Clinic visit, Clinic letter, Discharge
summary, Functional health assess-
ment, Diabetes review.
SECTION EHR data within a COMPOSITION that Reason for encounter, Past history,
belongs under one clinical heading, usually Family history, Allergy information,
reflecting the flow of information gathering Subjective symptoms, Objective find-
during a clinical encounter, or structured for ings, Analysis, Plan, Treatment, Diet,
the benefit of future human readership. Posture, Abdominal examination,
Retinal examination.
ENTRY The information recorded in an EHR as a A symptom, an observation, one test
result of one clinical action, one observation, result, a prescribed drug, an allergy
one clinical interpretation, or an intention. reaction, a diagnosis, a differential
This is also known as a clinical statement. diagnosis, a differential white cell
count, blood pressure measurement.
CLUSTER The means of organising nested multi-part Audiogram results, electro-enceph-
data structures such as time series, and to alogram interpretation, weighted
represent the columns of a table. differential diagnoses.
ELEMENT The leaf node of the EHR hierarchy, contain- Systolic blood pressure, heart rate,
ing a single data value. drug 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.
ENTRYs contain ELEMENTS, optionally contained within a CLUSTER hierarchy.
viii © ISO 2019 – All rights reserved

ISO 13606-1:2019(E)
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 Summary of changes made in this edition of the standard
The scope of all parts remains the same.
The objective of this revision was to:
— obtain implementer feedback on adoption experiences with the published version of the 13606
standard series;
— simplify the reference model by removing properties that have not proved useful to implementers;
— improve the demographics model to support the use of demographic archetypes;
— improve alignment with ISO 13940 System of concepts to support continuity of care (Contsys);
— align the data types with ISO 21090 Harmonized data types for information interchange (see
Annex A);
— prepare the ground for alignment with HL7 FHIR;
— update the archetype model to align with the openEHR Archetype Object Model 2.0;
— include reference archetypes for commonly needed information (e.g. demographics);
— update the audit log model to align with ISO 27789 Audit trails for electronic health records, and the
ISO 22600 series, Privilege management and access control.
Reference Model changes
Base Component
A class Base Component has been introduced higher in the inheritance hierarchy than Record
Component, which has a unique identifier, version history information and attestation information.
This allows all of the structures within an EHR Extract to be version managed and attested, including
LINK and demographic information, as well as the original family of Record Components.
Record Component
Several properties that had not proved useful have been removed from Record Component.
ISO 13606-1:2019(E)
Importantly, the model now semantically labels Record Components through archetype ID, avoiding
duplicating and possibly conflicting semantic labels such as name and meaning.
Experience is that these different properties were not differentially well used, and resulted in
inconsistent practices.
Consultation with vendors and providers who do not intend to use archetypes has confirmed that they
could create a library of archetypes mapping their data structures, should they choose to adopt this
standard series.
Properties relating to sensitivity and policy ID have been moved to Composition, to avoid the risk of a
Composition containing data of mixed policies and therefore inconsistently complete access by different
parties.
Structure Component
A generic parent class Structure Component is now the universal parent class of all Record Components
and demographic classes.
All such classes inherit an archetype ID, which now also importantly allows demographic structures to
be defined through archetypes, which was a popular change request.
EHR_Extract
Extract Criteria has been removed as implementers did not find it useful.
EHR_EXTRACT may now contain a set of extracted EHR components, and so may contain data on
multiple subjects of care.
Folder
The Folder has the property subject of care, which allows an EHR extract potentially to contain
information about more than one subject of care, such as a family, which was an important change
request we received
...

SLOVENSKI STANDARD
01-september-2019
Nadomešča:
SIST EN ISO 13606-1:2012
Zdravstvena informatika - Komunikacija z elektronskimi zdravstvenimi zapisi - 1.
del: Referenčni model (ISO 13606-1:2019)
Health informatics - Electronic health record communication - Part 1: Reference model
(ISO 13606-1:2019)
Medizinische Informatik - Kommunikation von Patientendaten in elektronischer Form -
Teil 1: Referenzmodell (ISO 13606-1:2019)
Informatique de santé - Communication du dossier de santé informatisé - Partie 1:
Modèle de référence (ISO 13606-1:2019)
Ta slovenski standard je istoveten z: EN ISO 13606-1:2019
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.

EN ISO 13606-1
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2019
EUROPÄISCHE NORM
ICS 35.240.80 Supersedes EN ISO 13606-1:2012
English Version
Health informatics - Electronic health record
communication - Part 1: Reference model (ISO 13606-
1:2019)
Informatique de santé - Communication du dossier de Medizinische Informatik - Kommunikation von
santé informatisé - Partie 1: Modèle de référence (ISO Patientendaten in elektronischer Form - Teil 1:
13606-1:2019) Referenzmodell (ISO 13606-1:2019)
This European Standard was approved by CEN on 2 July 2019.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 13606-1:2019 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 13606-1:2019) has been prepared by Technical Committee ISO/TC 215 "Health
informatics" in collaboration with Technical Committee CEN/TC 251 “Health informatics” the
secretariat of which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by January 2020, and conflicting national standards shall
be withdrawn at the latest by January 2020.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 13606-1:2012.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 13606-1:2019 has been approved by CEN as EN ISO 13606-1:2019 without any
modification.
INTERNATIONAL ISO
STANDARD 13606-1
Second edition
2019-06
Health informatics — Electronic
health record communication —
Part 1:
Reference model
Informatique de santé — Communication du dossier de santé
informatisé —
Partie 1: Modèle de référence
Reference number
ISO 13606-1:2019(E)
©
ISO 2019
ISO 13606-1:2019(E)
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved

ISO 13606-1:2019(E)
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 . 7
5.1 Overview of the reference model . 7
5.2 Representing roles and responsibilities within the EHR _EXTRACT. 8
5.2.1 General. 8
5.2.2 Actors playing a role in the actual healthcare process . 8
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 . 9
5.2.6 Composer . 9
5.2.7 Committer .10
5.2.8 Subject of information . .10
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 .13
6.1.3 Electronic health record component .14
6.1.4 Structure component .15
6.2 Attestation.16
6.2.1 General.16
6.2.2 Attestation information .18
6.3 Audit information .19
6.4 Linking record components .22
6.4.1 General.22
6.4.2 Link usages .22
6.4.3 Communicating referenced record components .24
6.4.4 Link .24
6.4.5 External link .25
7 Elements and Data Values .26
7.1 General .26
7.2 Data value .27
7.2.1 Boolean .29
7.2.2 Attachment .29
7.2.3 String .32
7.2.4 Simple text .33
7.2.5 Coded simple value .33
7.2.6 Coded value .34
7.2.7 Instance identifier . .37
7.2.8 URI .39
7.2.9 Physical quantity.40
ISO 13606-1:2019(E)
7.2.10 Duration.41
7.2.11 Real .42
7.2.12 Integer .43
7.2.13 Date time .43
7.2.14 Date .44
7.2.15 Time .45
7.2.16 Point in time .45
8 EHR Components .46
8.1 General .46
8.2 Folder .47
8.2.1 General.47
8.2.2 Folder .48
8.3 Compositions .49
8.3.1 General.49
8.3.2 Composition .50
8.4 Content and sections .51
8.4.1 General.51
8.4.2 Content .51
8.4.3 Section.52
8.5 Entries .53
8.5.1 General.53
8.5.2 Entry .53
8.6 Items and clusters .55
8.6.1 Item .55
8.6.2 Cluster .56
8.7 Element.57
9 EHR Extract .57
9.1 General .57
9.2 EHR extract.58
9.3 Extracted component set .59
9.4 Demographic extract .60
10 Demographics .61
10.1 General .61
10.2 Demographic folder .62
10.3 Demographic entity .63
10.4 Demographic item .64
10.5 Demographic cluster .65
10.6 Demographic element .66
11 Conformance .67
Annex A (informative) About the ISO 21090:2011 profile for datatypes .68
Annex B (informative) Alignment with HL7 FHIR .72
Annex C (informative) Cross-Domain Interoperability .73
Bibliography .78
iv © ISO 2019 – All rights reserved

ISO 13606-1:2019(E)
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 second edition cancels and replaces the first edition (ISO 13606-1:2008), which has been technically
revised. The main changes compared to the previous edition are summarised in the Introduction.
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.
ISO 13606-1:2019(E)
Introduction
0.1  Preface
The overall goal of this document is to define a rigorous and stable information architecture for
communicating 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:
— preserving the original clinical meaning intended by the author;
— incorporating the necessary provenance metadata to inform the recipient or receiving system about
the context in which the EHR data were obtained and composed;
— observing and communicating 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 in order to inform each subject’s future
healthcare and to provide a medico-legal record of care that has been provided. This corresponds to the
definition provided in ISO 18308:2011 (Requirements for an Electronic Health Record Architecture).
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 requires specific features in
the reference model to allow their communication.
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 second version of an original standard which was published in 2007 by CEN, and
in 2008 by ISO. This revision has taken into account the experiences gained by EHR system developers
and by large scale eHealth programmes from using the original standard. These were ascertained
through an international survey, a wide range of 1:1 interviews, a review of the academic literature,
and interactions with many experts active in R&D relating to the EHR. It also meets the relevant
requirements in ISO 18308:2011 (Requirements for an Electronic Health Record Architecture). The
vi © ISO 2019 – All rights reserved

ISO 13606-1:2019(E)
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 and by the Clinical Information Modeling Initiative (CIMI).
The information model in this document is an Information Viewpoint of the ISO Reference Model for
Open Distributed Processing (ISO/IEC 10746-1:1998).
Given the diversity of deployed EHR systems, this document has made most features of EHR
communication optional rather than mandatory. However, some degree of prescription is required
to make EHR Extracts safely processable by an EHR recipient system, which is reflected through
mandatory properties within the models in Parts 1, 2, and 4 of this series, and through normative term
lists (defined in Part 3 of this series).
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, templates etc. 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
to an Archetype Model, defined in Part 2 of this series), 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.
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.
ISO 13606-1:2019(E)
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 com-
munication between an EHR Provider system
and an EHR Recipient.
FOLDER The high level organisation within an EHR, Diabetes care, Schizophrenia, Chole-
dividing it into compartments relating to care cystectomy, Paediatrics, St Mungo’s
provided to a single subject of care, for a sin- Hospital, GP Folder, Episodes 2000-
gle condition, by a clinical team or institution, 2001.
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 form, Radiology report, Referral let-
encounter or record documentation session. ter, Clinic visit, Clinic letter, Discharge
summary, Functional health assess-
ment, Diabetes review.
SECTION EHR data within a COMPOSITION that Reason for encounter, Past history,
belongs under one clinical heading, usually Family history, Allergy information,
reflecting the flow of information gathering Subjective symptoms, Objective find-
during a clinical encounter, or structured for ings, Analysis, Plan, Treatment, Diet,
the benefit of future human readership. Posture, Abdominal examination,
Retinal examination.
ENTRY The information recorded in an EHR as a A symptom, an observation, one test
result of one clinical action, one observation, result, a prescribed drug, an allergy
one clinical interpretation, or an intention. reaction, a diagnosis, a differential
This is also known as a clinical statement. diagnosis, a differential white cell
count, blood pressure measurement.
CLUSTER The means of organising nested multi-part Audiogram results, electro-enceph-
data structures such as time series, and to alogram interpretation, weighted
represent the columns of a table. differential diagnoses.
ELEMENT The leaf node of the EHR hierarchy, contain- Systolic blood pressure, heart rate,
ing a single data value. drug 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.
ENTRYs contain ELEMENTS, optionally contained within a CLUSTER hierarchy.
viii © ISO 2019 – All rights reserved

ISO 13606-1:2019(E)
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 Summary of changes made in this edition of the standard
The scope of all parts remains the same.
The objective of this revision was to:
— obtain implementer feedback on adoption experiences with the published version of the 13606
standard series;
— simplify the reference model by removing properties that have not proved useful to implementers;
— improve the demographics model to support the use of demographic archetypes;
— improve alignment with ISO 13940 System of concepts to support continuity of care (Contsys);
— align the data types with ISO 21090 Harmonized data types for information interchange (see
Annex A);
— prepare the ground for alignment with HL7 FHIR;
— update the archetype model to align with the openEHR Archetype Object Model 2.0;
— include reference archetypes for commonly needed information (e.g. demographics);
— update the audit log model to align with ISO 27789 Audit trails for electronic health records, and the
ISO 22600 series, Privilege management and access control.
Reference Model changes
Base Component
A class Base Component has been introduced higher in the inheritance hierarchy than Record
Component, which has a unique identifier, version history information and attestation information.
This allows all of the structures within an EHR Extract to be version managed and attested, including
LINK and demographic information, as well as the original family of Record Components.
Record Component
Several properties that had not proved useful have been removed from Record Component.
ISO 13606-1:2019(E)
Importantly, the model now semantically labels Record Components through archetype ID, avoiding
duplicating and possibly conflicting semantic labels such as name and meaning.
Experience is that these different properties were not differentially well used, and resulted in
inconsistent practices.
Consultation with vendors and providers who do not intend to use archetypes has confirmed that they
could create a library of archetypes mapping their data structures, should they choose to adopt this
standard series.
Properties relating to sensitivity and policy ID have been moved to Composition, to avoid the risk of a
Composition containing data of mixed policies and therefore inconsistently complete access by different
parties.
Structure Component
A generic parent class Structure Component is now the universal parent class of all Record Components
and demographic classes.
All such classes inherit an archetype ID, which now also importantly allows demographic structures to
be defined through archetypes, which was a popular change request.
EHR_Extract
Extract Criteria has been removed as implementers did not find it useful.
EHR_EXTRACT may now contain a set of extracted EHR components, and so may contain data on
multiple subjects of care.
Folder
The Folder has the property subject of care, which allows an EHR extract potentially to contain
information about more than one subject of care, such as a family, which was an important change
request we received.
The EHR Extract is a kind of folder,
...