ISO 13606-3:2009

INTERNATIONAL ISO
STANDARD 13606-3
First edition
2009-02-01


Health informatics — Electronic health
record communication —
Part 3:
Reference archetypes and term lists
Informatique de santé — Communication du dossier de santé
informatisé —
Partie 3: Archétypes de référence et listes de termes





Reference number
ISO 13606-3:2009(E)
©
ISO 2009

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ISO 13606-3:2009(E)
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ISO 13606-3:2009(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Terms and definitions. 1
3 Abbreviations . 2
4 Conformance. 3
5 Term lists . 3
5.1 Introduction . 3
5.2 Term list SUBJECT_CATEGORY, Class ENTRY, attribute
subject_of_information_category. 3
5.3 Term list ITEM_CATEGORY, Class ITEM, attribute item_category . 4
5.4 Term list VERSION_STATUS, Class AUDIT_INFO, attribute version_status. 5
5.5 Term list MODE, Class FUNCTIONAL_ROLE, attribute mode. 6
5.6 Term list ACT_STATUS, Class ENTRY, attribute act_status. 7
5.7 Term list LINK_NATURE, Class LINK, attribute nature. 8
5.8 Term list LINK_ROLE, Optional term list for LINK attribute role (informative) . 9
5.9 Term list STRUCTURE_TYPE, Class CLUSTER, attribute structure_type. 16
Annex A (informative) Reference archetypes. 17
Annex B (informative) Clinical example of the mapping between HL7 v3 and the ISO 13606 series. 36
Bibliography . 46

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ISO 13606-3:2009(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 13606-3 was prepared by Technical Committee ISO/TC 215, Health informatics.
ISO 13606 consists of the following parts, under the general title Health informatics — Electronic health record
communication:
⎯ Part 1: Reference model
⎯ Part 2: Archetype interchange specification
⎯ Part 3: Reference archetypes and term lists
⎯ Part 5: Interface specification
The following part is in preparation:
⎯ Part 4: Security

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ISO 13606-3:2009(E)
Introduction
0.1 Summary
This part of ISO 13606 contains two kinds of specification:
1) a normative set of (coded) term lists that each define a controlled vocabulary for a Reference Model
attribute that is defined in ISO 13606-1;
2) an informative set of reference archetypes, expressed as mappings that each specify how the
Reference Model in ISO 13606-1 should be used to represent information originating from
⎯ the set of HL7 Version 3 Acts that form part of the Clinical Statement Pattern (Draft Standard for
Trial Use), and
⎯ the specializations of ENTRY that are defined in the openEHR Reference Model.
0.2 Term lists
Each term list is referenced by its corresponding attribute as an invariant constraint in ISO 13606-1, by
referring to its term list name. For each term list, every code value is accompanied by a phrase and
description; however, in each case it is the code that is to be used as the Reference Model attribute value.
Language translations of the phrase and description will therefore not affect the instances of
RECORD_COMPONENT that are communicated using this part of ISO 13606.
Should any revision to these term lists prove necessary in the future, a technical revision to this part of
ISO 13606 will be required. Such a revised version must specify an updated Reference Model identifier that
shall then be used as the value of the rm_id of an EHR_EXTRACT, to inform the recipient of the version of
this part of ISO 13606 that was used in its creation.
A cross-mapping of the term list for LINK.role to HL7 actRelationship typecodes is also provided, for the
convenience of those wishing to adopt or interface this part of ISO 13606 with HL7 Version 3. This is part of a
longer-term vocabulary harmonization project between the health informatics standards development
organizations (SDOs), and might therefore be extended in the future via other publications, such as the
planned HL7-13606 Implementation Guide (see below). It is therefore informative in this document.
0.3 Reference archetypes
Each reference archetype is represented in this part of ISO 13606 as a mapping correspondence table to
indicate the way in which the ITEM structure within an ISO 13606-1 ENTRY is to be used to represent the
classes and attributes of relevant HL7 v3 and openEHR classes. These two external models have been
chosen for inclusion as these are the most likely internationally used source models from which fine-grained
clinical data may need to be transformed into this document for communication.
These reference archetypes are included as an aid to those adopting this part of ISO 13606 and wishing to
transform Electronic Health Record (EHR) data from existing HL7 v3 or openEHR instances or messages. It is
recognised that full two-way interoperability between these various representations requires more detail,
including rich vocabulary and data type harmonization, and a corresponding set of technical artefacts such as
eXtensible Markup Language (XML) Schemata and Extensible Stylesheet Language Transformation (XSLT)
scripts. Such interoperability is very much the goal of current SDO harmonization efforts, and will be published
as an HL7-13606 Implementation Guide, possibly as an open-access and regularly updated resource.
However, the outstanding work required to achieve this level of interoperability might take up to another year
after publication of this part of ISO 13606. It has therefore been decided to offer what does exist towards
harmonization in an informative form within this part of ISO 13606, as an aid to those already needing to make
such data transformations. A worked example of the HL7 v3 to ISO 13606 mapping is given in Annex B.
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INTERNATIONAL STANDARD ISO 13606-3:2009(E)

Health informatics — Electronic health record
communication —
Part 3:
Reference archetypes and term lists
1 Scope
This part of ISO 13606 is for the communication of part or all of the electronic health record (EHR) of a single
identified subject of care between EHR systems, or between EHR systems and a centralized EHR data
repository. It may also be used for EHR communication between an EHR system or repository and clinical
applications or middleware components (such as decision support components) that need to access or
provide EHR data, or as the representation of EHR data within a distributed (federated) record system.
This part of ISO 13606 (EHR Communications Standard Series), defines term lists that each specify the set of
values that particular attributes of the Reference Model defined in ISO 13606-1 may take. It also defines
informative reference archetypes that correspond to ENTRY-level compound data structures within the
Reference Models of openEHR and HL7 Version 3, to enable those instances to be represented within a
consistent structure when communicated using this part of ISO 13606.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
archetype instance
individual metadata class instance of an Archetype Model, specifying the clinical concept and the value
constraints that apply to one class of Record Component instance in an electronic health record extract
2.2
clinical information
information about a person, relevant to his or her health or health care
2.3
committed
information that has been persisted within an electronic health record system and which constitutes part of the
electronic health record for a subject of care
2.4
committer
agent (party, device or software) whose direct actions have resulted in data being committed to an electronic
health record
2.5
composer
agent (party, device or software) responsible for creating, synthesising or organizing information that is
committed to an electronic health record
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ISO 13606-3:2009(E)
2.6
electronic health record extract
part or all of the electronic health record for a subject of care, communicated in compliance with the
ISO 13606 series of International Standards
2.7
electronic health record system
system for recording, retrieving and manipulating information in electronic health records
2.8
entries
health record data in general (clinical observations, statements, reasoning, intentions, plans or actions)
without particular specification of their formal representation, hierarchical organization or of the particular
Record Component class(es) that might be used to represent them
2.9
Record Component
part of the electronic health record extract of a single subject of care, represented as a node within a
hierarchical data structure conforming to the ISO 13606 series of International Standards
2.10
state (of a process)
condition or situation during the lifecycle of an object during which it satisfies some condition, performs some
activity or waits for some event
[ISO/TS 18308:2004, definition 3.39]
2.11
subject of care
patient
person scheduled to receive, receiving, or having received health care
3 Abbreviations
CEN Comité Européen de Normalisation (European Committee for Standardization)
CEN/TC 251 CEN Technical Committee 251, Health informatics
EHR electronic health record
EU European Union
HISA Health Information Systems Architecture
HL7 Health Level Seven
ISO International Organization for Standardization
UML Unified Modeling Language
XML Extensible Mark-up Language



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ISO 13606-3:2009(E)
4 Conformance
When electronic health record information is to be communicated using the ISO 13606 series of International
Standards and where an attribute of the Reference Model defined in ISO 13606-1 requires a value to be taken
from a bounded set of codes from a named term list, the code shall be one of those defined in Clause 5 of this
part of ISO 13606 for the correspondingly named term list.
5 Term lists
5.1 Introduction
The Reference Model defined in ISO 13606-1 defines several attributes whose values are to be selected from
a fixed list of values. This clause defines those value lists (term lists) for each of those attributes. Attributes not
included in this clause may take any value that conforms to the data type and invariant specifications defined
in ISO 13606-1.
5.2 Term list SUBJECT_CATEGORY, Class ENTRY, attribute
subject_of_information_category
This attribute provides a coarse-grained definition of the person who is the subject of an ENTRY. The default
value is DS00 (the patient, or subject of care). A more fine-grained definition of the information subject (such
as the precise relative with a family history) can be specified through the
ENTRY.subject_of_information.relationship attribute.
Code Meaning Description
DS00 subject of care the subject of care
DS01 relative of subject of care any human relative, without limitation to biological or adoptive
relatives
DS02 foetus or neonate or infant the baby or babies being described by an ENTRY in the EHR of the
mother
DS03 mother the mother of a foetus or neonate, if being described in the EHR of
a baby (e.g. during pregnancy)
DS04 donor The donor of an organ or body specimen being described by an
ENTRY in the EHR of the recipient
DS05 unrelated person any other person not related to the subject of care, such as an
employer, friend, carer

NOTE If ENTRY.subject_of_information_category is null, the value DS00 is assumed.







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ISO 13606-3:2009(E)
5.3 Term list ITEM_CATEGORY, Class ITEM, attribute item_category
Some kinds of ENTRY might have a complex internal data structure, comprising the main values of interest
and other kinds of context. This optional attribute in the Reference Model permits the communication of the
category of information for each ELEMENT or CLUSTER. This may be of value to a receiving EHR system, to
enable easier processing of the data.
Code Meaning Description
IC01 Principal or “core” value The CLUSTERS or ELEMENTS that contain the
main values that are the subject of the ENTRY
IC02 Supplementary/complementary details about the value Contextual information that most users would
regard as necessary to interpret the core values
IC03 Patient state/circumstances Contextual information about the subject of care’s
circumstances when an observation is made,
e.g. fasting, standing
IC04 Method details Contextual information about the method of an
observation, such as the technique or device used
IC05 Clinical reasoning Any explanatory information provided by the
author to explain a clinical decision or
interpretation, other than a specific reference to a
protocol or guideline or knowledge source
IC06 Protocol/guideline A description, reference or explanation of any
protocol or guideline that informed the ENTRY
(e.g. to perform an observation, or initiate a plan
of care)
IC07 Knowledge source A reference to any external knowledge source,
such as a web site or medical text, that explains or
amplifies a clinical decision
IC08 Presentation Any information about how the values in the
ENTRY should be presented; image rendering
information is one example
IC09 Assertion status To indicate that the ELEMENT contains a value
that indicates the presence/absence, normality/
abnormality of the core values (e.g. if the core
value is a questionnaire question, and the
ELEMENT contains the yes/no answer)










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ISO 13606-3:2009(E)
5.4 Term list VERSION_STATUS, Class AUDIT_INFO, attribute version_status
This attribute is used to indicate the status of a particular version of a RECORD_COMPONENT. This attribute
is optional, and if no value is provided it is to be assumed that the RECORD_COMPONENT is the first
definitive version corresponding to code value VER01. In all cases, the new version of a
RECORD_COMPONENT shall replace the former version, as specified in ISO 13606-1.
Code Meaning Description
VER00 Draft The version is known at the time of committal to be incomplete
(because additional information is expected later) or the
necessary authorizations have not been made: VER00 implies
that the EHR_recipient might in future expect to receive a more
definitive updated version of this RECORD_COMPONENT.
VER01 Finished The version is committed with the intention of being a final
version, with no anticipated reason for revision.
VER02 Update The version is an update of the previous version, usually by
adding supplementary information that was not available at the
time of committal.
NOTE Revision is intended for additions usually to be made by the
original author within a short time frame, and not for recoding an
evolving clinical story.
VER03 Correction The version corrects errors made in the recording of the
previous version.
VER04 Deletion The version logically deletes the previous version (e.g. if the
RECORD_COMPONENT had been placed in the wrong
patient’s EHR).

NOTE If AUDIT_INFO.version_status is null, the value VER01 is assumed.












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ISO 13606-3:2009(E)
5.5 Term list MODE, Class FUNCTIONAL_ROLE, attribute mode
This attribute is used to describe the physical or electronic means by which an entity has participated in the
provision or documentation of health care. This term list is taken from the corresponding code set in
EN 14822-2 except that codes have been added for use within an EHR extract.
Code Meaning Description EN14822-2 term
MOD01 electronic data Participation by non-human-language-based electronic signal. ELECTRONIC
MOD02 verbal Participation by voice communication. VERBAL
MOD03 dictated Participation by pre-recorded voice. Communication is limited to one DICTATED
direction (from the recorder to recipient).
MOD04 face-to-face Participation by voice communication where parties speak to each FACE
other directly.
MOD05 telephone Participation by voice communication where the voices of the PHONE
communicating parties are transported over an electronic medium.
MOD06 videoconferencing Participation by voice and visual communication where the voices and VIDEOCONF
images of the communicating parties are transported over an
electronic medium.
MOD07 written Participation by human language recorded on a physical material. WRITTEN
MOD08 e-mail Participation by text or diagrams transmitted over an electronic mail EMAIL
system.
MOD09 telefax Participation by text or diagrams printed on paper that have been FAX
transmitted over a fax device.
MOD10 handwritten Participation by text or diagrams printed on paper or other recording HANDWRITTEN
medium.
MOD11 typewritten Participation by text or diagrams printed on paper or other recording TYPEWRITTEN
medium where the recording was performed using a typewriter,
typesetter, computer or similar mechanism.
MOD12 physical presence Participation by direct action where subject and actor are in the same PHYSICAL
location. (The participation involves more than communication.)
MOD13 remote presence Participation by direct action where subject and actor are in separate REMOTE
locations, and the actions of the actor are transmitted by electronic or
mechanical means. (The participation involves more than
communication.)

NOTE If FUNCTIONAL_ROLE.mode is null, the value MOD04 is assumed.







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ISO 13606-3:2009(E)
5.6 Term list ACT_STATUS, Class ENTRY, attribute act_status
This term list is identical to the act status values in EN 12967-3 except that codes have been added for use
within an EHR extract.
Code Meaning Definition from EN 12967-3
ACT01 Foreseen The activity to be done has been identified by the
requestor, but a formal request or planning has not
been issued yet.
ACT02 Requested A formal request has been sent to the provider
supposed to deliver the service(s).
ACT03 Accepted The providing unit has formally accepted to provide the
service.
ACT04 Booked The actual activities to be executed have been
identified and a date, shift and time for execution has
been agreed between the involved agents (i.e.
requestor, provider and other involved units).
ACT05 Planned The act has been assigned to one (set of) Service
Point, which will be in charge for its execution.
ACT06 Ready All preliminary activities have been completed and the
execution of the act may actually start.
ACT07 In progress The execution of the act has actually started.
ACT08 Completed The provider has completed the actual execution of the
act.
ACT09 Reported The provider has delivered the final report on the act.
ACT10 Terminated The final report has been received and accepted by the
original requester.
ACT11 Forwarded The request of delivering the service has been
transferred by the initially envisaged provider to a
different provider.
ACT12 Suspended The processing of the act (in any moment of its life-
cycle) has been temporarily interrupted for various
reasons.
ACT13 Annulled-Cancelled The act has been annulled by the requestor (who
cancels the request).
ACT14 Annulled-Rejected The act has been annulled by the envisaged provider
(who rejects the request received).
ACT15 Substituted The act has been substituted with another one.







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ISO 13606-3:2009(E)
5.7 Term list LINK_NATURE, Class LINK, attribute nature
The LINK class contains two coded-value attributes to communicate the semantics of the relationship between
the source and target RECORD_COMPONENTS. The nature attribute, which is mandatory in ISO 13606-1, is
intended to be a coarse-grained category that can be used to enable interoperability between sender and
receiver. The role attribute, which is optional in ISO 13606-1, provides for a more specific description of the
actual role played by the target in relation to the source. This latter attribute may be populated from any
suitable terminology, and therefore might support human readership better than interoperable automated
processing. This part of ISO 13606 requires that the nature attribute be a value taken from the mandatory
term list defined in this subclause. This part of ISO 13606 offers a term list for the role attribute, in 5.8, but it is
not required that this be used.
Code Meaning Description
LINK-A0 is related to A generic category for any link, the details of
which will be given by the value of LINK.role.
LINK-B0 is confirmed by or authorized by The target link contains a COMPOSITION,
SECTION or ENTRY that acts as the legal or
authoritative basis for the activity documented in
the source RECORD_COMPONENT, or is a
declaration of intent to provide (or not to provide)
requested care. This Link shall be used to
connect two RECORD_COMPONENTS, as
opposed to the inclusion of a corroborating or
authorizing participant as an identified party within
a single COMPOSITION or ENTRY.
LINK-C0 is related to the same problem or health issue The target RECORD_COMPONENT documents
health or health care that pertains to the same
clinical situation as the source component. One of
the two might be defining a problem for which the
other is a manifestation, or the relationship might,
for example, be cause and effect, stages in an
evolving clinical history, a different interpretation
of an observation, a clinical indication or contra-
indication.
LINK-D0 is related to the same plan of care, act or episode The source and the target
RECORD_COMPONENTs each document parts
of the same plan of care, act or episode. One or
the other might be defining the same plan of care,
act or episode, or both might be related
milestones.
LINK-E0 is a related documentation The target RECORD_COMPONENT is an
alternative documentary form of the source
component, such as re-expression of the same
clinical information or additional supplementary
explanatory information.

NOTE A further understanding of each of these categories may be obtained by reviewing the detailed terms
proposed for each, as values of LINK.role in 5.8.




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ISO 13606-3:2009(E)
5.8 Term list LINK_ROLE, Optional term list for LINK attribute role (informative)
5.8.1 Introduction
Each of the link terms in the list is a sub-category of a corresponding term in the table of 5.7, where that
correspondence is indicated by the first letter after the code string “LINK-”, e.g. the term LINK-A1 is a
subcategory of term LINK-A0. If a term in the list is used for the LINK.role attribute, the appropriate
corresponding LINK.nature attribute value from 5.7 must be used.
5.8.2 Optional term list for LINK attribute role (informative)
Code Meaning Description
LINK-A1 unspecified link The term is used when no semantic information is
available for the Link in the EHR system from
which the EXTRACT has been created.
LINK-A2 suggests (tentatively related to) The interpretation expressed in the target
component is a possible cause or outcome of the
findings documented in the source component.
LINK-A2i is suggested by The inverse relationship of LINK-A2.
LINK-A3 re-occurrence or repeat of The source component documents a clinical
situation which, in the opinion of the composer, is
a repeat occurrence of the clinical situation
documented in the target. This is intended for
re-occurrences of real world situations, not
repeated documentation of the same real-world
event.
LINK-B1 endorses (agrees with, confirms, verifies) The interpretation expressed in the source
component provides confirmatory evidence or a
confirmatory opinion of the interpretation
expressed in the target component.
LINK-B2 disagrees with (e.g. another opinion) The interpretation expressed in the source
component disproves or disagrees with the
interpretation expressed in the target component.
LINK-B3 permits (sanctions, authorises) The source component documents a permission
or an authorisation of an action documented in the
target component.
LINK-B3i permitted by The inverse relationship of LINK-B3.
LINK-B4 assumes responsibility for The participant (e.g. composer) identified in the
source component is taking responsibility for the
care acts documented in the target component.
LINK-B5 declines (refuses, cancels) The participant (e.g. composer) identified in the
source component is declining or withdrawing
consent to take responsibility for the care acts
documented in the target component.
LINK-B6 consents to The participant identified in the source component
is proof of consent to care actions documented in
the target component.
LINK-B6i consented by The inverse relationship of LINK-B6.
LINK-C1 cause (interpretation) The clinical situation docu
...