SIST EN ISO 13606-5:2019
(Main)Health informatics - Electronic health record communication - Part 5: Interface specification (ISO 13606-5:2019)
Health informatics - Electronic health record communication - Part 5: Interface specification (ISO 13606-5:2019)
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.
Medizinische Informatik - Kommunikation von Patientendaten in elektronischer Form - Teil 5: Interface Spezifikation (ISO 13606-5:2019)
Informatique de santé - Communication du dossier de santé informatisé - Partie 5: Spécification d'interfaces (ISO 13606-5:2019)
Le présent document spécifie l'architecture d'informations exigée pour l'interopérabilité des communications entre les systèmes et les services qui ont besoin de données de DSI ou qui les émettent. Le présent document n'a pas pour vocation de spécifier l'architecture interne ou la conception de la base de données de ces systèmes.
Le sujet auquel se rapporte le dossier ou l'extrait de dossier à communiquer est un individu, et l'objet de la communication concerne principalement les soins de santé à cette personne.
L'utilisation de dossiers de santé à d'autres fins telles qu'administration, gestion, recherche et épidémiologie, qui exigent des agrégations de dossiers de patients individuels, ne constituent pas la préoccupation centrale du présent document, même si celui-ci peut également s'avérer utile pour ces utilisations secondaires.
Le présent document définit un ensemble d'interfaces permettant de demander et d'émettre:
— un EHR_EXTRACT pour un sujet de soins donné tel que défini dans l'ISO 13606-1;
— un ou plusieurs ARCHETYPE(s) tels que définis dans l'ISO 13606-2;
— un EHR_AUDIT_LOG_EXTRACT pour un sujet de soins donné tel que défini dans l'ISO 13606-4.
Le présent document définit l'ensemble des interactions pour la demande de chacun de ces artéfacts et pour la transmission des données à la partie demandeuse ou pour le rejet de la demande. Son domaine d'application ne couvre pas l'interface de demande d'un DSI ou de populations de DSI, par exemple pour une expertise médicale ou pour la recherche clinique, bien que les dispositions prises pour la spécification de certains critères de sélection lors de la demande d'un EHR_EXTRACT puissent également servir à des demandes sur des populations.
Le présent document définit pour chaque interface le point de vue du traitement, sans spécifier ou limiter des approches techniques particulières pour leur mise en œuvre sous la forme de messages ou d'interfaces de service.
Le présent document définit efficacement les informations «directement utiles» à communiquer à chaque interface. Elle ne spécifie pas les informations particulières et supplémentaires exigés par les différents protocoles de transmission, ni les procédures de sécurité ou d'authentification susceptibles d'être convenues entre les parties à la communication ou exigées par différentes législations.
Zdravstvena informatika - Komunikacija z elektronskimi zdravstvenimi zapisi - 5. del: Specifikacija vmesnika (ISO 13606-5:2019)
Ta del dokumenta določa informacijsko arhitekturo, ki je potrebna za interoperabilno komunikacijo med sistemi in storitvami, ki potrebujejo ali zagotavljajo podatke EHR. Namen tega dela dokumenta ni določitev notranje arhitekture ali zasnove podatkovne baze takih sistemov.
Predmet kartoteke ali izvlečka kartoteke, ki ga je treba posredovati, je posameznik, posredovano sporočilo pa večinoma obsega podatke v zvezi z oskrbo tega posameznika.
Uporaba zdravstvenih arhivov za druge namene, kot so upravljanje, vodenje, raziskave in epidemiologija, ki zahtevajo združevanje kartotek posameznikov, niso osrednji predmet tega dokumenta, vendar je ta dokument lahko uporaben tudi za tovrstno sekundarno uporabo.
Ta dokument opredeljuje nabor vmesnikov, s katerimi se zahteva in zagotovi:
– EHR_EXTRACT za določeni subjekt oskrbe, kot je opredeljeno v standardu ISO 13606-1;
– enega ali več elementov ARCHETYPE, kot je opredeljeno v standardu ISO 13606-2;
– EHR_AUDIT_LOG_EXTRACT za nek subjekt oskrbe, kot je opredeljeno v standardu ISO 13606-4.
Ta dokument opredeljuje nabor interakcij za zahtevanje vsakega od teh predmetov in za posredovanje podatkov prosilcu ali zavrnitev zahteve. Vmesnik za poizvedovanje po EHR ali populacijah EHR, na primer za klinično presojo ali raziskave, je zunaj njegovega obsega, čeprav je možno v zahtevi za EHR_EXTRACT navesti določene izbirne kriterije, ki bi lahko služili pri poizvedbah o prebivalstvu.
V tem dokumentu je določena računska točka za vsak vmesnik, ne da bi določili ali omejili posebne inženirske pristope za njihovo implementacijo v obliki sporočil ali storitvenih vmesnikov. Ta dokument dejansko določa uporabne podatke, ki se posredujejo pri posameznem vmesniku. Ne določa natančnih podatkov, ki jih bodo dodatno zahtevali različni transportni protokoli, niti varnostnih ali overitvenih postopkov, za katere bi se lahko dogovorile sodelujoče strani ali ki jih zahtevajo različne pristojnosti.
General Information
Relations
Related Packages
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 13606-5:2019
01-september-2019
Nadomešča:
SIST EN ISO 13606-5:2010
Zdravstvena informatika - Komunikacija z elektronskimi zdravstvenimi zapisi - 5.
del: Specifikacija vmesnika (ISO 13606-5:2019)
Health informatics - Electronic health record communication - Part 5: Interface
specification (ISO 13606-5:2019)
Medizinische Informatik - Kommunikation von Patientendaten in elektronischer Form -
Teil 5: Interface Spezifikation (ISO 13606-5:2019)
Informatique de santé - Communication du dossier de santé informatisé - Partie 5:
Spécification d'interfaces (ISO 13606-5:2019)
Ta slovenski standard je istoveten z: EN ISO 13606-5:2019
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN ISO 13606-5:2019 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 13606-5:2019
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SIST EN ISO 13606-5:2019
EN ISO 13606-5
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2019
EUROPÄISCHE NORM
ICS 35.240.80 Supersedes EN ISO 13606-5:2010
English Version
Health informatics - Electronic health record
communication - Part 5: Interface specification (ISO
13606-5:2019)
Informatique de santé - Communication du dossier de Medizinische Informatik - Kommunikation von
santé informatisé - Partie 5: Spécification d'interfaces Patientendaten in elektronischer Form - Teil 5:
(ISO 13606-5:2019) Interface Spezifikation (ISO 13606-5:2019)
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 13606-5:2019 E
worldwide for CEN national Members.
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SIST EN ISO 13606-5:2019
EN ISO 13606-5:2019 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 13606-5:2019
EN ISO 13606-5:2019 (E)
European foreword
This document (EN ISO 13606-5:2019) 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 13606-5:2010.
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 13606-5:2019 has been approved by CEN as EN ISO 13606-5:2019 without any
modification.
3
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SIST EN ISO 13606-5:2019
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SIST EN ISO 13606-5:2019
INTERNATIONAL ISO
STANDARD 13606-5
Second edition
2019-06
Health informatics — Electronic
health record communication —
Part 5:
Interface specification
Informatique de santé — Communication du dossier de santé
informatisé —
Partie 5: Spécification d'interfaces
Reference number
ISO 13606-5:2019(E)
©
ISO 2019
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SIST EN ISO 13606-5:2019
ISO 13606-5:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© 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.
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Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
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SIST EN ISO 13606-5:2019
ISO 13606-5:2019(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Abbreviations. 2
5 Conformance . 2
6 Interactions . 3
6.1 Introduction . 3
7 Interfaces . 6
7.1 Interface: REQUEST_EHR_EXTRACT . 6
7.2 Interface: REQUEST_ARCHETYPES . 8
7.3 Interface: REQUEST_EHR_AUDIT_LOG_EXTRACT . 9
7.4 Term Lists .11
Bibliography .12
© ISO 2019 – All rights reserved iii
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SIST EN ISO 13606-5:2019
ISO 13606-5:2019(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 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 second edition cancels and replaces the first edition (ISO 13606-5:2010), which has been
technically revised. The main changes compared to the previous edition are as follows:
— Removal of properties from the interface specifications that no longer correspond to properties
in the Reference Model defined in ISO 13606-1.
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 2019 – All rights reserved
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SIST EN ISO 13606-5:2019
ISO 13606-5:2019(E)
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 HISA standard series (ISO 12967
all parts);
— 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 that ISO 13606-1, ISO 13606-2 and ISO 13606-4 define the corresponding
information viewpoints, and that ISO 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 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; these guides will be published separately from ISO 13606-5, to enable
them to be maintained and updated more frequently (to reflect implementation experience) than is
possible for a standards document;
— to recognise 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 authorisation policies and services etc.; these are therefore not part of the formal
scope of ISO 13606-5 but are referred to as being assumed and necessary complementary services;
— to require an ISO/TS 22600 series (PMAC) 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.
This document defines a set of interfaces by which the artefacts defined in ISO 13606-1, ISO 13606-2
and ISO 13606-4 may be requested and provided:
a) ISO 13606-1 defines a reference model for an EHR_EXTRACT: part or all of the EHR of a subject
of care;
b) ISO 13606-2 defines an information model for an ARCHETYPE, and optionally a serialised form
represented using Archetype Definition Language;
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SIST EN ISO 13606-5:2019
ISO 13606-5:2019(E)
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.
(ISO 13606-3 defines term lists and reference archetypes, to which a direct interface is not required.
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
authorised 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) or service protocols (e.g. SOAP, Java RMI). 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 in ISO 13606-1, the ARCHETYPE defined in ISO 13606-2, and the EHR_AUDIT_
LOG_EXTRACT 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 authorisation credentials that are also beyond the scope of this document
but are specified in the ISO 22600 series (PMAC). 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.
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SIST EN ISO 13606-5:2019
INTERNATIONAL STANDARD ISO 13606-5:2019(E)
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:
— 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.
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 13606-1, Health informatics — Electronic health record communication — Part 1: Reference model
ISO 13606-2, Health informatics — Electronic health record communication — Part 2: Archetype
interchange specification
ISO 13606-4, Health informatics — Electronic health record communication — Part 4: Security
ISO TS 14265, Health Informatics — Classification of purposes for processing personal health information
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ISO 13606-5:2019(E)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 13606-1, ISO 13606-2,
ISO 13606-4 and the following apply.
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
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
electronic health record recipient
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
EU European Union
GP General Practitioner
HISA Health Information Systems Architecture
HL7 Health Level Seven
ISO International Organization for Standardization
PMAC Privilege Management and Access Control
RMI Remote Method Invocation
SDO Standards Development Organisation
SOAP Simple Object Access Protocol
UML Unified Modelling Language
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
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ISO 13606-5:2019(E)
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.
5.3 A message or service interface that serves to request part or all of the Audit Log pertaining to
an Electronic Health Record (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
6.1 Introduction
The five parts of ISO 13606 define the way in which the following may be communicated:
— part or all of the EHR (an EHR_EXTRACT, as defined in ISO 13606-1);
— an Archetype (an ARCHETYPE, as defined in ISO 13606-2);
— an Audit Log (an EHR_AUDIT_LOG_EXTRACT, as defined in ISO 13606-4).
ISO 13606-1, ISO 13606-2, ISO 13606-3 and ISO 13606-4 specify the information models and
terminology that together define the Information Viewpoint for EHR communication. This document
defines the set of communications interfaces (the Computational Viewpoint).
This Computational Viewpoint is deliberately expressed in a way that is generic to the many possible
Engineering Viewpoint approaches that might be used to implement these interfaces, for example via
messages or services, using standards such as HL7 v3, EDIFACT, ebXML, Java, CORBA, SOAP etc. This
document is also generic in terms of the user interaction scenarios it formally supports. There are many
use cases in health care that require the communication (or sharing) of EHR data, which can involve
many different kinds of actor (e.g. healthcare professionals, patients, families and carers, managers,
researchers and legal representatives) and system (e.g. clinical application, hand-held application, EHR
system, decision support, reporting, security or audit systems). The communication can take place
within or between organisations, or across a health care network.
Several examples of these use cases are listed below.
A clinician looking after a subject of care in a district hospital wishing to read any recent COMPOSITIONS
in the EHR system of the subject’s GP; in this case the parameters in the request will include a date range.
A GP looking after a subject of care wishing to read any COMPOSITIONS documenting recent progress
made in the management of the subject’s cancer care in the EHR system of the local hospital; in this case
the parameters in the request will include a date range and could specify the inclusion of certain kinds
of clinical entry through the inclusion of certain archetypes (using the archetype_ids parameter).
An emergency triage nurse wishing to identify all medications prescribed to the subject of care over
the past year right across the health system by requesting EHR_EXTRACT(S) that contain medication
entries from a national EHR repository or national virtual EHR.
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A GP retrieving the full EHR for a subject of care held in the EHR system of another GP (including all
versions of each COMPOSITION) in order to effect a complete transfer of care between the GPs.
A physiotherapist wishing to retrieve a COMPOSITION (not held locally) that is the target of a LINK
within a COMPOSITION already held locally in the EHR system, for example to the consultation that
was the presentation of an injury that triggered the physiotherapy referral; the request will include a
specific rc_id as the value of the rc_ids parameter.
A clinical system administrator who has been asked to develop a new screen and reports for the
management of diabetic ketoacidosis, wishing to request and download the most recent archetypes
for representing this information from the certified archetype repository maintained by a national
diabetes professional organisation.
A subject of care who is also a member of staff at a hospital, wishing to examine the audit log of their
recent in-patient stay to see who has accessed their EHR.
All of these scenarios have in common that EHR data (an EHR Extract, an Archetype or an Audit Log)
are being requested by one process and provided by another process, or the request may be declined. In
this document, the party or service making the request is termed the EHR_requester, the party or service
with capability to provide EHR data of a kind defined by this document is termed the EHR_provider,
the party or service who will receive the data is termed the EHR_recipient. Although many different
concrete scenarios will exist for EHR Communication, at a logical level they can all be subsumed by the
following interaction diagram (see Figure 1).
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SIST EN ISO 13606-5:2019
ISO 13606-5:2019(E)
Figure 1 — Interaction Diagram to depict the set of interfaces that are in scope for this
document
In order to implement and operationalise these int
...
SLOVENSKI STANDARD
SIST EN ISO 13606-5:2019
01-september-2019
Nadomešča:
SIST EN ISO 13606-5:2010
Zdravstvena informatika - Komunikacija z elektronskimi zapisi na področju
zdravstva - 5. del: Specifikacija vmesnika (ISO 13606-5:2019)
Health informatics - Electronic health record communication - Part 5: Interface
specification (ISO 13606-5:2019)
Medizinische Informatik - Kommunikation von Patientendaten in elektronischer Form -
Teil 5: Interface Spezifikation (ISO 13606-5:2019)
Informatique de santé - Communication du dossier de santé informatisé - Partie 5:
Spécification d'interfaces (ISO 13606-5:2019)
Ta slovenski standard je istoveten z: EN ISO 13606-5:2019
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN ISO 13606-5:2019 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 13606-5:2019
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SIST EN ISO 13606-5:2019
EN ISO 13606-5
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2019
EUROPÄISCHE NORM
ICS 35.240.80 Supersedes EN ISO 13606-5:2010
English Version
Health informatics - Electronic health record
communication - Part 5: Interface specification (ISO
13606-5:2019)
Informatique de santé - Communication du dossier de Medizinische Informatik - Kommunikation von
santé informatisé - Partie 5: Spécification d'interfaces Patientendaten in elektronischer Form - Teil 5:
(ISO 13606-5:2019) Interface Spezifikation (ISO 13606-5:2019)
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 13606-5:2019 E
worldwide for CEN national Members.
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SIST EN ISO 13606-5:2019
EN ISO 13606-5:2019 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 13606-5:2019
EN ISO 13606-5:2019 (E)
European foreword
This document (EN ISO 13606-5:2019) 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 13606-5:2010.
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 13606-5:2019 has been approved by CEN as EN ISO 13606-5:2019 without any
modification.
3
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SIST EN ISO 13606-5:2019
INTERNATIONAL ISO
STANDARD 13606-5
Second edition
2019-06
Health informatics — Electronic
health record communication —
Part 5:
Interface specification
Informatique de santé — Communication du dossier de santé
informatisé —
Partie 5: Spécification d'interfaces
Reference number
ISO 13606-5:2019(E)
©
ISO 2019
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SIST EN ISO 13606-5:2019
ISO 13606-5:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
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Email: copyright@iso.org
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Published in Switzerland
ii © ISO 2019 – All rights reserved
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ISO 13606-5:2019(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Abbreviations. 2
5 Conformance . 2
6 Interactions . 3
6.1 Introduction . 3
7 Interfaces . 6
7.1 Interface: REQUEST_EHR_EXTRACT . 6
7.2 Interface: REQUEST_ARCHETYPES . 8
7.3 Interface: REQUEST_EHR_AUDIT_LOG_EXTRACT . 9
7.4 Term Lists .11
Bibliography .12
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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 second edition cancels and replaces the first edition (ISO 13606-5:2010), which has been
technically revised. The main changes compared to the previous edition are as follows:
— Removal of properties from the interface specifications that no longer correspond to properties
in the Reference Model defined in ISO 13606-1.
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 2019 – All rights reserved
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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 HISA standard series (ISO 12967
all parts);
— 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 that ISO 13606-1, ISO 13606-2 and ISO 13606-4 define the corresponding
information viewpoints, and that ISO 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 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; these guides will be published separately from ISO 13606-5, to enable
them to be maintained and updated more frequently (to reflect implementation experience) than is
possible for a standards document;
— to recognise 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 authorisation policies and services etc.; these are therefore not part of the formal
scope of ISO 13606-5 but are referred to as being assumed and necessary complementary services;
— to require an ISO/TS 22600 series (PMAC) 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.
This document defines a set of interfaces by which the artefacts defined in ISO 13606-1, ISO 13606-2
and ISO 13606-4 may be requested and provided:
a) ISO 13606-1 defines a reference model for an EHR_EXTRACT: part or all of the EHR of a subject
of care;
b) ISO 13606-2 defines an information model for an ARCHETYPE, and optionally a serialised form
represented using Archetype Definition Language;
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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.
(ISO 13606-3 defines term lists and reference archetypes, to which a direct interface is not required.
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
authorised 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) or service protocols (e.g. SOAP, Java RMI). 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 in ISO 13606-1, the ARCHETYPE defined in ISO 13606-2, and the EHR_AUDIT_
LOG_EXTRACT 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 authorisation credentials that are also beyond the scope of this document
but are specified in the ISO 22600 series (PMAC). 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.
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INTERNATIONAL STANDARD ISO 13606-5:2019(E)
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:
— 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.
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 13606-1, Health informatics — Electronic health record communication — Part 1: Reference model
ISO 13606-2, Health informatics — Electronic health record communication — Part 2: Archetype
interchange specification
ISO 13606-4, Health informatics — Electronic health record communication — Part 4: Security
ISO TS 14265, Health Informatics — Classification of purposes for processing personal health information
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3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 13606-1, ISO 13606-2,
ISO 13606-4 and the following apply.
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
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
electronic health record recipient
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
EU European Union
GP General Practitioner
HISA Health Information Systems Architecture
HL7 Health Level Seven
ISO International Organization for Standardization
PMAC Privilege Management and Access Control
RMI Remote Method Invocation
SDO Standards Development Organisation
SOAP Simple Object Access Protocol
UML Unified Modelling Language
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
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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.
5.3 A message or service interface that serves to request part or all of the Audit Log pertaining to
an Electronic Health Record (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
6.1 Introduction
The five parts of ISO 13606 define the way in which the following may be communicated:
— part or all of the EHR (an EHR_EXTRACT, as defined in ISO 13606-1);
— an Archetype (an ARCHETYPE, as defined in ISO 13606-2);
— an Audit Log (an EHR_AUDIT_LOG_EXTRACT, as defined in ISO 13606-4).
ISO 13606-1, ISO 13606-2, ISO 13606-3 and ISO 13606-4 specify the information models and
terminology that together define the Information Viewpoint for EHR communication. This document
defines the set of communications interfaces (the Computational Viewpoint).
This Computational Viewpoint is deliberately expressed in a way that is generic to the many possible
Engineering Viewpoint approaches that might be used to implement these interfaces, for example via
messages or services, using standards such as HL7 v3, EDIFACT, ebXML, Java, CORBA, SOAP etc. This
document is also generic in terms of the user interaction scenarios it formally supports. There are many
use cases in health care that require the communication (or sharing) of EHR data, which can involve
many different kinds of actor (e.g. healthcare professionals, patients, families and carers, managers,
researchers and legal representatives) and system (e.g. clinical application, hand-held application, EHR
system, decision support, reporting, security or audit systems). The communication can take place
within or between organisations, or across a health care network.
Several examples of these use cases are listed below.
A clinician looking after a subject of care in a district hospital wishing to read any recent COMPOSITIONS
in the EHR system of the subject’s GP; in this case the parameters in the request will include a date range.
A GP looking after a subject of care wishing to read any COMPOSITIONS documenting recent progress
made in the management of the subject’s cancer care in the EHR system of the local hospital; in this case
the parameters in the request will include a date range and could specify the inclusion of certain kinds
of clinical entry through the inclusion of certain archetypes (using the archetype_ids parameter).
An emergency triage nurse wishing to identify all medications prescribed to the subject of care over
the past year right across the health system by requesting EHR_EXTRACT(S) that contain medication
entries from a national EHR repository or national virtual EHR.
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A GP retrieving the full EHR for a subject of care held in the EHR system of another GP (including all
versions of each COMPOSITION) in order to effect a complete transfer of care between the GPs.
A physiotherapist wishing to retrieve a COMPOSITION (not held locally) that is the target of a LINK
within a COMPOSITION already held locally in the EHR system, for example to the consultation that
was the presentation of an injury that triggered the physiotherapy referral; the request will include a
specific rc_id as the value of the rc_ids parameter.
A clinical system administrator who has been asked to develop a new screen and reports for the
management of diabetic ketoacidosis, wishing to request and download the most recent archetypes
for representing this information from the certified archetype repository maintained by a national
diabetes professional organisation.
A subject of care who is also a member of staff at a hospital, wishing to examine the audit log of their
recent in-patient stay to see who has accessed their EHR.
All of these scenarios have in common that EHR data (an EHR Extract, an Archetype or an Audit Log)
are being requested by one process and provided by another process, or the request may be declined. In
this document, the party or service making the request is termed the EHR_requester, the party or service
with capability to provide EHR data of a kind defined by this document is termed the EHR_provider,
the party or service who will receive the data is termed the EHR_recipient. Although many different
concrete scenarios will exist for EHR Communication, at a logical level they can all be subsumed by the
following interaction diagram (see Figure 1).
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Figure 1 — Interaction Diagram to depict the set of interfaces that are in scope for this
document
In order t
...
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