SIST EN ISO 13606-4:2019

SLOVENSKI STANDARD
SIST EN ISO 13606-4:2019
01-september-2019
Nadomešča:
SIST EN 13606-4:2008
Zdravstvena informatika - Komunikacija z elektronskimi zdravstvenimi zapisi - 4.
del: Varnost (ISO 13606-4:2019)
Health informatics - Electronic health record communication - Part 4: Security (ISO
13606-4:2019)
Medizinische Informatik - Kommunikation von Patientendaten in elektronischer Form -
Teil 4: Sicherheit (ISO 13606-4:2019)
Informatique de santé - Communication du dossier de santé informatisé - Partie 4:
Sécurité (ISO 13606-4:2019)
Ta slovenski standard je istoveten z: EN ISO 13606-4:2019
ICS:
35.030 Informacijska varnost IT Security
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN ISO 13606-4:2019 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 13606-4:2019

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SIST EN ISO 13606-4:2019


EN ISO 13606-4
EUROPEAN STANDARD

NORME EUROPÉENNE

July 2019
EUROPÄISCHE NORM
ICS 35.240.80 Supersedes EN 13606-4:2007
English Version

Health informatics - Electronic health record
communication - Part 4: Security (ISO 13606-4:2019)
Informatique de santé - Communication du dossier de Medizinische Informatik - Kommunikation von
santé informatisé - Partie 4: Sécurité (ISO 13606- Patientendaten in elektronischer Form - Teil 4:
4:2019) Sicherheit (ISO 13606-4:2019)
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 13606-4:2019 E
worldwide for CEN national Members.

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SIST EN ISO 13606-4:2019
EN ISO 13606-4:2019 (E)
Contents Page
European foreword . 3

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SIST EN ISO 13606-4:2019
EN ISO 13606-4:2019 (E)
European foreword
This document (EN ISO 13606-4:2019) 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 13606-4:2007.
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 13606-4:2019 has been approved by CEN as EN ISO 13606-4:2019 without any
modification.

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SIST EN ISO 13606-4:2019
INTERNATIONAL ISO
STANDARD 13606-4
First edition
2019-06
Health informatics — Electronic
health record communication —
Part 4:
Security
Informatique de santé — Communication du dossier de santé
informatisé —
Partie 4: Sécurité
Reference number
ISO 13606-4:2019(E)
©
ISO 2019

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SIST EN ISO 13606-4:2019
ISO 13606-4:2019(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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
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 13606-4:2019
ISO 13606-4:2019(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviations. 2
5 Conformance . 2
6 Record Component Sensitivity and Functional Roles . 3
6.1 RECORD_COMPONENT sensitivity. 3
6.2 Functional roles . 3
6.3 Mapping of Functional Role to COMPOSITION sensitivity . 4
7 Representing access policy information within an EHR_EXTRACT .4
7.1 Overview . 4
7.2 UML representation of the archetype of the access policy COMPOSITION . 6
7.2.1 Access policy. 7
7.2.2 Target . 7
7.2.3 Request criterion . 8
7.2.4 Sensitivity constraint . 9
7.2.5 Attestation information .10
7.3 Archetype of the access policy COMPOSITION .11
8 Representing audit log information .11
8.1 General .11
8.1.1 EHR audit log extract .11
8.1.2 Audit log constraint .12
8.1.3 EHR audit log entry .13
8.1.4 EHR extract description .14
8.1.5 Demographic extract .15
Annex A (informative) Illustrative access control example .16
Annex B (informative) Relations of ISO 13606-4 to alternative approaches .20
Bibliography .22
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SIST EN ISO 13606-4:2019
ISO 13606-4:2019(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 first edition of ISO 13606-4 cancels and replaces the first edition of ISO/TS 13606-4:2009, which
has been technically revised. The main changes compared to the previous edition are as follows:
— Functional Roles
— Some terms for functional roles have been updated to align with CONTSYS.
— The rules for using this vocabulary now state that jurisdictions can nominate alternatives or
specialisations of these terms if needed.
— Access policy model
The access policy model now also permits jurisdictional alternative terms to be used where
appropriate.
— Audit log model
The audit log model now aligns with the ISO 27789 standard for EHR audit trails. It contains more
information than is present in ISO 27789: it is a kind of specialisation specifically dealing with the
communication of EHR information and audit log information. It therefore includes information
about the EHR extract or the audit log extract being communicated, which is beyond the scope of
ISO 27789.
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.
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SIST EN ISO 13606-4:2019
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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  Challenge addressed by this document
The communication of electronic health records (EHRs) in whole or in part, within and across
organisational boundaries, and sometimes across national borders, is challenging from a security
perspective. Health records should be created, processed and managed in ways that assure the
confidentiality of their contents and legitimate control by patients in how they are used. Around the
globe, these principles are progressively becoming enshrined in national data protection legislation.
These instruments declare that the subject of care has the right to play a pivotal role in decisions on
the content and distribution of his or her electronic health record, as well as rights to be informed of its
contents. The communication of health record information to third parties should take place only with
patient consent (which can be any freely given specific and informed indication of his or her wishes
by which the data subject signifies his or her agreement to personal data relating to him or her being
processed). More details can be found in ISO 22600-3. For EHR communication across national borders,
ISO 22857 provides guidance that can be used to define appropriate security policy specifications.
Ideally, each fine grained entry in a patient's record should only be accessed by those persons who
have permissions to view that information, specified by or approved by the patient and reflecting the
dynamic nature of the set of persons with legitimate duty of care towards the patient through his or
her lifetime. The access control list will ideally also include those persons who have permissions to
access the data for reasons other than a duty of care (such as health service management, epidemiology
and public health, consented research) but exclude any information that they do not need to see or
which the patient feels is too personal for them to access. On the opposite side, the labelling by patients
or their representatives of information as personal or private should ideally not hamper those who
legitimately need to see the information in an emergency, nor accidentally result in genuine health
care providers having such a filtered perspective that they are misled into managing the patient
1)
inappropriately. Patients' views on the inherent sensitivity of entries in their health record can evolve
over time, as their personal health anxieties alter or as societal attitudes to health problems change.
Patients might wish to offer some heterogeneous levels of access to family, friends, carers and members
of their community. Families might wish to provide a means by which they are able to access parts of
each other’s records (but not necessarily to equal extents) in order to monitor the progress of inherited
conditions within a family tree.
Such a set of requirements is arguably more extensive than that required of the data controllers in most
other industry sectors. It is in practice made extremely complex by:
— the large number of health record entries made on a patient during the course of modern health care;
— the large number of health care personnel, often rotating through posts, who might potentially
come into contact with a patient at any one time;
— the large number of organisations with which a patient might come into contact during his or her
lifetime;
— the difficulty (for a patient or for anyone else) of classifying in a standardized way how sensitive a
record entry might be;
— the difficulty of determining how important a single health record entry might be to the future care
of a patient, and to which classes of user;
1) The term sensitivity is widely used in the security domain for a broad range of safeguards and controls, but in
this document the term refers only to access controls.
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— the logically indelible nature of the EHR and the need for revisions to access permissions to be
rigorously managed in the same way as revisions to the EHR entries themselves;
— the need to determine appropriate access very rapidly, in real time, and potentially in a distributed
computing environment;
— the high level of concern expressed by a growing minority of patients to have their consent for
disclosure recorded and respected;
— the low level of concern the majority of patients have about these requirements, which has historically
limited the priority and investment committed to tackling this aspect of EHR communications.
To support interoperable EHRs, and seamless communication of EHR data between health care
providers, the negotiation required to determine if a given requester for EHR data should be permitted
to receive the data should be capable of automation. If this were not possible, the delays and workload of
managing human decisions for all or most record communications would obviate any value in striving
for data interoperability.
The main principles of the approach to standards development in the area of EHR communications
access control are to match the characteristics and parameters of a request to the EHR provider’s
policies, and to any access control or consent declarations within the specified EHR, to maintain
appropriate evidence of the disclosure, and to make this capable of automated processing. In practice,
efforts are in progress to develop international standards for defining access control and privilege
management systems that would be capable of computer-to-computer negotiation. However, this kind
of work is predicated upon health services agreeing a mutually consistent framework for defining the
privileges they wish to assign to staff, and the spectrum of sensitivity they offer for patients to define
within their EHRs. This requires consistency in the way the relevant information is expressed, to make
this sensibly scalable at definition-time (when new EHR entries are being added), at run-time (when
a whole EHR is being retrieved or queried), and durable over a patient’s lifetime. It is also important
to recognize that, for the foreseeable future, diversity will continue to exist between countries on the
specific approaches to securing EHR communications, including differing legislation, and that a highly
prescriptive approach to standardization is not presently possible.
This document therefore does not prescribe the access rules themselves. It does not specify who should
have access to what and by means of which security mechanisms; these need to be determined by user
communities, national guidelines and legislation. However, it does define a basic framework that can
be used as a minimum specification of EHR access policy, and a richer generic representation for the
communication of more fine-grained detailed policy information. This framework complements the
overall architecture defined in ISO 13606-1, and defines specific information structures that are to be
communicated as part of an EHR_EXTRACT defined in ISO 13606-1. Some of the kinds of agreement
necessary for the security of EHR communication are inevitably outside the scope of this document,
and are covered more extensively in ISO 22600 (Privilege Management and Access Control).
It should be noted that there are a number of explicit and implicit dependencies on use of other standards
alongside this document, for overall cohesion of an interoperable information security deployment. In
addition to agreement about the complete range of appropriate standards, a relevant assurance regime
would be required (which is beyond the scope of this document).
0.3  Communication scenarios
0.3.1 Data flows
The interfaces and message models required to support EHR communication are the subject of
ISO 13606-5. The description here is an overview of the communications process in order to show the
interactions for which security features are needed. Figure 1 illustrates the key data flows and scenarios
that need to be considered by this document. For each key data flow there will be an acknowledgement
response, and optionally a rejection may be returned instead of the requested data.
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Figure 1 — Principal data flows and security-related business processes covered by this
document
The EHR Requester, EHR Recipient and Audit Log Reviewer might be healthcare professionals, the
patient, a legal representative or another party with sufficient authorization to access healthcare
information. Both the EHR_EXTRACT and the audit log, if provided, might need to be filtered to limit
the disclosure to match the privileges of the recipient. This aspect of access control is discussed later in
this introduction (all parties shown here will need to maintain an audit log, not just the EHR Provider.
However, for readability the other audit log processes are not shown or described here).
The following subclauses describe each data flow in Figure 1.
0.3.2  Request EHR data
This interaction is not always required (for example, EHR data might be pushed from Provider to
Recipient as in the case of a discharge summary). The request interface needs to include a sufficient
profile of the Requester to enable the EHR Provider to be in a position to make an access decision, to
populate an audit log, and provide the appropriate data to the intended Recipient. In some cases the
EHR Requester might not be the same party as the EHR Recipient – for example a software agent might
trigger a notification containing EHR data to be sent to a healthcare professional. In such cases it is the
EHR Recipient’s credentials that will principally determine the access decision to be made.
An EHR request might need to include or reference consents for access and mandates for care, for
example by providing some form of explicit consent from the patient, or a care mandate.
The negotiation between Requester and Provider of EHR data will increasingly be automated, and
the information included in this interaction should be sufficient to enable a fully computerised policy
negotiation.
The requirements for this interaction will be reflected in the REQUEST_EHR_EXTRACT interface model
defined in ISO 13606-5.
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0.3.3  Generate EHR access log entry
This is assumed practice in any EHR system, but it is not specified as a normative interface because of
the diverse approaches and capabilities in present-day systems. The internal audit systems within any
EHR system are not required to be interoperable except in support of the model defined in Clause 8 of
this document and the corresponding interface defined in ISO 13606-5.
0.3.4  Acknowledge receipt of the EHR request
No healthcare-specific security considerations.
0.3.5 Make access decision, filter EHR data
When processing the EHR request, policies pertaining to the EHR Provider and access policies in the
EHR itself all need to be taken into account in determining what data are extracted from the target
EHR. This document cannot dictate the overall set of policies that might influence the EHR Provider,
potentially deriving from national, regional, organisation-specific, professional and other legislation.
A decision to filter the EHR data on the basis of its sensitivity and the privileges of the EHR Requester
and Recipient will need to conform to relevant policies and might need to balance the clinical risks of
denying access to information with the medico-legal risks of releasing information.
This document however does define an overall framework for representing in an interoperable way
the access policies that might relate to any particular EHR, authored by the patient or representatives.
These might not be stored in the physical EHR system in this way; they might instead, for example, be
integrated within a policy server linked to the EHR server.
This access decision is discussed in more detail in Clause 7.
0.3.6  Deny provision of the EHR_EXTRACT
If the access decision is to decline, a coarse-grained set of reasons needs to be defined in order to frame a
suitable set of responses from the EHR Provider. However, it is important that the denial and any reason
given does not imply to the recipient that the requested EHR data does exist – even the disclosure of its
existence could itself be damaging to a patient.
No healthcare-specific security considerations– the interface model is defined in ISO 13606-5.
0.3.7  Provide the EHR_EXTRACT
It should be noted that the EHR Recipient need not be the same as an EHR Requester, and indeed the
provision of an EHR need not have been triggered by a request. It might instead have been initiated by
the provider as part of shared care pathway or to add new data to an existing EHR.
The EHR_EXTRACT is required to conform to the Reference Model defined in ISO 13606-1, and to the
interface model defined in ISO 13606-5.
The EHR_EXTRACT sh include or reference any relevant access policies, represented in conformance
with this document, to govern any onward propagation of the EHR data being communicated. Policies
may only be referenced if the EHR recipient is known to have direct access to the same information by
another means.
0.3.8  Acknowledge receipt of EHR_EXTRACT
No healthcare-specific security considerations.
0.3.9  Generate EHR access log entry
As described in 0.3.3.
0.3.10  Request EHR access log view
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This is now considered to be desirable practice, to enable a patient to discover who has accessed part
or all of his/her EHR in an information-sharing environment. The scope of this interface, as defined in
this document, is to request a view of the audit log that informs the recipient about who has accessed
what parts of his or her EHR within a given EHR system, and when. This interface is not intended to
support situations where a full inspection of an audit log is required for legal purposes or for other
investigations. This interface is discussed in Clause 6.
The i
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