EN ISO 13606-4:2019
(Main)Health informatics - Electronic health record communication - Part 4: Security (ISO 13606-4:2019)
Health informatics - Electronic health record communication - Part 4: Security (ISO 13606-4:2019)
This document describes a methodology for specifying the privileges necessary to access EHR data. This methodology forms part of the overall EHR communications architecture defined in ISO 13606-1.
This document seeks to address those requirements uniquely pertaining to EHR communications and to represent and communicate EHR-specific information that will inform an access decision. It also refers to general security requirements that apply to EHR communications and points at technical solutions and standards that specify details on services meeting these security needs.
NOTE Security requirements for EHR systems not related to the communication of EHRs are outside the scope of this document.
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)
Le présent document décrit une méthodologie permettant de spécifier les privilèges nécessaires pour accéder aux données de DSI. Cette méthodologie forme une partie de l'architecture générale de communication de DSI définie dans l'ISO 13606-1.
Le présent document cherche à traiter uniquement les exigences relatives aux communications de DSI et à représenter et communiquer les informations spécifiques au DSI qui permettent de prendre une décision d'accès. Elle fait également référence aux exigences de sécurité générale qui s'appliquent aux communications de DSI et signale des solutions techniques et des normes qui spécifient les détails de services répondant à ces besoins de sécurité.
NOTE Les exigences de sécurité pour les systèmes de DSI non associées à la communication de DSI ne relèvent pas du domaine d'application du présent document.
Zdravstvena informatika - Komunikacija z elektronskimi zdravstvenimi zapisi - 4. del: Varnost (ISO 13606-4:2019)
Ta del tega večdelnega standarda o komunikaciji z elektronskimi zapisi na področju zdravstva opisuje metodologijo za določitev privilegijev, potrebnih za dostop do podatkov EHR. Ta metodologija je del celotne komunikacijske arhitekture EHR, opredeljene v 1. delu tega standarda. Ta standard je namenjen obravnavanju zahtev, ki se nanašajo na komunikacije EHR, ter za predstavitev in posredovanje podatkov, specifičnih za EHR, ki bodo sporočali odločitev o dostopu. Prav tako se nanaša na splošne varnostne zahteve, ki veljajo za komunikacije EHR, ter opozarja na tehnične rešitve in standarde, ki določajo podrobnosti o storitvah, ki izpolnjujejo te varnostne potrebe.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2019
Nadomešča:
SIST EN 13606-4:2008
Zdravstvena informatika - Komunikacija z elektronskimi zapisi na področju
zdravstva - 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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
European foreword . 3
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.
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
ISO 13606-4:2019(E)
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
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Published in Switzerland
ii © ISO 2019 – All rights reserved
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
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.
iv © ISO 2019 – All rights reserved
ISO 13606-4:2019(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 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.
ISO 13606-4:2019(E)
— 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.
vi © ISO 2019 – All rights reserved
ISO 13606-4:2019(E)
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.
ISO 13606-4:2019(E)
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
viii © ISO 2019 – All rights reserved
ISO 13606-4:2019(E)
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 interface model is defined in ISO 13606-5.
0.3.11 Generate EHR access log entry
As described in 0.3.3.
0.3.12 Provide EHR access log view
This is desirable practice, and requires an interoperable representation of such an entry (or set of
entries). This interface is discussed in Clause 6.
Although a legal investigation will require that an audit log is provided in a complete and unmodified
form, the presentation of an audit log view to a patient or to a healthcare professional might require
that some entries are filtered out (such as those referring to EHR data to which the patient does not
have access).
The interface model is defined in ISO 13606-5.
0.3.13 Deny EHR access log view
If the request is not to be met, a coarse-grained set of reasons needs to be defined. 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.
0.3.14 Acknowledge receipt of EHR access log view
No healthcare-specific security considerations.
0.3.15 Generate EHR access log entry
As described in 0.3.3.
0.4 Requirements and technical approach
0.4.1 Generic healthcare security requirements
The most widely accepted requirements for an overall security approach in domains handling sensitive
and personal data are published in ISO/IEC 27002. This specifies the kinds of measures that should be
taken to protect assets such as EHR data, and ways in which such data might safely be communicated as
part of a distributed computing environment. A health specific guide to this general standard has been
published in ISO 27799 (Health informatics – Security management in health using ISO/IEC 27002). This
will facilitate the formulation of common security polices across healthcare, and should help promote
the adoption of interoperable security components and services. ISO 22600 (Health informatics —
Privilege management and access control) defines a comprehensive architectural approach to formally
and consistently defining and managing such policies. For EHR communication across national borders
ISO 22857 provides guidance that can be used to define appropriate security policy specifications.
The exact security requirements that need to be met to permit any particular EHR communication
instance will be governed by a number of national and local policies at both the sending and receiving
sites, and at any intermediate links in the communications chain. Many of these policies will apply to
healthcare communications in general, and will vary between countries and clinical settings in ways
that cannot and should not be directed by this document. The approach taken in drafting this document
has therefore been to assume that generic security policies, components and services will contribute to
ISO 13606-4:2019(E)
a negotiation phase (the access decision) prior to sanctioning the communication of an EHR Extract, and
will protect the actual EHR data flows.
This document therefore requires that an overall security policy or set of policies conforming to
ISO 27799 is in place at all of the sites participating in an EHR communication, and also that these
policies conform to national or trans-border data protection legislation. Additional polices might be
required to conform to specific national, local, professional or organisation regulations applicable to
the communication or use of EHR data. Defining such policies is beyond the scope of this document.
0.4.2 Relationship to other related security standards
Legitimate access to EHR data will be determined by a wide range of policies, some of which might exist
as documents, some will be encoded within applications, and some within formal authorization system
components. It is recognized that vendors and organisations differ in how they have implemented
access control policies and services, and the extent to which these are presently computerized.
ISO 22600 (all parts) defines a generic logical model for the representation of the privileges of principals
(entities), of access control policies that pertain to potential target objects, and of the negotiation
process that is required to arrive at an access decision. Figure 2 depicts the concepts of Role Based
Access Control defined in ISO 22600 (all parts).
Figure 2 — Main concepts and policy types defined in Role Based Access Control
[ISO 22600 (all parts)]
Defining constraints on roles, processes, target objects and related privileges by policies, Figure 2 turns
into Figure 3, according to ISO 22600 (all parts).
Figure 3 — Policy-driven RBAC Schema
x © ISO 2019 – All rights reserved
ISO 13606-4:2019(E)
As illustrated in Figure 3, principals (persons, agents etc.) are mapped to one or more Functional Roles,
which will be influenced by the Structural Roles that they are permitted to hold. For example, a person
who is medically qualified and a specialist in child health might hold one or more Structural Roles (such
as Consultant Paediatrician at a hospital, Head of Child Screening for the region). Those Structural Roles
might permit him or her at times to act with the Functional Role of Personal Clinician to a patient. The
Functional Role might be persistent, or limited to a single user session. Functional Roles are mapped to
permissions to perform particular operations (such as writing new entries in an EHR) and to particular
objects (such as the EHR data which that role-holder is permitted to view).
For the purposes of this document, the Target_Component class shown in Figure 3 is the EHR data held
by the EHR Provider. The Permission_Assignment association defines policies to permit or deny access
to part or all of the EHR, which need also to be communicated to the EHR Recipient for onward adoption
and propagation. Whilst this document assumes the adoption of that standard it is acknowledged
that national operational structures and terminology will differ and that variances will be possible.
However, this document only specifies the policy model as a framework to communicate actual access
policies in an interoperable way. It does not itself define the content of the access policies that are to be
determined at jurisdictional or more local levels.
As a complement to that standard, ISO 21298 define sets of Structural Roles and Functional Roles that
can be used internationally to support policy negotiation and policy bridging (for example during the
negotiation phase of an access decision). This document also assumes the adoption of that standard,
and aligns with it.
The relationship of the policy model defined in this document to the HL7 Healthcare Privacy and
Security Classification System is explained in Annex B.
ISO 27789 defines a comprehensive representation of audit log and audit trail information relating
to all of the events that might occur within electronic health record systems. This includes the
communication of EHR data between repositories and systems. This document assumes conformance
to that standard, and defines a profile (sub-set) of the ISO 27789 audit log model specifically for the
purpose of communicating with patients and other authorised parties’ information about who has
accessed the EHR of a specified patient, when and why.
A large number of EHR-specific medico-legal and ethical requirements are expressed within ISO 18308,
although compliance with these is primarily met through specific classes and attributes of the EHR
Reference Model (published in ISO 13606-1). The ISO 13606 standard as a whole enables conformance
to ISO 18308, and this document specifically enables conformance to its ethical and legal requirements
and fair information principles.
05 EHR access policy model
0.5.1 Overall approach
In the ISO 13606-1 Reference Model every COMPOSITION within the EHR_EXTRACT includes an
optional access_policy_ids attribute to permit references to such policies to be made at any level of
granularity within the EHR containment hierarchy. Every COMPOSITION may therefore reference any
number of access policies or consent declarations that define the intended necessary privileges and
profiles of principals (users, agents, software, devices, delegated actors etc.) for future access to it.
The information model in Clause 7 for representing and communicating access policy information has
been deliberately kept very generic, to allow for the diversity of policy criteria that will be stipulated
in different countries and regional healthcare networks. Standardized vocabularies for some of the
main properties of the model are defined as default term lists. Although it is recommended that these
be adopted whenever they are suitable, it is recognised that jurisdictions might have requirements or
legislation or existing investments that mean that they cannot adopt these internationally-standardised
term lists. This document therefore permits jurisdictions to declare conformance using alternative
term lists.
Health and care environments increasingly comprise complex networks of agencies and actors from
traditional healthcare settings, social care, informal carers and voluntary agencies (such as welfare
charities) patients themselves, families and sometimes their social networks. All of these might at
ISO 13606-4:2019(E)
times establish agreements to permit data sharing of personal health data. Given the dynamic nature
of this "virtual care team" it might not be practical for these data sharing agreements to be negotiated
in traditional human to human document based ways. It is therefore likely that such agencies will
establish framework agreements that specify in advance the standards they each comply with, any
mappings between their respective domains of privilege and how data are to be handled within each
such privilege domain. As stated above, this policy model permits jurisdictions to instead declare
alternative term lists that they will use. This allows for some flexibility in adoption of this document,
recognising that complex data sharing environments might need to establish new, potentially richer,
vocabularies to describe the wider range of actors and roles in that environment.
A number of existing and legacy systems might not be able to incorporate richly-defined policy
specifications, and many healthcare regions might not be in a position to define such policies for some
years. Therefore, as a complement to the overall policy model in Clause 7, this document defines two
vocabularies that can provide a minimum basis for making an access policy decision, and ensure a basic
level access policy interoperability, albeit at a coarse-grained level.
These two vocabularies are:
a) a sensitivity classification of EHR data (at the level of COMPOSITION);
b) a high-level classification of EHR Requesters and Recipients, through a set of Functional Roles.
0.5.2 Defining 'Need to Know' when handling EHR data
Within many healthcare environments (within and between collaborating healthcare teams involved
in the direct provision of care to patients) the norm is to share health record information openly. It
is indeed the wish of the vast majority of patients that teams do this, and many patients are actually
surprised at how little of their health record is shared today when it should be, for safety and for good
continuity of care.
Few contemporary healthcare systems (on paper or electronically) define complex internal access
control partitions to the health records that they hold. Even if it were considered useful to define
numerous fine-grained access policies, in practice it might take health care systems, national health
services and millions of patients quite a long time to specify suitable access control policies for all
of their EHR data, and to implement software components that can perform many complex policy-
bridging computations in real time. Maintenance of these policies as the clinical care requirements of
each patient evolve would also be a complex process.
Whilst a suite of access policies might in theory be defined (by patients or by others) to provide a multi-
level access level framework within any given EHR, in practice most clinical settings operate on the
basis of default privileges granted throughout the health record to any healthcare or health-related
professional who has a legitimate interest in that patient. (The definition of who has such a legitimate
interest will vary between organisations, and is not the scope of this document.) However, it is also well
accepted that patients and professionals might at times need to restrict access to some more personally-
sensitive EHR data. It is also common in most health services to ring-fence certain clinical settings as
having exclusive portions of an EHR (for example, sexual health clinics).
This kind of ring-fencing of clinical settings or the marking of EHR data as particularly sensitive is quite
distinct from any sub-divisions of the EHR that might be defined to assist navigation and workflow
within clinical specialties, for example by defining cancer or diabetes portions within the EHR. Figure 4
provides an illustration of the way in which an EHR might logically be subdivided from a need-to-know
point of view, in which the confidentiality classification (sensitivity) is represented through classes of
user, and for particular care settings.
xii © ISO 2019 – All rights reserved
ISO 13606-4:2019(E)
Key
A private entries shared with GP
B entries restricted to sexual health team
C entries accessible to administrative staff
D entries accessible to clinical support staff
E entries accessible to direct care teams
F private entries shared with several named parties
G entries restricted to prison health services
Figure 4 — Illustration of access domains within an example EHR
In this illustration, it is assumed that the patient has complete access to his or her EHR. The majority
of this patient’s EHR is accessible to any party providing direct clinical care. However, the EHR does
contain several private entries; some are restricted to the patient’s general (family) practitioner and
some to a separate list of named parties. The EHR also contains some entries created by and restricted
to a sexual health clinic, and others restricted to the prison health service – both can only be ac
...
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
European foreword . 3
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.
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
ISO 13606-4:2019(E)
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +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
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
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.
iv © ISO 2019 – All rights reserved
ISO 13606-4:2019(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 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.
ISO 13606-4:2019(E)
— 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.
vi © ISO 2019 – All rights reserved
ISO 13606-4:2019(E)
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.
ISO 13606-4:2019(E)
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
viii © ISO 2019 – All rights reserved
ISO 13606-4:2019(E)
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 interface model is defined in ISO 13606-5.
0.3.11 Generate EHR access log entry
As described in 0.3.3.
0.3.12 Provide EHR access log view
This is desirable practice, and requires an interoperable representation of such an entry (or set of
entries). This interface is discussed in Clause 6.
Although a legal investigation will require that an audit log is provided in a complete and unmodified
form, the presentation of an audit log view to a patient or to a healthcare professional might require
that some entries are filtered out (such as those referring to EHR data to which the patient does not
have access).
The interface model is defined in ISO 13606-5.
0.3.13 Deny EHR access log view
If the request is not to be met, a coarse-grained set of reasons needs to be defined. 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.
0.3.14 Acknowledge receipt of EHR access log view
No healthcare-specific security considerations.
0.3.15 Generate EHR access log entry
As described in 0.3.3.
0.4 Requirements and technical approach
0.4.1 Generic healthcare security requirements
The most widely accepted requirements for an overall security approach in domains handling sensitive
and personal data are published in ISO/IEC 27002. This specifies the kinds of measures that should be
taken to protect assets such as EHR data, and ways in which such data might safely be communicated as
part of a distributed computing environment. A health specific guide to this general standard has been
published in ISO 27799 (Health informatics – Security management in health using ISO/IEC 27002). This
will facilitate the formulation of common security polices across healthcare, and should help promote
the adoption of interoperable security components and services. ISO 22600 (Health informatics —
Privilege management and access control) defines a comprehensive architectural approach to formally
and consistently defining and managing such policies. For EHR communication across national borders
ISO 22857 provides guidance that can be used to define appropriate security policy specifications.
The exact security requirements that need to be met to permit any particular EHR communication
instance will be governed by a number of national and local policies at both the sending and receiving
sites, and at any intermediate links in the communications chain. Many of these policies will apply to
healthcare communications in general, and will vary between countries and clinical settings in ways
that cannot and should not be directed by this document. The approach taken in drafting this document
has therefore been to assume that generic security policies, components and services will contribute to
ISO 13606-4:2019(E)
a negotiation phase (the access decision) prior to sanctioning the communication of an EHR Extract, and
will protect the actual EHR data flows.
This document therefore requires that an overall security policy or set of policies conforming to
ISO 27799 is in place at all of the sites participating in an EHR communication, and also that these
policies conform to national or trans-border data protection legislation. Additional polices might be
required to conform to specific national, local, professional or organisation regulations applicable to
the communication or use of EHR data. Defining such policies is beyond the scope of this document.
0.4.2 Relationship to other related security standards
Legitimate access to EHR data will be determined by a wide range of policies, some of which might exist
as documents, some will be encoded within applications, and some within formal authorization system
components. It is recognized that vendors and organisations differ in how they have implemented
access control policies and services, and the extent to which these are presently computerized.
ISO 22600 (all parts) defines a generic logical model for the representation of the privileges of principals
(entities), of access control policies that pertain to potential target objects, and of the negotiation
process that is required to arrive at an access decision. Figure 2 depicts the concepts of Role Based
Access Control defined in ISO 22600 (all parts).
Figure 2 — Main concepts and policy types defined in Role Based Access Control
[ISO 22600 (all parts)]
Defining constraints on roles, processes, target objects and related privileges by policies, Figure 2 turns
into Figure 3, according to ISO 22600 (all parts).
Figure 3 — Policy-driven RBAC Schema
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ISO 13606-4:2019(E)
As illustrated in Figure 3, principals (persons, agents etc.) are mapped to one or more Functional Roles,
which will be influenced by the Structural Roles that they are permitted to hold. For example, a person
who is medically qualified and a specialist in child health might hold one or more Structural Roles (such
as Consultant Paediatrician at a hospital, Head of Child Screening for the region). Those Structural Roles
might permit him or her at times to act with the Functional Role of Personal Clinician to a patient. The
Functional Role might be persistent, or limited to a single user session. Functional Roles are mapped to
permissions to perform particular operations (such as writing new entries in an EHR) and to particular
objects (such as the EHR data which that role-holder is permitted to view).
For the purposes of this document, the Target_Component class shown in Figure 3 is the EHR data held
by the EHR Provider. The Permission_Assignment association defines policies to permit or deny access
to part or all of the EHR, which need also to be communicated to the EHR Recipient for onward adoption
and propagation. Whilst this document assumes the adoption of that standard it is acknowledged
that national operational structures and terminology will differ and that variances will be possible.
However, this document only specifies the policy model as a framework to communicate actual access
policies in an interoperable way. It does not itself define the content of the access policies that are to be
determined at jurisdictional or more local levels.
As a complement to that standard, ISO 21298 define sets of Structural Roles and Functional Roles that
can be used internationally to support policy negotiation and policy bridging (for example during the
negotiation phase of an access decision). This document also assumes the adoption of that standard,
and aligns with it.
The relationship of the policy model defined in this document to the HL7 Healthcare Privacy and
Security Classification System is explained in Annex B.
ISO 27789 defines a comprehensive representation of audit log and audit trail information relating
to all of the events that might occur within electronic health record systems. This includes the
communication of EHR data between repositories and systems. This document assumes conformance
to that standard, and defines a profile (sub-set) of the ISO 27789 audit log model specifically for the
purpose of communicating with patients and other authorised parties’ information about who has
accessed the EHR of a specified patient, when and why.
A large number of EHR-specific medico-legal and ethical requirements are expressed within ISO 18308,
although compliance with these is primarily met through specific classes and attributes of the EHR
Reference Model (published in ISO 13606-1). The ISO 13606 standard as a whole enables conformance
to ISO 18308, and this document specifically enables conformance to its ethical and legal requirements
and fair information principles.
05 EHR access policy model
0.5.1 Overall approach
In the ISO 13606-1 Reference Model every COMPOSITION within the EHR_EXTRACT includes an
optional access_policy_ids attribute to permit references to such policies to be made at any level of
granularity within the EHR containment hierarchy. Every COMPOSITION may therefore reference any
number of access policies or consent declarations that define the intended necessary privileges and
profiles of principals (users, agents, software, devices, delegated actors etc.) for future access to it.
The information model in Clause 7 for representing and communicating access policy information has
been deliberately kept very generic, to allow for the diversity of policy criteria that will be stipulated
in different countries and regional healthcare networks. Standardized vocabularies for some of the
main properties of the model are defined as default term lists. Although it is recommended that these
be adopted whenever they are suitable, it is recognised that jurisdictions might have requirements or
legislation or existing investments that mean that they cannot adopt these internationally-standardised
term lists. This document therefore permits jurisdictions to declare conformance using alternative
term lists.
Health and care environments increasingly comprise complex networks of agencies and actors from
traditional healthcare settings, social care, informal carers and voluntary agencies (such as welfare
charities) patients themselves, families and sometimes their social networks. All of these might at
ISO 13606-4:2019(E)
times establish agreements to permit data sharing of personal health data. Given the dynamic nature
of this "virtual care team" it might not be practical for these data sharing agreements to be negotiated
in traditional human to human document based ways. It is therefore likely that such agencies will
establish framework agreements that specify in advance the standards they each comply with, any
mappings between their respective domains of privilege and how data are to be handled within each
such privilege domain. As stated above, this policy model permits jurisdictions to instead declare
alternative term lists that they will use. This allows for some flexibility in adoption of this document,
recognising that complex data sharing environments might need to establish new, potentially richer,
vocabularies to describe the wider range of actors and roles in that environment.
A number of existing and legacy systems might not be able to incorporate richly-defined policy
specifications, and many healthcare regions might not be in a position to define such policies for some
years. Therefore, as a complement to the overall policy model in Clause 7, this document defines two
vocabularies that can provide a minimum basis for making an access policy decision, and ensure a basic
level access policy interoperability, albeit at a coarse-grained level.
These two vocabularies are:
a) a sensitivity classification of EHR data (at the level of COMPOSITION);
b) a high-level classification of EHR Requesters and Recipients, through a set of Functional Roles.
0.5.2 Defining 'Need to Know' when handling EHR data
Within many healthcare environments (within and between collaborating healthcare teams involved
in the direct provision of care to patients) the norm is to share health record information openly. It
is indeed the wish of the vast majority of patients that teams do this, and many patients are actually
surprised at how little of their health record is shared today when it should be, for safety and for good
continuity of care.
Few contemporary healthcare systems (on paper or electronically) define complex internal access
control partitions to the health records that they hold. Even if it were considered useful to define
numerous fine-grained access policies, in practice it might take health care systems, national health
services and millions of patients quite a long time to specify suitable access control policies for all
of their EHR data, and to implement software components that can perform many complex policy-
bridging computations in real time. Maintenance of these policies as the clinical care requirements of
each patient evolve would also be a complex process.
Whilst a suite of access policies might in theory be defined (by patients or by others) to provide a multi-
level access level framework within any given EHR, in practice most clinical settings operate on the
basis of default privileges granted throughout the health record to any healthcare or health-related
professional who has a legitimate interest in that patient. (The definition of who has such a legitimate
interest will vary between organisations, and is not the scope of this document.) However, it is also well
accepted that patients and professionals might at times need to restrict access to some more personally-
sensitive EHR data. It is also common in most health services to ring-fence certain clinical settings as
having exclusive portions of an EHR (for example, sexual health clinics).
This kind of ring-fencing of clinical settings or the marking of EHR data as particularly sensitive is quite
distinct from any sub-divisions of the EHR that might be defined to assist navigation and workflow
within clinical specialties, for example by defining cancer or diabetes portions within the EHR. Figure 4
provides an illustration of the way in which an EHR might logically be subdivided from a need-to-know
point of view, in which the confidentiality classification (sensitivity) is represented through classes of
user, and for particular care settings.
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ISO 13606-4:2019(E)
Key
A private entries shared with GP
B entries restricted to sexual health team
C entries accessible to administrative staff
D entries accessible to clinical support staff
E entries accessible to direct care teams
F private entries shared with several named parties
G entries restricted to prison health services
Figure 4 — Illustration of access domains within an example EHR
In this illustration, it is assumed that the patient has complete access to his or her EHR. The majority
of this patient’s EHR is accessible to any party providing direct clinical care. However, the EHR does
contain several private entries; some are restricted to the patient’s general (family) practitioner and
some to a separate list of named parties. The EHR also contains some entries created by and restricted
to a sexual health clinic, and others restricted to the prison health service – both can only be accessed
by parties with relevant additional
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