SIST EN ISO 27789:2021

SLOVENSKI STANDARD
oSIST prEN ISO 27789:2020
01-junij-2020
Zdravstvena informatika - Revizijske sledi za elektronske zdravstvene zapise
(ISO/DIS 27789:2020)
Health informatics -- Audit trails for electronic health records (ISO/DIS 27789:2020)
Medizinische Informatik - Audit-Trails für elektronische Gesundheitsakten (ISO/DIS
27789:2020)
Informatique de santé -- Historique d'expertise des dossiers de santé informatisés
(ISO/DIS 27789:2020)
Ta slovenski standard je istoveten z: prEN ISO 27789
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
oSIST prEN ISO 27789:2020 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 27789:2020

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oSIST prEN ISO 27789:2020
DRAFT INTERNATIONAL STANDARD
ISO/DIS 27789
ISO/TC 215 Secretariat: ANSI
Voting begins on: Voting terminates on:
2020-04-17 2020-07-10
Health informatics — Audit trails for electronic health
records
Informatique de santé — Historique d'expertise des dossiers de santé informatisés
ICS: 35.240.80
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 27789:2020(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2020

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oSIST prEN ISO 27789:2020
ISO/DIS 27789:2020(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
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
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ii © ISO 2020 – All rights reserved

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Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Symbols and abbreviated terms . 5
5 Requirements and uses of audit data . 5
5.1 Ethical and formal requirements . 5
5.1.1 General. 5
5.1.2 Access policy. 5
5.1.3 Unambiguous identification of information system users . 5
5.1.4 User roles . 5
5.1.5 Secure audit records . 6
5.2 Uses of audit data . 6
5.2.1 Governance and supervision . 6
5.2.2 Subjects of care exercising their rights . 6
5.2.3 Healthcare provider's ethical or legal proof of action . 6
6 Trigger events . 7
6.1 General . 7
6.2 Details of the event types and their contents . 7
6.2.1 Access events to the personal health information . 7
6.2.2 Query events to the personal health information . 8
7 Audit record details . 8
7.1 The general record format . 8
7.2 Trigger event identification . 9
7.2.1 Event ID . . . 9
7.2.2 Event action code .10
7.2.3 Event date and time . .10
7.2.4 Event outcome indicator .11
7.2.5 Event type code .11
7.3 User identification . .11
7.3.1 User ID .11
7.3.2 Alternative user ID .12
7.3.3 User name .12
7.3.4 User is requestor .12
7.3.5 Role ID code .12
7.3.6 Purpose of use .13
7.4 Access point identification .15
7.4.1 Network access point type code .15
7.4.2 Network access point ID .15
7.5 Audit source identification .15
7.5.1 Overview .15
7.5.2 Audit enterprise site ID .16
7.5.3 Audit source ID .16
7.5.4 Audit source type code .16
7.6 Participant object identification .17
7.6.1 Overview .17
7.6.2 Participant object type code .18
7.6.3 Participant object type code role .18
7.6.4 Participant object data life cycle .19
7.6.5 Participant object ID type code .20
7.6.6 Participant object Permission PolicySet .21
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7.6.7 Participant object sensitivity .21
7.6.8 Participant object ID .21
7.6.9 Participant object name .21
7.6.10 Participant object query .21
7.6.11 Participant object detail .22
8 Audit records for individual events .22
8.1 Access events .22
8.2 Query events .24
9 Secure management of audit data .26
9.1 Security considerations .26
9.2 Securing the availability of the audit system .26
9.3 Retention requirements .26
9.4 Securing the confidentiality and integrity of audit trails .26
9.5 Access to audit data .27
Annex A (informative) Audit scenarios .28
Annex B (informative) Audit log services .34
Bibliography .43
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oSIST prEN ISO 27789:2020
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Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International
Standards adopted by the technical committees are circulated to the member bodies for voting.
Publication as an International Standard requires approval by at least 75 % of the member bodies
casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 27789 was prepared by Technical Committee ISO/TC 215, Health informatics,.
This second edition cancels and replaces the first edition (ISO/TS 27789:2013), which has been
technically revised.
The main changes compared to the previous edition are as follows:
— update ISO27799 chapter titles to the latest
— match between audit record format and DICOM format
— review the content of Annex A audit scenarios
— review the chart of Annex B audit log services
— update bibliography.
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Introduction
0.1  General
Personal health information is regarded by many as among the most confidential of all types of
personal information and protecting its confidentiality is essential if the privacy of subjects of care is
to be maintained. In order to protect the consistency of health information, it is also important that its
entire life cycle be fully auditable. Health records should be created, processed and managed in ways
that guarantee the integrity and confidentiality of their contents and that support legitimate control by
subjects of care in how the records are created, used and maintained.
Trust in electronic health records requires physical and technical security elements along with data
integrity elements. Among the most important of all security requirements to protect personal health
information and the integrity of records are those relating to audit and logging. These help to ensure
accountability for subjects of care who entrust their information to electronic health record (EHR)
systems. They also help to protect record integrity, as they provide a strong incentive to users of such
systems to conform to organizational policies on the use of these systems.
Effective audit and logging can help to uncover misuse of EHR systems or EHR data and can help
organisations and subjects of care obtain redress against users abusing their access privileges. For
auditing to be effective, it is necessary that audit trails contain sufficient information to address a wide
variety of circumstances (see Annex A).
Audit logs are complementary to access controls. The audit logs provide a means to assess compliance
with organizational access policy and can contribute to improving and refining the policy itself. But as
such a policy has to anticipate the occurrence of unforeseen or emergency cases, analysis of the audit
logs becomes the primary means of ensuring access control for those cases.
This document is strictly limited in scope to logging of events. Changes to data values in fields of
an EHR are presumed to be recorded in the EHR database system itself and not in the audit log. It is
presumed that the EHR system itself contains both the previous and updated values of every field. This
is consistent with contemporary point-in-time database architectures. The audit log itself is presumed
to contain no personal health information other than identifiers and links to the record.
Electronic health records on an individual person may reside in many different information systems
within and across organisational or even jurisdictional boundaries. To keep track of all actions that
involve records on a particular subject of care, a common framework is a prerequisite. This document
provides such a framework. To support audit trails across distinct domains it is essential to include
references in this framework to the policies that specify the requirements within the domain,
such as access control rules and retention periods. Domain policies may be referenced implicitly by
identification of the audit log source.
0.2 Benefits of using this document
Standardization of audit trails on access to electronic health records aims at two goals:
— ensuring that information captured in an audit log is sufficient to clearly reconstruct a detailed
chronology of the events that have shaped the content of an electronic health record, and
— ensuring that an audit trail of actions relating to a subject of care’s record can be reliably followed,
even across organizational domains.
This document is intended for those responsible for overseeing health information security or privacy
and for healthcare organizations and other custodians of health information seeking guidance on audit
trails, together with their security advisors, consultants, auditors, vendors and third-party service
providers.
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0.3  Comparison with related standards on electronic health record audit trails
This document conforms to the requirements of ISO 27799, Health informatics — Security management
in health using ISO/IEC 27002, insofar as they relate to auditing and audit trails.
Some readers may be familiar with Internet Engineering Task Force (IETF) Request for Comment (RFC)
3881 Security Audit and Access Accountability Message XML Data Definitions for Healthcare Applications.
[13]
(Readers not already familiar with IETF RFC 3881 need not refer to that document, as familiarity
with it is not required to understand this document). Informational RFC 3881, dated 2004-09 and no
longer listed as active in the IETF database, was an early and useful attempt at specifying the content of
audit logs for healthcare. To the extent possible, this document builds upon, and is consistent with, the
work begun in RFC 3881 with respect to access to the EHR.
0.4  A note on terminology
Several closely related terms are defined in Clause 3 (Terms and definitions). An audit log is a
chronological sequence of audit records; each audit record contains evidence of directly pertaining
to and resulting from the execution of a process or system function. As EHR systems can be complex
aggregations of systems and databases, there may be more than one audit log containing information
on system events that have altered a subject of care’s EHR. Although the terms audit trail and audit log
are often used interchangeably, in this document the term audit trail refers to the collection of all audit
records from one or more audit logs that refer to a specific subject of care or specific electronic health
record or specific user. An audit system provides all the information processing functions necessary to
maintain one or more audit logs.
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oSIST prEN ISO 27789:2020
DRAFT INTERNATIONAL STANDARD ISO/DIS 27789:2020(E)
Health informatics — Audit trails for electronic health
records
1 Scope
This document specifies a common framework for audit trails for electronic health records (EHR), in
terms of audit trigger events and audit data, to keep the complete set of personal health information
auditable across information systems and domains.
It is applicable to systems processing personal health information which, complying with ISO 27799,
create a secure audit record each time a user accesses, creates, updates, or archives personal health
information via the system.
NOTE Such audit records at minimum uniquely identify the user, uniquely identify the subject of care,
identify the function performed by the user (record creation, access, update, etc.), and record the date and time at
which the function was performed.
This document covers only actions performed on the EHR, which are governed by the access policy
for the domain where the electronic health record resides. It does not deal with any personal health
information from the electronic health record, other than identifiers, the audit record only containing
links to EHR segments as defined by the governing access policy.
It does not cover the specification and use of audit logs for system management and system
security purposes, such as the detection of performance problems, application flaw, or support
for a reconstruction of data, which are dealt with by general computer security standards such as
[9]
ISO/IEC 15408 .
Annex A gives examples of audit scenarios. Annex B gives an overview of audit log services.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 27799:2016, Health informatics — Information security management in health using ISO/IEC 27002
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
access control
means to ensure that access to assets is authorized and restricted based on business and security
requirements
[SOURCE: ISO/IEC 27000:2009, definition 2.1]
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3.2
access policy
definition of the obligations for authorizing access to a resource
3.3
accountability
principle that individuals, organizations, and the community are responsible for their actions and may
be required to explain them to others
[SOURCE: ISO 15489-1:2001, definition 3.2]
3.4
audit
systematic and independent examination of accesses, additions, or alterations to electronic health
records to determine whether the activities were conducted, and the data were collected, used, retained
or disclosed according to organizational standard operating procedures, policies, good clinical practice,
and applicable regulatory requirement(s).
3.5
audit archive
archival collection of one or more audit logs
3.6
audit data
data obtained from one or more audit records
3.7
audit log
chronological sequence of audit records, each of which contains data about a specific event
3.8
audit record
record of a single specific event in the life cycle of an electronic health record
3.9
audit system
information processing system that maintains one or more audit logs
3.10
audit trail
collection of audit records from one or more audit logs relating to a specific subject of care or a specific
electronic health record
3.11
authentication
provision of assurance that a claimed characteristic of an entity is correct
[SOURCE: ISO/IEC 27000:2009, definition 2.5]
3.12
authorization
granting of privileges, which includes the granting of privileges to access data and functions
Note 1 to entry: derived from ISO 7498-2: the granting of rights, which includes the granting of access based on
access rights
3.13
authority
entity responsible for issuing certificates
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3.14
availability
property of being accessible and useable upon demand by an authorized entity
[SOURCE: ISO/IEC 27000:2009, definition 2.7]
3.15
confidentiality
property that information is not made available or disclosed to unauthorized individuals, entities, or
processes
[SOURCE: ISO/IEC 27000:2009, definition 2.9]
3.16
Coordinated Universal Time
UTC
time scale which format the basis of a coordinated radio dissemination of standard frequencies and
time signals; it corresponds exactly in rate with international atomic time, but differs from it by an
integral number of seconds
[SOURCE: IEC 60050-713:1998]
3.17
data integrity
property that data have not been altered or destroyed in an unauthorized manner
[SOURCE: ISO 7498-2:1989, definition 3.3.21]
3.18
electronic health record
EHR
comprehensive, structured set of clinical, demographic, environmental, social, and financial data in
electronic form, documenting the health caregiven to a single individual
[SOURCE: ASTM E 1769:1995]
3.19
EHR segment
part of an EHR that constitutes a distinct resource for the access policy
3.20
identification
performance of tests to enable a data processing system to recognize entities
[SOURCE: ISO/IEC 2382-8:1998, definition 08.04.12 (as identity authentication, identity validation)]
3.21
identifier
piece of information used to claim an identity, before a potential corroboration by a corresponding
authenticator
3.22
information security
preservation of confidentiality, integrity and availability of information
[SOURCE: ISO/IEC 27000:2009, definition 2.19]
3.23
integrity
property of protecting the accuracy and completeness of assets
[SOURCE: ISO/I
...