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BS EN ISO 27789:2021

BS EN ISO 27789:2021

$198.66

Health informatics. Audit trails for electronic health records

Published By Publication Date Number of Pages
BSI 2021 60
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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 that create a secure audit record each time a user reads, creates, updates, or archives personal health information via the system.

NOTE

Such audit records at a minimum uniquely identify the user, uniquely identify the subject of care, identify the function performed by the user (record creation, read, 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 ISO/IEC 15408 (all parts)[ 9].

Annex A gives examples of audit scenarios. Annex B gives an overview of audit log services.

PDF Catalog

PDF Pages PDF Title
2 undefined
3 64_e_stf.pdf
5 European foreword
Endorsement notice
8 Foreword
9 Introduction
12 1 Scope
2 Normative references
3 Terms and definitions
16 4 Abbreviated terms
5 Requirements and uses of audit data
5.1 Ethical and formal requirements
5.1.1 General
5.1.2 Access policy
17 5.1.3 Unambiguous identification of information system users
5.1.4 User roles
5.1.5 Secure audit records
5.2 Uses of audit data
5.2.1 Governance and supervision
18 5.2.2 Subjects of care exercising their rights
5.2.3 Evidence and retention requirements
6 Trigger events
6.1 General
19 6.2 Details of the event types and their contents
6.2.1 Access events to the personal health information
6.2.2 Query events to the personal health information
7 Audit record details
7.1 The general record format
21 7.2 Trigger event identification
7.2.1 Event ID
22 7.2.2 Event action code
7.2.3 Event date and time
23 7.2.4 Event outcome indicator
7.2.5 Event type code
7.3 User identification
7.3.1 User ID
24 7.3.2 Alternative user ID
7.3.3 User name
7.3.4 User is requestor
7.3.5 Role ID code
25 7.3.6 Purpose of use
26 7.4 Access point identification
7.4.1 Network access point type code
27 7.4.2 Network access point ID
7.5 Audit source identification
7.5.1 Overview
28 7.5.2 Audit enterprise site ID
7.5.3 Audit source ID
7.5.4 Audit source type code
29 7.6 Participant object identification
7.6.1 Overview
30 7.6.2 Participant object type code
7.6.3 Participant object type code role
31 7.6.4 Participant object data life cycle and record entry lifecycle events
33 7.6.5 Participant object ID type code
34 7.6.6 Participant object Permission PolicySet
7.6.7 Participant object sensitivity
35 7.6.8 Participant object ID
7.6.9 Participant object name
7.6.10 Participant object query
7.6.11 Participant object detail, Participant object description
36 8 Audit records for individual events
8.1 Access events
37 8.2 Query events
39 9 Secure management of audit data
9.1 Security considerations
9.2 Securing the availability of the audit system
40 9.3 Retention requirements
9.4 Securing the confidentiality and integrity of audit trails
9.5 Access to audit data
41 Annex A (informative) Audit scenarios
47 Annex B (informative) Audit log services
56 Bibliography

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BS EN ISO 27789:2021
$198.66