NF EN ISO 27789

NF EN ISO 27789

April 2013
Standard Cancelled

Health informatics - Audit trails for electronic health records

ISO 27789:2013 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. ISO 27789:2013 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 15408-2.

View the extract
Main informations

Collections

National standards and national normative documents

Publication date

April 2013

Number of pages

56 p.

Reference

NF EN ISO 27789

ICS Codes

35.240.80   IT applications in health care technology

Classification index

S97-556

Print number

1 - 26/03/2013

International kinship

European kinship

EN ISO 27789:2013
Sumary
Health informatics - Audit trails for electronic health records

ISO 27789:2013 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.

ISO 27789:2013 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 15408-2.

Standard replaced by (1)
NF EN ISO 27789
October 2021
Standard Current
Health informatics - Audit trails for electronic health records

<p>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.</p> <p>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.</p> <p>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.</p> <p>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.</p> <p>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)<sup>[9]</sup>.</p> <p>Annex A gives examples of audit scenarios. Annex B gives an overview of audit log services.</p>

Table of contents
View the extract
  • Avant-propos
    iv
  • 0 Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    1
  • 4 Symboles et abréviations
    5
  • 5 Exigences et usages des données d'expertise
    5
  • 5.1 Exigences éthiques et formelles
    5
  • 5.2 Usages des données d'expertise
    6
  • 6 Événements déclencheurs
    7
  • 6.1 Généralités
    7
  • 6.2 Détails des types d'événements et de leur contenu
    7
  • 7 Détails des enregistrements d'expertise
    8
  • 7.1 Format d'enregistrement général
    8
  • 7.2 Identification de l'événement déclencheur
    9
  • 7.3 Identification de l'utilisateur
    12
  • 7.4 Identification de point d'accès
    15
  • 7.5 Identification de la source d'expertise
    16
  • 7.6 Identification de l'objet participant
    18
  • 8 Enregistrements d'expertise des événements individuels
    24
  • 8.1 Événements d'accès
    24
  • 8.2 Événements de requêtes
    25
  • 9 Gestion sécurisée des données d'expertise
    27
  • 9.1 Considérations de sécurité
    27
  • 9.2 Sécuriser la disponibilité du système d'expertise
    27
  • 9.3 Exigences de conservation
    27
  • 9.4 Sécuriser la confidentialité et l'intégrité des historiques d'expertise
    27
  • 9.5 Accès aux données d'expertise
    28
  • Annexe A (informative) Scénarios d'expertise
    29
  • Annexe B (informative) Services de rapport d'expertise
    36
  • Bibliographie
    46
Need to identify, monitor and decipher standards?

COBAZ is the simple and effective solution to meet the normative needs related to your activity, in France and abroad.

Available by subscription, CObaz is THE modular solution to compose according to your needs today and tomorrow. Quickly discover CObaz!

Request your free, no-obligation live demo

I discover COBAZ