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  • ISO
    ISO 27789:2021 Health informatics - Audit trails for electronic health records
    Edition: 2021
    $460.92
    / user per year

Content Description

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.



About ISO

ISO, the International Organization for Standardization, brings global experts together to agree on the best way of doing things – for anything from making a product to managing a process. As one of the oldest non-governmental international organizations, ISO has enabled trade and cooperation between people and companies all over the world since 1946. The International Standards published by ISO serve to make lives easier, safer and better.
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