International Organization for Standardization

Health informatics - Audit trails for electronic health records - First Edition
 N 27789

Annotation

This International Standard 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 a 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 International Standard 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.[9]

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