Health informatics — Security requirements for archiving of electronic health records — Guidelines

This document provides additional guidance for the implementation of the requirements set by ISO/TS 21547, Health informatics — Security requirements for archiving of electronic health records — Principles.

This document provides a methodology that will facilitate the implementation of ISO/TS 21547 in all organisations that have the responsibility to securely archive electronic health records for the long term. It gives an overview of processes and factors to consider in organisations wishing to fulfil requirements set by ISO/TS 21547.

Main sections:

· Scope

· eArchive and eArchiving process

· Environment of the eArchive

· Responsibilities and policies

· Design and implementation of secure eArchiving process for EHRs

· Implementation of security requirements

· Security and privacy protection controls and instruments for archiving of EHRs

· Education and training

· Annex A: Summary of additional guidelines