Foreword

Introduction

Hauptteil

1Scope

2Normative references

3Terms and definitions

3.1General terms

3.2Security services terms

4Abbreviated terms

5General

6EHR-archive and eArchiving process

6.1EHR and record

6.1.1Overview

6.1.2Distributed EHR architecture

6.1.3Healthcare-specific features of the EHR

6.2Archiving

6.3EHR-archive

6.4Backup versus EHR-archive

6.5Elements of the EHR-archive

6.6Types of EHR-archive

6.7Online storage

6.8The eArchiving process for EHRs

6.9eArchiving process and records management

7Environment of the EHR-archive

8Policies and responsibilities

8.1Responsibilities

8.1.1Responsibilities of the EHR-archive

8.1.2Responsibilities of the EHR-system

8.1.3Shared responsibilities

8.2Policies

8.2.1Archiving policy

8.2.2Security policy

8.2.3Privacy protection policy

9Security and privacy protection architecture

10Security and privacy protection requirements for the eArchiving process

10.1Overview

10.2Policies and responsibilities

10.3Requirements derived from legislation

10.3.1Overview

10.3.2Preservation time of the health record

10.3.3Preservation of the original EHR

10.3.4Corrections and/or additions to the archived EHR

10.3.5Override conditions

10.3.6Deletion of the EHR

10.3.7The nature of the health records

10.3.8Archival authority

10.3.9Privacy protection and privacy of archived information

10.3.10Consent management

10.3.11Protection of the EHR based on its purpose

10.3.12Fine grain marking of objects

10.4Requirements for availability

10.5Requirements for integrity

10.6Requirements for confidentiality

10.7Requirement for non-repudiation

Annex AFramework for long-term archiving of EHRs in Finland (informative)

A.1General

A.2Legal and regulatory environment

A.3Archiving

A.4National strategy for the management, use and disclosure of electronic health information

Annex BFramework for digital archiving of health records in the UK (informative)

B.1General

B.2Legal and regulatory environment

B.3Records management policy in the UK

B.4Records management

B.5Data protection principles

B.6Archives

B.7NHS Care Record Service

Annex CFramework for digital archiving of health records in Japan (informative)

C.1Legal and regulatory environment

C.1.1Legislation

C.1.2Guidelines

C.1.3General security requirements

C.2Other security features included/mentioned

C.2.1General

C.2.2Specific safeguards mentioned

C.2.3Standards mentioned

Annex DFramework for digital archiving of health records in the USA — Rules and requirements derived from HIPAA (informative)

Annex EComparison of and security requirements for archiving of electronic health records (informative)

Annex FSummary of normative requirements (normative)

Bibliography