ISO/TS 21547:2010
(Main)Health informatics — Security requirements for archiving of electronic health records — Principles
Health informatics — Security requirements for archiving of electronic health records — Principles
The purpose of ISO/TS 21547:2010 is to define the basic principles needed to securely preserve health records in any format for the long term. It concentrates on previously documented healthcare specific archiving problems. It also gives a brief introduction to the general archiving principles. Unlike the traditional approach to standardization work, where the perspective is that of modelling, code sets and messages, this Technical Specification looks at archiving from the angle of document management and related privacy protection. In ISO/TS 21547:2010 archiving is understood to be a wider process than just the permanent preservation of selected records. ISO/TS 21547:2010 defines architecture and technology-independent security requirements for long-term preservation of EHRs having fixed content. ISO/TS 21547:2010 and a complementary Technical Report, ISO 21548, concentrate on the security requirements (integrity, confidentiality, availability and accountability) necessary for ensuring adequate protection of health information in long-term digital preservation. This Technical Specification will also address privacy protection requirements for both the EHR and eArchiving systems used in the healthcare environment. ISO/TS 21547:2010 defines functional security requirements for long term archiving of EHRs, but the practical archiving models and technology required are outside the concept of this Technical Specification.
Informatique de santé — Exigences de sécurité pour l'archivage des dossiers de santé électroniques — Principes
General Information
Standards Content (Sample)
TECHNICAL ISO/TS
SPECIFICATION 21547
First edition
2010-02-15
Health informatics — Security
requirements for archiving of electronic
health records — Principles
Informatique de santé — Exigences de sécurité pour l'archivage des
dossiers de santé électroniques — Principes
Reference number
©
ISO 2010
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ii © ISO 2010 – All rights reserved
Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Normative references.2
3 Terms and definitions .2
3.1 General terms .2
3.2 Security services terms .5
4 Abbreviated terms .8
5 General .9
6 EHR-archive and eArchiving process .10
6.1 EHR and record .10
6.2 Archiving .12
6.3 EHR-archive .13
6.4 Backup versus EHR-archive .14
6.5 Elements of the EHR-archive .14
6.6 Types of EHR-archive .15
6.7 Online storage .17
6.8 The eArchiving process for EHRs .17
6.9 eArchiving process and records management .19
7 Environment of the EHR-archive .21
8 Policies and responsibilities .22
8.1 Responsibilities .22
8.2 Policies .24
9 Security and privacy protection architecture.25
10 Security and privacy protection requirements for the eArchiving process.25
10.1 Overview.25
10.2 Policies and responsibilities .26
10.3 Requirements derived from legislation.27
10.4 Requirements for availability .30
10.5 Requirements for integrity.34
10.6 Requirements for confidentiality .36
10.7 Requirement for non-repudiation .37
Annex A (informative) Framework for long-term archiving of EHRs in Finland.39
Annex B (informative) Framework for digital archiving of health records in the UK.45
Annex C (informative) Framework for digital archiving of health records in Japan.53
Annex D (informative) Framework for digital archiving of health records in the USA — Rules and
requirements derived from HIPAA.56
Annex E (informative) Comparison of ISO 15489-1 and ISO/TS 21547 security requirements for
archiving of electronic health records .59
Annex F (normative) Summary of normative requirements .71
Bibliography.76
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
In other circumstances, particularly when there is an urgent market requirement for such documents, a
technical committee may decide to publish other types of document:
⎯ an ISO Publicly Available Specification (ISO/PAS) represents an agreement between technical experts in
an ISO working group and is accepted for publication if it is approved by more than 50 % of the members
of the parent committee casting a vote;
⎯ an ISO Technical Specification (ISO/TS) represents an agreement between the members of a technical
committee and is accepted for publication if it is approved by 2/3 of the members of the committee casting
a vote.
An ISO/PAS or ISO/TS is reviewed after three years in order to decide whether it will be confirmed for a
further three years, revised to become an International Standard, or withdrawn. If the ISO/PAS or ISO/TS is
confirmed, it is reviewed again after a further three years, at which time it must either be transformed into an
International Standard or be withdrawn.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO/TS 21547 was prepared by Technical Committee ISO/TC 215, Health informatics.
iv © ISO 2010 – All rights reserved
Introduction
The healthcare industry is faced with the challenge of reducing costs by moving from paper-based processes
to automated electronic processes. New models of healthcare delivery emphasise the need for patient
information to be shared among a growing number of specialist healthcare providers and across traditional
organizational boundaries.
Paper-based patient records have traditionally been stored in archives which were once located near work
sites; however, it is now common that these documents are located in the organization's centralized archive.
Due to lack of space or to ensure safekeeping, paper data from archives have been transferred to microfilm.
When patient data are transferred to an electronic format, data are either maintained in a simple database or
on paper printouts in an archive. During the past few years, electronic archives independent of basic systems
have been created, such as DICOM – a standard archival system for medical images. An electronic archive
can become a shared information storage system, an archive containing different software and even different
organizations. Centralized administration provides opportunities for managing good data security and
utilization of archival information in accordance with the patient's requests.
Electronic data storage is threatened by the same basic hazards as paper storage. Data can disappear or the
ability to read and understand it can be lost. Electronic media such as magnetic tapes, diskettes and hard
disks can break, be destroyed or get lost. We only have a few decades of experience as to their durability.
Merely retaining the media does not guarantee that the data will be available. As computer hardware and
software are quickly upgraded, older, yet still-functioning media cannot be used with current readers or
software because they are no longer able to read the stored data. With the development of technology, we
must be prepared to transfer old data to new media whenever necessary. Data structures must also be
converted or else unstructured data must be used.
Issues of stability and integrity threaten the storage of electronic data more than paper-based data. The
unlawful usurping or copying of data must also be effectively prevented.
Electronic patient records must be available throughout their whole lifecycle. The need to access patient
records regardless of place and time has increased data transfer between service provider organizations and
healthcare professionals within the last few years. Particularly, data transfer involving different software has
greatly increased over the past few years. The objective to reinforce patient rights to self-determination and
participation in healthcare at its different stages invites the opportunity for the patient to gain more information
concerning his or her care.
An EHR-archive (web-based, regionally centralized or organization-specifically distributed) can manage the
aforementioned data usage and transfer needs in a cost-effective and information-secure way. The use of
health services across national borders is continuously increasing due to mobility of inhabitants,
internationalization of companies and virtualization of health services. In cases where the EHR-archive
discloses records over borderlines, it is necessary that the archive be trusted.
The healthcare environment is unique. Any information system planned for use in this domain should
understand healthcare-specific features such as:
⎯ specific ethical and legal environments;
⎯ in cases where personal health information is accessed, used or disclosed, privacy protection should be
taken into account;
⎯ strong regulations for who can access or disclose healthcare records, when and for what purpose;
⎯ in many countries, citizens/patients have the right to control the use or disclosure of their records using
opt-out and/or consent methods;
⎯ citizens/patients can have the right to know who has used their electronic health records (EHRs) and for
what purpose;
⎯ health service providers or service provider organizations have the responsibility for managing the
records;
⎯ EHRs have a very long preservation time;
⎯ EHR content is sensitive and has specific context and purpose;
⎯ EHR content can grow (e.g. be dynamic) during the preservation time;
⎯ specific responsibilities for EHR managem
...
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