ISO/TR 21548:2010

TECHNICAL ISO/TR
REPORT 21548
First edition
2010-02-01
Health informatics — Security
requirements for archiving of electronic
health records — Guidelines
Informatique de santé — Exigences de sécurité pour l'archivage
des dossiers de santé électroniques — Lignes directrices

Reference number
©
ISO 2010
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ii © ISO 2010 – All rights reserved

Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Terms and definitions .1
3 Abbreviated terms .1
4 eArchive and eArchiving process .2
4.1 eArchive.2
4.2 eArchiving process .2
4.3 Backup and recovery .4
5 Environment of the eArchive .4
6 Responsibilities and policies .5
6.1 General .5
6.2 Responsibilities .5
6.3 Policies .7
7 Design and implementation of secure eArchiving process for EHRs .9
7.1 General discussion .9
7.2 Analysis of the business model.10
7.3 Identification of impact of ethical and legal requirements.11
7.4 Risk analysis of existing systems and the developed system.11
8 Implementation of security requirements.12
9 Security and privacy protection controls and instruments for archiving of EHRs .14
9.1 Tasks of the eArchive .14
9.2 Tasks of EHR system.15
9.3 Selection of security instruments.16
9.4 Privacy protection instruments .17
9.5 Audit-log.17
9.6 Security instruments.17
9.7 Administrative instruments.22
9.8 Metadata .22
9.9 Registration service .25
9.10 Destroying of records .25
9.11 Managing the security of EHRs with dynamic content .25
10 Education and training.25
Annex A (informative) Summary of additional guidelines .26
Bibliography.30

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 exceptional circumstances, when a technical committee has collected data of a different kind from that
which is normally published as an International Standard (“state of the art”, for example), it may decide by a
simple majority vote of its participating members to publish a Technical Report. A Technical Report is entirely
informative in nature and does not have to be reviewed until the data it provides are considered to be no
longer valid or useful.
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/TR 21548 was prepared by Technical Committee ISO/TC 215, Health informatics.
iv © ISO 2010 – All rights reserved

Introduction
This Technical Report is an informative report that provides additional guidance for implementation of
requirements set by ISO/TS 21547. This Technical Report provides a guideline and method to select (from the
requirements defined by ISO/TS 21547) a platform or domain-specific set of requirements fulfilling regulatory
and normative requirements. The platform can be local, regional, national or cross-border. This Technical
Report is planned to be used together with ISO/TS 21547.
This Technical Report provides guidelines that are intended as a supplement to ISO/TS 21547. The summary
of additional guidelines is shown in the Annex A. This Technical Report defines a practical method and
describes practical tools which can be used both in the development and management of eArchives fulfilling
security requirements set by ISO/TS 21547. Most of those tools are not healthcare specific, but the selection
and the implementation of security services and tools should always meet general and healthcare domain-
specific requirements set by national legislation, norms and ethical codes.

TECHNICAL REPORT ISO/TR 21548:2010(E)

Health informatics — Security requirements for archiving
of electronic health records — Guidelines
1 Scope
This Technical Report is an implementation guide for ISO/TS 21547. This Technical Report will provide a
methodology that will facilitate the implementation of ISO/TS 21547 in all organizations that have the
responsibility to securely archive electronic health records for the long term. This Technical Report gives an
overview of processes and factors to consider in organizations wishing to fulfil requirements set by
ISO/TS 21547.
2 Terms and definitions
For purposes of this document, the terms and definitions listed in ISO/TS 21547 apply.
3 Abbreviated terms
⎯ CDA Clinical documentation architecture
⎯ EHR Electronic health record
⎯ GP General practitioner
⎯ HIS Hospital information system
⎯ HL7 Health level 7
⎯ ISMS Information security management system
⎯ PKI Public Key Infrastructure
⎯ LAN Local area network
⎯ PACS Picture Archiving and Communication System
⎯ TTP Trusted Third Party
⎯ XML Extensible Mark-up Language
⎯ VPN Virtual Private Network
4 eArchive and eArchiving process
4.1 eArchive
In healthcare an archive is defined as being an organization that intends to preserve health records for access
and use for an identified group of consumers for a regulated period of time. An electronic archive (eArchive)
preserves information in digital format. An eArchive has the responsibility of making information available in a
correct and independently understandable form over a long period of time. To make this possible, the
eArchive stores not only the data but also meta-information (e.g. representation, description, content and
context information of the data, links between components and required preservation information).
Typically, an eArchive receives and stores fixed content of data (e.g. EHRs or parts of them) with associated
metadata and policies. An alternative is to use the weeding method – the EHR system moves selected EHRs
to a secondary storage area of the EHR system and stores the needed meta-information (including security
rules) in a separate repository.
A typical method of storing fixed content of data is to preserve documents with associated metadata such as
HL7, CDA or XML documents.
Digital archiving has a strong dependence on software. New file formats, software and platforms succeed
each other rapidly and digital material requires constant maintenance in order to retain accuracy.
An eArchive can be a centralized organization or it can be federated (ISO/TS 21547:—, 6.2). In healthcare,
the narrative patient record and images are typically archived separately (for example X-ray pictures are
preserved by dedicated PACS-systems or by a RIS, ECGs and other bio-signals by their own dedicated
systems).
The eArchive can serve only one dedicated user (e.g. one hospital or GP) in such a way that only health
records created by this organization are preserved. On the other hand, one technical eArchive can store
health records on behalf of many EHR systems. The federated eArchive can store records having the same
security and preservation policy or it can preserve records having different security policies. In the latter case,
the eArchive can be seen technically as one archive, but from a security point of view it includes many logical
EHR-archives.
In practice, an eArchive can be a separate archive (“a secondary storage”) or an EHR system can manage all
archiving functions without a separate technical eArchive. In the latter case the EHR system should meet
security requirements set by national legislation and principles and requirements defined in ISO/TS 21547.
4.2 eArchiving process
ISO/TS 21547 has already defined that eArchiving is a holistic and long-term process. During this process,
health records are moved between the EHR systems and the eArchive (the eArchive itself can be an external
repository or a place in the EHR system where fixed records are stored). Figure 1 shows one practical model,
where information is extracted from the local EHR-system database and transferred (in the form of
documents) to the eArchive. The eArchive can also disclose preserved documents, which can be either
viewed by end users or restored to the local database.

2 © ISO 2010 – All rights reserved

Extract
Metadata
Restoring
EHR
Semantic
mapping BODY
Relational DB
or parsing
EHR
eArchive
Metadata
Data
BODY
viewer
Destroying
Figure 1 — Example of the eArchiving process
A typical eArchiving process consists of the following phases. The archiving process starts when information
is extracted from the EHR-database. The next step is to make (if necessary) semantic mappings between
local terminology and terminology used for the long term archiving (e.g. to maintain semantic interoperability).
The third phase in this process is the generation of the archival packet (e.g. data and its metadata), which is
sent to the eArchive. The eArchive stores received information in a fixed format for a defined period of time.
The eArchive sends the requested information packets back to the EHR system, typically in the same format
as that in which the information has been received. The eArchive can also destroy records. At the level of an
EHR system the information can be either restored to the local database or viewed by the end user without
restoration. If it is necessary to maintain semantic interoperability, the EHR system information will parse
received information before it is restored.
Countries differ in their definition of the eArchiving process: it can cover the whole lifecycle of the EHR or only
a part of it. In Finland (ISO/TS 21547:—, Annex A) the eArchiving process starts when patient information is
initially created by the service provider and ends after the destruction of the record. In this case the service
provider organization should manage the whole eArchiving process.
In the UK (ISO/TS 21547:— Annex B), archives are records appraised for permanent preservation and the
term archiving is used to describe permanent preservation of records in the Place of Deposit.
Because the patient documents are dynamic during the care process, the information provider (typically a
patient information system or Hospital Information System) transfers patient documents to the eArchive for
long-term preservation at the time when the care process is ended and the patient's documents have been
signed by the responsible clinician(s).
It is not always easy to define exactly the time when the care process is ended. In the case of hospital
inpatient care this is typically the discharge time. Outpatient care, prevention and rehabilitation do not, in many
cases, have a well-defined end point. Therefore, healthcare service organizations should define a minimum
period after which the records of non-active patients should be extracted for long-term archiving. This period
can also be defined by national legislation.
ISO/TS 21547 has defined the eArchiving process as including the following security services:
⎯ security services when data are captured from the EHR system to the form defined and accepted by the
eArchive;
⎯ creation of security information (security metadata) connected to the record or data objects, and the
linkage of this information to the data;
⎯ security services needed to create the access request to the archive;
⎯ security services needed during the data transfer from the EHR system to the eArchive and vice versa;
⎯ security services needed by the eArchive to create a secure archival “packet” for long-term preservation;
⎯ security services during the preservation period and in the event of data disclosure;
⎯ security services needed to view and restore disclosed data;
⎯ security services needed to prove the non-repudiation of the eArchiving process.
Data can be transferred from the EHR system to the eArchive using different technologies. One method is to
send health records to the archive in the form of digital documents (for example in the form of XML or a
HL7CDA document). Another possibility is to use the EN 13606 extract model or HL7 R3 messages to move
information to the eArchive. It is outside the scope of this Technical Report to comment on specific technology
in use.
The whole eArchiving process should be documented. This documentation should describe all participants
and their roles and responsibilities (ISO 15489-1:2001, 9.10). Typical participants in the eArchiving process
are: health service providers, telecommunication operators, the eArchive, and customers as patients and
citizens.
4.3 Backup and recovery
The backup system is a method of copying electronic records to prevent loss through system failures
(ISO/TR 15489-2). The backup includes multiple copies of records and dispersed storage locations for backup
copies. Backups of health records are used to restore the archived information to its original state after any
disaster (ISO/TS 21547:—, 6.2.1). Backup is also a part of the records management process of the archive.
The backup system should guarantee the integrity, confidentiality and availability of EHRs.
A backup utility is typically a part of the operation system of the eArchive, but separate backup applications
also exist.
The eArchive shall make regular backups (ISO/IEC 27799:2008, 7.6.5.1). To prevent data loss or erosion, the
reliability of backups should be tested regularly. It is also necessary that information professionals managing
the eArchive have been both educated and trained to make backups.
The eArchive should have a recovery plan to prove the availability of records after a disaster. The functionality
of backups should be tested regularly.
5 Environment of the eArchive
ISO/TS Health Informatics — Security Requirements for Archiving of Electronic Health Records, has defined
the typical environment of the eArchive. Because healthcare ICT is very dynamic, the number of information
producers and customers will change. The environment of the eArchive should be fully controlled and the
eArchive should maintain an online information database of all data producers and customers.
4 © ISO 2010 – All rights reserved

6 Responsibilities and policies
6.1 General
Responsibilities among data producers, the eArchive and customers should be clearly defined, fully
documented and regularly maintained at all levels in the organization (ISO/TS 21547). This Technical Report
provides additional guidance on those responsibilities.
All participants (e.g. EHR systems, the eArchive and organizations offering communication services) should
define and document their own domain-specific security and data protection policies covering records
management inside their domain. ISO/TS 21547:—, Clause 10, states that any system archiving electronic
health records (e.g. eArchive) should have a well-defined and documented:
⎯ archiving policy;
⎯ security policy;
⎯ privacy protection policy.
All domain-specific policies should be bridged together to form a comprehensive security and data protection
policy for the whole eArchiving process.
Organizations should ensure that defined policies are implemented and maintained at all levels in the
organization. Support of these policies by all employees is necessary at all times.
This Technical Report provides additional guidance on those policies.
6.2 Responsibilities
6.2.1 Introduction
From a security standpoint, the eArchiving process should be understood as a holistic system
(ISO/TS 21547:—, 6.2). It is outside the scope of this Technical Report to define security responsibilities for
the management of active EHRs used by the health organization in direct care or treatment.
The objective of defining responsibilities and inter-relationships is to maintain an eArchiving process for long-
term preservation of EHRs that meets the security and data protection needs of internal and external
stakeholders. In healthcare, security responsibilities can be derived from medical ethics, legislation, norms,
standards, good practices and guidelines.
All participants in the eArchiving process have both domain-specific and common responsibilities. It is
necessary to define responsibilities connected to the eArchiving process in such a way that no gaps exist. It
should always be clear who is responsible for taking the necessary action (ISO 15489-1).
In healthcare, typically the service provider has the responsibility for archiving health records. It can do this by
itself or it can procure the necessary archiving services from an external organization. Where the archiving of
EHRs is outsourced to an external archiving organization, responsibilities for security management should be
explicitly defined between contractors. It is important to ensure that they meet the standards laid down in the
organization’s policies (ISO 15489-1).
It is necessary to clearly define the security and privacy protection responsibilities between the EHR system
and the eArchive. Responsibilities should be derived from existing legislation and norms. More practically, the
eArchive and the health organization should have a written document or contract in which all responsibilities
are defined.
eArchiving professionals and information managers have the primary responsibility for the implementation of
Technical Specifications. In particular, they establish implemented procedures and processes. It is also their
responsibility to implement other International Standards such as ISO 15489-1 and ISO 27799.
6.2.2 Responsibilities of the eArchive
The main tasks of the eArchive are to securely preserve health records for a regulated period of time and to
make stored information available. The eArchive has the responsibility to make EHRs available for authorized
users and for acceptable purposes. The eArchive also has the responsibility to ensure that records are not
disclosed to unauthorized persons, processes or entities. Additionally, the eArchive has the responsibility to
manage migrations in such a way that the integrity of the record is secured and that the process does not
affect the characteristics of the record (ISO 15489-1). The eArchive may also have the responsibility to prove
the non-repudiation of all these activities if national legislation so stipulates.
During the long preservation time, it is possible that regulations, access rules and storage time norms can
change. The eArchive should regularly check for possible changes and, if necessary, update its internal rules,
procedures and records management software. If necessary, the archive can also update the archival
metadata of EHRs (for example change the preservation time information of the EHR). All changes should be
documented.
The eArchive discloses stored records to other computer systems for further processing. The archive can
disclose records in the form of messages or through online access services.
Security responsibilities of all stakeholders participating in the eArchiving process should be defined, including
those of professionals managing the eArchive and its records. The latter requires that the eArchive define
responsibilities of all its employees involved in records management (ISO/TR 15489-2). Responsibilities
should be included in policy documents and formal contracts.
The eArchive should collect, store and make available all audit logs and prove both the integrity and non-
repudiation of those logs.
6.2.3 Responsibilities of the EHR system
The “ownership” of EHRs is not closely or uniformly defined in most countries, but in the health care domain
we can say that organizations controlling and managing EHRs have the stewardship of them. Typically a
national law, decree or guideline defines:
⎯ who has control responsibilities for the management of EHRs;
⎯ when the archiving process is initiated, where and by whom;
⎯ who is responsible for the management of the archiving process (e.g. the archiving department of the
hospital or the chief medical doctor).
It is the responsibility of the EHR system to capture information that will be transferred for archiving from its
local information systems (e.g. EHR system, laboratory system, radiological system or primary care
information system) and add to the captured data, security information required for long-term eArchiving.
Metadata needed for long-term preservation of EHRs should be added to the captured information.
ISO 23081-1 as well as existing national standards and norms can be used in defining the actual content of
the required meta-information.
It is also the responsibility of the EHR system to ensure that only those persons, processes and entities
having the right to access archived records can use applications developed for this purpose. This can be
realised using a role based access control service (RBAC).
The EHR system has the responsibility to generate and transfer all necessary information required for data
disclosure to the archive. Depending on national legislation, this information can include:
⎯ the certification of the existence of a patient-clinician relationship;
⎯ patient consent information;
⎯ information about the purpose of requested data;
6 © ISO 2010 – All rights reserved

⎯ definition of acts and norms that enable data disclosure;
⎯ information needed to enable the overriding condition.
6.2.4 Shared responsibilities
Communication between the eArchive and the EHR system should be trustworthy. Typically, the requisite
telecommunication services are bought from a third party (e.g. tele-operator). Before signing a contract both
the eArchive and the service provider should:
⎯ analyse existing legislation, security norms and rules;
⎯ perform a risk analysis,
⎯ select the required security level;
⎯ define to whom, when and how the network operator should communicate the details of security events or
any potential security and data protection incidents.
It is the responsibility of the telecommunication service provider to prove that health records are not made
available to any unauthorized person, process or entity during the data transmission. It should also prove the
integrity of data. There exists a wide selection of technologies for these purposes, such as data encryption,
electronic envelopes, secure communication lines and protocols (e.g. VPN and SSL).
Trusted communication means that all partners have been identified and authenticated uniquely. Both mutual
authentication and certification services offered by a trusted third party can be deployed to assure trust.
6.3 Policies
6.3.1 Overview
The eArchive is designed to receive, maintain, store, disclose and destroy electronic health records with the
help of automated computer processes. This means that software used by the eArchive should meet
requirements derived from archiving, security and data protection policies. This can be realised by deriving
rules from policies and using policy languages for implementation of those rules.
The archive can receive health records from different sources, and records creators can have different
security and privacy protection policies. Therefore the archive should always be concurrent and compliant with
those policies relevant to the received information. This can be realised by:
⎯ including necessary policy information to the metafile of the archival data packet (ISO 23081-1);
⎯ an automatic negotiation process between the EHR system and the eArchive;
⎯ including policy information to the contract regulating the eArchiving process.
The eArchive and the whole eArchiving process should be audited and/or certified to meet policies.
6.3.2 Archiving policy
ISO/TS 21547 defines that the eArchive should have a written archiving policy. The policy should be derived
from an analysis of the eArchiving business plan (ISO 15489-1). It should meet requirements set by legislation,
norms, standards and best practice rules.
It is necessary that not only the eArchive, but also the whole eArchiving process have a comprehensive
eArchiving policy. ISO/TS 21547 defines major elements of this policy document.
The archiving policy document should be accepted by all partners to the eArchiving process, documented and
published.
6.3.3 Security policy
ISO/IEC 17799 and ISO 27799 define general security requirements for the management of health information.
However, those International Standards do not address specific problems arising when EHRs are archived.
The aim of this Technical Report is to give additional guidelines for the secure eArchiving process.
Organizations archiving personal health information shall have a written security policy document. It is
proposed that this policy is based on requirements set by ISO/IEC 17799 and ISO 27799. The security policy
should cover the entire eArchiving process. The policy should be derived from the results of the risk analysis
of the eArchiving process. The security policy should meet requirements set by national legislation, norms,
standards and best practice rules.
The security policy document should be accepted by all partners to the eArchiving process, documented and
published.
Because the eArchive can preserve health records having differing/varying security requirements, the security
policy of the eArchive should define principles to preserve, disclose and destroy stored EHRs according to
their security policy.
6.3.4 Privacy protection policy
Privacy protection legislation defines the rights and duties of organizations and people with respect to the
processing of personal data. Processing covers the entire lifecycle of personal data from creation to
destruction. Basic privacy protection principles are universal. The EU Personal Data Protection Act has
defined seven principles. Those principles focusing on the long-term archiving of health records are shown in
1)
Table 1 .
The eArchive shall have a privacy protection policy. The main target of this policy is to protect patient privacy
and also verify that patients can exercise their rights (e.g. inspect their own health data) in accordance with
agreed procedures. This policy should meet requirements set by national (and/or international) legislation,
norms and guidelines (e.g. HIPAA-legislation, Act on patient rights, EC Data Protection Directive). Table 1 can
be used as the starting point to formulate the privacy protection policy for long term archiving of electronic
health records.
The privacy protection policy document should be accepted by all partners to the eArchiving process,
documented and published.
The privacy protection policy should define how conflicts about privacy policies of partners of the eArchiving
process are resolved and settled.

1) Source: Privacy-Enhancing Technologies, White paper, the Dutch Ministry of the Interior and Kingdom Relations.
8 © ISO 2010 – All rights reserved

Table 1 — Summary of privacy protection principles for eArchiving of health records
Privacy protection principle Application to eArchiving of health records
The patient must be informed about health organizations and reasons for
Transparency processing his or her health data. The patient must be informed about the rules to
exercise his or her consent and opt-out rights.
The health data can be used only for purposes for which they are collected. No
further processing or the use of data for other purposes is allowed without informed
consent or specific national legislation.
Justification
Basic purpose to process health data is to organize care and/or treatment. Not all
data collected by a health person or organization is aimed solely for care or
treatment. Therefore the data should be marked by their purpose before they are
sent to the eArchive.
National and international legislations regulate and restrict who, when and why
health records can be processed. They also restrict the transfer of health data to
countries which do not set out adequate privacy rules.
The eArchiving process must meet national privacy protection regulations.
Regulatory and legal frameworks in different countries can provide varying degrees
of protection of privacy, and the “adequacy” of protection can remain open to
Legitimate grounds
interpretation. Companies offering eArchiving services must comply with the
regulations of countries in which they operate. They should also inform clients of
the impact those regulations may have upon the level of security and privacy
protection of EHRs they store on behalf of those clients. The outsourcing decision
should be based on business needs and risk assessments. Generally, the
EHR-archive cannot be outsourced to companies that cannot guarantee adequate
privacy protection of archived EHRs.
Collected health data should be relevant and proportional to the processing
purposes, accurate and not kept longer than necessary.
Quality
Preservation periods are typically regulated at national level. The data sent to the
eArchive shall include preservation period information. The eArchive should
destroy a record when its preservation period ends.
These rights are based on national legislation. The patient can exercise his
consent or opt-out privileges to prevent the eArchiving or disclosure of any record.
Rights of the patient
The eArchive shall check patient opt-out or consent before any EHR disclosure.
The partners of the eArchiving process should take all necessary technical and
organizational precautions to safeguard EHRs from loss or against any form of
unlawful processing.
Security
This Technical Report, ISO 27799 and ISO 15489-1 are targeted both to underpin
the security requirements and to provide the tools for secure archiving of health
records
7 Design and implementation of secure eArchiving process for EHRs
7.1 General discussion
Most EHR systems in use are not specified for secure long-term preservation of health records. They are,
predominantly, online systems targeted to support local workflows in the conduct and administration of direct
care. During the care process, the patient EHR may be updated many times daily by many people, computer
systems or applications. Typical security services implemented at a legacy systems level are: identification of
users, privilege management and access control services, systems logs, back-up and/or replication services.
Some systems may also have the ability to “close” the record at a point in the care period in such a way that it
is no longer possible to change the content of the record.
In healthcare the traditional archive is paper-storage, but dedicated electronic archives also exist (e.g. PACS
for digitalized images). Because online EHR systems are not planned for secure long-term preservation of
health records, they in most cases do not fulfil all security requirements needed for long term eArchiving of
EHRs. However, when designing and implementing a secure eArchiving process, the presence of legacy EHR
systems and their functionality should be taken into consideration.
It is theoretically possible to develop an EHR system having the ability to archive health records securely
without requiring a separate eArchive. Such a system can prove the non-repudiation of any event occurring
during the lifetime of the computer system, and can also restore any state of the EHR occurring during its
lifetime. Whichever type of system is used, online systems archiving health records should meet security
requirements defined by this Technical Report and national legislation.
ISO/TR 15489-2 sets out a generic model for the design and implementation of records systems. ISO 27799
proposes use of the concept of an information security management system (ISMS) as a starting point.
Merging those two models, the following nine-step model can be used for the design and development of a
secure eArchiving process:
Step A: Understand the environment of the eArchiving process, together with the administrative, legal,
business and social contexts in which it operates.
Step B: Analyse business activity and develop a conceptual model that sets out what each organization
participating in the eArchiving process does and how.
Step C: Assess existing EHR systems and eArchives, and the security services they support.
Step D: Identify existing security requirements for eArchiving of EHRs. This includes requirements set by
legislation and International Standards (e.g. this Technical Report, ISO 27799 and ISO 15489-1).
Step E: Perform a risk analysis covering the whole eArchiving process. This step includes both planning the
risk analysis and performing it systematically.
Step F: Create strategies to satisfy security requirements. This includes the creation of policies and the
selection of security safeguards and tools. Contracts with other partners and vendors should also be
completed at this stage.
Step G: Design the eArchiving process and the eArchive. This step includes all necessary changes to the
current security services of EHR systems, together with any processes and changes to the content
or structure of the EHR (if needed).
Step H: Implement eArchiving service and processes. This includes the implementation of selected security
and privacy protection services.
Step I: Conduct a post-implementation review. This includes security audits and, if required, security
certification of the entire eArchiving process.
7.2 Analysis of the business model
The purpose of the business model is to develop a map showing what the eArchiving process and its partners
(e.g. the eArchive, EHR system and third parties) do and how. This model includes a definition of methods by
which EHRs are prepared for archiving, sent or received to the archive and distributed in a secure way. The
business model includes identification and classification of organizations participating in both the eArchiving
process and the classification of customers. The business model should identify both the model of the
eArchive which is or will be implemented and its means of communication with EHR systems and customers.
One part of the business model is to define the purpose of the eArchive itself. The business model can be for
example:
⎯ long-term preservation of legally defined EHRs;
⎯ acting as a notary archive for long-term preservations of all kinds of healthcare documents;
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⎯ archiving only fixed health documents (e.g. the whole EHR or set of fixed objects);
⎯ an online electronic storage archiving active multimedia records;
⎯ a permanent repository for EHRs.
7.3 Identification of impact of ethical and legal requirements
The eArchive should meet ethical principles and legal requirements set by international societal norms and
national legislation. The archive should therefore identify those requirements. In more practical terms, it
should model tasks and processes of the archive and identify at each step:
⎯ from where health records are received;
⎯ which data are processed and by whom;
⎯ security requirements connected to the record and its elements;
⎯ legal and ethical requirements concerning data processing in all steps;
⎯ for what purposes the EHR is processed;
⎯ which data are transferred to the archive.
Findings of this kind of analysis can be used both for risk analysis and for defining the privilege levels required
for data access.
The main ethical principles to take into account are:
⎯ patient-clinician relationship, needed for access (the relationship principle);
⎯ only those professionals who are participating in the explicit care process have privileges to access the
EHR;
⎯ an acceptable reason to access is needed;
⎯ access is to be given based on the needs arising in the care and treatment of the patient (the need-to-
know principle).
Those principles mean that before responding to a request for any data disclosure the eArchive should ensure
that acceptable reason exists and the application or person requesting data disclosure from the eArchive has
an appropriate right to access the required data.
7.4 Risk analysis of existing systems and the developed system
ISO/TS 21547 states that the eArchive should both analyse risks and have a risk management mechanism.
An eArchive can be a new service connected to existing EHR systems. It is necessary to perform a holistic
risk analysis including all components of the eArchiving process (e.g. including network operators/operations)
and prove that all components fulfil security requirements.
The eArchive operates over many decades and during this period new EHR systems will be connected to it. It
is necessary to perform the risk analysis in advance as a part of the development of those systems before
they are connected to the archive.
Both ISO/IEC 27001 and ISO/IEC 13335-3 define the components of risk analysis. Those International
Standards and ISO 27799 can be used as a starting point for the risk analysis.
ISO/IEC 15408 (which describes the common criteria or CC) is a widely used multipart International Standard
aimed at the development of products and systems with IT security functions or systems and the procurement
of commercial products and systems with such
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