Health informatics - Privilege management and access control - Part 1: Overview and policy management

ISO/TS 22600-1:2006 is intended to support the needs of healthcare information sharing across unaffiliated providers of healthcare, healthcare organizations, health insurance companies, their patients, staff members and trading partners. It is also intended to support inquiries from both individuals and application systems. ISO/TS 22600-1:2006 supports collaboration between several authorization managers that may operate over organizational and policy borders.

Informatique de santé — Gestion de privilèges et contrôle d'accès — Partie 1: Vue d'ensemble et gestion des politiques

General Information

Status
Withdrawn
Publication Date
23-Jul-2006
Withdrawal Date
23-Jul-2006
Current Stage
9599 - Withdrawal of International Standard
Start Date
22-Sep-2014
Completion Date
13-Dec-2025
Ref Project

Relations

Technical specification
ISO/TS 22600-1:2006 - Health informatics -- Privilege management and access control
English language
28 pages
sale 15% off
Preview
sale 15% off
Preview

Frequently Asked Questions

ISO/TS 22600-1:2006 is a technical specification published by the International Organization for Standardization (ISO). Its full title is "Health informatics - Privilege management and access control - Part 1: Overview and policy management". This standard covers: ISO/TS 22600-1:2006 is intended to support the needs of healthcare information sharing across unaffiliated providers of healthcare, healthcare organizations, health insurance companies, their patients, staff members and trading partners. It is also intended to support inquiries from both individuals and application systems. ISO/TS 22600-1:2006 supports collaboration between several authorization managers that may operate over organizational and policy borders.

ISO/TS 22600-1:2006 is intended to support the needs of healthcare information sharing across unaffiliated providers of healthcare, healthcare organizations, health insurance companies, their patients, staff members and trading partners. It is also intended to support inquiries from both individuals and application systems. ISO/TS 22600-1:2006 supports collaboration between several authorization managers that may operate over organizational and policy borders.

ISO/TS 22600-1:2006 is classified under the following ICS (International Classification for Standards) categories: 35.240.80 - IT applications in health care technology. The ICS classification helps identify the subject area and facilitates finding related standards.

ISO/TS 22600-1:2006 has the following relationships with other standards: It is inter standard links to ISO 22600-1:2014. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

You can purchase ISO/TS 22600-1:2006 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of ISO standards.

Standards Content (Sample)


TECHNICAL ISO/TS
SPECIFICATION 22600-1
First edition
2006-08-01
Health informatics — Privilege
management and access control —
Part 1:
Overview and policy management
Informatique de santé — Gestion de privilèges et contrôle d'accès —
Partie 1: Vue d'ensemble et gestion des politiques

Reference number
©
ISO 2006
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.

©  ISO 2006
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2006 – All rights reserved

Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Terms and definitions. 2
3 Abbreviations . 4
4 Goal and structure of privilege management and access control . 4
4.1 Goal of privilege management and access control. 4
4.2 Structure of privilege management and access control. 4
5 Policy agreement . 10
5.1 Overview . 10
5.2 Identification. 10
5.3 Patient consent . 10
5.4 Patient privacy . 10
5.5 Information identification. 10
5.6 Information location . 10
5.7 Information integrity. 11
5.8 Security. 11
5.9 Authorization. 11
5.10 Role structures. 11
5.11 Attestation rights . 11
5.12 Delegation rights. 11
5.13 Validity time. 11
5.14 Authentication of users/roles . 11
5.15 Access . 12
5.16 Agreement validity period. 12
5.17 Ethics . 12
5.18 Secure audit trail. 12
5.19 Audit check. 12
5.20 Risk analysis . 12
5.21 Continuity and disaster management. 12
5.22 Future system developments . 12
6 Documentation. 13
Annex A (informative) Example of a documentation template . 14
Annex B (informative) Example of an information exchange policy agreement . 22
Bibliography . 28

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 normative 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 22600-1 was prepared by Technical Committee ISO/TC 215, Health informatics.
ISO/TS 22600 consists of the following parts, under the general title Health informatics — Privilege
management and access control:
⎯ Part 1: Overview and policy management
⎯ Part 2: Formal models
iv © ISO 2006 – All rights reserved

Introduction
A common situation today is that hospitals are supported by several vendors providing different applications,
who are not able to communicate authentication and authorization since each has its own way of handling
these functions. To achieve an integrated scenario one has to spend a huge amount of money to get users
and organizational information mapped before starting communication. Resources are required for
development and maintenance of security functions that grow exponentially with the number of applications.
If, on the other hand, one looks on authorization from the health care organization's point of view, we need a
flexible bridging model due to the fact that organizations change continuously. Units close down, open and
merge.
The situation becomes even more complex when communications across security policy domain boundaries
are necessary. The policy differences between these domains then have to be bridged through policy
agreements between the parties.
Another complexity is found in roles when it comes to users. A user can adopt different roles related to
different periods of time and even have two or more roles simultaneously. For example, a user may work as a
nurse for two months and as a midwife for the next two or have both roles within the same time period.
Moreover, different responsibilities can be identified in the healthcare organization depending on the role and
activities of the users. Moving from country to country or from one healthcare centre to another, different types
or levels of authorization may be applied to similar types of user, both for execution of particular functions and
for access to the information.
Another most important issue today is how to improve the quality of care by using IT, without infringing the
privacy of the patient. To allow physicians to have more adequate information about the patient you need to
have something like a ‘virtual electronic health care record’ which makes it possible to keep track of all the
activities belonging to one patient regardless of where and by whom they have been documented. With such
an approach we need to have a generic model or specific agreement between the parties for authorization.
Besides the needs for support of a diversity of roles and responsibilities, which are typical in any type of large
organization, additional critical aspects can be identified such as ethical and legal aspects in the healthcare
scenario due to the particular type of information that is managed.
The need for restrictive authorization is already high today but is going to dramatically increase over the next
two years. The reason is the increase of exchange of information between applications in order to fulfil the
physicians’ demands on having access to more and more patient-related information to ensure the quality and
efficiency of patient treatment.
The situation, with respect to health care and its communication and application security services has
changed during the last decade. Reasons are, for example:
⎯ moving from mainframe based proprietary legacy systems to distributed systems running in local
environments;
⎯ more data are stored in information systems and are therefore also more valuable to the users;
⎯ patients are more ambulant and in need of their medical information at different locations.
From this it follows that advanced security is required in communication and use of health information due to
the sensitivity of person-related information and its corresponding personal and social impact. Those security
services concern both communication and application security. Regarding communication security services,
such as authentication, integrity, confidentiality, availability, accountability (including traceability and
non-repudiation), control of access to entities as well as notary’s services, it is authentication that is of crucial
importance for most of the other services. This is also true for application security such as access control to
data and functions of applications running at the aforementioned entity, integrity, confidentiality, availability,
accountability, audibility and the notary’s services.
The implementation of this Technical Specification will be very complex since the involved parties will already
have systems in operation and will not be willing to update their system immediately to newer versions or new
systems. It is therefore very important that a policy agreement is written between the parties, which states that
they intend to progress towards this standard when any change in the systems is intended.
The policy agreement shall also contain defined differences in the security systems and agreed solutions on
how to overcome the differences. For example, the authentication service, rights and duties of a requesting
party at the responding site have to be managed according to the agreed policy written down in the
agreement. For that reason, information and service requester, as well as information and service provider on
the one hand, and information and services requested and provided on the other hand, have to be grouped
and classified properly. Based on that classification, claimant mechanisms, target sensitivity mechanisms and
policy specification and management mechanisms, can be implemented. Once all parties have underwritten
the policy agreement the communication and information exchange can start with the existing systems if the
parties do not see any risks. If there are risks which are of such importance that they have to be eliminated
before the information exchange starts they shall also be recorded in the policy agreement together with an
action plan for how these risks shall be removed. The policy agreement shall also contain a time plan for this
work and an agreement on how it shall be financed.
The documentation process is very important and provides the platform for the policy agreement.
⎯ Part 1: Overview and policy management, describes the scenarios and the critical parameters in cross
border information exchange. It also gives examples of necessary documentation methods as the basis
for the policy agreement.
⎯ Part 2: Formal models, describes and explains, in a more detailed manner, the architectures and
underlying models for the privileges and privilege management, which are necessary for secure
information sharing plus examples of policy agreement templates.
Privilege management and access control address security services required for communication and
distributed use of health information. This document introduces principles and specifies services needed for
managing privileges and access control. Cryptographic protocols are out of the scope of this document.
Technical Specification ISO/TS 22600 references existing architectural and security standards as well as
specifications in the healthcare area such as ISO, CEN, ASTM, OMG, W3C etc., and endorses existing
appropriate standards or identifies enhancements or modifications or the need for new standards.
This part of ISO/TS 22600 is strongly related to other corresponding International Standards such as
ISO/TS 17090 and ISO/TS 21091. It is also related to work in progress on a future Technical Specification,
ISO/TS 21298.
The distributed architecture of shared care information systems is increasingly based on networks. Due to
their user friendliness, the use of standardized user interfaces, tools and protocols, which ensure platform
independence, is growing and consequently the number of really open information systems based on
corporate networks and virtual private networks has also been rapidly growing during the last couple of years.
ISO/TS 22600 defines privilege management and access control services required for communication and use
of distributed health information over domain and security borders. The document introduces principles and
specifies services needed for managing privileges and access control. It specifies the necessary component
based concepts and is intended to support their technical implementation. It will not specify the use of these
concepts in particular clinical process pathways.
vi © ISO 2006 – All rights reserved

TECHNICAL SPECIFICATION ISO/TS 22600-1:2006(E)

Health informatics — Privilege management and access
control —
Part 1:
Overview and policy management
1 Scope
This part of ISO/TS 22600 is intended to support the needs of healthcare information sharing across
unaffiliated providers of healthcare, healthcare organizations, health insurance companies, their patients, staff
members and trading partners. It is also intended to support inquiries from both individuals and application
systems.
ISO/TS 22600 defines methods for managing authorization and access control to data and/or functions. It
accommodates policy bridging. It is based on a conceptual model where local authorization servers and cross-
border directory and policy repository services can assist access control in various applications (software
components). The policy repository provides information on rules for access to various application functions
based on roles and other attributes. The directory service enables identification of the individual user. The
granted access will be based on four aspects:
⎯ the authenticated identification of the user;
⎯ the rules for access connected with a specific information object;
⎯ the rules regarding authorization attributes linked to the user provided by the authorization manager;
⎯ the functions of the specific application.
This part of ISO/TS 22600 should be used in a perspective ranging from a local situation to a regional or
national one. One of the key points in these perspectives is to have organizational criteria combined with
authorization profiles agreed upon from both the requesting and delivering side in a written policy agreement.
This part of ISO/TS 22600 supports collaboration between several authorization managers that may operate
over organizational and policy borders.
The collaboration is defined in a policy agreement, signed by all involved organizations, and constitutes the
basic platform for the operation.
A documentation format is proposed, as a platform for the policy agreement, which makes it possible to obtain
comparable documentation from all parties involved in the information exchange of information.
This part of ISO/TS 22600 excludes platform-specific and implementation details. It does not specify technical
communication security services and protocols that have been established in other standards,
e.g. ENV 13608. It also excludes authentication techniques.
2 Terms and definitions
For the purposes of this document the following terms and definitions apply.
2.1
access control
means of ensuring that the resources of a data processing system can be accessed only by authorized
entities in authorized ways
[ISO/IEC 2382-8, definition 08.04.01]
2.2
accountability
property that ensures that the actions of an entity may be traced uniquely to the entity
[ISO 7498-2, definition 3.3.3]
2.3
attribute certificate
data structure, digitally signed by an attribute authority, which binds some attribute values with identification
about its holder
2.4
authentication
process of reliably identifying security subjects by securely associating an identifier and its authenticator
NOTE See also data origin authentication and peer entity authentication.
2.5
authority
entity that is responsible for the issuance of certificates
NOTE Two types are defined in this part of ISO/TS 22600: certification authority that issues public-key certificates
and attribute authority that issues attribute certificates.
2.6
authorization
process of granting rights, which includes the granting of access rights
2.7
availability
property of being accessible and useable upon demand by an authorized entity
[ISO 7498-2, definitioin 3.3.11]
2.8
certification authority
CA
authority trusted by one or more relying parties to create and assign certificates
[ISO/IEC 9594-8, definition 3.3.17]
NOTE 1 Optionally the certification authority may create the relying parties' keys.
NOTE 2 Authority in the CA term does not imply any government authorization only that it is trusted. Certificate issuer
may be a better term but CA is used very broadly.
2 © ISO 2006 – All rights reserved

2.9
confidentiality
property that information is not made available or disclosed to unauthorized individuals, entities or processes
[ISO 7498-2, definition 3.3.16]
2.10
delegation
conveyance of privilege from one entity that holds such privilege, to another entity
2.11
identification
performance of tests to enable a data processing system to recognize entities
2.12
key
sequence of symbols that controls the operations of encipherment and decipherment
[ISO 7498-2, definition 3.3.32]
2.13
policy
set of legal, political, organizational, functional and technical obligations for communication and cooperation
2.14
policy agreement
written agreement where all involved parties commit themselves to a specified set of policies
2.15
principal
actor able to realize specific scenarios (user, organization, system, device, application, component, object)
2.16
private key
key that is used with an asymmetric cryptographic algorithm and whose possession is restricted (usually to
only one entity)
[ISO/IEC 10181-1, definition 3.3.10]
2.17
privilege
capacity assigned to an entity by an authority according to the entity’s attribute
2.18
public key
key that is used with an asymmetric cryptographic algorithm and that can be made publicly available
[ISO/IEC 10181-1, definition 3.3.11]
2.19
role
set of competences and/or performances which is associated with a task
2.20
security
combination of availability, confidentiality, integrity and accountability
[ENV 13608-1]
2.21
security policy
plan or course of action adopted for providing computer security
2.22
security service
service, provided by a layer of communicating open systems, which ensures adequate security of the systems
or of data transfers
[ISO 7498-2, definition 3.3.51]
2.23
strong authentication
authentication by means of cryptographically derived credentials
2.24
target
resource being accessed by a claimant
3 Abbreviations
This list of abbreviations includes all abbreviations used in this part of ISO/TS 22600.
CA Certification Authority
PKI Public Key Infrastructure
4 Goal and structure of privilege management and access control
4.1 Goal of privilege management and access control
The goals are listed under a) to c).
a) To give directions for sharing information. This includes the policy agreement document template, which
defines and determines the structure and the contents of the agreement document.
b) To be a standard for privilege management and access control, which govern secure exchange of
information between security domains. In order to achieve this, a basic process for the information
exchange is defined. The standard for privilege management and access control also defines the method
for the secure trans-border information exchange process.
c) To establish a route for transformation of existing systems to future systems, which fulfils all criteria for the
cross-border information exchange according to this part of ISO/TS 22600.
The privilege and access control information exchange process takes into account existing situations and
takes care of standardization of information exchange over domain and security borders in existing systems.
The policy agreement, the policy repository and the directory are central elements in this document.
4.2 Structure of privilege management and access control
4.2.1 Structure elements
This description of the structure for the process model of the information exchange across security domain
borders consists of the elements listed below. In this part of ISO/TS 22600 the structure is explained in a
broad sense.
4 © ISO 2006 – All rights reserved

The structure consists of the following elements:
⎯ domain;
⎯ policy;
⎯ roles;
⎯ directory;
⎯ authentication;
⎯ process.
The rules for these elements, agreed by the involved domains, are stored in a repository and can be
considered as a part of this structure.
4.2.2 Domain
To keep information systems that support shared care, manageable and operating, principal-related
components of the system are grouped by common organizational, logical and technical properties, into
domains. Any kind of interoperability internal to a domain is called an intra-domain communication and
co-operation, whereas interoperability between domains is called an inter-domain communication and
co-operation. For example, communication could be realized between departments of a hospital internal to the
domain hospital (intra-domain communication), or externally to the domain of a special department
(inter-domain communication).
A domain might consist of sub-domains (which will inherit and might specialize policies from the parent
domain). The smallest-scale domain might be an individual workplace or a specific component within an
information system. Domains can be extended into super-domains, by chaining a set of distinct domains and
forming a common larger-scale domain for communication and co-operation.
4.2.3 Policy
4.2.3.1 Access control policy
A policy describes the framework including rules and regulations, the organizational and administrative
framework, functionalities, claims and objectives, the parties involved, agreements, rights, duties and
penalties defined as well as the technological solution implemented for collecting, recording, processing and
communicating data in information systems.
For describing policies, methods such as policy templates or formal policy modelling might be deployed. The
policy model is described in 5.4 of ISO/TS 22600-2:2006. Regarding security requirements, security policy is
of special interest. The security policy is dealt with in 5.1 of ISO/TS 22600-2:2006.
The particular policy in this document regards an access control infrastructure. It specifies the requirements
and conditions for trustworthy communication, creation, storage, processing and use of sensitive information.
This includes legal and ethical implications, organizational and functional aspects as well as technical
solutions.
Co-operation between domains requires the definition of a common set of policies, which applies to all
collaborating domains. It must be derived from the relevant domain-specific policies across all of those
domains. These common policies are derived (negotiated) through a process known as policy bridging. The
eventual agreed policies need to be documented and signed by all of the domain authorities. Ideally this whole
process will be capable of electronic representation and negotiation, to permit real-time electronic
collaboration to take place within a (pre-agreed) permitted and regulated framework. The policy negotiation or
verification would then take place at every service interaction.
The policy agreement is introduced in Clause 6 and is formally modelled using structured schemata and
templates in ISO/TS 22600-2. An agreement process for information exchange shall precede the actual
information exchange process. The next subsection describes a scenario for the agreement process. The
agreement will constitute the basis for the actual information exchange process described in 4.2.7.
4.2.3.2 Agreement process
The agreement process starts with the formation of a group of persons who have good knowledge about the
systems involved in the exchange process and who are mandated to take decisions about which information
shall be exchanged and which security level it demands.
When the decision about the information to be exchanged has been made the next step is to look at the level
of security in both systems and define the level that satisfies all parties. The way to do this is to list all the
requirements both parties have and make up an evaluation form like the one described in Annex A.
The next step in this agreement process is that both parties compare their system with the evaluation criteria
by completing the evaluation form. These forms then constitute the basis for the agreement between the
parties for the information exchange. In each occasion where there is a situation in which one system does
not reach the level of agreed security, this has to be noted in the agreement together with what action shall be
taken. One example of action is that one decides that there shall not be any information exchange before this
has been taken care of. Another example may be that one decides that it is possible to start the information
exchange but the deficiency shall be corrected before a specified date.
The services and the level of services in the policy repository shall also be defined by the parties involved and
registered in the agreement. One example of this can be the mapping of roles within these two domains if they
do not agree.
Provisions for management and operations of the common directory and policy repository services shall be
specified in the agreement.
4.2.4 Roles
Assignment of roles, privileges, and credentials as well as resulting resource access decisions has to be
dedicated to a specific principal. Therefore, identification and authentication of principals are basic services for
authorization, access control, and other application security services.
The role assignments can show great variation between healthcare establishments, both in granularity and
hierarchical organization. This creates difficulties for interoperability, which policy bridging should overcome.
The generic concept of roles is described in 5.4 and Annex A of ISO/TS 22600-2:2006 and will be covered in
a future Technical Specification, ISO/TS 21298.
4.2.5 Policy repository
A policy repository holds the set of rules for access control and the set of roles to which these apply. For
inter-domain access control these rules and the mechanism for role mapping are stored in a common policy
repository.
The common policy repository presents a formal representation of the policy agreement. It is used by an
access control service in conjunction with the role information for an individual entity to grant or deny access.
If all requirements are fulfilled, a user of an application in one security domain will be privileged to access or
retrieve appropriate information from the other security domain.
4.2.6 Directory
A directory service provides information about entities. Directory specifications should follow ISO/TS 21091.
6 © ISO 2006 – All rights reserved

The common directory service to be used for inter-domain access control shall provide the necessary
information on all entities that are covered by the policy agreement. This will include information on role
assignment and authentication.
4.2.7 Authentication
There are different levels for principal authentication. Due to the sensitivity of health information and the
related security requirements, the highest level of both the requesting and the responding principals within a
communication and co-operation relationship shall be provided through strong mutual authentication. Strong
authentication should be realized in a token-based way (e.g. by smartcards).
The authentication framework has been specified in ISO 9798-3 and ISO 10181-1. The authentication
procedure is based on a PKI. The PKI framework is given in ISO/TS 17090-1. The authentication certificate
follows the X.509V3 specification.
4.2.8 Process
Care processes are changing rapidly. It is therefore very important to create solutions that will allow making
the necessary changes in communication processes without any disturbances in the care process. Many of
the routines for allocation and withdrawal of roles and authorization shall be made as automatic as possible
without losing the control. There are situations where persons involved in the care of a patient shall have the
ability to override authorization assigned to roles and to be prepared to justify it later.
The process will vary from site to site but the following process describes the guiding process for this part of
ISO/TS 22600.
It consists of two security domains with one application in each domain.
An example scenario is that a person in security domain 1 needs information about a patient under his care
from security domain 2, where the patient has been treated at an earlier stage.
Under certain circumstances the applications need to deliver to, and/or retrieve information from, each other.
The users of the applications govern the need. User access is controlled by each security domain but can also
be granted upon a request from a user in another security domain. The foreign request is approved after it has
been checked, with a positive result, against the agreed rules in the policy repository. All these rules shall be
specified in the policy agreement.
Both domains have their authorization system with roles according to their needs and different rules for
granting access to different information for the different roles.
The process model is illustrated in Figure 1.
The steps in the process are as follows:
1) A new employee gets his/her role defined and assigned by the manager for the organizational unit in
which he or she is going to work as described in 4.2.4.
2) The new employee will then be registered in the authorization system that belongs to the appropriate
domain with the restrictions and authorization relevant for this role. This implies that the employee is
authenticated as described in 4.2.7.
3) Users in the two security domains, which fulfil the rules as defined in the policy agreement, can then be
found through the common directory service. The directory is reached from any application in the
domains covered by the policy agreement. See 4.2.6.
4) When an employee belonging to security domain 1 starts to use application 1, in system 1, in security
domain 1, the first the application has to do is to check his authorization in access control service 1 (see
Figure 1).
5) Access to application 1 in security domain 1 is granted to the employee. The rules for intra- and inter-
domain communication of information are described in 5.1 of ISO/TS 22600:2006.
6) The employee using application 1 starts a request for information from application 2 in security domain 2.
The request contains the identity and role of the requester and a reference to the relevant rule in the
common policy repository.
7) In this situation both systems will look in the policy repository to check if the requirements for the
information exchange are fulfilled. It is therefore necessary that security domains 1 and 2 have agreed
upon a policy for this type of information exchange and that the rules are available for verification in the
policy repository. If the qualifications are fulfilled the procedure continues according to point 8 below.
Otherwise application 1 will notify the user that the request has been denied.
8) Application 1 then sends a request for that information to application 2 in security domain 2.
9) The result of the request is then sent to application 1 where the employee can read and store it together
with the other information about that patient.
10) All transactions in application 1, application 2, the directory and policy repository, and all communication
between the two domains shall be logged. Routines for monitoring the log shall be defined in the policy
agreement.
8 © ISO 2006 – All rights reserved

Figure 1 — Process model
5 Policy agreement
5.1 Overview
The basic part of the policy agreement shall contain descriptions of the actual legal framework including rules
and regulations. The organizational and administrative framework, functionalities, claims and objectives, the
principals involved, agreements, rights, duties and penalties are defined as well as the technological solution
implemented for collecting, recording, processing and communicating data in the applications in the domains.
The policy agreement shall also contain a standardized document, the purpose of which is to make it easier to
write an agreement that covers the necessary functions for the information interchange. A standard template
for the policy agreement is presented in Annex A of this part of ISO/TS 22600.
Steps shall be taken to ensure that the Policy Agreement is understood by everybody using the
communication between the domains. The responsibility for the observance of the agreement lies with the
main managers for the domains.
The functions are described in 5.2 to 5.22.
5.2 Identification
The policy agreement shall define the identification methods used in the domains including identification of
persons (patient, healthcare professionals, health professionals, etc.), organizations, systems, devices,
applications, components, etc. If different identification systems are used, the system has to be defined.
Linking, mapping or conversion mechanisms shall also be defined. In that context the use of a unique patient
ID as well as namespace related master patient indexes and the use of a patient identification service shall be
considered and specified.
5.3 Patient consent
The rules for patient consent shall be harmonized or agreements defined on how differences shall be bridged
when harmonization is not possible. Both parties shall agree to this in the policy agreement.

5.4 Patient privacy
Patient privacy is a key issue in trans-border information exchange.
In order to gain a patient's full confidence with the information transactions, it is of utmost importance that the
rules be clear and easily understood by the patients.
5.5 Information identification
The policy agreement shall identify the procedure for how to reach the data over the domain borders. There
are many ways to bring this about and it is therefore very important that this be specified in the agreement.
For read-only, the foreign user can obtain the right to access the application in another domain as a normal
domain user. If the user wants to transfer information it shall be possible to specify/identify and limit the
information that shall be transferred.
5.6 Information location
In order to secure the information retrieval, the data structure in the applications shall be specified and
understood by all parties. The policy agreement shall therefore contain detailed information and structure
descriptions.
10 © ISO 2006 – All rights reserved

5.7 Information integrity
The integrity of the data shall be checked in order to detect corruption of data during transfer between the
domains. The rules and techniques for this shall be agreed upon and specified in the policy agreement.
5.8 Security
It is most likely that each domain will have its own security rules. It would be ideal, of course, if the involved
domains could commit themselves to one and the same security model. This is the primary goal and the
security standards defined in both CEN and ISO shall be the primary tools to achieve this.
If this is not possible, it shall be specified in the agreement which security level in one domain corresponds
with which security level in another domain and authority for the users shall be designed for the various levels
in both domains.
NOTE The security aspects are dealt with in ISO/TS 22600-2.
5.9 Authorization
The authorization process shall be defined in the policy agreement both internally in the domain and externally
in the other jurisdiction domains. Authorization is further described in Clause 5 of ISO/TS 22600-2:2006.
5.10 Role structures
Roles are defined within each domain. Rights and responsibilities in specific contexts are defined in policies
that are bound to one or more roles. Role assignments are a very important part of the solution for the final
standard for policy bridging. The role model is explained in 5.6 to 5.9 of ISO/TS 22600-2:2006.
5.11 Attestation rights
The policy agreement shall name the individuals in the organization who have the right to assign roles and
attestation authority to employees. An employee with attestation authority has the right to attest medical
information.
5.12 Delegation rights
Delegation is often necessary in daily operations. In order to be able to keep this under control, delegation
rights shall be specified in the agreement since it is particularly difficult to know who has which rights inside
and between the domains. Delegation shall be well structured in order for it to be possible to follow up and is
explained in 5.7 of ISO/TS 22600-2:2006.
5.13 Validity time
Authorization, roles, attestation rights and delegation rights shall have a well-defined and specified time period
for the access rights to information both within the domain and across domain borders. These time periods
shall be notified in the agreement.
5.14 Authentication of users/roles
PKI is recommended as the authentication method. For cases where the domains cannot agree upon a
common standardized authentication system this part of ISO/TS 22600 will specify a number of stipulations to
be fulfilled.
5.15 Access
The circumstances allowing access to the information in the other domain are described in 5.8 of
ISO/TS 22600-2:2006.
Ru
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.

Loading comments...