EN ISO 22600-1:2014
(Main)Health informatics - Privilege management and access control - Part 1: Overview and policy management (ISO 22600-1:2014)
Health informatics - Privilege management and access control - Part 1: Overview and policy management (ISO 22600-1:2014)
ISO 22600 defines principles and specifies services needed for managing privileges and access control to data and/or functions.
It focuses on communication and use of health information distributed across policy domain boundaries. This includes healthcare information sharing across unaffiliated providers of healthcare, healthcare organizations, health insurance companies, their patients, staff members, and trading partners by both individuals and application systems ranging from a local situation to a regional or even national situation.
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.
ISO 22600-1:2014 proposes a template for the policy agreement. It enables the comparable documentation from all parties involved in the information exchange.
Medizinische Informatik - Privilegienmanagement und Zugriffssteuerung - Teil 1: Übersicht und Policy-Management (ISO 22600-1:2014)
Diese mehrteilige Internationale Norm legt Grundsätze fest und spezifiziert die für das Privilegienmanagement und die Zugriffssteuerung auf Daten und Funktionen erforderlichen Dienste.
Sie konzentriert sich auf die Kommunikation und Nutzung von gesundheitsbezogene Informationen, die über die Grenzen von Policy-Domains hinweg verteilt werden. Das umfasst die gemeinsame Nutzung von gesundheitsbezogenen Informationen durch nicht miteinander verbundene Anbieter und Organisationen des Gesundheitswesens, Krankenversicherungen, deren Patienten, Mitarbeiter und Handelspartner sowohl durch Einzelpersonen als auch durch Anwendungssysteme im Bereich von einer lokalen zu einer regionalen oder auch nationalen Situation.
Sie legt die erforderlichen komponentenbasierten Begriffe fest und soll deren technische Implementierung unterstützen. Sie legt jedoch nicht fest, wie diese Begriffe in speziellen klinischen Prozessabläufen zu verwenden sind.
Dieser Teil von ISO 22600 schlägt eine Textschablone (Template) für die Darstellung der Policy-Vereinbarung vor. Es ermöglicht die vergleichbare Dokumentation von allen am Informationsaustausch beteiligten Parteien.
Dieser Teil von ISO 22600 enthält weder plattformspezifische noch implementierungstechnische Einzelheiten. Sie legt keine technischen Kommunikationsdienste und -protokolle fest, die bereits in anderen Normen festgelegt sind. Sie enthält auch keine Authentisierungsverfahren.
Informatique de santé - Gestion de privilèges et contrôle d'accès - Partie 1: Vue d'ensemble et gestion des politiques (ISO 22600-1:2014)
L'ISO 22600 définit les principes de gestion des privilèges et de contrôle d'accès aux données et/ou aux fonctions et spécifie les services nécessaires à ces activités.
Elle se concentre sur la communication et l'utilisation des informations de santé distribuées au-delà des limites d'un domaine de politique. Cela inclut le partage d'informations de santé entre professionnels de santé non affiliés, établissements de santé, sociétés d'assurance-maladie, patients, membres du personnel et partenaires commerciaux, par des individus tout comme par des systèmes d'application utilisés dans un contexte local, voire régional ou même national.
Elle spécifie les concepts nécessaires pour chaque composante et est destinée à faciliter leur mise en oeuvre technique. Elle ne spécifiera pas l'utilisation de ces concepts pour des cheminements de processus cliniques particuliers.
L'ISO 22600-1:2014 propose un modèle d'accord de politique, qui permet d'obtenir de toutes les parties impliquées dans l'échange d'informations une documentation comparable.
Zdravstvena informatika - Upravljanje privilegijev in dostopovno krmiljenje - 1. del: Pregled in politika upravljanja (ISO 22600-1:2014)
Porazdeljena arhitektura informacijskih sistemov v skupni rabi vedno bolj temelji na omrežjih. Za izboljšanje interoperabilnosti se povečuje uporaba standardiziranih uporabniških vmesnikov, orodij in protokolov, kar zagotavlja neodvisnost platforme, in posledično se v zadnjih nekaj letih hitro povečuje tudi število odprtih informacijskih sistemov, ki temeljijo na poslovnih omrežjih in navideznih zasebnih omrežjih. Ta mednarodni standard v več delih določa storitve za upravljanje privilegijev in dostopovno krmiljenje, ki so potrebne za sporočanje in uporabo porazdeljenih zdravstvenih informacij prek političnih meja in meja domen. Dokument predstavlja načela in določa storitve, ki so potrebne za upravljanje privilegijev in dostopovno krmiljenje. Določa potrebne koncepte za komponente in je namenjen za podporo njihovi tehnični izvedbi. Ne določa uporabe teh konceptov na določenih poteh kliničnih postopkov. Ta mednarodni standard je močno povezan z drugimi dokumenti ISO/TC 215, kot so ISO 17090 »Infrastruktura javnih ključev«, ISO 22857 »Zdravstvena informatika – Smernice za zaščito podatkov za omogočanje čezmejnega pretoka osebnih zdravstvenih informacij« in ISO 21091 »Zdravstvena informatika – Imeniške storitve za varnost, komunikacijo in identifikacijo zdravstvenega osebja in pacientov«. Povezan je tudi z nastajajočim dokumentom ISO/TS 21298 »Zdravstvena informatika – Funkcijske in strukturne vloge«. Namen tega mednarodnega standarda je podpora potrebam po skupni rabi zdravstvenih informacij med nepovezanimi izvajalci zdravstvenega varstva, zdravstvenimi organizacijami, podjetji, ki se ukvarjajo z zdravstvenim zavarovanjem, njihovimi pacienti, člani osebja in poslovnimi partnerji. Namen tega mednarodnega standarda je tudi podpora poizvedbam s strani posameznikov in sistemov uporabe. Ta specifikacija mednarodnega standarda v več delih določa metode za upravljanje avtorizacije in dostopovno krmiljenje podatkov in/ali funkcij. Omogoča premostitev politike. Temelji na konceptualnem modelu, v katerem so lahko lokalni strežniki za avtorizacijo ter čezmejne imeniške storitve in storitve za repozitorije politike v pomoč pri dostopovnem krmiljenju v različnih aplikacijah (komponente programske opreme). Repozitorij politike vsebuje informacije o pravilih za dostop do različnih funkcij aplikacij na podlagi vlog in drugih atributov. Imeniška storitev omogoča identifikacijo posameznega uporabnika. Omogočen dostop bo temeljil na štirih vidikih: overjeni identifikaciji uporabnika; pravilih za dostop do določenega informacijskega objekta, vključno z namenom uporabe; pravilih glede atributov za avtorizacijo, povezanih z uporabnikom, ki jih zagotovi upravitelj avtorizacije; funkcijah določene aplikacije. Ta mednarodni standard naj bi se uporabljal na lokalni, regionalni ali nacionalni ravni. Eden ključnih delov pri tem je združitev organizacijskih kriterijev s profili avtorizacije na podlagi pisnega sporazuma o politiki, ki ga skleneta obe udeleženi strani. Mednarodni standard podpira sodelovanje med upravitelji avtorizacije, ki lahko delujejo prek organizacijskih in političnih meja. Sodelovanje je določeno v sporazumu o politiki, ki ga podpišejo vse udeležene organizacije in vsebuje nabor pravil za delovanje. V 1. delu je predlagana oblika dokumentacije kot predloga za predstavitev sporazuma o politiki, kar omogoča pridobitev primerljive dokumentacije od vseh strani, ki so udeležene v izmenjavi informacij. Ta mednarodni standard ne vključuje podrobnosti o platformi in izvedbi. Ne določa storitev za tehnično komunikacijo in protokolov, ki so bili vzpostavljeni v drugih standardih. Prav tako ne vključuje tehnik za overjanje.
General Information
Overview
EN ISO 22600-1:2014 (Health informatics - Privilege management and access control - Part 1: Overview and policy management) defines principles and services for managing privileges and access control to health data and functions. The standard focuses on secure healthcare information sharing across policy domain boundaries - between unaffiliated providers, health organizations, insurers, patients, staff and trading partners - and supports component-based concepts intended for technical implementation. It includes a template for a policy agreement to enable comparable documentation among parties involved in information exchange.
Key topics and technical requirements
The standard outlines essential topics and requirements for interoperable access control and privilege management:
- Policy agreement: template and elements required to document cross-domain rules for information exchange.
- Identification and authentication: requirements for identifying users, roles and authentication of users/roles.
- Authorization and role structures: defining roles, delegation rights, assignment and attestation authorities.
- Patient consent and privacy: documenting consent, privacy expectations and ethical considerations.
- Information governance: identification, location, integrity and security of exchanged health information.
- Access rules and validity: access conditions, validity times and policy agreement validity periods.
- Audit and accountability: requirements for secure audit trails and audit checks.
- Risk and continuity: risk analysis, continuity and disaster management, and planning for future system developments.
- Documentation: recommended documentation templates (Annex A) and example information exchange policy agreements (Annex B).
Applications and who uses it
EN ISO 22600-1 is intended for organizations and professionals responsible for secure health information exchange and access control:
- Health IT architects and system integrators designing cross-organizational access control.
- Hospitals, health information exchanges (HIEs), insurers and regional/national health authorities establishing interoperable policies.
- Security architects and identity/access management teams implementing privilege management services.
- Privacy officers and compliance/legal teams drafting policy agreements and consent management.
- Vendors of clinical and administrative applications aligning implementations with agreed policies.
Practically, the standard helps bridge differing local security policies, document mutual agreements, and provide a pathway toward interoperable technical implementations of privilege management in distributed healthcare environments.
Related standards
- ISO 22600 series: Part 2 (Formal models) and Part 3 (Implementations) - complementary documents that provide formal modeling and implementation guidance to accompany Part 1’s policy and overview.
Standards Content (Sample)
SLOVENSKI STANDARD
01-februar-2015
Zdravstvena informatika - Upravljanje privilegijev in dostopovno krmiljenje - 1. del:
Pregled in politika upravljanja (ISO 22600-1:2014)
Health informatics - Privilege management and access control - Part 1: Overview and
policy management (ISO 22600-1:2014)
Medizinische Informatik - Privilegienmanagement und Zugriffssteuerung - Teil 1:
Übersicht und Policy-Management (ISO 22600-1:2014)
Informatique de santé - Gestion de privilèges et contrôle d'accès - Partie 1: Vue
d'ensemble et gestion des politiques (ISO 22600-1:2014)
Ta slovenski standard je istoveten z: EN ISO 22600-1:2014
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 22600-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2014
ICS 35.240.80
English Version
Health informatics - Privilege management and access control -
Part 1: Overview and policy management (ISO 22600-1:2014)
Informatique de santé - Gestion de privilèges et contrôle Medizinische Informatik - Privilegienmanagement und
d'accès - Partie 1: Vue d'ensemble et gestion des politiques Zugriffssteuerung - Teil 1: Übersicht und Policy-
(ISO 22600-1:2014) Management (ISO 22600-1:2014)
This European Standard was approved by CEN on 22 May 2014.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same
status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
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EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 22600-1:2014 E
worldwide for CEN national Members.
Contents Page
Foreword .3
Foreword
This document (EN ISO 22600-1:2014) has been prepared by Technical Committee ISO/TC 215 "Health
informatics" in collaboration with Technical Committee CEN/TC 251 “Health informatics” the secretariat of
which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by April 2015, and conflicting national standards shall be withdrawn at the
latest by April 2015.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 22600-1:2014 has been approved by CEN as EN ISO 22600-1:2014 without any modification.
INTERNATIONAL ISO
STANDARD 22600-1
First edition
2014-10-01
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 22600-1:2014(E)
©
ISO 2014
ISO 22600-1:2014(E)
© ISO 2014
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
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Published in Switzerland
ii © ISO 2014 – All rights reserved
ISO 22600-1:2014(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviated terms . 4
5 Goal and structure of privilege management and access control .4
5.1 Goal of privilege management and access control . 4
5.2 Structure of privilege management and access control . 4
6 Policy agreement . 9
6.1 Overview . 9
6.2 Identification .10
6.3 Patient consent .10
6.4 Patient privacy.10
6.5 Information identification .10
6.6 Information location .10
6.7 Information integrity .11
6.8 Security .11
6.9 Authorization .11
6.10 Role structures .11
6.11 Assignment and attestation authorities .11
6.12 Delegation rights .11
6.13 Validity time .11
6.14 Authentication of users/roles .12
6.15 Access .12
6.16 Policy agreement validity period .12
6.17 Ethics .12
6.18 Secure audit trail .12
6.19 Audit check .12
6.20 Risk analysis .12
6.21 Continuity and disaster management .13
6.22 Future system developments .13
7 Documentation .13
Annex A (informative) Example of a documentation template .14
Annex B (informative) Example of an information exchange policy agreement .21
Bibliography .27
ISO 22600-1:2014(E)
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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 215, Health informatics.
This first edition of ISO 22600-1 cancels and replaces ISO/TS 22600-1:2006, which has been technically
revised.
ISO 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
— Part 3: Implementations
iv © ISO 2014 – All rights reserved
ISO 22600-1:2014(E)
Introduction
The distributed architecture of shared care information systems is increasingly based on corporate
networks and virtual private networks. For meeting the interoperability challenge, the use of
standardized user interfaces, tools, and protocols, which ensures platform independence, but also the
number of really open information systems, is rapidly growing during the last couple of years.
As a common situation today, hospitals are supported by several vendors providing different applications,
which are not able to communicate authentication and authorization since each has its own way of
handling these functions. For achieving an integrated scenario, it takes a remarkable amount of money,
time, and efforts to get users and changing organizational environments dynamically mapped before
starting communication and cooperation. Resources required for the development and maintenance
of security functions grow exponentially with the number of applications, with the complexity of
organizations towards a regional, national, or even international level, and with the flexibility of users
playing multiple roles, sometimes even simultaneously.
The situation becomes even more challenging when inter-organizational communications happens,
thereby crossing security policy domain boundaries. Moving from one healthcare centre to another or
from country to country, different rules for privileges and their management can apply to similar types
of users, both for execution of particular functions and for access to information. The policy differences
between these domains have to be bridged automatically or through policy agreements, defining sets of
rules followed by the parties involved, for achieving interoperability.
Another challenge to be met is how to improve the quality of care by using IT without infringing the
privacy of the patient. To provide physicians with adequate information about the patient, a virtual
electronic health care record is required which makes it possible to keep track of all the activities
belonging to one patient regardless of where and by whom they have been performed and documented.
In such an environment, a generic model or specific agreement between the parties for managing
privileges and access control including the patient or its representative is needed.
Besides a diversity of roles and responsibilities, typical for any type of large organization, also ethical
and legal aspects in the healthcare scenario due to the sensitivity of person-related health information
managed and its personal and social impact have to be considered.
Advanced solutions for privilege management and access control are required today already, but
this challenge will even grow over the next couple of years. The reason is the increase of information
exchanged between systems in order to fulfil the demands of health service providers at different care
levels for having access to more and more patient-related information to ensure the quality and efficiency
of patient’s diagnosis and treatment, however combined with increased security and privacy risks.
The implementation of this International Standard might be currently too advanced and therefore not
feasible in certain organizational and technical settings. For meeting the basic principle of best possible
action, it is therefore very important that at least a policy agreement is written between the parties
stating to progress towards this International Standard when any update/upgrade of the systems is
intended. The level of formalization and granularity of policies and the objects these policies are bound
to defines the solution maturity on a pathway towards the presented specification.
The policy agreement also has to contain defined differences in the security systems and agreed
solutions on how to overcome the differences. For example, the authentication service and privileges
of a requesting party at the responding site have to be managed according to the policy declared 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 in a limited number of concepts for enabling the specification of a limited
number of solution categories. Based on that classification, claimant mechanisms, target sensitivity
mechanisms, and policy specification and management mechanisms can be implemented. Once all
parties have signed the policy agreement, the communication and information exchange can start with
the existing systems if the parties can accept the risks. If there are unacceptable risks which have to be
eliminated before the information exchange starts, they also have to be recorded in the policy agreement
ISO 22600-1:2014(E)
together with an action plan stating how these risks have to be removed. The policy agreement also has
to contain a time plan for this work and an agreement on how it has to be financed.
The documentation of the negotiation process is very important and provides the platform for the policy
agreement.
Privilege management and access control address security and privacy services required for
communication and cooperation, i.e. distributed use of health information. It also implies safety aspects,
professional standards, and legal and ethical issues. This International Standard introduces principles
and specifies services needed for managing privileges and access control. Cryptographic protocols are
out of the scope of this International Standard.
This three-part International Standard 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. It
comprises of:
— ISO 22600-1: describes the scenarios and the critical parameters in information exchange across
policy domains. It also gives examples of necessary documentation methods as the basis for the
policy agreement.
— ISO 22600-2: describes and explains, in a more detailed manner, the architectures and underlying
models for privilege management and access control which are necessary for secure information
sharing including the formal representation of policies.
— ISO 22600-3: describes examples of implementable specifications of application security services
and infrastructural services using different specification languages.
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 principals (i.e. human users and objects that need to operate
under their own rights) involved;
— the rules for access to a specific information object including purpose of use;
— the rules regarding authorization attributes linked to the principal provided by the authorization
manager;
— the functions of the specific application.
The International Standard supports collaboration between several authorization managers that can
operate over organizational and policy borders.
This International Standard is strongly related to other ISO/TC 215 works such as ISO 17090 (all parts),
ISO 22857, ISO 21091, and ISO 21298.
This International Standard is meant to be read in conjunction with its complete set of associated
standards.
vi © ISO 2014 – All rights reserved
INTERNATIONAL STANDARD ISO 22600-1:2014(E)
Health informatics — Privilege management and access
control —
Part 1:
Overview and policy management
1 Scope
This multi-part International Standard defines principles and specifies services needed for managing
privileges and access control to data and/or functions.
It focuses on communication and use of health information distributed across policy domain boundaries.
This includes healthcare information sharing across unaffiliated providers of healthcare, healthcare
organizations, health insurance companies, their patients, staff members, and trading partners by
both individuals and application systems ranging from a local situation to a regional or even national
situation.
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.
This part of ISO 22600 proposes a template for the policy agreement. It enables the comparable
documentation from all parties involved in the information exchange.
This part of ISO 22600 excludes platform-specific and implementation details. It does not specify
technical communication services and protocols which have been established in other standards. It also
excludes authentication techniques.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 17090 (all parts), Health informatics — Public key infrastructure
ISO 21091, Health informatics — Directory services for healthcare providers, subjects of care and other
entities
1)
ISO 21298:— , Health informatics — Functional and structural roles
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
access control
means of ensuring that the resources of a data processing system can be accessed only by authorized
entities in authorized ways
[SOURCE: ISO/IEC 2382-8:1998]
1) To be published (revision of ISO/TS 21298).
ISO 22600-1:2014(E)
3.2
accountability
property that ensures that the actions of an entity can be traced uniquely to the entity
[SOURCE: ISO 7498-2:1989]
3.3
attribute certificate
data structure, digitally signed by an attribute authority, that binds some attribute values with
identification about its holder
[SOURCE: ISO/IEC 9594-8:2008]
3.4
authentication
provision of assurance of the claimed identity of an entity by securely associating an identifier and its
authenticator
Note 1 to entry: See also data origin authentication and peer entity authentication.
[SOURCE: ISO/IEC 15944-5:2008, 3.5]
3.5
authority
entity that is responsible for the issuance of certificates
Note 1 to entry: Two types are defined in this part of ISO 22600: certification authority, which issues public key
certificates, and attribute authority, which issues attribute certificates.
3.6
authorization
granting of privileges, which includes the granting of privileges to access data and functions
[SOURCE: ISO 7498-2:1989, modified]
3.7
availability
property of being accessible and useable upon demand by an authorized entity
[SOURCE: ISO 7498-2:1989]
3.8
certification authority
CA
certificate issuer; an authority trusted by one or more relying parties to create, assign, and manage
certificates
Note 1 to entry: Optionally, the certification authority can create the relying parties’ keys.
Note 2 to entry: Authority in the CA term does not imply any government authorization, only that it is trusted.
Certificate issuer might be a better term but CA is used very broadly.
[SOURCE: ISO/IEC 9594-8:2008]
3.9
confidentiality
property that information is not made available or disclosed to unauthorized individuals, entities, or
processes
[SOURCE: ISO 7498-2:1989]
2 © ISO 2014 – All rights reserved
ISO 22600-1:2014(E)
3.10
delegation
conveyance of privilege from one entity that holds such privilege to another entity
3.11
identification
performance of tests to enable a data processing system to recognize entities
[SOURCE: ISO/IEC 2382-8:1998]
3.12
key
sequence of symbols that controls the operations of encipherment and decipherment
[SOURCE: ISO 7498-2:1989]
3.13
policy
set of legal, political, organizational, functional, and technical obligations for communication and
cooperation
3.14
policy agreement
written agreement where all involved parties commit themselves to a specified set of policies
3.15
principal
human users and objects that need to operate under their own rights
[SOURCE: OMG Security Services Specification: 2001]
3.16
private key
key that is used with an asymmetric cryptographic algorithm and whose possession is restricted
(usually to only one entity)
[SOURCE: ISO/IEC 10181-1:1996]
3.17
privilege
capacity assigned to an entity by an authority according to the entity’s attribute
3.18
public key
key that is used with an asymmetric cryptographic algorithm and that can be made publicly available
[SOURCE: ISO/IEC 10181-1:1996]
3.19
role
set of competences and/or performances that is associated with a task
3.20
security
combination of availability, confidentiality, integrity, and accountability
[SOURCE: ENV 13608-1:2000]
ISO 22600-1:2014(E)
3.21
security policy
plan or course of action adopted for providing computer security
[SOURCE: ISO/IEC 2382-8:1998]
3.22
security service
service provided by a layer of communicating open systems which ensures adequate security of the
systems or of data transfers
[SOURCE: ISO 7498-2:1989]
3.23
strong authentication
authentication by means of cryptographically derived multi-factor credentials
3.24
target
resource being accessed by a claimant
4 Abbreviated terms
This list of abbreviated terms includes all abbreviations used in this part of ISO 22600.
CA Certification Authority
PKI Public Key Infrastructure
5 Goal and structure of privilege management and access control
5.1 Goal of privilege management and access control
The goals are:
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 that fulfils all criteria
for the cross-border information exchange according to this International Standard.
The privilege and access control information exchange process takes into account existing situations
and takes care of standardization of information exchange across policy domain boundaries in existing
systems. The policy agreement, the policy repository, and the directory are central elements in this part
of ISO 22600.
5.2 Structure of privilege management and access control
5.2.1 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 22600, the structure is explained
in a broad sense. For more detailed specifications, references to ISO 22600-2 are given.
4 © ISO 2014 – All rights reserved
ISO 22600-1:2014(E)
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.
5.2.2 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 internally 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
internally 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.
5.2.3 Policy
5.2.3.1 Access control policy
A policy describes the organizational, administrative, legal, and technical framework including rules
and regulations, functionalities, claims and objectives, 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.
In this International Standard, the policy model is described in ISO 22600-2:2014, 6.4. Regarding security
requirements, security policy is of special interest. The security policy is dealt with in ISO 22600-2:2014,
6.1.
The particular policy in this part of ISO 22600 regards a privilege management and 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.
Trustworthy co-operation between policy domains requires the definition of a common set of security
and privacy policies that applies to all collaborating entities. It shall be derived from the relevant
domain-specific policies across all of those policy domains. Those common security and privacy policies
are derived (negotiated) through a process known as policy bridging. The eventually 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 taking
place within a (pre-agreed) permitted and regulated framework. The policy negotiation in the case of
changing constraints, but at least identification, verification, and enforcement of the applicable policy,
has to take place at every service interaction.
ISO 22600-1:2014(E)
The policy agreement is introduced in Clause 5 and is formally modelled using structured schemata
and templates in ISO 22600-2. An agreement process for information exchange shall precede the actual
information exchange process. The next subclause describes a scenario for the agreement process. The
agreement will constitute the basis for the actual information exchange process described in 5.2.8.
5.2.3.2 Agreement process
A successful agreement process depends upon the formation of a group of persons who have in-depth
knowledge of the business process requirements and systems involved in the information exchange
process and who are mandated to take decisions about the business process requirements for the
information exchange including but not limited to such attributes as the type, volume, content, quality,
timeliness, relevance, and currency of the data to be exchanged.
When the decision about the information to be exchanged has been made, the next step is to look at the
security and privacy policy in both systems and define a common policy that satisfies all parties. This
common policy can further constrain data and function permitted for communication and co-operation.
Annex A exemplifies the policy evaluation process, listing all requirements of both parties to assess
them using the proposed evaluation form. This International Standard offers an explicit way to express
policies. In legacy systems, the constraints are frequently just attributed in security levels.
In the next step of this agreement process, both parties compare their system with the evaluation
criteria by completing the evaluation form. These forms constitute the basis for the agreement between
the parties for the information exchange. Every situation where one system does not reach the level of
agreed security has to be noted in the agreement together with the action to be taken. A possible action
is to decide that no information exchange is permitted before the problem has been solved. Another
policy decided could be to constrain the communication and co-operation process in time, i.e. fixing the
requirement that the deficiency shall be corrected before a specified date.
Provisions for management and operations of common directory and policy repository services shall be
specified in the agreement.
5.2.4 Roles
Assignment of roles, privileges, and credentials as well as resulting resource access decisions have to
be dedicated to a specific principal. Therefore, identification and authentication of principals are basic
services for authorization, access control, and other application security and privacy 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 ISO 22600-2:2014, 6.4 and Annex A. It will be covered in
ISO 21298.
5.2.5 Policy repository
A policy repository holds the set of rules for privilege management and access control as well as 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
policy decision services, i.e. an access control service, in conjunction with the role information for an
individual entity to grant or deny access. If all requirements are met, a user of an application in one
security policy and privacy domain will be privileged to access or retrieve appropriate information
from the other security and privacy policy domain.
5.2.6 Directory
A directory service provides information about entities. Directory specifications should follow ISO 21091.
6 © ISO 2014 – All rights reserved
ISO 22600-1:2014(E)
The common directory service to be used for inter-domain access control shall provide the necessary
information about all entities that are covered by the policy agreement. This includes information on
role assignment and authentication.
5.2.7 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 has to be provided through strong mutual
authentication. Strong authentication should be realized in a multi-factor token-based way (minimally
by two factor credentials such as smartcards and passwords).
The authentication framework has been specified in ISO 9798 and ISO 10181. The authentication
procedure is based on a PKI. The PKI framework is given in ISO/TS 17090. The authentication certificate
follows the X.509v3 specification.
5.2.8 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 authorizations 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 authorizations 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
International Standard.
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 visualized 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 5.2.4.
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 5.2.7.
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 5.2.6.
4) When an employee belonging to security domain 1 starts to use application 1, in system 1, in
security domain 1, the application has first to check his authorization in access control service 1
(see Figure 1).
ISO 22600-1:2014(E)
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 ISO 22600-2:2014, 6.1.
6) The employee using application 1 starts a request for information from application 2 in security
domain 2. The request contains the identifier and role of the requestor 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 the 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 2014 – All rights reserved
ISO 22600-1:2014(E)
Figure 1 — Process model
6 Policy agreement
6.1 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
...
Frequently Asked Questions
EN ISO 22600-1:2014 is a standard published by the European Committee for Standardization (CEN). Its full title is "Health informatics - Privilege management and access control - Part 1: Overview and policy management (ISO 22600-1:2014)". This standard covers: ISO 22600 defines principles and specifies services needed for managing privileges and access control to data and/or functions. It focuses on communication and use of health information distributed across policy domain boundaries. This includes healthcare information sharing across unaffiliated providers of healthcare, healthcare organizations, health insurance companies, their patients, staff members, and trading partners by both individuals and application systems ranging from a local situation to a regional or even national situation. 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. ISO 22600-1:2014 proposes a template for the policy agreement. It enables the comparable documentation from all parties involved in the information exchange.
ISO 22600 defines principles and specifies services needed for managing privileges and access control to data and/or functions. It focuses on communication and use of health information distributed across policy domain boundaries. This includes healthcare information sharing across unaffiliated providers of healthcare, healthcare organizations, health insurance companies, their patients, staff members, and trading partners by both individuals and application systems ranging from a local situation to a regional or even national situation. 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. ISO 22600-1:2014 proposes a template for the policy agreement. It enables the comparable documentation from all parties involved in the information exchange.
EN ISO 22600-1:2014 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.
You can purchase EN ISO 22600-1:2014 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 CEN standards.








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