1、BSI Standards PublicationBS EN ISO 22600-1:2014Health informatics Privilegemanagement and accesscontrolPart 1: Overview and policy managementBS EN ISO 22600-1:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO22600-1:2014. It supersedes DD ISO/TS 22600-1:2
2、006 which iswithdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee IST/35, Health informatics.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a
3、contract. Users are responsible for its correctapplication. The British Standards Institution 2014. Published by BSI StandardsLimited 2014ISBN 978 0 580 80568 4ICS 35.240.80Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the a
4、uthority of theStandards Policy and Strategy Committee on 31 October 2014.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 22600-1 October 2014 ICS 35.240.80 English Version Health informatics - Privilege management and access control - Pa
5、rt 1: Overview and policy management (ISO 22600-1:2014) Informatique de sant - Gestion de privilges et contrle daccs - Partie 1: Vue densemble et gestion des politiques (ISO 22600-1:2014) Medizinische Informatik - Privilegienmanagement und Zugriffssteuerung - Teil 1: bersicht und Policy-Management (
6、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 bibli
7、ographical 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 respons
8、ibility 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 Repub
9、lic 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 COMIT EUROPEN DE NORMAL
10、ISATION EUROPISCHES KOMITEE FR 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 worldwide for CEN national Members. Ref. No. EN ISO 22600-1:2014 EBS EN ISO 22600-1:2014EN ISO 22600-1:2014 (E) 3 Foreword
11、 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, ei
12、ther 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
13、 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 R
14、epublic, 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. E
15、ndorsement notice The text of ISO 22600-1:2014 has been approved by CEN as EN ISO 22600-1:2014 without any modification. BS EN ISO 22600-1:2014ISO 22600-1:2014(E) ISO 2014 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Abb
16、reviated terms 45 Goal and structure of privilege management and access control . 45.1 Goal of privilege management and access control . 45.2 Structure of privilege management and access control 46 Policy agreement 96.1 Overview 96.2 Identification . 106.3 Patient consent 106.4 Patient privacy 106.5
17、 Information identification 106.6 Information location . 106.7 Information integrity 116.8 Security . 116.9 Authorization 116.10 Role structures . 116.11 Assignment and attestation authorities . 116.12 Delegation rights 116.13 Validity time . 116.14 Authentication of users/roles . 126.15 Access . 12
18、6.16 Policy agreement validity period . 126.17 Ethics 126.18 Secure audit trail 126.19 Audit check 126.20 Risk analysis . 126.21 Continuity and disaster management 136.22 Future system developments 137 Documentation 13Annex A (informative) Example of a documentation template 14Annex B (informative)
19、Example of an information exchange policy agreement .21Bibliography .27BS EN ISO 22600-1:2014ISO 22600-1:2014(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards i
20、s 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 par
21、t 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 particul
22、ar 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
23、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.is
24、o.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 ISOs adherence to the WT
25、O principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe 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 revise
26、d.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: Implementationsiv ISO 2014 All rights reservedBS EN ISO 22600-1:2014ISO 22600-1:2014(E)IntroductionThe
27、 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 o
28、f 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 th
29、ese 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 fun
30、ctions 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-or
31、ganizational 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 fo
32、r 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 w
33、ithout 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 per
34、formed 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, als
35、o 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
36、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 patients
37、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,
38、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 t
39、o 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
40、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
41、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
42、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 2014
43、 All rights reserved vBS EN ISO 22600-1:2014ISO 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 ver
44、y 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 e
45、thical 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
46、 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
47、 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 a
48、re 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 ba
49、sed 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 r
