1、February 2015Translation by DIN-Sprachendienst.English price group 15No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).IC
2、S 35.240.80!%?c“2286425www.din.deDDIN EN ISO 22600-1Health informatics Privilege management and access control Part 1: Overview and policy management (ISO 22600-1:2014);English version EN ISO 22600-1:2014,English translation of DIN EN ISO 22600-1:2015-02Medizinische Informatik Privilegienmanagement
3、und Zugriffssteuerung Teil 1: bersicht und Policy-Management (ISO 22600-1:2014);Englische Fassung EN ISO 22600-1:2014,Englische bersetzung von DIN EN ISO 22600-1:2015-02Informatique de sant Gestion de privilges et contrle daccs Partie 1: Vue densemble et gestion des politiques (ISO 22600-1:2014);Ver
4、sion anglaise EN ISO 22600-1:2014,Traduction anglaise de DIN EN ISO 22600-1:2015-02www.beuth.deIn case of doubt, the German-language original shall be considered authoritative.Document comprises 34 pages01.15 DIN EN ISO 22600-1:2015-02 2 A comma is used as the decimal marker. National foreword This
5、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” (Secretariat: NEN, Netherlands). The responsible German body involved in its preparation was the DIN-Normenausschuss Mediz
6、in (DIN Standards Committee Medicine), Working Committee NA 063-07-04 AA Sicherheit. The text of ISO 22600-1 has been adopted without any modification. In translating the text into German particular attention was paid to the use of a correct and consistent technical terminology in German. The full E
7、nglish term is given for each term in Clause 3 “Terms and definitions”. The DIN Standard corresponding to the International Standard referred to in this document is as follows: ISO 21091 DIN EN ISO 21091 DIN EN ISO 22600 consists of the following parts, under the general title Health informatics Pri
8、vilege management and access control: Part 1: Overview and policy management Part 2: Formal models Part 3: Implementations National Annex NA (informative) Bibliography DIN EN ISO 21091, Health informatics Directory services for healthcare providers, subjects of care and other entities EN ISO 22600-1
9、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 sant - Gestion de privilges et contrle daccs - Partie 1: Vue densemble et gestion des politiques (ISO 22600-1:2014) Medi
10、zinische Informatik - Privilegienmanagement und Zugriffssteuerung - Teil 1: bersicht und Policy-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
11、 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 offici
12、al 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 A
13、ustria, 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, Sw
14、eden, Switzerland, Turkey and United Kingdom. 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 EEUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROP
15、EN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMContents Page Foreword . 3 Introduction . 4 1 Scope . 6 2 Normative references. 6 3 Terms and definitions 6 4 Abbreviated terms 9 5 Goal and structure of privilege management and access control 9 5.1 Goal
16、 of privilege management and access control 9 5.2 Structure of privilege management and access control 9 6 Policy agreement 14 6.1 Overview . 14 6.2 Identification . 15 6.3 Patient consent . 15 6.4 Patient privacy 15 6.5 Information identification 15 6.6 Information location . 15 6.7 Information int
17、egrity 16 6.8 Security . 16 6.9 Authorization 16 6.10 Role structures . 16 6.11 Assignment and attestation authorities. 16 6.12 Delegation rights 16 6.13 Validity time 16 6.14 Authentication of users/roles . 17 6.15 Access . 17 6.16 Policy agreement validity period 17 6.17 Ethics . 17 6.18 Secure au
18、dit trail 17 6.19 Audit check . 17 6.20 Risk analysis . 17 6.21 Continuity and disaster management 18 6.22 Future system developments . 18 7 Documentation . 18 Annex A (informative) Example of a documentation template 19 Annex B (informative) Example of an information exchange policy agreement . 26
19、Bibliography 32 2DIN EN ISO 22600-1:2015-02 EN ISO 22600-1:2014 (E) ForewordThis 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. Th
20、is 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
21、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 thi
22、s 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, Slovaki
23、a, 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. “”3DIN EN ISO 22600-1:2015-02EN ISO 22600-1:2014 (E)IntroductionThe distributed architecture of shared car
24、e 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 r
25、apidly 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 integra
26、ted 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 numb
27、er 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, th
28、ereby 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 dif
29、ferences 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 pa
30、tient. 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 envir
31、onment, 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 heal
32、thcare 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
33、 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 diagnosis and treatment, however combin
34、ed 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
35、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 pa
36、thway 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 manag
37、ed 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 conce
38、pts 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
39、 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 4DIN EN ISO 22600-1:2015-02 EN ISO 22600-1:2014
40、 (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 agree
41、ment.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 prin
42、ciples 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 are
43、a 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 gi
44、ves 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
45、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 server
46、s 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 iden
47、tification 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
48、 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 Int
49、ernational 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.5DIN EN ISO 22600-1:2015-02EN ISO 22600-1:2014 (E)1 ScopeThis multi-part International Standard defines principles and specifies services needed for managing privileges and access control to data and/or functions.It focuses o
