BS ISO 17090-2-2015 Health informatics Public key infrastructure Certificate profile《健康信息学 公开密钥基础设施 认证配置文件》.pdf

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1、BSI Standards PublicationBS ISO 17090-2:2015Health informatics Publickey infrastructurePart 2: Certificate profileBS ISO 17090-2:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 17090-2:2015.It supersedes BS ISO 17090-2:2008 which is withdrawn.The UK partic

2、ipation 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 contract. Users are responsible for

3、 its correctapplication. The British Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 81170 8ICS 35.240.80Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and

4、 Strategy Committee on 30 November 2015.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dBS ISO 17090-2:2015 ISO 2015Health informatics Public key infrastructure Part 2: Certificate profileInformatique de sant Infrastructure de cl publique Partie 2: Profil de certificatINTER

5、NATIONAL STANDARDISO17090-2Second edition2015-11-15Reference numberISO 17090-2:2015(E)BS ISO 17090-2:2015ISO 17090-2:2015(E)ii ISO 2015 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2015, Published in SwitzerlandAll rights reserved. Unless otherwise specified, no part of this publication may b

6、e 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 ISOs member body in the country of the re

7、quester.ISO copyright officeCh. de Blandonnet 8 CP 401CH-1214 Vernier, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgwww.iso.orgBS ISO 17090-2:2015ISO 17090-2:2015(E)Foreword vIntroduction vi1 Scope . 12 Normative references 13 Terms and definitions . 14 Abbreviated ter

8、ms 15 Healthcare CPs 25.1 Certificate types required for healthcare . 25.2 CA certificates 25.2.1 Root CA certificates . 25.2.2 Subordinate CA certificates 25.3 Cross/Bridge certificates . 35.4 End entity certificates . 35.4.1 Individual identity certificates . 35.4.2 Organization identity certifica

9、te 45.4.3 Device identity certificate 45.4.4 Application certificate . 45.4.5 AC 45.4.6 Role certificates 56 General certificate requirements 66.1 Certificate compliance 66.2 Common fields for each certificate type . 66.3 Specifications for common fields 76.3.1 General 76.3.2 Signature . 86.3.3 Vali

10、dity 86.3.4 Subject public key information 86.3.5 Issuer name field . 96.3.6 The subject name field .106.4 Requirements for each healthcare certificate type .116.4.1 Issuer fields . 116.4.2 Subject fields 117 Use of certificate extensions 147.1 General 147.2 General extensions 147.2.1 authorityKeyId

11、entifier .147.2.2 subjectKeyIdentifier 147.2.3 keyUsage 147.2.4 privateKeyUsagePeriod . 147.2.5 certificatePolicies .147.2.6 subjectAltName 147.2.7 basicConstraints 157.2.8 CRLDistributionPoints .157.2.9 ExtKeyUsage .157.2.10 Authority information access 157.2.11 Subject information access 157.3 Spe

12、cial subject directory attributes . 157.3.1 hcRole attribute .157.3.2 subjectDirectoryAttributes 177.4 Qualified certificate statements extension 177.5 Requirements for each health industry certificate type.177.5.1 Extension fields 17 ISO 2015 All rights reserved iiiContents PageBS ISO 17090-2:2015I

13、SO 17090-2:2015(E)Annex A (informative) Certificate profile examples 19Bibliography .31iv ISO 2015 All rights reservedBS ISO 17090-2:2015ISO 17090-2:2015(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The

14、 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-gove

15、rnmental, 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

16、 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 po

17、ssibility 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

18、 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 a

19、s information about ISOs 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 second edition cancels and replaces the first edition (ISO

20、17090-2:2008), which has been technically revised.ISO 17090 consists of the following parts, under the general title Health informatics Public Key Infrastructure: Part 1: Overview of digital certificate services Part 2: Certificate profile Part 3: Policy management of certification authority Part 4:

21、 Digital Signatures for healthcare documentsThe following document is under preparation: Part 5: Authentication using Healthcare PKI credentialsAnnex A of this part of ISO 17090 is for information only. ISO 2015 All rights reserved vBS ISO 17090-2:2015ISO 17090-2:2015(E)IntroductionThe healthcare in

22、dustry is faced with the challenge of reducing costs by moving from paper-based processes to automated electronic processes. New models of healthcare delivery are emphasizing the need for patient information to be shared among a growing number of specialist healthcare providers and across traditiona

23、l organizational boundaries.Healthcare information concerning individual citizens is commonly interchanged by means of electronic mail, remote database access, electronic data interchange and other applications. The Internet provides a highly cost-effective and accessible means of interchanging info

24、rmation, but is also an insecure vehicle that demands additional measures be taken to maintain the privacy and confidentiality of information. Threats to the security of health information through unauthorized access (either inadvertent or deliberate) are increasing. It is essential to have availabl

25、e to the healthcare system reliable information security services that minimize the risk of unauthorized access.How does the healthcare industry provide appropriate protection for the data conveyed across the Internet in a practical, cost-effective way? Public key infrastructure (PKI) technology see

26、ks to address this challenge.The proper deployment of digital certificates requires a blend of technology, policy and administrative processes that enable the exchange of sensitive data in an unsecured environment by the use of “public key cryptography” to protect information in transit and “certifi

27、cates” to confirm the identity of a person or entity. In healthcare environments, this technology uses authentication, encipherment and digital signatures to facilitate confidential access to, and movement of, individual health records to meet both clinical and administrative needs. The services off

28、ered by the deployment of digital certificates (including encipherment, information integrity and digital signatures) are able to address many of these security issues. This is especially the case if digital certificates are used in conjunction with an accredited information security standard. Many

29、individual organizations around the world have started to use digital certificates for this purpose.Interoperability of digital certificate technology and supporting policies, procedures and practices is of fundamental importance if information is to be exchanged between organizations and between ju

30、risdictions in support of healthcare applications (for example, between a hospital and a community physician working with the same patient).Achieving interoperability between different digital certificate implementations requires the establishment of a framework of trust, under which parties respons

31、ible for protecting an individuals information rights may rely on the policies and practices and, by extension, the validity of digital certificates issued by other established authorities.Many countries are deploying digital certificates to support secure communications within their national bounda

32、ries. Inconsistencies will arise in policies and procedures between the certification authorities (CAs) and registration authorities (RAs) of different countries if standards development activity is restricted to within national boundaries.Digital certificate technology is still evolving in certain

33、aspects that are not specific to healthcare. Important standardization efforts and, in some cases, supporting legislation are ongoing. On the other hand, healthcare providers in many countries are already using or planning to use digital certificates. This International Standard seeks to address the

34、 need for guidance of these rapid international developments.This International Standard describes the common technical, operational and policy requirements that need to be addressed to enable digital certificates to be used in protecting the exchange of healthcare information within a single domain

35、, between domains and across jurisdictional boundaries. Its purpose is to create a platform for global interoperability. It specifically supports digital certificate enabled communication across borders, but could also provide guidance for national or regional deployment of digital certificates in h

36、ealthcare. The Internet is increasingly used as the vehicle of choice to support the movement of healthcare data between healthcare organizations and is the only realistic choice for cross-border communication in this sector.vi ISO 2015 All rights reservedBS ISO 17090-2:2015ISO 17090-2:2015(E)This I

37、nternational Standard should be approached as a whole, with the three parts all making a contribution to defining how digital certificates can be used to provide security services in the health industry, including authentication, confidentiality, data integrity and the technical capacity to support

38、the quality of digital signature.ISO 17090-1 defines the basic concepts underlying the use of digital certificates in healthcare and provides a scheme of interoperability requirements to establish digital certificate enabled secure communication of health information.ISO 17090-2 provides healthcare

39、specific profiles of digital certificates based on the International Standard X.509 and the profile of this specified in IETF/RFC 5280 for different types of certificates.ISO 17090-3 deals with management issues involved in implementing and using digital certificates in healthcare. It defines a stru

40、cture and minimum requirements for certificate policies (CPs) and a structure for associated certification practice statements. This part is based on the recommendations of the IETF/RFC 3647 Internet X.509 Public Key Infrastructure Certificate Policy and Certification Practices Framework and identif

41、ies the principles needed in a healthcare security policy for cross border communication. It also defines the minimum levels of security required, concentrating on the aspects unique to healthcare.Comments on the content of this International Standard, as well as comments, suggestions and informatio

42、n on the application of these standards may be forwarded to the ISO/TC 215 Secretariat: Lisa.Spellmanahima.org or WG4 PKI project leader Ross Fraser at RossFraserSextantS. ISO 2015 All rights reserved viiBS ISO 17090-2:2015BS ISO 17090-2:2015Health informatics Public key infrastructure Part 2: Certi

43、ficate profile1 ScopeThis part of ISO 17090 specifies the certificate profiles required to interchange healthcare information within a single organization, between different organizations and across jurisdictional boundaries. It details the use made of digital certificates in the health industry and

44、 focuses, in particular, on specific healthcare issues relating to certificate profiles.2 Normative referencesThe following referenced 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 a

45、pplies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 17090-1, Health informatics Public key infrastructure Part 1: Overview of digital certificate servicesISO 17090-3:2008, Health informatics Public key infrastructure Part 3: Policy man

46、agement of certification authorityIETF/RFC 5280, Internet X.509 Public Key Infrastructure Certificate and Certificate Revocation List (CRL) Profile3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 17090-1 apply.4 Abbreviated termsAA attribute authorityA

47、C attribute certificateCA certification authorityCP certificate policyCPS certification practice statementCRL certificate revocation listPKC public key certificatePKI public key infrastructureRA registration authorityTTP trusted third partyINTERNATIONAL STANDARD ISO 17090-2:2015(E) ISO 2015 All righ

48、ts reserved 1BS ISO 17090-2:2015ISO 17090-2:2015(E)5 Healthcare CPs5.1 Certificate types required for healthcareIdentity certificates shall be issued to: individuals (regulated health professionals, non-regulated health professionals, sponsored healthcare providers, supporting organization employees

49、 and patients/consumers); organizations (healthcare organizations and supporting organizations); devices; applications.The roles of individuals and organizations are to be captured; either in the identity certificate itself (in a certificate extension) or in an associated AC. The different kinds of certificates and the way they interrelate are shown in Figure 1.5.2 CA certificates5.2.1 Root CA certificatesRoot CA certificates are used when the subject of the certificate is itself a CA, they are self-signed and are