ISO 17090-2:2015

Health informatics — Public key infrastructure — Part 2: Certificate profile

ISO 17090-2:2015 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 focuses, in particular, on specific healthcare issues relating to certificate profiles.

Informatique de santé — Infrastructure de clé publique — Partie 2: Profil de certificat

General Information

• Status: Published
• Publication Date: 15-Nov-2015
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ISO/TC 215 - Health informatics
• Drafting Committee: ISO/TC 215/WG 4 - Security, Safety and Privacy
• Current Stage: 9093 - International Standard confirmed
• Completion Date: 09-Jul-2021

Relations

• Revises: ISO 17090-2:2008 - Health informatics — Public key infrastructure — Part 2: Certificate profile
• Effective Date: 03-Nov-2012

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 17090-2
Second edition
2015-11-15
Health informatics — Public key
infrastructure —
Part 2:
Certificate profile
Informatique de santé — Infrastructure de clé publique —
Partie 2: Profil de certificat
Reference number
ISO 17090-2:2015(E)
©
ISO 2015

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ISO 17090-2:2015(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2015, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
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written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
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ISO 17090-2:2015(E)

Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviated terms . 1
5 Healthcare CPs . 2
5.1 Certificate types required for healthcare . 2
5.2 CA certificates . 2
5.2.1 Root CA certificates . 2
5.2.2 Subordinate CA certificates . 2
5.3 Cross/Bridge certificates . 3
5.4 End entity certificates . 3
5.4.1 Individual identity certificates . 3
5.4.2 Organization identity certificate . 4
5.4.3 Device identity certificate . 4
5.4.4 Application certificate . 4
5.4.5 AC . 4
5.4.6 Role certificates . 5
6 General certificate requirements . 6
6.1 Certificate compliance . 6
6.2 Common fields for each certificate type . 6
6.3 Specifications for common fields . 7
6.3.1 General. 7
6.3.2 Signature . 8
6.3.3 Validity . 8
6.3.4 Subject public key information . 8
6.3.5 Issuer name field . 9
6.3.6 The subject name field .10
6.4 Requirements for each healthcare certificate type .11
6.4.1 Issuer fields .11
6.4.2 Subject fields .11
7 Use of certificate extensions .14
7.1 General .14
7.2 General extensions.14
7.2.1 authorityKeyIdentifier .14
7.2.2 subjectKeyIdentifier .14
7.2.3 keyUsage .14
7.2.4 privateKeyUsagePeriod .14
7.2.5 certificatePolicies .14
7.2.6 subjectAltName .14
7.2.7 basicConstraints .15
7.2.8 CRLDistributionPoints .15
7.2.9 ExtKeyUsage .15
7.2.10 Authority information access .15
7.2.11 Subject information access .15
7.3 Special subject directory attributes .15
7.3.1 hcRole attribute .15
7.3.2 subjectDirectoryAttributes .17
7.4 Qualified certificate statements extension .17
7.5 Requirements for each health industry certificate type.17
7.5.1 Extension fields .17
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ISO 17090-2:2015(E)

Annex A (informative) Certificate profile examples .19
Bibliography .31
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ISO 17090-2:2015(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 second edition cancels and replaces the first edition (ISO 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: Digital Signatures for healthcare documents
The following document is under preparation:
— Part 5: Authentication using Healthcare PKI credentials
Annex A of this part of ISO 17090 is for information only.
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ISO 17090-2:2015(E)

Introduction
The healthcare industry 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 traditional 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 information, 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 available 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 seeks 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 “certificates” 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 offered 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 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
jurisdictions 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 responsible for protecting an individual’s
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 boundaries. 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 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 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, 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 healthcare. 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.
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ISO 17090-2:2015(E)

This International 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
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 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 structure 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 identifies 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
information on the application of these standards may be forwarded to the ISO/TC 215 Secretariat:
[e-mail] or WG4 PKI project leader Ross Fraser at [e-mail].
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INTERNATIONAL STANDARD ISO 17090-2:2015(E)
Health informatics — Public key infrastructure —
Part 2:
Certificate profile
1 Scope
This 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 focuses, in particular, on specific
healthcare issues relating to certificate profiles.
2 Normative references
The 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 applies. 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 services
ISO 17090-3:2008, Health informatics — Public key infrastructure — Part 3: Policy management of
certification authority
IETF/RFC 5280, Internet X.509 Public Key Infrastructure Certificate and Certificate Revocation List
(CRL) Profile
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 17090-1 apply.
4 Abbreviated terms
AA attribute authority
AC attribute certificate
CA certification authority
CP certificate policy
CPS certification practice statement
CRL certificate revocation list
PKC public key certificate
PKI public key infrastructure
RA registration authority
TTP trusted third party
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ISO 17090-2:2015(E)

5 Healthcare CPs
5.1 Certificate types required for healthcare
Identity certificates shall be issued to:
— individuals (regulated health professionals, non-regulated health professionals, sponsored
healthcare providers, supporting organization employees 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 certificates
5.2.1 Root CA certificates
Root CA certificates are used when the subject of the certificate is itself a CA, they are self-signed and
are used to issue certificates to relying parties, including subordinate CAs. The basic constraints field
indicates whether the certificate is a CA. The Root CA certificate is used to establish a chain of trust by
Internet browsers and other applications that rely on PKI for entity identification and authentication.
5.2.2 Subordinate CA certificates
Subordinate CA certificates are issued for a CA that is in itself certified by another CA higher up in
the hierarchy to be able to issue certificates for either other CAs lower down the hierarchy or for end
entities. The Subordinate CA certificate is used, along with other certificates, to establish a chain of trust
by Internet browsers and other applications that rely on PKI for entity identification and authentication.
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ISO 17090-2:2015(E)

Figure 1 — Healthcare certificate types
5.3 Cross/Bridge certificates
In an Internet environment, it is not feasible to expect the health industry in cross border and
jurisdictional situations to trust a top level CA. Instead, “islands of trust” are to be provided in each
health industry domain, based on speciality, jurisdiction, setting or geography that trust a particular CA.
Each central root CA for each “island of trust” can then cross-certify another root. In these situations, a
group of CAs may agree on a minimum set of standards to be embodied in their policies and associated
practice statements. When this occurs, a relying party may accept a certificate from a CA outside its
own domain. This could be particularly useful for organizations such as state or provincial health
authorities to enable the transfer of information across boundaries.
Cross/Bridge certificates are certificate types that cross-certify different CA domains. This supports
the large-scale deployment of public key applications, such as secure electronic mail and others
required in the health industry.
5.4 End entity certificates
End entity certificates are issued to entities that may include individuals, organizations, applications
or devices. They are called end entity certificates because there are no further entities beneath them
relying on that certificate.
5.4.1 Individual identity certificates
Individual identity certificates are a particular subtype of end entity certificates that are issued to
individual persons for the purpose of authentication. The following five types of healthcare actors are
recognized as being individuals:
a) regulated health professional:
— each certificate holder is a health professional who, in order to practice his/her profession
requires a license or registration from a government body (ISO 17090-1:2013, 5.1); these
certificates may be qualified certificates (7.3 and ISO 17090-1:2013, 8.2);
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ISO 17090-2:2015(E)

b) non-regulated health professional:
— each certificate holder is a health professional who is not subject to registration or licensing
from a government body (ISO 17090-1:2013, 5.1); these certificates may be qualified certificates;
c) sponsored healthcare provider:
— each certificate holder is an individual who is active in his/her healthcare community and is
sponsored by a regulated healthcare organization or professional. These certificates may be
qualified certificates;
d) supporting organization employee:
— each certificate holder is an individual who is person employed by a healthcare organization or
a supporting organization. These certificates may be qualified certificates;
e) patient/consumer:
— each certificate holder is an individual person who, at some stage, is about to receive, is receiving
or has received the services of a regulated or non-regulated health professional. These may be
qualified certificates.
5.4.2 Organization identity certificate
An organization that is involved in the health industry may hold a certificate to identify itself or to use
for encryption purposes. In accordance with IETF/RFC 3647, provision is made in this part of ISO 17090
for an organizational unit name.
5.4.3 Device identity certificate
A device can be a computer server, medical machine, such as a radiology machine, a vital signs
monitoring device or a prosthetic device that needs to be individually identified and authenticated.
5.4.4 Application certificate
An application is a computer information system, such as a hospital patient administration system, that
needs to be individually identified and authenticated.
This part of ISO 17090 concentrates on the providers, but recognizes that patients/consumers will
increasingly require the security services that digital certificates can provide in managing their
own healthcare.
5.4.5 AC
An AC is a digitally signed (or certified) set of attributes. An AC is a structure similar to a PKC; the
main difference being that it contains no public key. An AC may contain attributes that specify group
membership, role, security clearance and other information associated with the AC holder that could be
used for access control. The AC shall be in accordance with the specifications given in IETF/RFC 5755,
An Internet Attribute Certificate Profile for Authorization.
Within the health industry context, ACs can fulfil the valuable role of communicating authorization
information. Authorization information is distinct from information on healthcare roles or licences,
which may be appropriately included in a PKC. Role or licence implies an authorization level, but
they are not necessarily authorization information in themselves. It is important to note that the
detailed specification for ACs is still evolving and that this specification still needs to be more widely
implemented in the software industry.
The syntax of an AC is specified in IETF/RFC 3281, An Internet Attribute Certificate Profile for
Authorization
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The components of the AC are used as follows.
The version number differentiates between different versions of the AC. If objectDigestInfo is present
or if issuer is identified with baseCertificateID, version shall be v2.
The owner field conveys the identity of the AC’s holder. Use of the issuer name and serial number of a
specific PKC is required; use of the general name(s) is optional and use of the object digest is prohibited.
There is a risk with use of GeneralNames by itself to identify the holder, in that there is insufficient
binding of a name to a public key to enable the authentication process of the owner’s identity to be
bound to the use of an AC. In addition, some of the options in GeneralNames (e.g. IPAddress) are
inappropriate for use in naming an AC holder which is a role rather than an individual entity. General
name forms should be restricted to distinguished name, RFC 822 (electronic ma
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