ISO/TR 11636:2009
(Main)Health Informatics — Dynamic on-demand virtual private network for health information infrastructure
Health Informatics — Dynamic on-demand virtual private network for health information infrastructure
ISO/TR 11636:2009 explains the network requirements in the healthcare field, the network security of an open network for the healthcare field, and the minimum guidelines for security management of health information exchange, including personal data, between external institutions. These requirements will assist in understanding the operation of security and evaluation of security issues in the healthcare field, and the usefulness of a managed VPN, like a dynamic on-demand VPN. ISO/TR 11636:2009 introduces examples of security measures taken in a dynamic on-demand VPN for exchange of medical information; it is not intended to specify the dynamic on-demand VPN itself. These examples provide network solutions to potential risks in such a user environment.
Informatique de santé — Réseau privé, virtuel, dynamique, sur demande pour infrastructure d'information de santé
General Information
Standards Content (Sample)
TECHNICAL ISO/TR
REPORT 11636
First edition
2009-12-01
Health Informatics — Dynamic
on-demand virtual private network for
health information infrastructure
Informatique de santé — Réseau privé, virtuel, dymanique, sur
demande pour infrastructure d'information de santé
Reference number
ISO/TR 11636:2009(E)
©
ISO 2009
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ISO/TR 11636:2009(E)
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ISO/TR 11636:2009(E)
Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Terms and definitions .1
3 Abbreviated terms .3
4 Network features in the healthcare field .4
4.1 Pattern of current or expected information services in the healthcare field .4
4.2 Category of healthcare information to be protected (information assets).5
4.3 Network requirements in the healthcare field .6
5 Concept of network construction in the healthcare field.6
5.1 Overview.6
5.2 Responsibility to manage security of healthcare information exchange including personal
information between independent institutions .7
5.3 Security concepts in network systems for medical institutions .8
6 Threat analysis and measures .9
7 Network construction in the healthcare field .10
7.1 Minimum guidelines for security management of healthcare information exchange
including personal information between external institutions.10
7.2 Technical and operational checklists for evaluation of network security.11
7.3 Application of an on-demand VPN .11
8 Cases of security measures in a dynamic on-demand VPN for exchange of healthcare
information with external institutions .12
8.1 Introduction.12
8.2 Regional healthcare cooperation model with a healthcare portal.12
8.3 Online maintenance model.13
8.4 Regional cooperation model with the lead taken by a regional core hospital.14
8.5 Model for teleradiology, remote maintenance and network conferencing with the
cooperation of university hospitals, research institutions and regional hospitals .15
8.6 University hospital model centred around teleradiology, telepathology and network
conferences conducted between a university hospital and regional hospitals .16
Annex A (informative) Threat analysis and measures .18
Annex B (informative) Security management of medical information exchange including personal
data between independent institutions (see reference [6]) .25
Annex C (informative) Technical and operational checklists for the guideline.35
Annex D (informative) Technology used: Dynamic on-demand VPN.62
Bibliography.70
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ISO/TR 11636:2009(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
In exceptional circumstances, when a technical committee has collected data of a different kind from that
which is normally published as an International Standard (“state of the art”, for example), it may decide by a
simple majority vote of its participating members to publish a Technical Report. A Technical Report is entirely
informative in nature and does not have to be reviewed until the data it provides are considered to be no
longer valid or useful.
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.
ISO/TR 11636 was prepared by Technical Committee ISO/TC 215, Health informatics.
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ISO/TR 11636:2009(E)
Introduction
Currently, healthcare information is normally transferred in the form of paper documents or electronic data
through schemes such as dedicated fixed lines connecting the headquarters and branches within a company,
through public networks such as an Integrated Services Digital Network (ISDN), or through a dedicated
network between specific institutions, enabling a virtual network for the specified users in a dedicated service
network managed by communication providers, such as an Internet Protocol virtual private network (IP-VPN).
Therefore, healthcare information cannot be transferred easily while maintaining security in most cases,
because network configurations adequate to these solutions are limited and the costs are very high.
The uses of various service networks in the healthcare field include online claims for medical fees, online
maintenance of medical devices, and remote medical care, such as teleradiology, telepathology and
healthcare information services for regional healthcare cooperation. To provide such services however, it is
necessary for multiple medical institutions to pass healthcare information to each other. A network in which a
single medical institution is dynamically connected to multiple medical institutions and switched to another
institution is required.
To make such a network available to many medical institutions at low cost, an open network such as the
Internet can be used for connecting with different medical institutions, medical device providers, and patients.
We can use the following VPNs as secure channel systems in an open network:
Internet Protocol Security (IPsec) with Internet key exchange (IKE), described as IPsec + IKE which runs
in the network layer with authentication and exchange of encryption keys, and
Secure Sockets Layer (SSL) protocol, which runs in the session layer with encrypted communication
between a Web browser on a client and SSL servers.
Thus, this is adapted to web applications, but other applications, such as e-mail, File Transfer Protocol (FTP),
and unique client/server systems, cannot be used. On the other hand, the combination of IPsec + IKE can be
used with any application needed by medical institutions to provide secure channels without reconstructing
any application software. In addition, SSL has an inherent risk because it provides no protection methods
against well-known lower-layer attacks, session hijacking, false Address Resolution Protocol (ARP)
statements, and so on.
The conventional VPN using IPsec + IKE however, requires complicated configuration of network devices,
and setting up the system without expertise could result in failure to protect healthcare information. Also, it is a
fixed-type VPN and can only be connected with fixed parties.
Lately, telecommunication carriers and online service providers (OSPs) have been developing systems to
provide services with security on network lines, including setting up network devices to safeguard against
these threats, even for a VPN connected in an open network. When a medical institution uses these types of
service, most of the responsibilities related to managing the communication lines fall to these service
providers (SPs). This reduces the responsibility of the medical institution in terms of its security-related
liabilities, which is well suited for organizations without many IT engineers.
A dynamic on-demand VPN, which this Technical Report describes, is one type of VPN. It is not a fixed
connection like 1-to-1, which is generally used in ordinary VPN services. It can easily change connection to
N-to-N, and the connection parameters are provided automatically by the telecommunication carrier. This
makes it suitable for healthcare network infrastructure, as medical institutes are not required to be responsible
for or have expertise in setting up such networks. Also, utilizing the Internet makes the dynamic on-demand
VPN an inexpensive network and thus readily acceptable to medical institutions in terms of cost.
This Technical Report describes the threats anticipated in a healthcare network, as well as how a dynamic
on-demand VPN is actually applied in the healthcare field.
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TECHNICAL REPORT ISO/TR 11636:2009(E)
Health Informatics — Dynamic on-demand virtual private
network for health information infrastructure
1 Scope
This Technical Report explains the network requirements in the healthcare field, the network security of an
open network for the healthcare field, and the minimum guidelines for security management of health
information exchange, including personal data, between external institutions.
These requirements will assist in understanding the operation of security and evaluation of security issues in
the healthcare field, and the usefulness of a managed VPN, like a dynamic on-demand VPN.
This Technical Report introduces examples of security measures taken in a dynamic on-demand VPN for
exchange of medical information; it is not intended to specify the dynamic on-demand VPN itself.
These examples provide network solutions to potential risks in such a user environment.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
demilitarized zone
DMZ
area of a network in which any data exchange with areas outside is allowed
2.2
high security zone
HSZ
area of a network in which no data is exchanged directly with areas outside, except for the purpose of certain
remote maintenance
2.3
IPsec
standard for cipher communication, a protocol that prevents data tampering and provides confidentiality
functions for each IP packet by using an encryption technique
2.4
internet VPN
VPN created via the Internet
NOTE By using the Internet, connections between remote networks can be managed as connections in a LAN, while
maintaining confidentiality.
2.5
IP-VPN
VPN created via a wide-area IP network owned by a communication carrier
NOTE By using an IP-VPN, connections between remote networks can be managed in the same manner as
connections in a local area network (LAN).
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ISO/TR 11636:2009(E)
2.6
local area network
LAN
network in which computers, printers and other equipment are connected and data are transferred within one
building
2.7
OSI reference model
model that divides the functions of communication equipment, such as computers, into a layer structure based
on the design policy of Open Systems Interconnection (OSI) established by ISO for network structuring, in
order to facilitate heterogeneous network data transfer
NOTE Communication functions are divided into seven layers, and the standard function module for each layer is
defined.
2.8
provider service
service that exchanges data between a telecommunication carrier and an OSP
2.9
relay service
service that establishes a connection for the sole purpose of exchanging data between a network-connected
device within a medical institute and an outside device
2.10
remote access
connection to a network or computer from outside by using lines such as telephone lines
NOTE Remotely accessing a distant computer enables direct operation of the computer as though it is right in front of
the user.
2.11
social insurance medical fee payment fund
organization that reviews medical fees invoiced by medical institutions and makes appropriate payments
NOTE The reviews are performed by a three-party committee consisting of representatives of medical institute
workers, medical insurers (e.g., health insurance companies), and academic experts. The medical institute submits a
medical bill statement (receipt) and claims a payment for the treatment from the health insurance organization. An
organization such as a social insurance medical fee payment fund reviews the receipt and makes a payment to the
medical institution submitting the invoice.
2.12
SSL
protocol that encrypts and transfers data on the internet being able to encrypt current widely used data, such
as World Wide Web (www) and File Transfer Protocol (FTP) data and securely transmit and receive
privacy-related information and credit card numbers
2.13
security zone
SZ
area of a network in which limited data exchange with areas outside is allowed
2.14
virtual private network
VPN
service in which a public line can be used as if it is a dedicated line
NOTE It is used for connecting different bases of a company's internal network, instead of installing dedicated lines,
in order to reduce cost.
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ISO/TR 11636:2009(E)
2.15
wide area network
WAN
network in which computers in geographically different locations (e.g., at a headquarters building and multiple
branches) are connected through telephone lines or dedicated lines to transfer data
3 Abbreviated terms
For the purposes of this document, the following abbreviations apply.
AES Advanced Encryption Standard
AH authentication header
ASP application service provider
ESP Encapsulating Security Payload
FTP File Transfer Protocol
HEASNET HEAlthcare information Secure NETwork consortium
HMAC Hash Message Authentication Code
IC integrated circuit
IKE Internet key exchange
IPsec Internet Protocol Security
IP-VPN Internet-Protocol-based virtual private network
ISAKMP Internet Security Association and Key Management Protocol
ISDN Integrated Services Digital Network
IT information technology
LAN local area network
L2TP Layer 2 Tunneling Protocol
NAT network address translation
OSI Open Systems Interconnection
OSP online service provider
OSPF Open Shortest Path First
PKI public key infrastructure
QOS quality of service
RADIUS Remote Authentication Dial In User Service
RFC Request for Comments
SHA Secure Hash Algorithm
SI System Integrator
TLS Transport Layer Security
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ISO/TR 11636:2009(E)
TOS Type of Service
TTL time to live
WAN wide area network
4 Network features in the healthcare field
4.1 Pattern of current or expected information services in the healthcare field
In the healthcare field, the information services listed below are provided. In a healthcare network, both data
security and security by way of access control must be considered so that these services will not influence
each other. In order to clarify the form of network use for currently available or future information services, the
form of service provision for these services will be defined according to the characteristics of data access.
a) Information provision service
This is a service to provide a particular medical institution with access to patient healthcare information from
another medical institution. It includes the following.
⎯ Local collaboration service (for medical institutions and healthcare-related services, such as welfare
and nursing care).
Patient medical treatment or nursing care records, including medical records, examination data,
medical record summaries, physical check-up data, and care records are provided in a variety of
forms, such as letters of referral and local collaboration databases.
⎯ Medical treatment/nursing care information provision service (for patient enquiry).
A patient's medical treatment and nursing care records are disclosed to the patient according to
certain criteria.
⎯ Medical treatment/nursing care information provision service (for general enquiry).
Information on hospitals, diseases and various medical and nursing care practices are provided for
general enquiry.
b) Internet connection service
This is a service to provide medical institutions with access to information sites on the Internet. It includes the
following.
⎯ Internet connection service (for businesses).
Medical institutions access sites judged safe by institutions related to business clients, via the Internet
according to the medical institutions' security policies, obtaining academic information sites and sites providing
service information, such as that of Japan's Ministry of Health, Labour and Welfare.
c) Storage/relay service
Information is stored in a location within or outside a medical institution and then transferred to another
medical institution in order to exchange the information with the distant institution. This service includes the
following.
⎯ Mail service.
E-mails are stored and relayed by mail servers.
⎯ Online claim for medical fee service.
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ISO/TR 11636:2009(E)
Online claims for medical fees are electronically received and transferred to other institutions. For example, a
social insurance medical fee payment fund receives and examines a claim and then relays or transmits the
claim to an insurer.
⎯ Examination data delivery service.
Results of clinical examination or image diagnosis are delivered from an examination company. The
examination results are later used for electronic medical charts and the ordering and information processing
department systems in a hospital, so that the data are readily available in these systems, for reference.
d) Information processing service
An external institution that has been entrusted with information processing functions by a medical institution
receives information from the medical institution and processes the information as a proxy. This service
includes the following.
⎯ ASP service.
Services for medical institutions, such as electronic medical charts and online claims for medical fees, are
provided as shared-use services. The healthcare information is externally stored.
⎯ External storage (backup) service.
In the event of faults or disasters, to perform system recovery of electronic medical charts and data from
ordering and information processing department systems in a hospital, backup data are transmitted to and
stored in an external institution.
e) Remote maintenance service
Various maintenance services, such as fault diagnosis of medical devices and fault recovery, are remotely
provided by a subcontracted service company. Only connections with specific medical devices whose services
are subcontracted should be available to the service company.
f) Authentication/audit service
Fundamental authentication and audit services, such as public key infrastructure, digital signatures and time
delivery, are used by medical institutions to access particular information. These services include the following.
⎯ Time stamp service.
Time stamps affixed on digital signatures are issued, and a system clock is adjusted to collect audit
logs.
⎯ Validation authority (VA) service.
The validity of public key certificates issued by a certificate authority (CA) is verified.
The forms of provision of these systems are analysed, and the form of secure connection in the network is
defined.
4.2 Category of healthcare information to be protected (information assets)
External attacks on networks are becoming more and more frequent. To protect healthcare information
against such network threats requires maintaining its confidentiality, integrity and availability. Information to be
protected in the healthcare field includes the following, in accordance with ISO/IEC 27799:2008, 5.4:
⎯ personal healthcare information;
⎯ pseudonymised data derived from personal healthcare information via some methodology for
pseudonymous identification;
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ISO/TR 11636:2009(E)
⎯ statistical and research data, including anonymised data derived from personal healthcare information by
removing personally identifying data;
⎯ clinical/medical knowledge not related to a specific patient or patients, including clinical decision support
data (e.g., data on adverse drug reactions);
⎯ data on health professionals and staff;
⎯ information related to public health surveillance;
⎯ audit trail data produced by healthcare information systems and containing personal healthcare
information or pseudonymous data derived from personal healthcare information, or data about the
actions of users in regard to personal health information;
⎯ system security data, including access control data and other system-related configuration data, for
healthcare information systems.
Such healthcare information will be used in networks for a variety of healthcare/hygiene services, including
online claims for medical fees for medical treatment, online maintenance of medical devices, remote medical
care such as teleradiology and telepathology, and healthcare information services for regional healthcare
cooperation. Ensuring the security of healthcare information with respect to the privacy of patients' personal
information requires a more secure network.
4.3 Network requirements in the healthcare field
The following are the key features for a network used in the healthcare field:
⎯ patients' sensitive personal information is handled;
⎯ large-volume data such as image data are handled;
⎯ medical institutions exchange information in a local area;
⎯ medical devices, network devices, and users must be authenticated as the number of parties to
communication increases;
⎯ network construction expenses will increase.
In view of these features, the requirements for a network in the healthcare field are as follows:
⎯ secure communication;
⎯ high-speed communication of large-volume data;
⎯ implementation and extension of the network to support N-to-N connection;
⎯ authentication of members (users, organizations and devices);
⎯ cost deduction related to secure network connection.
5 Concept of network construction in the healthcare field
5.1 Overview
A typical situation of healthcare information exchange with external institutions involves networks connecting a
regional core hospital, clinics, pharmacies and examination centres as part of regional healthcare cooperation
efforts, together with online maintenance companies for medical devices. Another situation involves online
claims for medical fees to a medical fee payment fund by using ASP-type services.
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ISO/TR 11636:2009(E)
If medical institutions use networks to exchange healthcare information with other institutions, the information
must be sent to the intended organization in a secure way that never allows others to have access. This
network security must be guaranteed on the communication path from the sender's device to the recipient's
device. Transmitted data must be protected from threats like wiretapping, tampering, intrusion, spoofing and
interference.
This clause assumes certain situations inherent to healthcare information exchange via networks, focusing on
the network connection methods that are to be used.
5.2 Responsibility to manage security of healthcare information exchange including
personal information between independent institutions
5.2.1 Clear demarcation of responsibility
By contract, the sender and the recipient must agree on demarcation of responsibility for data transmission on
the communication path, such as handling of communications failure and other accidents. Then, they must
decide how to share managerial responsibility among themselves, the OSP and the telecommunication carrier.
They must also clarify the scope of managerial responsibility to be assigned to another organization and
define which organization should take the initiative in dealing with possible service failures.
5.2.2 Precautionary measures taken within a medical institution
The medical institution sending healthcare information has managerial responsibility for the information during
the whole process in which the information is transmitted via networks (provided by the telecommunication
carrier) and then received by the intended recipient in an appropriate manner.
Note here that “managerial responsibility” means responsibility for the information in electronic form; in other
words, it means responsibility for ensuring the authenticity of both the content and the persons referred to. For
example, encryption here means encrypting healthcare information to prevent outsiders from determining
what the information means, even if they have wiretapped the communication path. Digital signatures are
helpful for detecting tampering.
From these viewpoints, medical institutions that are going to transmit information are responsible for suitably
protecting the information and must therefore be aware of the following.
a) Protection against wiretapping
When information is exchanged over networks, it can be stolen by way of, for example, a virtual bypass built
on the communication path or a physical device attached to a network device. Medical institutions should take
proper measures to protect healthcare information even if it is stolen during transmission or an unexpected
information leakage or incorrect transmission occurs. One possible measure is to encr
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