IEC/TR 80001-2-2:2012
(Main)Application of risk management for IT-networks incorporating medical devices — Part 2-2: Guidance for the communication of medical device security needs, risks and controls
Application of risk management for IT-networks incorporating medical devices — Part 2-2: Guidance for the communication of medical device security needs, risks and controls
IEC/TR 80001-2-2:2012(E), which is a technical report, creates a framework for the disclosure of security-related capabilities and risks necessary for managing the risk in connecting medical devices to IT-networks and for the security dialog that surrounds the IEC 80001-1 risk management of IT-network connection. This security report presents an informative set of common, high-level security-related capabilities useful in understanding the user needs, the type of security controls to be considered and the risks that lead to the controls. Intended use and local factors determine which exact capabilities will be useful in the dialog about risk. The capability descriptions in this report are intended to supply health delivery organizations (HDOs), medical device manufacturers (MDMs), and IT vendors with a basis for discussing risk and their respective roles and responsibilities toward its management. This discussion among the risk partners serves as the basis for one or more responsibility agreements as specified in IEC 80001-1.
Application du management du risque aux réseaux des technologies de l'information contenant les dispositifs médicaux — Partie 2-2: Directives pour la communication des besoins de sécurité du dispositif médical, risques et contrôles
General Information
Standards Content (Sample)
IEC/TR 80001-2-2
Edition 1.0 2012-07
TECHNICAL
REPORT
colour
inside
Application of risk management for IT-networks incorporating medical devices –
Part 2-2: Guidance for the disclosure and communication of medical device
security needs, risks and controls
IEC/TR 80001-2-2:2012(E)
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IEC/TR 80001-2-2
Edition 1.0 2012-07
TECHNICAL
REPORT
colour
inside
Application of risk management for IT-networks incorporating medical devices –
Part 2-2: Guidance for the disclosure and communication of medical device
security needs, risks and controls
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
PRICE CODE
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ICS 11.040.01 ISBN 978-2-83220-202-9
Warning! Make sure that you obtained this publication from an authorized distributor.
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– 2 – TR 80001-2-2 IEC:2012(E)
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 Scope . 7
2 Normative references . 8
3 Terms and definitions . 8
4 Use of SECURITY CAPABILITIES . 12
4.1 Structure of a SECURITY CAPABILITY entry. 12
4.2 Guidance for use of SECURITY CAPABILITIES in the RISK MANAGEMENT PROCESS . 12
4.3 Relationship of ISO 14971-based RISK MANAGEMENT to IT security RISK
MANAGEMENT . 13
5 SECURITY CAPABILITIES . 14
5.1 Automatic logoff – ALOF . 14
5.2 Audit controls – AUDT . 14
5.3 Authorization – AUTH . 15
5.4 Configuration of security features – CNFS . 16
5.5 Cyber security product upgrades – CSUP . 16
5.6 HEALTH DATA de-identification – DIDT . 17
5.7 Data backup and disaster recovery – DTBK . 17
5.8 Emergency access – EMRG . 17
5.9 HEALTH DATA integrity and authenticity – IGAU . 18
5.10 Malware detection/protection – MLDP . 18
5.11 Node authentication – NAUT . 18
5.12 `Person authentication – PAUT . 19
5.13 Physical locks on device – PLOK . 19
5.14 Third-party components in product lifecycle roadmaps – RDMP . 20
5.15 System and application hardening – SAHD . 20
5.16 Security guides – SGUD . 21
5.17 HEALTH DATA storage confidentiality – STCF . 21
5.18 Transmission confidentiality – TXCF. 22
5.19 Transmission integrity – TXIG . 22
6 Example of detailed specification under SECURITY CAPABILITY: Person
authentication – PAUT . 22
7 References . 23
8 Other resources . 25
8.1 General . 25
8.2 Manufacture disclosure statement for medical device security (MDS2) . 25
8.3 Application security questionnaire (ASQ) . 25
8.4 The Certification Commission for Healthcare Information Technology
(CCHIT). 25
8.5 http://www.cchit.org/get_certifiedHL7 Functional Electronic Health Record
(EHR) . 26
8.6 Common criteria – ISO/IEC 15408 . 26
9 Standards and frameworks . 26
Annex A (informative) Sample scenario showing the exchange of security information . 27
Annex B (informative) Examples of regional specification on a few SECURITY
CAPABILITIES . 48
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TR 80001-2-2 IEC:2012(E) – 3 –
Annex C (informative) SECURITY CAPABILITY mapping to C-I-A-A . 52
Bibliography . 53
Table 1 – Relationship of IT security and ISO 14971-based terminology . 13
Table C.1 – Sample mapping by a hypothetical HDO . 52
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INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
APPLICATION OF RISK MANAGEMENT FOR
IT-NETWORKS INCORPORATING MEDICAL DEVICES –
Part 2-2: Guidance for the disclosure and communication of medical
device security needs, risks and controls
FOREWORD
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The main task of IEC technical committees is to prepare International Standards. However, a
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data of a different kind from that which is normally published as an International Standard, for
example "state of the art".
IEC 80001-2-2, which is a technical report, has been prepared a Joint Working Group of
subcommittee 62A: Common aspects of electrical equipment used in medical practice, of
IEC technical committee 62: Electrical equipment in medical practice and ISO technical
committee 215: Health informatics.
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TR 80001-2-2 IEC:2012(E) – 5 –
The text of this technical report is based on the following documents:
Enquiry draft Report on voting
62A/783/DTR 62A/807/RVC
Full information on the voting for the approval of this technical report can be found in the
report on voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
Terms used throughout this technical report that have been defined in Clause 3 appear in
SMALL CAPITALS.
The committee has decided that the contents of this publication will remain unchanged until
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colour printer.
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– 6 – TR 80001-2-2 IEC:2012(E)
INTRODUCTION
IEC 80001-1, which deals with the application of RISK MANAGEMENT to IT-networks
incorporating medical devices, provides the roles, responsibilities and activities necessary for
RISK MANAGEMENT. This technical report provides additional guidance in how SECURITY
CAPABILITIES might be referenced (disclosed and discussed) in both the RISK MANAGEMENT
PROCESS and stakeholder communications and agreements.
The informative set of common, high-level SECURITY CAPABILITIES presented here i intended to
be the starting point for a security-centric discussion between vendor and purchaser or among
a larger group of stakeholders involved in a MEDICAL DEVICE IT-NETWORK project. Scalability is
possible across a range of different sized RESPONSIBLE ORGANIZATIONS as each evaluates RISK
under the capabilities and decides what to include or not include according to its RISK
tolerance and resource planning. This technical report might be used in the preparation of
documentation designed to communicate product SECURITY CAPABILITIES and options. This
documentation could be used by the RESPONSIBLE ORGANIZATION as input to their IEC 80001
PROCESS or to form the basis of RESPONSIBILITY AGREEMENTS among stakeholders. Other IEC-
80001-1 technical reports will provide step-by-step guidance in the RISK MANAGEMENT
PROCESS. Furthermore, the SECURITY CAPABILITIES encourage the disclosure of more detailed
security controls – perhaps those specified in one or more security standards as followed by
the RESPONSIBLE ORGANIZATION or the MEDICAL-DEVICE manufacturer (for example,
ISO 27799:2008, ISO/IEC 27001:2005, ISO/IEC 27002:2005, ISO/IEC 27005:2011, the
ISO 22600 series, the ISO 13606 series, and ISO/HL7 10781:2009, which covers the
Electronic Health Record System Functional Model). This report remains agnostic as to the
underlying controls framework; it only proposes a structure for the disclosure and
communication among the RESPONSIBLE ORGANIZATION (here called the healthcare delivery
organization – HDO), the MEDICAL DEVICE manufacturer (MDM) and the IT-vendor.
The capabilities outlined here comprise a disclosure set of controls which support the
maintenance of confidentiality and the protection from malicious intrusion that might lead to
compromises in integrity or system/data availability. Capabilities can be added to or further
elaborated as the need arises. Controls are intended to protect both data and systems but
special attention is given to the protection of both PRIVATE DATA and its subset called HEALTH
DATA. Both of these special terms have been defined to carefully avoid any law-specific
references (e.g., EC Sensitive Data or USA ePHI).
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TR 80001-2-2 IEC:2012(E) – 7 –
APPLICATION OF RISK MANAGEMENT FOR
IT-NETWORKS INCORPORATING MEDICAL DEVICES –
Part 2-2: Guidance for the disclosure and communication of medical
device security needs, risks and controls
1 Scope
This part of IEC 80001 creates a framework for the disclosure of security-related capabilities
and RISKS necessary for managing the RISK in connecting MEDICAL DEVICES to IT-NETWORKS
and for the security dialog that surrounds the IEC 80001-1 RISK MANAGEMENT of IT-NETWORK
connection. This security report presents an informative set of common, high-level security-
related capabilities useful in understanding the user needs, the type of security controls to be
considered and the RISKS that lead to the controls. INTENDED USE and local factors determine
which exact capabilities will be useful in the dialog about RISK.
The capability descriptions in this report are intended to supply:
a) health delivery organizations (HDOs),
b) MEDICAL DEVICE manufacturers (MDMs), and
c) IT vendors
with a basis for discussing RISK and their respective roles and responsibilities toward its
management. This discussion among the RISK partners serves as the basis for one or more
RESPONSIBILITY AGREEMENTS as specified in IEC 80001-1.
The present report provides broad descriptions of the security-related capabilities with the
intent that any particular device or use of a device will have to have at least one additional
level of specification detail under each capability. This will often be site and application-
specific and may invoke RISK and security controls standards as applicable.
At this introductory stage of IEC 80001-1 standardization, the SECURITY CAPABILITIES in this
report provide a common, simple classification of security controls particularly suited to
MEDICAL IT NETWORKS and the incorporated devices. The list is not intended to constitute or to
support rigorous IT security standards-based controls and associated programs of certification
and assurance such as might be found in other ISO standards (e.g., ISO/IEC 15408 with its
Common Criteria for Information Technology Security Evaluation). The present report does
not contain sufficient detail for exact specification of requirements in a request for proposal or
product security disclosure sheet. However, the classification and structure can be used to
organize such requirements with underlying detail sufficient for communication during the
purchase and integration PROCESS for a MEDICAL DEVICE or IT equipment component. Again,
this report is intended to act as a basis for discussion and agreement sufficient to initial
integration project RISK MANAGEMENT. Additionally, security only exists in the context of the
organizational security policies. Both:
a) the security policies of the healthcare delivery organization (HDO), and
b) the product and services security policies of the MEDICAL DEVICE manufacturer (MDM)
are outside of the scope of this report. In addition, the Technical Report does not address
clinical studies where there is a need for securing the selective disclosure of PRIVATE DATA or
HEALTH DATA.
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– 8 – TR 80001-2-2 IEC:2012(E)
2 Normative references
The following 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.
IEC 80001-1:2010, Application of risk management for IT-networks incorporating medical
devices – Part 1: Roles, responsibilities and activities
3 Terms and definitions
3.1
DATA AND SYSTEMS SECURITY
operational state of a MEDICAL IT-NETWORK in which information assets (data and systems) are
reasonably protected from degradation of confidentiality, integrity, and availability
[SOURCE: IEC 80001-1:2010, definition 2.5, modified — two notes integral to understanding
the scope of the original definition have been deleted.]
3.2
EFFECTIVENESS
ability to produce the intended result for the patient and the RESPONSIBLE ORGANIZATION
[SOURCE: IEC 80001-1:2010, definition 2.6]
3.3
EVENT MANAGEMENT
PROCESS that ensures that all events that can or might negatively impact the operation of the
IT-NETWORK are captured, assessed, and managed in a controlled manner
[SOURCE: IEC 80001-1:2010, definition 2.7]
3.4
HARM
physical injury or damage to the health of people, or damage to property or the environment,
or reduction in EFFECTIVENESS, or breach of DATA AND SYSTEM SECURITY
[SOURCE: IEC 80001-1:2010, definition 2.8]
3.5
HAZARD
potential source of HARM
[SOURCE: IEC 80001-1:2010, definition 2.9]
3.6
HAZARDOUS SITUATION
circumstance in which people, property, or the environment are exposed to one or more
HAZARD(s)
[SOURCE: ISO 14971:2007, definition 2.4]
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TR 80001-2-2 IEC:2012(E) – 9 –
3.7
HEALTH DATA
PRIVATE DATA that indicates physical or mental health
Note 1 to entry: This generically defines PRIVATE DATA and it subset, HEALTH DATA, within this document to permit
users of this document to adapt it easily to different privacy compliance laws and regulations. For example, in
Europe, the requirements might be taken and references changed to “Personal Data” and “Sensitive Data”; in the
USA, HEALTH DATA might be changed to “Protected Health Information (PHI)” while making adjustments to text as
necessary.
3.8
INTENDED USE
INTENDED PURPOSE
use for which a product, PROCESS or service is intended according to the specifications,
instructions and information provided by the manufacturer
[SOURCE: IEC 80001-1:2010, definition 2.10]
3.9
INTEROPERABILITY
a property permitting diverse systems or components to work together for a specified purpose
[SOURCE: IEC 80001-1:2010, definition 2.11]
3.10
IT-NETWORK
INFORMATION TECHNOLOGY NETWORK
a system or systems composed of communicating nodes and transmission links to provide
physically linked or wireless transmission between two or more specified communication
nodes
[SOURCE: IEC 80001-1:2010, definition 2.12, modified – the two notes to the original
definition have not been retained.]
3.11
KEY PROPERTIES
three RISK managed characteristics (SAFETY, EFFECTIVENESS, and DATA AND SYSTEMS SECURITY)
of MEDICAL IT-NETWORKS
[SOURCE: IEC 80001-1:2010, definition 2.13]
3.12
MEDICAL DEVICE
means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or
calibrator, software, material or other similar or related article:
a) intended by the manufacturer to be used, alone or in combination, for human beings for
one or more of the specific purpose(s) of:
– diagnosis, prevention, monitoring, treatment or alleviation of disease,
– diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
– investigation, replacement, modification, or support of the anatomy or of a
physiological process,
– supporting or sustaining life,
– control of conception,
– disinfection of MEDICAL DEVICES,
– providing information for medical or diagnostic purposes by means of in vitro
examination of specimens derived from the human body; and
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– 10 – TR 80001-2-2 IEC:2012(E)
b) which does not achieve its primary intended action in or on the human body by
pharmacological, immunological or metabolic means, but which may be assisted in its
intended function by such means.
Note 1 to entry: The definition of a device for in vitro examination includes, for example, reagents, calibrators,
sample collection and storage devices, control materials, and related instruments or apparatus. The information
provided by such an in vitro diagnostic device may be for diagnostic, monitoring or compatibility purposes. In some
jurisdictions, some in vitro diagnostic devices, including reagents and the like, may be covered by separate
regulations.
Note 2 to entry: Products which may be considered to be MEDICAL DEVICES in some jurisdictions but for which
there is not yet a harmonized approach, are:
– aids for disabled/handicapped people;
– devices for the treatment/diagnosis of diseases and injuries in animals;
– accessories for MEDICAL DEVICES (see Note 3);
– disinfection substances;
– devices incorporating animal and human tissues which may meet the requirements of the above definition but
are subject to different controls.
Note 3 to entry: Accessories intended specifically by manufacturers to be used together with a ‘parent’ MEDICAL
DEVICE to enable that MEDICAL DEVICE to achieve its INTENDED PURPOSE should be subject to the same GHTF
procedures as apply to the MEDICAL DEVICE itself. For example, an accessory will be classified as though it is a
MEDICAL DEVICE in its own right. This may result in the accessory having a different classification than the ‘parent’
device.
Note 4 to entry: Components to MEDICAL DEVICES are generally controlled through the manufacturer’s quality
management system and the conformity assessment procedures for the device. In some jurisdictions, components
are included in the definition of a ‘medical device’.
[SOURCE: IEC 80001-1:2010, definition 2.14]
3.13
MEDICAL IT-NETWORK
IT-NETWORK that incorporates at least one MEDICAL DEVICE
[SOURCE: IEC 80001-1:2010, definition 2.16]
3.14
OPERATOR
person handling equipment
[SOURCE: IEC 80001-1:2010, definition 2.18]
3.15
PRIVATE DATA
any information relating to an identified or identifiable person
3.16
PROCESS
set of interrelated or interacting activities which transforms inputs into outputs
[SOURCE: IEC 80001-1:2010, definition 2.19]
3.17
RESIDUAL RISK
RISK remaining after RISK CONTROL measures have been taken
[SOURCE: IEC 80001-1:2010, definition 2.20]
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TR 80001-2-2 IEC:2012(E) – 11 –
3.18
RESPONSIBILITY AGREEMENT
one or more documents that together fully define the responsibilities of all relevant
stakeholders
[SOURCE: IEC 80001-1:2010, definition 2.21, modified – a note to the original definition,
containg examples, has not been retained.]
3.19
RESPONSIBLE ORGANIZATION
entity accountable for the use and maintenance of a MEDICAL IT-NETWORK
Note 1 to entry: In this Technical Report, to avoid confusion associated with the notion of security responsibility,
the RESPONSIBLE ORGANIZATION of IEC 80001-1 is given the name healthcare delivery organization (HDO).
[SOURCE: IEC 80001-1:2010, definition 2.22, modified — a note to the original definition,
containing examples, has not been retained; a note to entry has been added.]
3.20
RISK
combination of the probability of occurrence of HARM and the severity of that HARM
[SOURCE: IEC 80001-1:2010, definition 2.23]
3.21
RISK ANALYSIS
systematic use of available information to identify HAZARDS and to estimate the RISK
[SOURCE: IEC 80001-1:2010, definition 2.24]
3.22
RISK ASSESSMENT
overall PROCESS comprising a RISK ANALYSIS and a RISK EVALUATION
[SOURCE: IEC 80001-1:2010, definition 2.25]
3.23
RISK CONTROL
PROCESS in which decisions are made and measures implemented by which RISKS are reduced
to, or maintained within, specified levels
[SOURCE: IEC 80001-1:2010, definition 2.26]
3.24
RISK EVALUATION
PROCESS of comparing the estimated RISK against given RISK criteria to determine the
acceptability of the RISK
[SOURCE: IEC 80001-1:2010, definition 2.27]
3.25
RISK MANAGEMENT
systematic application of management policies, procedures and practices to the tasks of
analyzing, evaluating, controlling, and monitoring RISK
[SOURCE: IEC 80001-1:2010, definition 2.28]
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– 12 – TR 80001-2-2 IEC:2012(E)
3.26
SAFETY
freedom from unacceptable RISK of physical injury or damage to the health of people or
damage to property or the environment
[SOURCE: IEC 80001-1:2010, definition 2.30]
3.27
SECURITY CAPABILITY
broad category of technical, administrative or organizational controls to manage RISKS to
confidentiality, integrity, availability and accountability of data and systems
3.28
VERIFICATION
confirmation through provision of objective evidence that specified requirements have been
fulfilled
[SOURCE: IEC 80001-1:2010, definition 2.32, modifi
...
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