IEC TR 80001-2-8:2016

Application of risk management for IT-networks incorporating medical devices - Part 2-8: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2

IEC TR 80001-2-8:2016, which is a Technical Report, provides guidance to Health Delivery Organizations (HDOs) and Medical Device Manufacturers (MDMs) for the application of the framework outlined in IEC TR 80001-2-2.

General Information

• Status: Published
• Publication Date: 18-May-2016
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: SC 62A - Common aspects of medical equipment, software, and systems
• Drafting Committee: JWG 7 - TC 62/SC 62A/JWG 7
• Current Stage: PPUB - Publication issued
• Start Date: 19-May-2016
• Completion Date: 15-Jul-2016

Standards Content (Sample)

IEC TR 80001-2-8
Edition 1.0 2016-05
TECHNICAL
REPORT
Application of risk management for IT-networks incorporating medical devices –
Part 2-8: Application guidance – Guidance on standards for establishing the
security capabilities identified in IEC TR 80001-2-2
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IEC TR 80001-2-8
Edition 1.0 2016-05
TECHNICAL
REPORT
Application of risk management for IT-networks incorporating medical devices –

Part 2-8: Application guidance – Guidance on standards for establishing the

security capabilities identified in IEC TR 80001-2-2

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.01 ISBN 978-2-8322-3412-9

– 2 – IEC TR 80001-2-8:2016 © IEC 2016
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
1 Scope . 9
2 Normative references. 9
3 Terms and definitions . 10
4 Guidance for establishing SECURITY CAPABILITIES . 13
4.1 General . 13
4.2 Automatic logoff – ALOF . 14
4.3 Audit controls – AUDT . 15
4.4 Authorization – AUTH . 17
4.5 Configuration of security features – CNFS . 19
4.6 Cyber security product upgrades – CSUP . 21
4.7 HEALTH DATA de-identification – DIDT . 24
4.8 Data backup and disaster recovery – DTBK . 25
4.9 Emergency access – EMRG . 27
4.10 HEALTH DATA integrity and authenticity – IGAU . 28
4.11 Malware detection/protection – MLDP . 30
4.12 Node authentication – NAUT . 32
4.13 Person authentication – PAUT . 35
4.14 Physical locks on device – PLOK . 37
4.15 Third-party components in product lifecycle roadmaps – RDMP . 39
4.16 System and application hardening – SAHD . 42
4.17 Security guides – SGUD . 44
4.18 HEALTH DATA storage confidentiality – STCF . 47
4.19 Transmission confidentiality – TXCF . 48
4.20 Transmission integrity – TXIG . 50
Bibliography . 51

Table 1 – ALOF controls . 14
Table 2 – AUDT controls . 16
Table 3 – AUTH controls . 18
Table 4 – CNFS controls . 20
Table 5 – CSUP controls . 22
Table 6 – DIDT controls . 24
Table 7 – DTBK controls . 26
Table 8 – EMRG controls . 28
Table 9 – IGAU controls . 29
Table 10 – MLDP controls . 30
Table 11 – NAUT controls . 33
Table 12 – PAUT controls . 36
Table 13 – PLOK controls . 38
Table 14 – RDMP controls . 40
Table 15 – SAHD controls . 43

Table 16 – SGUD controls. 45
Table 17 – STCF controls . 48
Table 18 – TXCF controls . 49
Table 19 – TXIG controls . 50

– 4 – IEC TR 80001-2-8:2016 © IEC 2016
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS
INCORPORATING MEDICAL DEVICES –

Part 2-8: Application guidance – Guidance on standards for
establishing the security capabilities identified in IEC TR 80001-2-2

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
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8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
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9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
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The main task of IEC technical committees is to prepare International Standards. However, a
technical committee may propose the publication of a technical report when it has collected
data of a different kind from that which is normally published as an International Standard, for
example "state of the art".
IEC 80001-2-8, which is a technical report, has been prepared by 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
1)
informatics.
___________
1)
This document contains original material that is © 2013, Dundalk Institute of Technology, Ireland. Permission is
granted to ISO and IEC to reproduce and circulate this material, this being without prejudice to the rights of
Dundalk Institute of Technology to exploit the original text elsewhere.

It is published as a double logo technical report.
The text of this technical report is based on the following documents of IEC:
Enquiry draft Report on voting
62A/1018/DTR 62A/1043A/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. In ISO, the standard has been approved by
14 P-members out of 31 having cast a vote.
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.
A list of all parts of the IEC 80001 series, published under the general title Application of risk
management for it-networks incorporating medical devices, can be found on the IEC website.
The committee has decided that the contents of this publication will remain unchanged until
the stability date indicated on the IEC website under "http://webstore.iec.ch" in the data
related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
A bilingual version of this publication may be issued at a later date.

– 6 – IEC TR 80001-2-8:2016 © IEC 2016
INTRODUCTION
The IEC 80001-1 standard, the Application of risk management to IT-networks incorporating
medical devices, provides the roles, responsibilities and activities necessary for RISK
MANAGEMENT. IEC TR 80001-2-2, the 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 is a technical report that provides additional
guidance in relation to how SECURITY CAPABILITIES might be referenced (disclosed and
discussed) in both the RISK MANAGEMENT PROCESS and stakeholder communications and
agreements. This technical report provides guidance for the establishment of each of the
SECURITY CAPABILITIES presented in IEC TR 80001-2-2.
IEC TR 80001-2-2 contains an informative set of common, descriptive SECURITY CAPABILITIES
intended to be the starting point for a security-centric discussion between the 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 sizes of RESPONSIBLE ORGANIZATIONS
(henceforth called healthcare delivery organizations – HDOs) as each evaluates RISK using
the SECURITY CAPABILITIES and decides what to include or not to include according to their RISK
tolerance and available resources. This documentation can be used by HDOs as input to their
IEC 80001 PROCESS or to form the basis of RESPONSIBILITY AGREEMENTS among stakeholders.
Other IEC 80001 technical reports will provide step-by-step guidance in the RISK MANAGEMENT
PROCESS. IEC TR 80001-2-2 SECURITY CAPABILITIES encourage the disclosure of more detailed
SECURITY CONTROLS. This technical report identifies SECURITY CONTROLS from key security
standards which aim to provide guidance to a RESPONSIBLE ORGANIZATION when adapting the
framework outlined in IEC TR 80001-2-2.
The framework outlined in IEC TR 80001-2-2 requires shared responsibility between HDOs
and MEDICAL DEVICE manufacturers (MDMs). Similarly, this guidance applies to both
stakeholders, as a shared responsibility, to ensure safe MEDICAL DEVICE IT networks. In order
to build a secure MEDICAL DEVICE IT network a joint effort from both stakeholders is required.
A SECURITY CAPABILITY, as defined in IEC TR 80001-2-2, represents a broad category of
2)
technical, administrative and/or organizational SECURITY CONTROLS required to manage RISKS
to confidentiality, integrity, availability and accountability of data and systems. This document
presents these categories of SECURITY CONTROLS prescribed for a system and the operational
environment to establish SECURITY CAPABILITIES to protect the confidentiality, integrity,
availability and accountability of data and systems. The SECURITY CONTROLS support the
maintenance of confidentiality and the protection from malicious intrusion that might lead to
compromises in integrity or system/data availability. The SECURITY CONTROLS for each
3)
SECURITY CAPABILITY can be added to 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.
In addition to providing a basis for discussing RISK and respective roles and responsibilities
toward RISK MANAGEMENT, this report is intended to supply:
a) Health Delivery Organizations (HDOs) with a catalogue of management, operational and
administrative SECURITY CONTROLS to maintain the EFFECTIVENESS of a SECURITY CAPABILITY
for a MEDICAL DEVICE on a MEDICAL DEVICE IT-NETWORK;
b) MEDICAL DEVICE manufacturers (MDMs) with a catalogue of technical SECURITY CONTROLS
for the establishment of each of the 19 SECURITY CAPABILITIES.
___________
2)
For the purpose of consistency throughout this report, the term SECURITY CONTROLS refers to the technical,
administrative and organizational controls/safeguards prescribed to establish SECURITY CAPABILITIES.
3)
The selection of SECURITY CAPABILITIES and SECURITY CONTROLS will vary due to the diversity of MEDICAL DEVICE
products and context in relation to environment and INTENDED USE. Therefore, this technical report is not
intended as a “one size fits all” solution.

This report presents the 19 SECURITY CAPABILITIES, their respective “requirement goal” and
“user need” (identical to that in IEC TR 80001-2-2) with a corresponding list of SECURITY
CONTROLS from a number of security standards. The security standards used for mapping
4)
SECURITY CONTROLS to SECURITY CAPABILITIES include :
• NIST SP 800-53, Revision 4, Recommended Security Controls for Federal Information
Systems and Organizations
NIST Special Publication 800-53 covers the steps in the RISK MANAGEMENT Framework
that address SECURITY CONTROL selection for federal information systems in accordance
with the security requirements in Federal Information Processing Standard (FIPS) 200.
This includes selecting an initial set of baseline SECURITY CONTROLS based on a FIPS 199
worst-case impact analysis, tailoring the baseline SECURITY CONTROLS, and supplementing
the SECURITY CONTROLS based on an organizational assessment of RISK. The security rules
cover 17 areas including access control, incident response, business continuity, and
disaster recoverability.
• ISO IEC 15408-2:2008, Information technology – Security techniques – Evaluation criteria
for IT security – Part 2: Security functional components
This standard defines the content and presentation of the security functional requirements
to be assessed in a security evaluation using ISO IEC 15408. It contains a comprehensive
catalogue of predefined security functional components that will fulfil the most common
security needs of the marketplace. These are organized using a hierarchical structure of
classes, families and components, and supported by comprehensive user notes.
This standard also provides guidance on the specification of customized security
requirements where no suitable predefined security functional components exist.
• ISO IEC 15408-3:2008, Information technology – Security techniques – Evaluation criteria
for IT security – Part 3: Security assurance components
This standard defines the assurance requirements of the evaluation criteria. It includes the
evaluation assurance levels that define a scale for measuring assurance for component
targets of evaluation (TOEs), the composed assurance packages that define a scale for
measuring assurance for composed TOEs, the individual assurance components from
which the assurance levels and packages are composed, and the criteria for evaluation of
protection profiles and security targets.
This standard defines the content and presentation of the assurance requirements in the
form of assurance classes, families and components and provides guidance on the
organization of new assurance requirements. The assurance components within the
assurance families are presented in a hierarchical order.
• IEC 62443-3-3:2013, Industrial communication networks – Network and system security –
Part 3-3: System security requirements and security levels
This standard provides detailed technical control system requirements (SRs) associated
with the seven foundational requirements (FRs) described in IEC TS 62443-1-1 including
defining the requirements for control system capability security levels, SL-C (control
system). These requirements would be used by various members of the industrial
automation and control system (IACS) community along with the defined zones and
conduits for the system under consideration (SuC) while developing the appropriate
control system target SL, SL-T(control system), for a specific asset.
• ISO IEC 27002:2013, Information technology – Security techniques – Code of practice for
information security controls
This standard outlines guidelines for organizational information security standards and
information security management practices including the selection, implementation and
management of controls taking into consideration the organization's information security
RISK environment(s). It is designed to be used by organizations that intend to:
___________
4)
The selection of security standards used in this technical report does not represent an exhaustive list of all
potentially useful standards.
– 8 – IEC TR 80001-2-8:2016 © IEC 2016
1) select controls within the PROCESS of implementing a MEDICAL DEVICE system based on
ISO IEC 27001;
2) implement commonly accepted information SECURITY CONTROLS;
3) develop their own information security management guidelines.
5)
• ISO 27799:— , Health informatics – Information security management in health using ISO
IEC 27002
This standard defines guidelines to support the interpretation and implementation in health
informatics of ISO IEC 27002 and is a companion to that standard.
It specifies a set of detailed controls for managing health information security and provides
health information security best practice guidelines. By implementing this International
Standard, HDOs and other custodians of health information will be able to ensure a
minimum requisite level of security that is appropriate to their organization's
circumstances and that will maintain the confidentiality, integrity and availability of
personal health information.
___________
5)
To be published.
APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS
INCORPORATING MEDICAL DEVICES –

Part 2-8: Application guidance – Guidance on standards for
establishing the security capabilities identified in IEC TR 80001-2-2

1 Scope
This part of IEC 80001, which is a Technical Report, provides guidance to Health Delivery
Organizations (HDOs) and MEDICAL DEVICE manufacturers (MDMs) for the application of the
framework outlined in IEC TR 80001-2-2. Managing the RISK in connecting MEDICAL DEVICES to
IT-NETWORKS requires the disclosure of security-related capabilities and RISKS.
IEC TR 80001-2-2 presents a framework for this disclosure and the security dialog that
surrounds the IEC 80001-1 RISK MANAGEMENT of IT-NETWORKS. IEC TR 80001-2-2 presents an
informative set of common, descriptive security-related capabilities that are useful in terms of
gaining an understanding of user needs. This report addresses each of the SECURITY
CAPABILITIES and identifies SECURITY CONTROLS for consideration by HDOs and MDMs during
RISK MANAGEMENT activities, supplier selection, device selection, device implementation,
operation etc.
It is not intended that the security standards referenced herein are exhaustive of all useful
standards; rather, the purpose of this technical report is to identify SECURITY CONTROLS, which
exist in these particular security standards (listed in the introduction of this technical report),
that apply to each of the SECURITY CAPABILITIES.
This report provides guidance to HDOs and MDMs for the selection and implementation of
management, operational, administrative and technical SECURITY CONTROLS to protect the
confidentiality, integrity, availability and accountability of data and systems during
development, operation and disposal.
All 19 SECURITY CAPABILITIES are not required in every case and the identified SECURITY
CAPABILITIES included in this report should not be considered exhaustive in nature. The
selection of SECURITY CAPABILITIES and SECURITY CONTROLS should be based on the RISK
EVALUATION and the RISK tolerance with consideration for protection of patient SAFETY, life and
health. INTENDED USE, operational environment, network structure and local factors should
also determine which SECURITY CAPABILITIES are necessary and which SECURITY CONTROLS
most suitably assist in establishing that SECURITY CAPABILITY.
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

– 10 – IEC TR 80001-2-8:2016 © IEC 2016
IEC TR 80001-2-2:2012, Application of risk management for IT-networks incorporating
medical devices – Part 2-2: Guidance for the communication of medical device security
6)
needs, risks and controls
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
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, 2.5]
3.2
EFFECTIVENESS
ability to produce the intended result for the patient and the RESPONSIBLE ORGANIZATION
[SOURCE: IEC 80001-1:2010, 2.6]
3.3
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 SYSTEMS SECURITY
[SOURCE: IEC 80001-1:2010, 2.8]
3.4
HAZARD
potential source of HARM
[SOURCE: IEC 80001-1:2010, 2.9]
3.5
HEALTH DATA
PRIVATE DATA that indicates physical or mental health
Note 1 to entry: This term generically defines PRIVATE DATA and it subset, HEALTH DATA, within this report to permit
users of this report 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.
3.6
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, 2.10]
___________
6)
IEC TR 80001-2-2 contains many additional standards, policies and reference materials which are also
indispensable for the application of this Technical Report.

3.7
IT-NETWORK
INFORMATION TECHNOLOGY NETWORK
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, 2.12]
3.8
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
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 to entry 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, 2.14]
3.9
MEDICAL IT-NETWORK
IT-NETWORK that incorporates at least one MEDICAL DEVICE

– 12 – IEC TR 80001-2-8:2016 © IEC 2016
[SOURCE: IEC 80001-1:2010, 2.16]
3.10
OPERATOR
person handling equipment
[SOURCE: IEC 80001-1:2010, 2.18]
3.11
PRIVATE DATA
any information relating to an identified or identifiable person
3.12
PROCESS
set of interrelated or interacting activities which transforms inputs into outputs
[SOURCE: IEC 80001-1:2010, 2.19]
3.13
RESPONSIBILITY AGREEMENT
one or more documents that together fully define the responsibilities of all relevant
stakeholders
[SOURCE: IEC 80001-1:2010, 2.21, modified – The note has been deleted.]
3.14
RESPONSIBLE ORGANIZATION
entity accountable for the use and maintenance of a MEDICAL IT-NETWORK
[SOURCE: IEC 80001-1:2010, 2.22, modified – The notes have been deleted.]
3.15
RISK
combination of the probability of occurrence of HARM and the severity of that HARM
[SOURCE: IEC 80001-1:2010, 2.23]
3.16
RISK ANALYSIS
systematic use of available information to identify HAZARDS and to estimate the RISK
[SOURCE: IEC 80001-1:2010, 2.24]
3.17
RISK ASSESSMENT
overall PROCESS comprising a RISK ANALYSIS and a RISK EVALUATION
[SOURCE: IEC 80001-1:2010, 2.25]
3.18
RISK EVALUATION
PROCESS of comparing the estimated RISK against given RISK criteria to determine the
acceptability of the RISK
[SOURCE: IEC 80001-1:2010, 2.27]

3.19
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, 2.28]
3.20
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, 2.30]
3.21
SECURITY CAPABILITY
broad category of technical, administrative or organizational controls to manage RISKS to
confidentiality, integrity, availability and accountability of data and systems
3.22
SECURITY CONTROL
management, operational, and technical controls (i.e., safeguards or countermeasures)
prescribed for an information system to protect the confidentiality, integrity, and availability of
the system and its information
[SOURCE: NIST IR 7298]
3.23
VERIFICATION
confirmation through provision of objective evidence that specified requirements have been
fulfilled
[SOURCE: IEC 80001-1:2010, 2.32]
4 Guidance for establishing SECURITY CAPABILITIES
4.1 General
This clause presents each of SECURITY CAPABILITIES, as outlined in IEC TR 80001-2-2, with
corresponding tables (Tables 1 to 19) of recommended SECURITY CONTROLS from the following
standards:
Technical SECURITY CONTROLS:
• NIST SP-800-53;
• ISO IEC 15408-2;
• ISO IEC 15408-3;
• IEC 62443-3-3;
Operational/administrative SECURITY CONTROLS:
• ISO IEC 27002;
• ISO 27799.
For infrastructure and MEDICAL IT NETWORK SECURITY CONTROLS, ISO IEC 27002 and
ISO 27799 are grouped together in the below tables as the standards are fully aligned.

– 14 – IEC TR 80001-2-8:2016 © IEC 2016
ISO IEC 27002 specifies a set of detailed controls for managing information security.
ISO 27799 specifies additional guidance specifically for health information security and
provides health information security best practice guidelines.
4.2 Automatic logoff – ALOF
Requirement goal: Reduce the RISK of unauthorized access to HEALTH DATA from an
unattended workspot.
Prevent misuse by other users if a system or workspot is left idle for a
period of time.
User need: Unauthorized users are not able to access HEALTH DATA at an
unattended workspot.
Authorized user sessions need to automatically terminate or lock after a
pre-set period of time. This reduces the RISK of unauthorized access to
HEALTH DATA when an authorized user left the workspot without logging
off or locking the display or room.
Automatic logoff needs to include a clearing of HEALTH DATA from all
displays as appropriate.
The local authorized IT administrator needs to be able to disable the
function and set the expiration time (including screen saver)
A screen saver with short inactivity time or manually enabled by a
shortcut key might be an additional feature. This HEALTH DATA display
clearing could be invoked when no key is pressed for some short period
(e.g. 15 s to several minutes). This would not log out the user but would
reduce RISK of casual viewing of information.
It is desirable that clinical users should not lose uncommitted work due
to automatic logoff. Consider detailing characteristics under ALOF that
distinguish between (a) logoff and (b) screen locking with resumption of
session.
Table 1 – ALOF controls
Standard Reference Control
SP 800-53 AC-1 Access control policy and management
AC-2 Account management
AC-7 Unsuccessful logon attempts
AC-11 Session lock
AC-12 Session termination
AC-23 Data mining protection
AC-24 Access control decisions
CM-4 Security impact analysis
IA-4 Identifier management
IA-11 Re-authentication
ISO IEC 15408-2 FTA_SSL Session locking and termination
FMT_SAE Security attribute expiration
FIA_UAU User authentication
ISO IEC 15408-3 No applicable SECURITY CONTROLS

Table 1 (continued)
Standard Reference Control
IEC 62443-3-3 SR 2.5 Session lock
SR 2.6 Remote session termination
ISO IEC 27002 5.1.1 Policies for information security
ISO 27799 5.1.2 Review of the Information Security Policy
9.1.1 Access control policy
9.4.2 Secure logon procedures
11.2.8 Unattended user equipment
11.2.9 Clear desk and clear screen policy
18.2.2 Compliance with security policies and standards

4.3 Audit controls – AUDT
Requirement goal: Define harmonized approach towards reliably auditing who is doing
what with HEALTH DATA, allowing HDO IT to monitor this using public
frameworks, standards and technology.
Our industry agreed upon and HDO IT strongly prefers Integrating the
Healthcare Enterprise (IHE) audit trail profile support.
Audit goal (from IHE): To allow a security officer in an institution to
audit activities, to assess compliance with a secure domain’s policies,
to detect instances of non-compliant behaviour, and to facilitate
detection of improper creation, access, modification and deletion of
Protected Health Information (PHI).
User need: Capability to record and examine system activity by creating audit trails
on a device to track system and HEALTH DATA access, modification, or
deletion.
Support for use either as a stand-alone repository (logging audit files in
its own file system) or, when configured as such, will send logged
information to a separate, HDO-managed central repository.
Audit creation and maintenance supported by appropriate audit review
tools.
Securing of audit data as appropriate (especially if they contain
personal data themselves).
Audit data that cannot be edited or deleted.
Audit data likely contains personal data and/or HEALTH DATA and all
processing (e.g. access, storage and transfer) should have appropriate
controls.
– 16 – IEC TR 80001-2-8:2016 © IEC 2016
Table 2 – AUDT controls
Standard Reference Control
SP 800-53 AC-21 Information sharing
AC-23 Data mining protection
AU-1 Audit and accountability policy and procedures
AU-2 Audit events
AU-3 Content of audit records
AU-4 Audit storage capacity
AU-5 Response to audit processing failures
AU-6 Audit review, analysis and reporting
AU-7 Audit reduction and report generation
AU-8 Time stamps
AU-9 Protection of audit information
AU-10 Non-repudiation
AU-11 Audit record retention
AU-12 Audit generation
AU-13 Monitoring for information disclosure
AU-14 Session audit
AU-15 Alternate audit capacity
AU-16 Cross-organizational auditing
ISO IEC 15408-2 FAU_ARP Security audit automatic response
FAU_GEN Security audit data generation
FAU_SAA Security audit analysis
FAU_SAR Security audit review
FAU_SEL Security audit event selection
FAU_STG Security audit event storage
FCO_NRO Non-repudiation of origin
FCO_NRR Non-repudiation of receipt
FMT_SAE Security attribute expiration
FPT_STM Time stamps
ISO IEC 15408-3 No applicable SECURITY CONTROLS
IEC 62443-3-3 SR 2.8 Auditable events
SR 2.9 Audit storage capacity
SR 2.10 Response to audit processing failures
SR 2.11 Timestamps
SR 2.12 Non-repudiation
SR 3.9 Protection of audit information
SR 6.1 Audit reduction and report generation
SR 6.2 Continuous monitoring
Table 2 (continued)
Standard Reference Control
ISO IEC 27002 5.1.1 Policies for information security
ISO 27799
5.1.2 Review of the information security policy
6.1.2 Segregation of duties
6.2.2 Teleworking
12.4.1 Event logging
12.4.2 Protection of log information
12.4.3 Administrator and OPERATOR logs
12.4.4 Clock synchronisation
12.7.1 Information systems audit controls
16.1.7 Collection of evidence
18.1.3 Protection of records
18.1.4 Privacy and protection of personally identifiable information

4.4 Authorization – AUTH
Requirement goal: Following the principle of data minimization, provide control of access to
HEALTH DATA and functions only as necessary to perform the tasks
required by the HDO consistent with the INTENDED USE.
User need: Avoiding unauthorized access to data and functions in order to (1)
preserve system and data confidentiality, integrity and availability and
(2) remain within permitted uses of data and systems.
As defined by HDO IT policy and based on the authenticated individual
user’s identification, the authorization capability allows each user to
only access approved data and only perform approved functions on the
device.
Authorized users include HDO and service staff as defined by that
policy.
• MEDICAL DEVICES typically support a permissions-based system
providing access to system functions and data appropriate to the
role(s) of the individual in the HDO (role-based access control,
RBAC). For example: OPERATORS can perform their assigned tasks
using all appropriate device functions (e.g. monitor or scan
patients).
• Quality staff (e.g. medical physicist) can engage in all appropriate
quality and assurance testing activities.
• Service staff can access the system in a manner that supports their
preventive maintenance, problem investigation, and problem
elimination activities.
Authorization permits the RISK to effectively deliver healthcare while (1)
maintaining system and data security and (2) following the principle of
appropriate data access minimization. Authorization can be managed
locally or enterprise-wide (e.g. via centralized directory).
Where INTENDED USE does not permit the time necessary for logging
onto and off of a device (e.g. high-throughput use), the local IT Policy
can permit reduced authorization controls presuming adequacy of
controlled and restricted physical access.

– 18 – IEC TR 80001-2-8:2016 © IEC 2016
Table 3 – AUTH controls
Standard Reference Control
SP 800-53 AC-1 Access control policy and management
AC-2 Account management
AC-3 Access enforcement
AC-5 Separation of duties
AC-6 Least privilege
AC-7 Unsuccessful logon attempts
AC-17 Remote access
AC-18 Wireless access
AC-19 Access control for mobile devices
AC-21 Information sharing
AC-23 Data mining protection
AC-24 Access control decisions
PL-4 Rul
...