ISO 81001-1:2021

INTERNATIONAL ISO
STANDARD 81001-1
First edition
2021-03
Health software and health IT systems
safety, effectiveness and security —
Part 1:
Principles and concepts
Sécurité, efficacité et sûreté des logiciels de santé et des systèmes TI
de santé —
Partie 1: Principes et concepts
Reference number
ISO 81001-1:2021(E)
©
ISO 2021

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ISO 81001-1:2021(E)

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ISO 81001-1:2021(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
3.1 Organizations, people, and roles . 2
3.2 Key properties and processes . 3
3.3 Health information and technology . 5
3.4 Risk management . 8
4 Core themes .11
4.1 General .11
4.2 Sociotechnical ecosystem .12
4.3 System of systems .13
4.4 Life cycle of health software and health IT systems .14
4.5 Roles and responsibilities .17
4.6 Communication .18
4.7 Interdependence of safety, effectiveness and security .20
5 Foundational elements .21
5.1 General .21
5.2 Governance (intra organization focus) .22
5.2.1 General.22
5.2.2 Organization culture, roles and competencies .22
5.2.3 Quality management .24
5.2.4 Information management .25
5.2.5 Human factors and usability .26
5.3 Knowledge transfer (inter- and intra- organization collaboration) .28
5.3.1 General.28
5.3.2 Risk management .28
5.3.3 Safety management .30
5.3.4 Security management .33
5.3.5 Privacy management . .36
Annex A (informative) Rationale .39
Annex B (informative) Concept diagrams .43
Annex C (informative) Use of assurance cases for knowledge transfer .48
Bibliography .59
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ISO 81001-1:2021(E)

Foreword
ISO (the International Organization for Standardization) and IEC (the International Electrotechnical
Commission) form the specialized system for worldwide standardization. National bodies that
are members of ISO or IEC participate in the development of International Standards through
technical committees established by the respective organization to deal with particular fields of
technical activity. ISO and IEC technical committees collaborate in fields of mutual interest. Other
international organizations, governmental and non-governmental, in liaison with ISO and IEC, also
take part in the work.
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 document 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 and IEC 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) or the IEC
list of patent declarations received (see http:// patents .iec .ch).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www .iso .org/
iso/ foreword .html.
This document was prepared jointly by Technical Committee ISO/TC 215, Health informatics, and
Technical Committee IEC/TC 62, Electrical equipment in medical practice, Subcommittee SC 62A,
Common aspects of electrical equipment used in medical practice.
A list of all parts in the ISO 81001 and IEC 81001 series can be found on the ISO and IEC websites.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
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ISO 81001-1:2021(E)

Introduction
While the benefits of digital health are widely accepted, the potential for inadvertent and adverse
impacts on safety, effectiveness and security caused by health software and health IT systems is also
becoming more apparent. Today’s sophisticated health software and health IT systems provide advanced
levels of decision support and integrate patient data between systems, across organizational lines, and
across the continuum of care. In addition to the patient and healthcare system benefits this creates,
there is also increased likelihood of software-induced adverse events causing harm to both patients and
healthcare organizations. Design flaws, coding errors, incorrect implementation or configuration, data
integrity issues, faults in decision support tools, poor alignment with clinical workflows and improper
maintenance and use of health software and health IT systems are examples of events with the potential
to cause harm.
Managing safety, effectiveness and security for health software and health IT systems (including medical
devices), requires a comprehensive and coordinated approach to optimizing these three properties.
Many organizations and roles are involved throughout the life cycle of health software and health IT
systems (see Figure 1). Therefore, a common understanding of the concepts, principles and terminology
is important in standardizing the processes and inter-organizational communications to support a
coordinated approach to managing safety, effectiveness and security. This document takes into account
the evolving complex internal and external context in healthcare, including people, technology
(hardware/software), organizations, processes, and external environment.
Annex A provides further information on the rationale for this document, the terms and definitions
being used and their relationship to other standards addressing various aspects of health software and
health IT systems safety, effectiveness and security.
In addition to a common set of terms, definitions and concepts, this document describes eight
foundational elements in Clause 5, which support the overarching themes articulated in Clause 4. For
each foundational element, there is a “statement” describing each element; a “rationale” explaining why
it is important; “key concepts and principles” pertinent for managing safety, effectiveness and security;
and high-level guidance on the “approach” organizations can take to apply the concepts and principles.
Given the importance of communication between the various organizations, roles and responsibilities
involved across the life cycle of health software and health IT systems for the four foundational cross-
organizational elements, additional sub-clauses on communication and information sharing at major
transition points are also included for 5.3.2, 5.3.3, 5.3.4 and 5.3.5.
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ISO 81001-1:2021(E)

Figure 1 — Life cycle framework addressing safety, effectiveness and security of health software
and health IT systems
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INTERNATIONAL STANDARD ISO 81001-1:2021(E)
Health software and health IT systems safety, effectiveness
and security —
Part 1:
Principles and concepts
1 Scope
This document provides the principles, concepts, terms and definitions for health software and health
IT systems, key properties of safety, effectiveness and security, across the full life cycle, from concept to
decommissioning, as represented in Figure 1. It also identifies the transition points in the life cycle where
transfers of responsibility occur, and the types of multi-lateral communication that are necessary at
these transition points. This document also establishes a coherent concepts and terminology for other
standards that address specific aspects of the safety, effectiveness, and security (including privacy) of
health software and health IT systems.
This document is applicable to all parties involved in the health software and health IT systems life cycle
including the following:
a) Organizations, health informatics professionals and clinical leaders designing, developing,
integrating, implementing and operating health software and health IT systems – for example health
software developers and medical device manufacturers, system integrators, system administrators
(including cloud and other IT service providers);
b) Healthcare service delivery organizations, healthcare providers and others who use health software
and health IT systems in providing health services;
c) Governments, health system funders, monitoring agencies, professional organizations and
customers seeking confidence in an organization’s ability to consistently provide safe, effective and
secure health software, health IT systems and services;
d) Organizations and interested parties seeking to improve communication in managing safety,
effectiveness and security risks through a common understanding of the concepts and terminology
used in safety, effectiveness and security management;
e) Providers of training, assessment or advice in safety, effectiveness and security risk management for
health software and health IT systems;
f) Developers of related safety, effectiveness and security standards.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
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NOTE Annex B contains a diagrammatic representation of how the terms used in this document relate
conceptually.
3.1 Organizations, people, and roles
3.1.1
administrator
person with role (3.1.10) responsible for the ongoing operation of the implemented health IT system
(3.3.8) and ensuring it is safeguarded and maintained on an ongoing basis
3.1.2
customer
person or organization (3.1.8) that could or does receive a product (3.3.15) or a service that is intended
for or required by this person or organization
Note 1 to entry: A customer can be internal or external to the organization.
[SOURCE: ISO 9000:2015, 3.2.4, modified — Example deleted.]
3.1.3
developer
entity responsible for executing the design and development phase (from concept to release and
maintenance) of a health software (3.3.9) or health IT system (3.3.8)
Note 1 to entry: A developer could, for example, be part of a manufacturing organization (3.1.8), a supplier of
services, or an healthcare delivery organization (3.1.4).
3.1.4
healthcare delivery organization
HDO
facility or enterprise such as a clinic or hospital that provides healthcare services
3.1.5
implementer
entity responsible for the clinical installation, workflow optimization, and training of health software
(3.3.9) and health IT systems (3.3.8) in the clinical setting
Note 1 to entry: An implementer can be the manufacturer (3.1.7), the healthcare delivery organization (3.1.4), or a
third party.
3.1.6
integrator
entity responsible for the incorporation of components (3.3.5) into the health IT infrastructure (3.3.7)
used by the healthcare delivery organization (3.1.4), including technical installation, configuration, and
data migration
3.1.7
manufacturer
organization (3.1.8) with responsibility for design or production of a product (3.3.15)
3.1.8
organization
person or group of people that has its own functions with responsibilities, authorities and relationships
to achieve its objectives
Note 1 to entry: The concept of organization includes, but is not limited to, sole-trader, company, corporation,
firm, enterprise, authority, partnership, association, charity or institution, or part or combination thereof,
whether incorporated or not, public or private
[SOURCE: ISO 9000:2015, 3.2.1, modified — Removed note 2 to entry.]
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3.1.9
responsibility agreement
document that fully defines the responsibilities of all relevant stakeholders
Note 1 to entry: This agreement can be a legal document, for example, a contract.
3.1.10
role
function or position
[SOURCE: ISO/HL7 21731:2006]
3.1.11
subject of care
person who seeks to receive, is receiving, or has received healthcare
[SOURCE: ISO 13940:2015, 5.2.1, modified - the words "healthcare actor with a person role" was
replaced with "person"]
3.1.12
system owner
senior executive accountable for ensuring the health IT system (3.3.8) being acquired and implemented
will meet their organization’s (3.1.8) healthcare delivery services needs for its intended use (3.2.7)
3.1.13
top management
executive management
group of people who direct and control an organization (3.1.8) and have overall accountability in an
organization
3.1.14
user
person using the system (3.3.17) for a health-related purpose
Note 1 to entry: The user can be the subject of care directly, or an individual assisting (as proxy for) the subject
of care.
3.2 Key properties and processes
3.2.1
change management
process (3.2.10) for recording, coordination, approval and monitoring of all changes
[SOURCE: ISO/IEC TS 22237-7:2018, 3.1.3]
3.2.2
change-release management
process (3.2.10) that ensures that all changes to the health IT infrastructure [and its components
(3.3.5)] are assessed, approved, implemented and reviewed in a controlled manner and that changes
are delivered, distributed, and tracked, leading to release of the change in a controlled manner with
appropriate input and output with configuration management (3.2.4)
3.2.3
clinical change management
strategic and systematic process (3.2.10) that supports people and their organizations (3.1.8) in the
successful transition and adoption of electronic health solutions, with a focus on outcomes including
solution adoption by users (3.1.14) and the realization of benefits
Note 1 to entry: Adapted from Reference [39].
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3.2.4
configuration management
process (3.2.10) that ensures that configuration information of components (3.3.5) within the health IT
infrastructure (3.3.7) are defined and maintained in an accurate and controlled manner, and provides a
mechanism for identifying, controlling and tracking versions of the health IT infrastructure
Note 1 to entry: Adapted from ISO/IEC 20000-1:2018, 8.2.6.
3.2.5
effectiveness
ability to produce the intended result
3.2.6
implementation
life cycle (3.3.12) phase at the end of which the hardware, software and procedures of the system
(3.3.17) considered become operational
[SOURCE: ISO/IEC 2382:2015, 2122692, modified — Changed “system development” to “life cycle” and
delete notes to entry.]
3.2.7
intended use
intended purpose
use for which a product (3.3.15), process (3.2.10) or service is intended according to the specifications,
instructions and information provided by the manufacturer (3.1.7)
Note 1 to entry: The intended medical indication, patient population, part of the body or type of tissue interacted
with, user profile, use environment, and operating principle are typical elements of the intended use.
[SOURCE: ISO/IEC Guide 63:2019, 3.4, modified — Added admitted term intended purpose.]
3.2.8
key properties
three risk management (3.4.16) characteristics of safety (3.2.12), effectiveness (3.2.5), and security
(3.2.13)
3.2.9
privacy
freedom from intrusion into the private life or affairs of an individual when that intrusion results from
undue or illegal gathering and use of data about that individual
[SOURCE: ISO/TS 27790:2009, 3.56]
3.2.10
process
set of interrelated or interacting activities that use inputs to deliver an intended result
[SOURCE: ISO 9000:2015, 3.4.1, modified — Notes to entry deleted.]
3.2.11
quality
degree to which all the properties and characteristics of a product (3.3.15), process (3.2.10), or service
satisfy the requirements which ensue from the purpose for which that product, process, or service is used
[SOURCE: ISO/TS 13972:2015, 2.45, modified — Deleted "to be".]
3.2.12
safety
freedom from unacceptable risk (3.4.10)
[SOURCE: ISO/IEC Guide 63:2019, 3.16]
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3.2.13
security
cybersecurity
state where information and systems (3.3.17) are protected from unauthorized activities, such as access,
use, disclosure, disruption, modification, or destruction to a degree that the risks (3.4.10) related to
violation of confidentiality, integrity, and availability are maintained at an acceptable level throughout
the life cycle (3.3.12)
3.2.14
security capability
broad category of technical, administrative or organizational controls to manage risks (3.4.10) to
confidentiality, integrity, availability and accountability of data and systems (3.3.17)
3.2.15
usability
characteristic of the user (3.1.14) interface that facilitates use and thereby establishes effectiveness
(3.2.5), efficiency and user satisfaction in the intended use (3.2.7) environment
Note 1 to entry: All aspects of usability, including effectiveness, efficiency and user satisfaction, can either increase
or decrease safety (3.2.12).
[SOURCE: IEC 62366-1:2015, 3.16]
3.2.16
verification
confirmation, through the provision of objective evidence, that specified requirements have been
fulfilled
Note 1 to entry: The objective evidence needed for a verification can be the result of an inspection or of other
forms of determination such as performing alternative calculations or reviewing documents.
Note 2 to entry: The activities carried out for verification are sometimes called a qualification process (3.2.10).
Note 3 to entry: The word “verified” is used to designate the corresponding status.
[SOURCE: ISO 9000:2015, 3.8.12]
3.3 Health information and technology
3.3.1
accompanying information
accompanying document
accompanying documentation
information accompanying or marked on a health IT (3.3.6), product (3.3.15) or accessory for the user
(3.1.14) or those accountable for the installation, use, processing, maintenance, decommissioning and
disposal of the medical device (3.3.13) or accessory, particularly regarding safe use
3.3.2
asset
physical or digital entity that has value to an individual, an organization (3.1.8) or a government
[SOURCE: ISO/IEC 27032:2012, 4.6, modified — “anything” has been replaced by “physical entity or
digital entity”.]
3.3.3
cloud computing
paradigm for enabling network access to a scalable and elastic pool of shareable physical or virtual
resources with self-service provisioning and administration on-demand
[SOURCE: ISO/IEC 17788:2014, 3.25]
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3.3.4
cloud service
one or more capabilities offered via cloud computing (3.3.3) invoked using a defined interface
[SOURCE: ISO/IEC 17788:2014, 3.2.8]
3.3.5
component
collection of system (3.3.17) resources that (a) forms a physical or logical part of the system, (b) has
specified functions and interfaces, and (c) is treated (e.g., by policies or specifications) as existing
independently of other parts of the system
[SOURCE: IETF RFC 4949, modified — Note 1 deleted.]
3.3.6
health information technology
health IT
documented and intended application of information technology for the collection, storage, processing,
retrieval, and communication of information relevant to health, patient care, and well-being
3.3.7
health IT infrastructure
combined set of IT assets (3.3.2) available to the individual or organization (3.1.8) for developing,
configuring, integrating, maintaining, and using IT services and supporting health, patient care and
other organizational objectives
Note 1 to entry: Health IT infrastructure can include the following:
a) data and information;
b) health software (3.3.9);
c) medical devices (3.3.13);
d) IT hardware and services including mobile and desktop devices, IT networks (3.3.11), data centres, security
(3.2.13), software development, IT operations and externally provided services such as internet, software-
as-a-service and cloud computing (3.3.3);
e) people, and their qualifications, skills and experience;
f) technical procedures and documentation to manage and support the health IT infrastructure;
g) health IT systems (3.3.8) that are configured and implemented to address organizational objectives by
leveraging the above assets (3.3.2);
h) intangibles, such as reputation and image.
3.3.8
health IT system
combination of interacting health IT (3.3.6) elements that is configured and implemented to support
and enable an individual or organization’s (3.1.8) specific health objectives
Note 1 to entry: Such elements include health software (3.3.9), medical devices (3.3.13), IT hardware, interfaces,
data, procedures and documentation.
3.3.9
health software
software intended to be used specifically for managing, maintaining, or improving health of individual
persons, or the delivery of care, or which has been developed for the purpose of being incorporated into
a medical device (3.3.13)
Note 1 to entry: Health software fully includes what is considered software as a medical device.
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3.3.10
interoperability
ability of two or more systems (3.3.17) or components (3.3.5) to exchange information and to use the
information that has been exchanged
[SOURCE: Reference [49]]
3.3.11
IT network
system (3.3.17) or systems composed of communicating nodes and transmission links to provide
physically linked or wireless transmission between two or more specified communication nodes
Note 1 to entry: Adapted from IEC 61907:2009, 3.1.1.
3.3.12
life cycle
series of all phases in the life of a product (3.3.15) or system (3.3.17), from the initial conception to final
decommissioning and disposal
[SOURCE: ISO/IEC Guide 63:2019, 3.5, modified — “medical device” has been replaced with “product or
system”.]
3.3.13
medical device
instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software,
material or other similar or related article, intended by the manufacturer (3.1.7) to be used, alone or in
combination, for human beings, for one of more of the specific medical 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 by means of in vitro examination of specimens derived from the human body,
and which does not achieve its primary intended action by pharmacological, immunological or metabolic
means, in or on the human body, but which can be assisted in its intended function by such means
Note 1 to entr
...