Health software and health IT systems safety, effectiveness and security

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.

Sécurité, efficacité et sûreté des logiciels de santé et des systèmes TI de santé

General Information

Status
Published
Publication Date
30-Mar-2021
Current Stage
5060 - Close of voting Proof returned by Secretariat
Start Date
10-Feb-2021
Completion Date
09-Feb-2021
Ref Project

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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
---------------------- Page: 1 ----------------------
ISO 81001-1:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting

on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
---------------------- Page: 2 ----------------------
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

© ISO 2021 – All rights reserved iii
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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.
iv © ISO 2021 – All rights reserved
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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.
© ISO 2021 – All rights reserved v
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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
vi © ISO 2021 – All rights reserved
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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/
© ISO 2021 – All rights reserved 1
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ISO 81001-1:2021(E)

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.]
2 © ISO 2021 – All rights reserved
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ISO 81001-1:2021(E)
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].
© ISO 2021 – All rights reserved 3
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ISO 81001-1:2021(E)
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]
4 © ISO 2021 – All rights reserved
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ISO 81001-1:2021(E)
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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ISO 81001-1:2021(E)
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.

6 © ISO 2021 – All rights reserved
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ISO 81001-1:2021(E)
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
...

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 81001-1
ISO/TC 215
Health software and health IT systems
Secretariat: ANSI
safety, effectiveness and security —
Voting begins on:
2020-12-15
Part 1:
Voting terminates on:
Principles and concepts
2021-02-09
Sécurité, efficacité et sûreté des logiciels de santé et des systèmes TI
de santé —
Partie 1: Principes et concepts
This draft is submitted to a parallel vote in ISO and in IEC.
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 81001-1:2020(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. ISO 2020
---------------------- Page: 1 ----------------------
ISO/FDIS 81001-1:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting

on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/FDIS 81001-1:2020(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/FDIS 81001-1:2020(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.
iv © ISO 2020 – All rights reserved
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ISO/FDIS 81001-1:2020(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 such 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/FDIS 81001-1:2020(E)

Figure 1 — Life cycle framework addressing safety, effectiveness and security of health software

and health IT systems
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FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 81001-1:2020(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 these 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 these 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 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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ISO/FDIS 81001-1:2020(E)

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 manufacture 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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ISO/FDIS 81001-1:2020(E)
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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ISO/FDIS 81001-1:2020(E)
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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ISO/FDIS 81001-1:2020(E)
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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ISO/FDIS 81001-1:2020(E)
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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ISO/FDIS 81001-1:2020(E)
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[50]]
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, tre
...

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