SIST EN IEC 80001-1:2022

Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software (IEC 80001-1:2021)

This document specifies general requirements for ORGANIZATIONS in the application of RISK
MANAGEMENT before, during and after the connection of a HEALTH IT SYSTEM within a HEALTH IT
INFRASTRUCTURE, by addressing the KEY PROPERTIES of SAFETY, EFFECTIVENESS and SECURITY
whilst engaging appropriate stakeholders.

Sicherheit, Effektivität und Daten- und Systemsicherheit bei Implementierung und Gebrauch von eingebundenen Medizinprodukten oder eingebundener Gesundheitssoftware - Teil 1: Anwendung von Risikomanagement (IEC 80001-1:2021)

Application de la gestion des risques aux réseaux des technologies de l’information contenant des dispositifs médicaux - Partie 1: Sûreté, efficacité et sécurité dans la mise en œuvre et l'utilisation des dispositifs médicaux connectés ou des logiciels de santé connectés (IEC 80001-1:2021)

L'IEC 80001-1:2021 spécifie des exigences générales au profit des ORGANISATIONS pour l’application de la GESTION DES RISQUES avant, pendant et après la connexion d’un SYSTEME TI DE SANTE au sein d’une INFRASTRUCTURE TI DE SANTE. Il traite des PROPRIETES CLES de SECURITE, d’EFFICACITE et de SURETE tout en impliquant les intervenants concernés.
L'IEC 80001-1:2021 annule et remplace la première édition parue en 2010. Cette édition constitue une révision technique.
Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente:
a) modification de la structure pour mieux s’aligner sur l’ISO 31000;
b) établissement d’exigences en faveur d’une ORGANISATION dans l’application de la GESTION DES RISQUES;
c) communication de la valeur, de l’objectif et de la finalité de la GESTION DES RISQUES à travers des principes qui favorisent la préservation des PROPRIETES CLES lors de la mise en œuvre et de l’utilisation des LOGICIELS DE SANTE et/ou SYSTEMES TI DE SANTE connectés.

Uporaba upravljanja tveganja za omrežja IT, ki vključujejo medicinske naprave - 1. del: Varnost, učinkovitost in varnost pri izvajanju in uporabi povezanih medicinskih pripomočkov ali povezane zdravstvene programske opreme (IEC 80001-1:2021)

Ta dokument določa splošne zahteve za ORGANIZACIJE, ki uporabljajo upravljanje tveganja pred, med in po povezovanju ZDRAVSTVENEGA SISTEMA IT v ZDRAVSTVENO INFRASTRUKTURO IT, tako da obravnava KLJUČNE LASTNOSTI VARNOSTI, UČINKOVITOSTI in ZAŠČITE ob vključevanju ustreznih deležnikov.

General Information

• Status: Published
• Publication Date: 23-Nov-2021
• ICS: 11.040.01 - Medical equipment in general
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 10-Nov-2021
• Due Date: 15-Jan-2022
• Completion Date: 24-Nov-2021
• Ref Project: EN IEC 80001-1:2021 - Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software

Relations

• Revised: SIST EN 80001-1:2011 - Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities (IEC 80001-1:2010)
• Effective Date: 27-Feb-2018
• Replaces: SIST EN 80001-1:2011 - Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities (IEC 80001-1:2010)
• Effective Date: 02-Nov-2021

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN IEC 80001-1:2022
01-januar-2022
Nadomešča:
SIST EN 80001-1:2011
Uporaba upravljanja tveganja za omrežja IT, ki vključujejo medicinske naprave - 1.
del: Varnost, učinkovitost in varnost pri izvajanju in uporabi povezanih
medicinskih pripomočkov ali povezane zdravstvene programske opreme (IEC
80001-1:2021)
Application of risk management for IT-networks incorporating medical devices - Part 1:
Safety, effectiveness and security in the implementation and use of connected medical
devices or connected health software (IEC 80001-1:2021)
Sicherheit, Effektivität und Daten- und Systemsicherheit bei Implementierung und
Gebrauch von eingebundenen Medizinprodukten oder eingebundener
Gesundheitssoftware - Teil 1: Anwendung von Risikomanagement (IEC 80001-1:2021)
Application de la gestion des risques aux réseaux des technologies de l’information
contenant des dispositifs médicaux - Partie 1: Sûreté, efficacité et sécurité dans la mise
en œuvre et l'utilisation des dispositifs médicaux connectés ou des logiciels de santé
connectés (IEC 80001-1:2021)
Ta slovenski standard je istoveten z: EN IEC 80001-1:2021
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN IEC 80001-1:2022 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN IEC 80001-1:2022


EUROPEAN STANDARD EN IEC 80001-1

NORME EUROPÉENNE

EUROPÄISCHE NORM
October 2021
ICS 11.040.01; 35.240.80 Supersedes EN 80001-1:2011 and all of its amendments
and corrigenda (if any)
English Version
Application of risk management for IT-networks incorporating
medical devices - Part 1: Safety, effectiveness and security in
the implementation and use of connected medical devices or
connected health software
(IEC 80001-1:2021)
Application de la gestion des risques aux réseaux des Sicherheit, Effektivität und Daten- und Systemsicherheit bei
technologies de l'information contenant des dispositifs Implementierung und Gebrauch von eingebundenen
médicaux - Partie 1: Sûreté, efficacité et sécurité dans la Medizinprodukten oder eingebundener
mise en œuvre et l'utilisation des dispositifs médicaux Gesundheitssoftware - Teil 1: Anwendung von
connectés ou des logiciels de santé connectés Risikomanagement
(IEC 80001-1:2021) (IEC 80001-1:2021)
This European Standard was approved by CENELEC on 2021-10-26. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.


European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN IEC 80001-1:2021 E

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SIST EN IEC 80001-1:2022
EN IEC 80001-1:2021 (E)
European foreword
The text of document 62A/1434/FDIS, future edition 2 of IEC 80001-1, prepared by SC 62A “Common
aspects of electrical equipment used in medical practice” of IEC/TC 62 “Electrical equipment in
medical practice” was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
EN IEC 80001-1:2021.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2022–07–26
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2024–10–26
document have to be withdrawn
This document supersedes EN 80001-1:2011 and all of its amendments and corrigenda (if any).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 80001-1:2021 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards
indicated:
ISO 14971:2019 NOTE Harmonized as EN ISO 14971:2019 (not modified)
ISO 13940:2015 NOTE Harmonized as EN ISO 13940:2016 (not modified)
IEC 60601-1:2005 NOTE Harmonized as EN 60601-1:2006 (not modified) +A11:2011


2

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IEC 80001-1


Edition 2.0 2021-09




INTERNATIONAL



STANDARD




NORME


INTERNATIONALE
colour

inside










Application of risk management for IT-networks incorporating medical devices –

Part 1: Safety, effectiveness and security in the implementation and use of

connected medical devices or connected health software



Application de la gestion des risques aux réseaux des technologies de

l’information contenant des dispositifs médicaux –


Partie 1: Sûreté, efficacité et sécurité dans la mise en œuvre et l'utilisation des

dispositifs médicaux connectés ou des logiciels de santé connectés












INTERNATIONAL

ELECTROTECHNICAL

COMMISSION


COMMISSION

ELECTROTECHNIQUE


INTERNATIONALE




ICS 11.040.01; 35.240.80 ISBN 978-2-8322-9748-3




Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

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CONTENTS
FOREWORD . 4
INTRODUCTION . 7
1 Scope . 9
2 Normative references . 9
3 Terms and definitions . 9
4 Principles . 10
5 Framework . 11
5.1 General . 11
5.2 Leadership and commitment . 11
5.3 Integrating RISK MANAGEMENT . 11
5.4 Design/planning . 12
5.4.1 General . 12
5.4.2 RISK MANAGEMENT FILE . 13
5.4.3 Understanding the organization and the SOCIOTECHNICAL ECOSYSTEM . 13
5.4.4 Articulating RISK MANAGEMENT commitment . 13
5.4.5 Assigning organizational roles, authorities, responsibilities and
accountabilities . 13
5.4.6 Allocating resources . 14
5.4.7 Establishing communication and consultation . 14
5.5 Implementation . 15
5.6 Evaluation . 15
5.7 Improvement . 15
6 RISK MANAGEMENT PROCESS . 15
6.1 Generic requirements. 15
6.1.1 General . 15
6.1.2 RISK ANALYSIS . 16
6.1.3 RISK EVALUATION . 18
6.1.4 RISK CONTROL . 19
6.2 Lifecycle specific requirements . 21
6.2.1 General . 21
6.2.2 Acquisition . 21
6.2.3 Installation, customization and configuration . 22
6.2.4 Integration, data migration, transition and validation . 22
6.2.5 Implementation, workflow optimization and training . 22
6.2.6 Operation and maintenance . 23
6.2.7 Decommission . 24
Annex A (informative) IEC 80001-1 requirements mapping table . 25
Annex B (informative) Guidance for accompanying document Information . 31
B.1 Foreword . 31
B.2 Information system categorization . 32
B.3 Overview. 32
B.4 Reference documents . 32
B.5 System level description . 32
B.5.1 Environment description . 32
B.5.2 Network ports, protocols and services . 33
B.5.3 Purpose of connection to the health IT infrastructure . 33

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B.5.4 Networking requirements . 33
B.5.5 Required IT-network services . 33
B.5.6 Data flows and protocols . 33
B.6 Security and user access . 34
B.6.1 General . 34
B.6.2 Malware / antivirus / allow-list . 34
B.6.3 Security exclusions . 34
B.6.4 System access . 34
B.7 RISK MANAGEMENT . 36
Bibliography . 37

Figure 1 – Lifecycle framework addressing safety, effectiveness and security of health
software and health IT systems . 8
Figure 2 – RISK MANAGEMENT PROCESS . 12

Table A.1 – IEC 80001-1 requirements table . 25
Table B.1 – Organization name and location . 31
Table B.2 – Cybersecurity device characterization level . 32
Table B.3 – Ports, protocols and services . 33
Table B.4 – Information system name and title . 34
Table B.5 – Roles and privileges . 35

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INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________

APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS
INCORPORATING MEDICAL DEVICES –

Part 1: Safety, effectiveness and security in the implementation and use
of connected medical devices or connected health software

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international
co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and
in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports,
Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their
preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with
may participate in this preparatory work. International, governmental and non-governmental organizations liaising
with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for
Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence between
any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent
rights. IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 80001-1 has been prepared by a Joint Working Group of
Subcommittee 62A: Common aspects of electrical equipment used in medical practice, of IEC
Technical Committee 62: Electrical equipment in medical practice, and of ISO Technical
Committee 215: Health informatics.
It is published as a double logo standard.
This second edition cancels and replaces the first edition published in 2010. This edition
constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous
edition:
a) structure changed to better align with ISO 31000;
b) establishment of requirements for an ORGANIZATION in the application of RISK MANAGEMENT;

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c) communication of the value, intention and purpose of RISK MANAGEMENT through principles
that support preservation of the KEY PROPERTIES during the implementation and use of
connected HEALTH SOFTWARE and/or HEALTH IT SYSTEMS.
The text of this document is based on the following documents:
FDIS Report on voting
62A/1434/FDIS 62A/1448/RVD

Full information on the voting for the approval of this document can be found in the report on
voting indicated in the above table.
This document has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this document, the following print types are used:
• requirements and definitions: roman type;
• test specifications: italic type;
• informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smaller type;
• TERMS DEFINED IN CLAUSE 3 OF THIS DOCUMENT OR AS NOTED ARE PRINTED IN SMALL CAPITALS.
In referring to the structure of this document, the term
• “clause” means one of the five numbered divisions within the table of contents, inclusive of
all subdivisions (e.g. Clause 5 includes subclauses 5.1, 5.2, etc.);
• “subclause” means a numbered subdivision of a clause (e.g. 5.1, 5.2 and 5.3 are all
subclauses of Clause 5).
References to clauses within this document are preceded by the term “Clause” followed by the
clause number. References to subclauses within this particular standard are by number only.
In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this document conform to usage described in Clause 7 of the ISO/IEC
Directives, Part 2. For the purposes of this document, the auxiliary verb:
• “shall” means that compliance with a requirement or a test is mandatory for compliance with
this document;
• “should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this document;
• “may” is used to describe a permissible way to achieve compliance with a requirement or
test.
A list of all parts of the IEC 80001 series, published under the general title Safety, effectiveness
and security in the implementation and use of connected medical devices or connected health
software, can be found on the IEC website.
Future standards in this series will carry the new general title as cited above. Titles of existing
standards in this series will be updated at the time of the next edition.

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The committee has decided that the contents of this standard will remain unchanged until the
stability date indicated on the IEC website under "https://webstore.iec.ch" in the data related to
the specific standard. At this date, the standard will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.

IMPORTANT – The "colour inside" logo on the cover page of this document indicates
that it contains colours which are considered to be useful for the correct understanding
of its contents. Users should therefore print this document using a colour printer.

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INTRODUCTION
HEALTHCARE DELIVERY ORGANIZATIONS rely on safe, effective and secure systems as business-
critical factors. However, ineffective management of the implementation and use of connected
systems can threaten the ability to deliver health services.
Connected systems that deliver health services, generally involve multiple software
applications, various medical devices and complex HEALTH IT SYSTEMS that rely upon shared
infrastructure including wired or wireless networks, point to point connections, application
servers and data storage, interface engines, security and performance management software,
etc. These HEALTH IT INFRASTRUCTURES are often used for both clinical (e.g. patient monitoring
systems) and non-clinical organizational functions (e.g. accounting, scheduling, social
networking, multimedia, file sharing). These connected systems can involve small departmental
networks to large integrated infrastructures spanning multiple locations as well as cloud-based
services operated by third parties. The requirements in this document are intended for multiple
stakeholders involved in the application of RISK MANAGEMENT to systems that include HEALTH IT
SYSTEMS and / or HEALTH IT INFRASTRUCTURE.
Within the context of ISO 81001-1, this document covers the generic lifecycle phase
“implementation and clinical use” (see the lifecycle diagram in Figure 1).

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Figure 1 – Lifecycle framework addressing safety, effectiveness and security
of health software and health IT systems
ORGANIZATIONS in using or adapting existing work practices and
This document facilitates
processes, personnel and tools wherever practicable to address the requirements of this
document. For example, if an organization has an existing RISK MANAGEMENT PROCESS, this can
be used or adapted to support the three KEY PROPERTIES of SAFETY, EFFECTIVENESS, and
SECURITY. Requirements are defined such that they can be evaluated and as such support an
ORGANIZATION in verifying and demonstrating the degree of compliance with this document.
RISK MANAGEMENT requirements of this document are based upon existing concepts adapted
The
and extended for use by all stakeholders supporting implementation and clinical use of
connected HEALTH SOFTWARE and HEALTH IT SYSTEMS (including medical devices). This
document aligns with ISO 81001-1, ISO/IEC Guide 63, IEC Guide 120.

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APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS
INCORPORATING MEDICAL DEVICES –

Part 1: Safety, effectiveness and security in the implementation and use
of connected medical devices or connected health software




1 Scope
This document specifies general requirements for ORGANIZATIONS in the application of RISK
MANAGEMENT before, during and after the connection of a HEALTH IT SYSTEM within a HEALTH IT
INFRASTRUCTURE, by addressing the KEY PROPERTIES of SAFETY, EFFECTIVENESS and SECURITY
whilst engaging appropriate stakeholders.
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:
• IEC Electropedia: available at https://www.electropedia.org/
• ISO Online browsing platform: available at https://www.iso.org/obp
NOTE For the purpose of this document, the terms and definitions given in ISO 81001-1:20XX and the following
apply.
3.1
CONSEQUENCE
outcome of an event affecting objectives
Note 1 to entry: A CONSEQUENCE can be certain or uncertain and can have positive or negative direct or indirect
effects on objectives.
Note 2 to entry: CONSEQUENCES can be expressed qualitatively or quantitatively.
Note 3 to entry: Any CONSEQUENCE can escalate through cascading and cumulative effects.
[SOURCE:ISO 31000:2018, 3.6]
3.2
HEALTHCARE
care activities, services, management or supplies related to the health of an individual or
population
Note 1 to entry: This includes more than performing procedures for subjects of care. It includes, for example, the
management of information about patients, health status and relations within the HEALTHCARE delivery framework
and may also include the management of clinical knowledge.
[SOURCE: ISO 13940:2015, 3.1.1, modified – The definition was reworded to include
population.]

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3.3
INCIDENT
unplanned interruption to a service a reduction in the quality of a service or an event that has
not yet impacted the service to the customer or user
[SOURCE: ISO/IEC 20000-1:2018, 3.2.5]
3.4
INITIAL RISK
RISK derived during risk estimation taking into consideration any retained RISK control measures
[SOURCE: ISO/IEC/IEEE 15026-1:2019, 3.3.3, modified – The definition was reworded.]
3.5
LIKELIHOOD
chance of something happening
Note 1 to entry: In risk management terminology, the word “LIKELIHOOD” is used to refer to the chance of something
happening, whether defined, measured or determined objectively or subjectively, qualitatively or quantitatively, and
described using general terms or mathematically (such as a probability or a frequency over a given time period).
Note 2 to entry: The English term “LIKELIHOOD” does not have a direct equivalent in some languages; instead, the
equivalent of the term “probability” is often used. However, in English, “probability” is often narrowly interpreted as
a mathematical term. Therefore, in risk management terminology, “LIKELIHOOD” is used with the intent that it should
have the same broad interpretation as the term “probability” has in many languages other than English.
[SOURCE: ISO 31000:2018, 3.7]
3.6
PROCESS
set of interrelated or interacting activities that use inputs to deliver an intended result
Note 1 to entry: The term “activities” covers use of resources.
[SOURCE: IEC 81001-1:2021, 3.2.10]
3.7
HEALTH IT RISK MANAGER
person accountable for risk management of a HEALTH IT SYSTEM
3.8
RISK MANAGEMENT PLAN
description of how the elements and resources of the risk management PROCESS will be
implemented within an organization or project
[SOURCE: ISO/IEC/IEEE 24765:2017, 3.3529]
4 Principles
The following principles provide the basis for RISK MANAGEMENT. They communicate the value,
intention and purpose of RISK MANAGEMENT and their application supports the preservation of
the KEY PROPERTIES during the implementation and use of HEALTH IT SYSTEMS within a HEALTH IT
INFRASTRUCTURE:
– RISK MANAGEMENT is an integral part of an ORGANIZATION’S activities at all stages of the
HEALTH IT SYSTEM lifecycle;
– accountability for the RISK MANAGEMENT PROCESS remains with the HEALTHCARE DELIVERY
ORGANIZATION;

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– a HEALTHCA
...