SIST EN ISO/IEEE 11073-40102:2022
(Main)Health informatics - Device interoperability - Part 40102: Foundational - Cybersecurity - Capabilities for mitigation (ISO/IEEE 11073-40102:2022)
Health informatics - Device interoperability - Part 40102: Foundational - Cybersecurity - Capabilities for mitigation (ISO/IEEE 11073-40102:2022)
Within the context of secure plug-and-play interoperability, cybersecurity is the process and capability of
preventing unauthorized access or modification, misuse, denial of use, or the unauthorized use of information that is stored on, accessed from, or transferred to and from a PHD/PoCD. The capability part of cybersecurity is information security controls related to both digital data and the relationships to safety and usability. For PHDs/PoCDs, this standard defines a security baseline of application layer cybersecurity mitigation techniques for certain use cases or for times when certain criteria are met. This standard provides a scalable information security toolbox appropriate for PHD/PoCD interfaces, which fulfills the intersection of requirements and recommendations from National Institute of Standards and Technology (NIST) and the European Network and Information Security Agency (ENISA). This standard maps to the NIST cybersecurity framework [B15]; IEC TR 80001-2-2 [B8]; and the Spoofing, Tampering, Repudiation, Information Disclosure, Denial of Service, and Elevation of Privilege (STRIDE) classification scheme. The mitigation techniques are based on the extended CIA triad (Clause 4) and are described generally to allow manufacturers to determine the most appropriate algorithms and implementations.
Medizinische Informatik - Geräteinteroperabilität - Teil 40102: Grundlagen - Cybersicherheit - Möglichkeiten zur Schadensbegrenzung (ISO/IEEE 11073-40102:2022)
Informatique de santé - Interopérabilité des dispositifs - Partie 40102: Fondamentaux - Cybersécurité - Capacités d'atténuation (ISO/IEEE 11073-40102:2022)
Dans le contexte de l'interopérabilité sécurisée de type prêt à l'emploi, la cybersécurité est le processus et la capacité d'empêcher l'accès ou la modification non autorisés, l'utilisation abusive, le déni d'utilisation ou l'utilisation non autorisée des informations qui sont stockées sur un PHD/PoCD, accessibles depuis celui-ci ou transférées vers et depuis celui-ci. La partie capacité de la cybersécurité est constituée de contrôles de sécurité de l'information liés à la fois aux données numériques et aux relations avec la sûreté et l'utilisabilité.
Pour les PHD/PoCD, la présente norme définit un référentiel de sécurité pour les techniques d'atténuation en matière de cybersécurité de la couche d'application pour certains cas d'utilisation ou pour les cas où certains critères sont remplis. La présente norme fournit une boîte à outils évolutive pour la sécurité de l'information, adaptée aux interfaces PHD/PoCD, qui répond à l'intersection des exigences et des recommandations du National Institute of Standards and Technology (NIST) et de l'Agence européenne chargée de la sécurité des réseaux et de l'information (ENISA). La présente norme met en correspondance le Référentiel de sécurité informatique du NIST [B15], l'IEC TR 80001-2-2 [B8] et le schéma de classification STRIDE (usurpation d'identité, falsification, répudiation, divulgation d'informations, déni de service, élévation du privilège). Les techniques d'atténuation sont fondées sur la triade CID étendue (Article 4) et sont décrites de manière générale afin de permettre aux fabricants de déterminer les algorithmes et les mises en œuvre les plus appropriés.
Zdravstvena informatika - Interoperabilnost naprav - 40102. del: Temeljno - Kibernetska varnost - Sposobnosti za ublažitev (ISO/IEEE 11073-40102:2022)
V okviru varne interoperabilnosti s takojšnjim učinkom (»vstavi in poženi«) je kibernetska varnost postopek in zmožnost
preprečevanja nepooblaščenega dostopa ali spreminjanja, zlorabe, zavrnitve uporabe ali nepooblaščene uporabe informacij, ki so shranjene ali dostopne v osebnih zdravstvenih napravah/napravah na mestu oskrbe (PHD/PoCD) ali prenesene vanje ter iz njih. Zmožnost pri kibernetski varnosti so kontrole informacijske varnosti v zvezi z digitalnimi podatki in razmerji do varnosti in uporabnosti. Za osebne zdravstvene naprave/naprave na mestu oskrbe ta standard določa varnostno osnovo za tehnike blažitve za kibernetsko varnost na namenski ravni programov za določene primere uporabe ali primere, ko so izpolnjena določena merila. Ta standard zagotavlja nadgradljiv komplet orodij za informacijsko varnost, ki je primeren za vmesnike osebnih zdravstvenih naprav/naprav na mestu oskrbe ter izpolnjuje skupne zahteve in priporočila Nacionalnega inštituta za standarde in tehnologijo (NIST) ter Evropske agencije za varnost omrežij in informacij (ENISA). Ta standard se uporablja vzporedno z okvirjem kibernetske varnosti NIST [B15]; standardom IEC TR 80001-2-2 [B8]; in razvrstitveno shemo STRIDE (Spoofing (slepljenje), Tampering (nedovoljeno spreminjanje), Repudiation (zavrnitev), Information Disclosure (razkritje podatkov), Denial of Service (zavrnitev storitve) in Elevation of Privilege (prisvojitev pravic)). Tehnike blažitve temeljijo na razširjeni triadi CIA (zaupnost, neokrnjenost, razpoložljivost, ang. confidentiality, integrity, availability) (točka 4) in so opisane na splošno, da lahko proizvajalci določijo najprimernejše algoritme in izvedbe.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO/IEEE 11073-40102:2022
01-julij-2022
Zdravstvena informatika - Interoperabilnost naprav - 40102. del: Temeljno -
Kibernetska varnost - Sposobnosti za ublažitev (ISO/IEEE 11073-40102:2022)
Health informatics - Device interoperability - Part 40102: Foundational - Cybersecurity -
Capabilities for mitigation (ISO/IEEE 11073-40102:2022)
Informatique de santé - Interopérabilité des dispositifs - Partie 40102: Fondamentaux -
Cybersécurité - Capacités d'atténuation (ISO/IEEE 11073-40102:2022)
Ta slovenski standard je istoveten z: EN ISO/IEEE 11073-40102:2022
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN ISO/IEEE 11073-40102:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO/IEEE 11073-40102:2022
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SIST EN ISO/IEEE 11073-40102:2022
EN ISO/IEEE 11073-
EUROPEAN STANDARD
40102
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2022
ICS 35.240.80
English Version
Health informatics - Device interoperability - Part 40102:
Foundational - Cybersecurity - Capabilities for mitigation
(ISO/IEEE 11073-40102:2022)
Informatique de santé - Interopérabilité des dispositifs Medizinische Informatik - Geräteinteroperabilität - Teil
- Partie 40102: Fondamentaux - Cybersécurité - 40102: Grundlagen - Cybersicherheit - Möglichkeiten
Capacités d'atténuation (ISO/IEEE 11073-40102:2022) zur Schadensbegrenzung (ISO/IEEE 11073-
40102:2022)
This European Standard was approved by CEN on 13 March 2022.
CEN 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 CEN
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 CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO/IEEE 11073-40102:2022 E
worldwide for CEN national Members.
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SIST EN ISO/IEEE 11073-40102:2022
EN ISO/IEEE 11073-40102:2022 (E)
Contents Page
European foreword . 3
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SIST EN ISO/IEEE 11073-40102:2022
EN ISO/IEEE 11073-40102:2022 (E)
European foreword
This document (EN ISO/IEEE 11073-40102:2022) has been prepared by Technical Committee ISO/TC
215 "Health informatics" in collaboration with Technical Committee CEN/TC 251 “Health informatics”
the secretariat of which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by September 2022, and conflicting national standards
shall be withdrawn at the latest by September 2022.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN 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 standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO/IEEE 11073-40102:2022 has been approved by CEN as EN ISO/IEEE 11073-
40102:2022 without any modification.
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SIST EN ISO/IEEE 11073-40102:2022
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SIST EN ISO/IEEE 11073-40102:2022
INTERNATIONAL ISO/IEEE
STANDARD 11073-40102
First edition
2022-03
Health informatics — Device
interoperability —
Part 40102:
Foundational — Cybersecurity —
Capabilities for mitigation
Informatique de santé — Interopérabilité des dispositifs —
Partie 40102: Fondamentaux — Cybersécurité — Capacités
d'atténuation
Reference number
ISO/IEEE 11073-40102:2022(E)
© IEEE 2021
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SIST EN ISO/IEEE 11073-40102:2022
ISO/IEEE 11073-40102:2022(E)
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Published in Switzerland
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© IEEE 2021 – All rights reserved
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SIST EN ISO/IEEE 11073-40102:2022
ISO/IEEE 11073-40102:2022(E) )
Foreword
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© IEEE 2021 – All rights reserved iii
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SIST EN ISO/IEEE 11073-40102:2022
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SIST EN ISO/IEEE 11073-40102:2022
IEEE Std 11073-40102™-2020
Health informatics—Device interoperability
Part 40102:
Foundational—Cybersecurity—
Capabilities for mitigation
Developed by the
IEEE 11073 Standards Committee
of the
IEEE Engineering in Medicine and Biology Society
Approved 24 September 2020
IEEE SA Standards Board
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SIST EN ISO/IEEE 11073-40102:2022
ISO/IEEE 11073-40102:2022(E)
Abstract: For Personal Health Devices (PHDs) and Point-of-Care Devices (PoCDs), a security
baseline of application layer cybersecurity mitigation techniques is defined by this standard for
certain use cases or for times when certain criteria are met. The mitigation techniques are based
on an extended confidentiality, integrity, and availability (CIA) triad and are described generally to
allow manufacturers to determine the most appropriate algorithms and implementations. A scalable
information security toolbox appropriate for PHD/PoCD interfaces is specified that fulfills the
intersection of requirements and recommendations from the National Institute of Standards and
Technology (NIST) and the European Network and Information Security Agency (ENISA). A
mapping of this standard to the NIST cybersecurity framework; IEC TR 80001-2-2; and the
Spoofing, Tampering, Repudiation, Information Disclosure, Denial of Service, and Elevation of
Privilege (STRIDE) classification scheme is defined.
Keywords: cybersecurity, IEEE 11073-40102™, medical device communication, mitigation
techniques, Personal Health Devices, Point-of-Care Devices
The Institute of Electrical and Electronics Engineers, Inc.
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Copyright © 2021 by The Institute of Electrical and Electronics Engineers, Inc.
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PDF: ISBN 978-1-5044-7088-9 STD24424
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SIST EN ISO/IEEE 11073-40102:2022
ISO/IEEE 11073-40102:2022(E)
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SIST EN ISO/IEEE 11073-40102:2022
ISO/IEEE 11073-40102:2022(E)
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SIST EN ISO/IEEE 11073-40102:2022
ISO/IEEE 11073-40102:2022(E)
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SIST EN ISO/IEEE 11073-40102:2022
ISO/IEEE 11073-40102:2022(E)
Participants
At the time this standard was submitted to the IEEE SA Standards Board for approval, the Public Health
Device Working Group had the following membership:
Daidi Zhong, Chair
Michael Kirwan and Christoph Fischer, Vice Chairs
Karsten Aalders Cory Condek Shu Han
Charles R. Abbruscato Todd H. Cooper Nathaniel Hamming
Nabil Abujbara David Cornejo Rickey L. Hampton
Maher Abuzaid Douglas Coup Sten Hanke
James Agnew Nigel Cox Aki Harma
Manfred Aigner Hans Crommenacker Jordan Hartmann
Jorge Alberola Tomio Crosley Kai Hassing
David Aparisi Allen Curtis Avi Hauser
Lawrence Arne Jesús Daniel Trigo Wolfgang Heck
Diego B. Arquillo Nathaniel Heintzman
David Davenport
Serafin Arroyo Russell Davis Charles Henderson
Muhammad Asim Sushil K. Deka Jun-Ho Her
Kit August Ciro de la Vega Helen B. Hernandez
Doug Baird Pedro de-las-Heras-Quiros Timothy L. Hirou
David Baker Jim Dello Stritto Allen Hobbs
Anindya Bakshi Kent Dicks Alex Holland
Abira Balanadarasan Hyoungho Do Arto Holopainen
Ananth Balasubramanian Jonathan Dougherty Kris Holtzclaw
Sunlee Bang Xiaolian Duan Robert Hoy
M. Jonathan Barkley Sourav Dutta Anne Huang
Gilberto Barrón Jakob Ehrensvard Zhiyong Huang
David Bean Fredrik Einberg Ron Huby
John Bell Javier Escayola Calvo David Hughes
Olivia Bellamou-Huet Mark Estes Robert D. Hughes
Rudy Belliardi Leonardo Estevez Jiyoung Huh
Daniel Bernstein Bosco T. Fernandes Hugh Hunter
George A. Bertos Morten Flintrup Philip O. Isaacson
Chris Biernacki Joseph W. Forler Atsushi Ito
Ola Björsne Russell Foster Michael Jaffe
Thomas Blackadar Eric Freudenthal Praduman Jain
Thomas Bluethner Matthias Frohner Hu Jin
Douglas P. Bogia Ken Fuchs Danny Jochelson
Xavier Boniface Jing Gao Akiyoshi Kabe
Shannon Boucousis Marcus Garbe Steve Kahle
Julius Broma John Garguilo Tomio Kamioka
Lyle G. Bullock, Jr. Liang Ge James J. Kang
Bernard Burg Rick Geimer Kei Kariya
Chris Burns Igor Gejdos Andy Kaschl
Jeremy Byford-Rew Ferenc Gerbovics Junzo Kashihara
Satya Calloji Alan Godfrey Colin Kennedy
Carole C. Carey Nicolae Goga Ralph Kent
Craig Carlson Julian Goldman Laurie M. Kermes
Santiago Carot-Nemesio Raul Gonzalez Gomez Ahmad Kheirandish
Randy W. Carroll Chris Gough Junhyung Kim
Seungchul Chae Channa Gowda Minho Kim
Peggy Chien Charles M. Gropper Min-Joon Kim
David Chiu Amit Gupta Taekon Kim
Jinyong Choi Jeff Guttmacher Tetsuya Kimura
Chia-Chin Chong Rasmus Haahr Alfred Kloos
Saeed A. Choudhary Christian Habermann Jeongmee Koh
Jinhan Chung Michael Hagerty Jean-Marc Koller
John A. Cogan Jerry Hahn John Koon
John T. Collins Robert Hall Patty Krantz
6
Copyright © 2021 IEEE. All rights reserved.
---------------------- Page: 16 ----------------------
SIST EN ISO/IEEE 11073-40102:2022
ISO/IEEE 11073-40102:2022(E)
Raymond Krasinski Carl Pantiskas Raymond A. Strickland
Alexander Kraus Harry P. Pappas Chandrasekaran Subramaniam
Ramesh Krishna Hanna Park Hermanni Suominen
Geoffrey Kruse Jong-Tae Park Lee Surprenant
Falko Kuester Myungeun Park Ravi Swami
Rafael Lajara Soojun Park Ray Sweidan
Pierre Landau Phillip E. Pash Na Tang
Jaechul Lee TongBi Pei Haruyuyki Tatsumi
JongMuk Lee Soren Petersen Isabel Tejero
Kyong Ho Lee James Petisce Tom Thompson
Rami Lee Peter Piction Jonas Tirén
Sungkee Lee Michael Pliskin Janet Traub
Woojae Lee Varshney Prabodh Gary Tschautscher
Qiong Li Jeff Price Masato Tsuchid
Xiangchen Li Harald Prinzhorn Ken Tubman
Zhuofang Li Harry Qiu Akib Uddin
Patrick Lichter Tanzilur Rahman Sunil Unadkat
Jisoon Lim Phillip Raymond Fabio Urbani
Joon-Ho Lim Terrie Reed Philipp Urbauer
Xiaoming Liu Barry Reinhold Laura Vanzago
Wei-Jung Lo Brian Reinhold Alpo Värri
Charles Lowe Melvin I. Reynolds Andrei Vasilateanu
Don Ludolph John G. Rhoads Dalimar Velez
Christian Luszick Jeffrey S. Robbins Martha Velezis
Bob MacWilliams Chris Roberts Rudi Voon
Srikkanth Madhurbootheswaran Stefan Robert Barry Vornbrock
Miriam L. Makhlouf Scott M. Robertson Isobel Walker
Romain Marmot Timothy Robertson David Wang
Sandra Martinez David Rosales Linling Wang
Miguel Martínez de Bill Saltzstein Jerry P. Wang
Espronceda Cámara Giovanna Sannino Yao Wang
Peter Mayhew Jose A. Santos-Cadenas Yi Wang
Jim McCain Stefan Sauermann Steve Warren
László Meleg John Sawyer Fujio Watanabe
Alexander Mense Alois Schloegl Toru Watsuji
Behnaz Minaei Paul S. Schluter David Weissman
Jinsei Miyazaki Mark G. Schnell Kathleen Wible
Erik Moll Richard A. Schrenker Paul Williamson
Darr Moore Antonio Scorpiniti Jan Wittenber
Chris Morel KwangSeok Seo Jia-Rong Wu
Robert Moskowitz Riccardo Serafin Will Wykeham
Carsten Mueglitz Sid Shaw Ariton Xhafa
Soundharya Nagasubramanian Frank Shen Ricky Yang
Alex Neefus Min Shih Melanie S. Yeung
Trong-Nghia Nguyen-Dobinsky Mazen Shihabi Qiang Yin
Michael E. Nidd Redmond Shouldice Done-Sik Yoo
Jim Niswander Sternly K. Simon Zhi Yu
Hiroaki Niwamoto Marjorie Skubic Jianchao Zeng
Thomas Norgall Robert Smith Jason Zhang
Yoshiteru Nozoe Ivan Soh Jie Zhao
Abraham Ofek Motoki Sone Thomas Zhao
Brett Olive Emily Sopensky Yuanhong Zhong
Begonya Otal Rajagopalan Srinivasan Qing Zhou
Marco Paleari Nicholas Steblay Miha Zoubek
Bud Panjwani Lars Steubesand Szymon Zyskoter
John (Ivo) Stivoric
7
Copyright © 2021 IEEE. All rights reserved.
---------------------- Page: 17 ----------------------
SIST EN
...
SLOVENSKI STANDARD
oSIST prEN ISO/IEEE 11073-40102:2021
01-november-2021
Zdravstvena informatika - Interoperabilnost naprav - 40102. del: Temeljno -
Kibernetska varnost - Sposobnosti za ublažitev (ISO/IEEE FDIS 11073-40102:2021)
Health informatics - Device interoperability - Part 40102: Foundational - Cybersecurity -
Capabilities for mitigation (ISO/IEEE FDIS 11073-40102:2021)
(ISO/IEEE FDIS 11073-40102:2021)
Informatique de santé - Interopérabilité des dispositifs - Partie 40102: Fondamentaux -
Cybersécurité - Capacités d'atténuation (ISO/IEEE FDIS 11073-40102:2021)
Ta slovenski standard je istoveten z: prEN ISO/IEEE 11073-40102
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
oSIST prEN ISO/IEEE 11073-40102:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
oSIST prEN ISO/IEEE 11073-40102:2021
---------------------- Page: 2 ----------------------
oSIST prEN ISO/IEEE 11073-40102:2021
FINAL
INTERNATIONAL ISO/IEEE/
DRAFT
STANDARD FDIS
11073-40102
ISO/TC 215
Health informatics — Device
Secretariat: ANSI
interoperability —
Voting begins on:
2021-09-13
Part 40102:
Voting terminates on:
Foundational — Cybersecurity —
2022-01-31
Capabilities for mitigation
This document is circulated as received from the committee secretariat.
FAST TRACK PROCEDURE
ISO/CEN PARALLEL PROCESSING
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/IEEE FDIS 11073-40102:2021(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. IEEE 2021
---------------------- Page: 3 ----------------------
oSIST prEN ISO/IEEE 11073-40102:2021
ISO/IEEE FDIS 11073-40102:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© IEEE 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 IEEE at the address below.
Institute of Electrical and Electronics Engineers, Inc
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Email: stds.ipr@ieee.org
Website: www.ieee.org
Published in Switzerland
ii © IEEE 2021 – All rights reserved
---------------------- Page: 4 ----------------------
oSIST prEN ISO/IEEE 11073-40102:2021
ISO/IEEE 11073-40102:2021(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
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electrotechnical standardization.
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 ISO documents should be noted (see www.iso.org/directives).
IEEE Standards documents are developed within the IEEE Societies and the Standards Coordinating
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standards through a consensus development process, approved by the American National Standards
Institute, which brings together volunteers representing varied viewpoints and interests to achieve the
final product. Volunteers are not necessarily members of the Institute and serve without compensation.
While the IEEE administers the process and establishes rules to promote fairness in the consensus
development process, the IEEE does not independently evaluate, test, or verify the accuracy of any of the
information contained in its standards.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any
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ISO/IEEE 11073-40102 was prepared by the IEEE 11073 Standards Committee of the IEEE Engineering
in Medicine and Biology Society (as IEEE Std 11073-40102-2020) and drafted in accordance with its
editorial rules. It was adopted, under the “fast-track procedure” defined in the Partner Standards
Development Organization cooperation agreement between ISO and IEEE, by Technical Committee
ISO/TC 215, Health informatics.
A list of all parts in the ISO/IEEE 11073 series can be found on the ISO website.
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
© IEEE 2021 – All rights reserved iii
---------------------- Page: 5 ----------------------
oSIST prEN ISO/IEEE 11073-40102:2021
---------------------- Page: 6 ----------------------
oSIST prEN ISO/IEEE 11073-40102:2021
IEEE Std 11073-40102™-2020
Health informatics—Device interoperability
Part 40102:
Foundational—Cybersecurity—
Capabilities for mitigation
Developed by the
IEEE 11073 Standards Committee
of the
IEEE Engineering in Medicine and Biology Society
Approved 24 September 2020
IEEE SA Standards Board
---------------------- Page: 7 ----------------------
oSIST prEN ISO/IEEE 11073-40102:2021
ISO/IEEE FDIS 11073-40102:2021(E)
Abstract: For Personal Health Devices (PHDs) and Point-of-Care Devices (PoCDs), a security
baseline of application layer cybersecurity mitigation techniques is defined by this standard for
certain use cases or for times when certain criteria are met. The mitigation techniques are based
on an extended confidentiality, integrity, and availability (CIA) triad and are described generally to
allow manufacturers to determine the most appropriate algorithms and implementations. A scalable
information security toolbox appropriate for PHD/PoCD interfaces is specified that fulfills the
intersection of requirements and recommendations from the National Institute of Standards and
Technology (NIST) and the European Network and Information Security Agency (ENISA). A
mapping of this standard to the NIST cybersecurity framework; IEC TR 80001-2-2; and the
Spoofing, Tampering, Repudiation, Information Disclosure, Denial of Service, and Elevation of
Privilege (STRIDE) classification scheme is defined.
Keywords: cybersecurity, IEEE 11073-40102™, medical device communication, mitigation
techniques, Personal Health Devices, Point-of-Care Devices
The Institute of Electrical and Electronics Engineers, Inc.
3 Park Avenue, New York, NY 10016-5997, USA
Copyright © 2021 by The Institute of Electrical and Electronics Engineers, Inc.
All rights reserved. Published 8 January 2021. Printed in the United States of America.
IEEE is a registered trademark in the U.S. Patent & Trademark Office, owned by The Institute of Electrical and Electronics Engineers,
Incorporated.
PDF: ISBN 978-1-5044-7088-9 STD24424
Print: ISBN 978-1-5044-7089-6 STDPD24424
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No part of this publication may be reproduced in any form, in an electronic retrieval system or otherwise, without the prior written permission
of the publisher.
2
Copyright © 2021 IEEE. All rights reserved.
---------------------- Page: 8 ----------------------
oSIST prEN ISO/IEEE 11073-40102:2021
ISO/IEEE FDIS 11073-40102:2021(E)
Important Notices and Disclaimers Concerning IEEE Standards Documents
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3
Copyright © 2021 IEEE. All rights reserved.
---------------------- Page: 9 ----------------------
oSIST prEN ISO/IEEE 11073-40102:2021
ISO/IEEE FDIS 11073-40102:2021(E)
Official statements
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4
Copyright © 2021 IEEE. All rights reserved.
---------------------- Page: 10 ----------------------
oSIST prEN ISO/IEEE 11073-40102:2021
ISO/IEEE FDIS 11073-40102:2021(E)
Updating of IEEE Standards documents
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5
Copyright © 2021 IEEE. All rights reserved.
---------------------- Page: 11 ----------------------
oSIST prEN ISO/IEEE 11073-40102:2021
ISO/IEEE FDIS 11073-40102:2021(E)
Participants
At the time this standard was submitted to the IEEE SA Standards Board for approval, the Public Health
Device Working Group had the following membership:
Daidi Zhong, Chair
Michael Kirwan and Christoph Fischer, Vice Chairs
Karsten Aalders Cory Condek Shu Han
Charles R. Abbruscato Todd H. Cooper Nathaniel Hamming
Nabil Abujbara David Cornejo Rickey L. Hampton
Maher Abuzaid Douglas Coup Sten Hanke
James Agnew Nigel Cox Aki Harma
Manfred Aigner Hans Crommenacker Jordan Hartmann
Jorge Alberola Tomio Crosley Kai Hassing
David Aparisi Allen Curtis Avi Hauser
Lawrence Arne Jesús Daniel Trigo Wolfgang Heck
Diego B. Arquillo Nathaniel Heintzman
David Davenport
Serafin Arroyo Russell Davis Charles Henderson
Muhammad Asim Sushil K. Deka Jun-Ho Her
Kit August Ciro de la Vega Helen B. Hernandez
Doug Baird Pedro de-las-Heras-Quiros Timothy L. Hirou
David Baker Jim Dello Stritto Allen Hobbs
Anindya Bakshi Kent Dicks Alex Holland
Abira Balanadarasan Hyoungho Do Arto Holopainen
Ananth Balasubramanian Jonathan Dougherty Kris Holtzclaw
Sunlee Bang Xiaolian Duan Robert Hoy
M. Jonathan Barkley Sourav Dutta Anne Huang
Gilberto Barrón Jakob Ehrensvard Zhiyong Huang
David Bean Fredrik Einberg Ron Huby
John Bell Javier Escayola Calvo David Hughes
Olivia Bellamou-Huet Mark Estes Robert D. Hughes
Rudy Belliardi Leonardo Estevez Jiyoung Huh
Daniel Bernstein Bosco T. Fernandes Hugh Hunter
George A. Bertos Morten Flintrup Philip O. Isaacson
Chris Biernacki Joseph W. Forler Atsushi Ito
Ola Björsne Russell Foster Michael Jaffe
Thomas Blackadar Eric Freudenthal Praduman Jain
Thomas Bluethner Matthias Frohner Hu Jin
Douglas P. Bogia Ken Fuchs Danny Jochelson
Xavier Boniface Jing Gao Akiyoshi Kabe
Shannon Boucousis Marcus Garbe Steve Kahle
Julius Broma John Garguilo Tomio Kamioka
Lyle G. Bullock, Jr. Liang Ge James J. Kang
Bernard Burg Rick Geimer Kei Kariya
Chris Burns Igor Gejdos Andy Kaschl
Jeremy Byford-Rew Ferenc Gerbovics Junzo Kashihara
Satya Calloji Alan Godfrey Colin Kennedy
Carole C. Carey Nicolae Goga Ralph Kent
Craig Carlson Julian Goldman Laurie M. Kermes
Santiago Carot-Nemesio Raul Gonzalez Gomez Ahmad Kheirandish
Randy W. Carroll Chris Gough Junhyung Kim
Seungchul Chae Channa Gowda Minho Kim
Peggy Chien Charles M. Gropper Min-Joon Kim
David Chiu Amit Gupta Taekon Kim
Jinyong Choi Jeff Guttmacher Tetsuya Kimura
Chia-Chin Chong Rasmus Haahr Alfred Kloos
Saeed A. Choudhary Christian Habermann Jeongmee Koh
Jinhan Chung Michael Hagerty Jean-Marc Koller
John A. Cogan Jerry Hahn John Koon
John T. Collins Robert Hall Patty Krantz
6
Copyright © 2021 IEEE. All rights reserved.
---------------------- Page: 12 ----------------------
oSIST prEN ISO/IEEE 11073-40102:2021
ISO/IEEE FDIS 11073-40102:2021(E)
Raymond Krasinski Carl Pantiskas Raymond A. Strickland
Alexander Kraus Harry P. Pappas Chandrasekaran Subramaniam
Ramesh Krishna Hanna Park Hermanni Suominen
Geoffrey Kruse Jong-Tae Park Lee Surprenant
Falko Kuester Myungeun Park Ravi Swami
Rafael Lajara Soojun Park Ray Sweidan
Pierre Landau Phillip E. Pash Na Tang
Jaechul Lee TongBi Pei Haruyuyki Tatsumi
JongMuk Lee Soren Petersen Isabel Tejero
Kyong Ho Lee James Petisce Tom Thompson
Rami Lee Peter Piction Jonas Tirén
Sungkee Lee Michael Pliskin Janet Traub
Woojae Lee Varshney Prabodh Gary Tschautscher
Qiong Li Jeff Price Masato Tsuchid
Xiangchen Li Harald Prinzhorn Ken Tubman
Zhuofang Li Harry Qiu Akib Uddin
Patrick Lichter Tanzilur Rahman Sunil Unadkat
Jisoon Lim Phillip Raymond Fabio Urbani
Joon-Ho Lim Terrie Reed Philipp Urbauer
Xiaoming Liu Barry Reinhold Laura Vanzago
Wei-Jung Lo Brian Reinhold Alpo Värri
Charles Lowe Melvin I. Reynolds Andrei Vasilateanu
Don Ludolph John G. Rhoads Dalimar Velez
Christian Luszick Jeffrey S. Robbins Martha Velezis
Bob MacWilliams Chris Roberts Rudi Voon
Srikkanth Madhurbootheswaran Stefan Robert Barry Vornbrock
Miriam L. Makhlouf Scott M. Robertson Isobel Walker
Romain Marmot Timothy Robertson David Wang
Sandra Martinez David Rosales Linling Wang
Miguel Martínez de Bill Saltzstein Jerry P. Wang
Espronceda Cámara Giovanna Sannino Yao Wang
Peter Mayhew Jose A. Santos-Cadenas Yi Wang
Jim McCain Stefan Sauermann Steve Warren
László Meleg John Sawyer Fujio Watanabe
Alexander Mense Alois Schloegl Toru Watsuji
Behnaz Minaei Paul S. Schluter David Weissman
Jinsei Miyazaki Mark G. Schnell Kathleen Wible
Erik Moll Richard A. Schrenker Paul Williamson
Darr Moore Antonio Scorpiniti Jan Wittenber
Chris Morel KwangSeok Seo Jia-Rong Wu
Robert Moskowitz Riccardo Serafin Will Wykeham
Carsten Mueglitz Sid Shaw Ariton Xhafa
Soundharya Nagasubramanian Frank Shen Ricky Yang
Alex Neefus Min Shih Melanie S. Yeung
Trong-Nghia Nguyen-Dobinsky Mazen Shihabi Qiang Yin
Michael E. Nidd Redmond Shouldice Done-Sik Yoo
Jim Niswander Sternly K. Simon Zhi Yu
Hiroaki Niwamoto Marjorie Skubic Jianchao Zeng
Thomas Norgall Robert Smith Jason Zhang
Yoshiteru Nozoe Ivan Soh Jie Zhao
Abraham Ofek Motoki Sone Thomas Zhao
Brett Olive Emily Sopensky Yuanhong Zhong
Begonya Otal Rajagopalan Srinivasan Qing Zhou
Marco Paleari Nicholas Steblay Miha Zoubek
Bud Panjwani Lars Steubesand Szymon Zyskoter
John (Ivo) Stivoric
7
Copyright © 2021 IEEE. All rights reserved.
---------------------- Page: 13 ----------------------
oSIST prEN ISO/IEEE 11073-40102:2021
ISO/IEEE FDIS 11073-40102:2021(E)
The following members of the individual balloting group voted on this standard. Balloters may have voted
for approval, disapproval, or abstention.
Robert Aiello David Fuschi Bansi Patel
Johann Amsenga Randall Groves Beth Pumo
Bjoern Andersen Robert Heile Stefan Schlichting
Pradeep Balachandran Werner Hoelzl Thomas Starai
Demetrio Bucaneg, Jr. Raj Jain Mark-Rene Uchida
Lyle G. Bullock, Jr. Martin Kasparick John Vergis
Craig Carlson Stuart Kerry J. Wiley
Juan Carreon Yongbum Kim Yu Yuan
Pin Chang Raymond Krasinski Oren Yuen
Malcolm Clarke Javier Luiso Janusz Zalewski
Christoph Fischer H. Moll Daidi Zhong
Nick S. A. Nikjoo
When the IEEE SA Standards Board approved this standard on 24 September 2020, it had the following
membership:
Gary Hoffman, Chair
Jon Walter Rosdahl, Vice Chair
John D. Kulick, Past Chair
Konstantinos Karachalios, Secretary
Ted Burse David J. Law Mehmet Ulema
Doug Edwards Howard Li Lei Wang
J. Travis Griffith Dong Liu Sha Wei
Grace Gu Kevin Lu Philip B. Winston
Guido R. Hiertz Paul Nikolich Daidi Zhong
Joseph L. Koepfinger* Damir Novosel Jingyi Zhou
Dorothy Stanley
*Member Emeritus
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oSIST prEN ISO/IEEE 11073-40102:2021
ISO/IEEE FDIS 11073-40102:2021(E)
Introduction
This introduction is not part of IEEE Std 11073-40102-2020, Health informatics—Device interoperability—Part 40102:
Foundational—Cybersecurity—Capabilities for mitigation.
Users of Personal Health Devices (PHDs) and Point-of-Care Devices (PoCDs) have implicit expectations on
convenience, connectivity, accessibility, and security of data. For example, they expect to connect
PHDs/PoCDs to their mobile devices and dashboards, view the data in the cloud, and easily share the
information with clinicians or care providers. In some cases, the users themselves are taking action to build
connections between PHDs/PoCDs, mobile devices, and the cloud to create the desired system. While many
manufacturers are working on solving PHD/PoCD connectivity challenges with proprietary solutions, no
standardized approach exists to provide secure plug-and-play interoperability.
The ISO/IEEE 11073 PHDs/PoCDs family of standards, Bluetooth Special Interest Group profiles and
services specifications, and the Continua Design Guidelines (PCHAlliance [B20]) were developed to
specifically address plug-and-play interoperability of PHDs/PoCDs (e.g., physical activity monitor,
physiological monitor, pulse oximeter, sleep apnoea breathing therapy equipment, ventilator, insulin delivery
device, infusion pump, continuous glucose monitor). In this context, the following terms have specific
meanings:
Interoperability is the ability of client components to communicate and share data with service
components in an unambiguous and predictable manner as well as to understand and use the
information that is exchanged (PCHAlliance [B20]).
Plug and play are all the user has to do to make a connection—the systems automatically detect,
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configure, and communicate without any other human interaction (ISO/IEEE 11073-10201 [B13]).
Within the context of secure plug-and-play interoperability, cybersecurity is the process and capability of
preventing unauthorized access or modification, misuse, denial of use, or the unauthorized use of information
that is stored on, accessed from, or transferred to and f
...
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