SIST EN ISO/IEEE 11073-40102:2022

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.

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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

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oSIST prEN ISO/IEEE 11073-40102:2021
ISO/IEEE FDIS 11073-40102:2021(E)

COPYRIGHT PROTECTED DOCUMENT
© IEEE 2021
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Published in Switzerland
ii © IEEE 2021 – All rights reserved

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oSIST prEN ISO/IEEE 11073-40102:2021
ISO/IEEE 11073-40102:2021(E)
Foreword
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ISO/IEEE 11073-40102 was prepared by the IEEE 11073 Standards Committee of the IEEE Engineering
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© IEEE 2021 – All rights reserved iii

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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

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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



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Copyright © 2021 by The Institute of Electrical and Electronics Engineers, Inc.
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oSIST prEN ISO/IEEE 11073-40102:2021
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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
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oSIST prEN ISO/IEEE 11073-40102:2021
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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

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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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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,
1
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
...