ISO/IEEE 11073-20601:2022
(Main)Health informatics — Device interoperability — Part 20601: Personal health device communication — Application profile — Optimized exchange protocol
Health informatics — Device interoperability — Part 20601: Personal health device communication — Application profile — Optimized exchange protocol
Within the context of the ISO/IEEE 11073 personal health device standard family, this document defines an optimized exchange protocol and modeling techniques to be used by implementers of personal health devices to create interoperability between device types and vendors. This document establishes a common framework for an abstract model of personal health data available in transport-independent transfer syntax required to establish logical connections between systems and to provide presentation capabilities and services needed to perform communication tasks. The protocol is optimized to personal health usage requirements and leverages commonly used methods and tools wherever possible.
Informatique de santé —Interopérabilité des dispositifs — Partie 20601: Communication entre dispositifs de santé personnels — Profil d'application — Protocole d'échange optimisé
Dans le contexte de la famille de norme ISO/IEEE 11073 relative à la communication entre dispositifs, la présente norme définit un cadre commun pour mettre à disposition un modèle abstrait de données relatives à la santé personnelle dans une syntaxe de transfert indépendante du transport requise aux fins d'établir des connexions logiques entre systèmes et de fournir des capacités et des services de présentation nécessaires pour effectuer les tâches de communication. Le protocole est optimisé pour répondre aux exigences des utilisations relatives à la santé des personnes et s'appuie dans la mesure du possible sur des méthodes et des outils couramment utilisés.
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INTERNATIONAL ISO/IEEE
STANDARD 11073-20601
Third edition
2022-12
Health informatics — Device
interoperability —
Part 20601:
Personal health device communication
— Application profile — Optimized
exchange protocol
Informatique de santé — Interopérabilité des dispositifs —
Partie 20601: Communication entre dispositifs de santé personnels —
Profil d'application — Protocole d'échange optimisé
Reference number
ISO/IEEE 11073-20601:2022(E)
© IEEE 2019
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ISO/IEEE 11073-20601:2022(E)
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ISO/IEEE 11073-20601:2022(E)
Foreword
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ISO/IEEE 11073-20601 was prepared by the IEEE 11073 Standards Committee of the IEEE Engineering in
Medicine and Biology Society (as IEEE Std 11073-20601-2019) 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.
This third edition cancels and replaces the second edition (ISO/IEEE 11073-20601:2016), which has
been technically revised. It also incorporates the Technical Corrigendum ISO/IEEE 11073-
20601:2016/Cor 1:2016.
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 2019 – All rights reserved iii
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IEEE Std 11073-20601™-2019
(Revision of IEEE Std 11073-20601-2014)
Health informatics—Personal health device communication
Part 20601: Application profile—
Optimized Exchange Protocol
Developed by the
IEEE 11073™ Standards Committee
of the
IEEE Engineering in Medicine and Biology Society
Approved 5 September 2019
IEEE SA Standards Board
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ISO/IEEE 11073-20601:2022(E)
Abstract: Within the context of the ISO/IEEE 11073 family of standards for device
communication, a common framework for making an abstract model of personal health data
available in transport-independent transfer syntax required to establish logical connections
between systems and to provide presentation capabilities and services needed to perform
communication tasks is described in this standard. The protocol is optimized to personal health
usage requirements and leverages commonly used methods and tools wherever possible.
Keywords: IEEE 11073-20601™, medical device communication, personal health devices
•
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ISO/IEEE 11073-20601:2022(E)
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ISO/IEEE 11073-20601:2022(E)
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ISO/IEEE 11073-20601:2022(E)
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ISO/IEEE 11073-20601:2022(E)
Participants
At the time this standard was completed, the Personal Health Devices Working Group had the following
membership:
Daidi Zhong, Co-Chair
Michael J. Kirwan, Co-Chair
Karsten Aalders Wenjuan Chen Rick Geimer
Charles R. Abbruscato James Cheng Igor Gejdos
Nabil Abujbara Ferenc Gerbovics
Peggy Chien
Maher Abuzaid Alan Godfrey
David Chiu
James Agnew
Jinyong Choi Nicolae Goga
Haidar Ahmad Chia-Chin Chong Julian Goldman
Manfred Aigner Saeed A. Choudhary Raul Gonzalez Gomez
Jorge Alberola Jinhan Chung Chris Gough
Rolf Ambuehl John A. Cogan Channa Gowda
David Aparisi John T. Collins Charles M. Gropper
Lawrence Arne Cory Condek Amit Gupta
Diego B. Arquillo Todd H. Cooper Jeff Guttmacher
Serafin Arroyo David Cornejo Rasmus Haahr
Muhammad Asim Douglas Coup Christian Habermann
Kit August Nigel Cox Michael Hagerty
Doug Baird Hans Crommenacker Jerry Hahn
David Baker Tomio Crosley Robert Hall
Anindya Bakshi Allen Curtis Shu Han
Ananth Balasubramanian Eyal Dassau Nathaniel Hamming
Sunlee Bang Rickey L. Hampton
David Davenport
M. Jonathan Barkley
Russell Davis Sten Hanke
Gilberto Barrón Sushil K. Deka Aki Harma
David Bean Ciro de la Vega Jordan Hartmann
John Bell Pedro de-las-Heras-Quiros Kai Hassing
Rudy Belliardi Jim Dello Stritto Wolfgang Heck
Kathryn M. Bennett Matthew d’Entremont Nathaniel Heintzman
Daniel Bernstein Kent Dicks Charles Henderson
George A. Bertos Hyoungho Do Jun-Ho Her
Chris Biernacki Alistair Donaldson Helen B. Hernandez
Ola Björsne Xiaolian Duan Takashi Hibino
Thomas Blackadar Brian Dubreuil Timothy L. Hirou
Marc Blanchet Sourav Dutta Allen Hobbs
Thomas Bluethner Jakob Ehrensvard Alex Holland
Douglas P. Bogia Fredrik Einberg Arto Holopainen
Xavier Boniface Michihiro Enokida Kris Holtzclaw
Shannon Boucousis Javier Escayola Calvo Xinyi Hong
Julius Broma Mark Estes Robert Hoy
Leonardo Estevez
Lyle G. Bullock, Jr. Frank Hsu
Hailing Feng
Bernard Burg Anne Huang
Chris Burns Bosco T. Fernandes Sen-Der Huang
Anthony Butt Christoph Fischer Zhiyong Huang
Jeremy Byford-Rew Morten Flintrup Ron Huby
Satya Calloji Joseph W. Forler David Hughes
Xiaoying Cao Russell Foster Robert D. Hughes
Carole C. Carey Eric Freudenthal Jiyoung Huh
Craig Carlson Matthias Frohner Hugh Hunter
Santiago Carot-Nemesio Ken Fuchs Hitoshi Ikeda
Randy W. Carroll Jing Gao Yutaka Ikeda
Simon Carter Qi Gao Philip O. Isaacson
Seungchul Chae Marcus Garbe Atsushi Ito
Rahul Chauhan John Garguilo Michael Jaffe
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ISO/IEEE 11073-20601:2022(E)
Praduman Jain Jim McCain Jose A. Santos-Cadenas
Danny Jochelson Stefan Sauermann
László Meleg
Phaneeth Junga John Sawyer
Alexander Mense
Akiyoshi Kabe Behnaz Minaei Guillaume Schatz
Steve Kahle Jinsei Miyazaki Alois Schloegl
Tomio Kamioka Erik Moll Paul S. Schluter
James J. Kang Darr Moore Lars Schmitt
Kei Kariya Carsten Mueglitz Mark G. Schnell
Andy Kaschl Piotr Murawski Richard A. Schrenker
Junzo Kashihara Soundharya Nagasubramanian Antonio Scorpiniti
Kohichi Kashiwagi Jae-Wook Nah KwangSeok Seo
Ralph Kent Alex Neefus Riccardo Serafin
Laurie M. Kermes Trong-Nghia Nguyen-Dobinsky Sid Shaw
Ikuo Keshi Michael E. Nidd Frank Shen
Ahmad Kheirandish Jim Niswander Min Shih
Junhyung Kim Hongliang Niu Mazen Shihabi
Minho Kim Hiroaki Niwamoto Redmond Shouldice
Min-Joon Kim Sternly K. Simon
Thomas Norgall
Taekon Kim Marjorie Skubic
Anand Noubade
Tetsuya Kimura
Yoshiteru Nozoe Robert Smith
Alfred Kloos Abraham Ofek Ivan Soh
Jeongmee Koh Brett Olive Motoki Sone
Jean-Marc Koller Begonya Otal Emily Sopensky
John Koon Marco Paleari Rajagopalan Srinivasan
Patty Krantz Bud Panjwani Nicholas Steblay
Raymond Krasinski Carl Pantiskas Lars Steubesand
Alexander Kraus Harry P. Pappas John (Ivo) Stivoric
Ramesh Krishna Hanna Park Raymond A. Strickland
Geoffrey Kruse Jong-Tae Park Chandrasekaran Subramaniam
Falko Kuester Myungeun Park Hermanni Suominen
Rafael Lajara Soojun Park Lee Surprenant
Pierre Landau Phillip E. Pash Ravi Swami
Jaechul Lee TongBi Pei Ray Sweidan
JongMuk Lee Lucian Pestritu Yi Tang
Kyong Ho Lee Soren Petersen Haruyuyki Tatsumi
Rami Lee James Petisce
Isabel Tejero
Peter Piction
Sungkee Lee John W. Thomas
Michael Pliskin
Woojae Lee Tom Thompson
Yonghee Lee Varshney Prabodh Jonas Tirén
Joe Lenart Jeff Price Alexandra Todiruta
Kathryn A. Lesh Harald Prinzhorn Janet Traub
Qiong Li Harry Qiu Jesús Daniel Trigo
Xiangchen Li Arif Rahman Gary Tschautscher
Yingsong Li Tanzilur Rahman Masato Tsuchid
Zhuofang Li Steve Ray Ken Tubman
Patrick Lichter Phillip Raymond Yoshihiro Uchida
Jisoon Lim Terrie Reed Akib Uddin
Joon-Ho Lim Tim Reilly Sunil Unadkat
John Lin Barry Reinhold Fabio Urbani
Xiaoming Liu Brian Reinhold Philipp Urbauer
Wei-Jung Lo Melvin I. Reynolds Laura Vanzago
Charles Lowe John G. Rhoads
Alpo Värri
Jeffrey S. Robbins
Don Ludolph Andrei Vasilateanu
Chris Roberts
Christian Luszick Dalimar Velez
Bob MacWilliams Moskowitz Robert Martha Velezis
Srikkanth Madhurbootheswaran Scott M. Robertson Rudi Voon
Miriam L. Makhlouf Timothy Robertson Barry Vornbrock
Romain Marmot Patricia Order Isobel Walker
Sandra Martinez David Rosales David Wang
Miguel Martínez de Espronceda Fatemeh Saki Jerry P. Wang
Cámara Bill Saltzstein Yao Wang
Peter Mayhew Giovanna Sannino Yi Wang
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ISO/IEEE 11073-20601:2022(E)
Steve Warren Jia-Rong Wu Zhi Yu
Fujio Watanabe Will Wykeham Jianchao Zeng
Toru Watsuji Ariton Xhafa Jason Zhang
Mike Weng Ricky Yang Zhiqiang Zhang
Yuefeng Weng Shaoqin Ye Thomas Zhao
Kathleen Wible Melanie S. Yeung Hongyuan Zhong
Paul Williamson Qiang Yin Miha Zoubek
Jan Wittenber Done-Sik Yoo Szymon Zyskoter
The following members of the individual Standards Association balloting group voted on this standard.
Balloters may have voted for approval, disapproval, or abstention.
Juan Carreon Werner Hoelzl Beth Pumo
Randy W. Carroll Noriyuki Ikeuchi Bartien Sayogo
Lawrence Catchpole Atsushi Ito Paul S. Schluter
Keith Chow Stefan Karl Carl Singer
Malcolm Clarke Piotr Karocki Walter Struppler
Russell Davis Stuart Kerry Lai King (Anna) Tee
David Fuschi Joerg-Uwe Meyer Jan Wittenber
Randall Groves Michael Newman Oren Yuen
Nathaniel Hamming Daidi Zhong
When the IEEE SA Standards Board approved this standard on 5 September 2019, it had the following
membership:
Gary Hoffman, Chair
Ted Burse, Vice Chair
Jean-Philippe Faure, Past Chair
Konstantinos Karachalios, Secretary
Masayuki Ariyoshi
David J. Law Annette Reilly
Stephen D. Dukes Joseph Levy Dorothy Stanley
J. Travis Griffith Howard Li Sha Wei
Guido Hiertz Xiaohui Liu Phil Wennblom
Christel Hunter Kevin Lu Philip Winston
Joseph L. Koepfinger* Daleep Mohla Howard Wolfman
Thomas Koshy Andrew Myles Feng Wu
John D. Kulick Jingyi Zhou
*Member Emeritus
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ISO/IEEE 11073-20601:2022(E)
Introduction
This introduction is not part of IEEE Std 11073-20601-2019, Health informatics—Personal health device
communication—Part 20601: Application profile—Optimized Exchange Protocol.
ISO and IEEE 11073 standards enable communication between medical devices and external computer
systems. This standard and corresponding IEEE 11073-104zz standards address a need for a simplified and
optimized communication approach for personal health devices, which may or may not be regulated
devices. These standards align with, and draw upon, the existing clinically focused standards to provide
easy management of data from either a clinical or personal health device.
This document addresses a need for an openly defined, independent standard for converting the collected
information into an interoperable transmission format so the information can be exchanged between agents
and managers.
Other closely related standards include the following:
1
IEEE Std 11073-00103™ [B6] provides an overview of the personal health space and defines the
underlying use cases and usage models.
ISO/IEEE 11073-10201:2004 [B17] documents the extensive domain information model (DIM)
leveraged by this standard.
ISO/IEEE 11073-104zz standards define specific device specializations. For example,
ISO/IEEE 11073-10404 [B18] defines how interoperable pulse oximeters work.
ISO/IEEE 11073-20101:2004 [B21] defines the medical device encoding rules (MDER) used in
this standard.
1
The numbers in brackets correspond to the numbers of the bibliography in Annex M.
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ISO/IEEE 11073-20601:2022(E)
Contents
1. Overview .13
1.1 Scope .13
1.2 Purpose .13
1.3 Context .13
1.4 Word usage .17
2. Normative references .17
3. Definitions, acronyms, and abbreviations .18
3.1 Definitions .18
3.2 Acronyms and abbreviations .19
4. Guiding principles .20
5. Introduction to IEEE 11073 personal health devices .21
5.1 General .21
5.2 Domain information model (DIM) .21
5.3 Service model .21
5.4 Communication model.22
5.5 Compliance with other standards .22
5.6 Security .22
6. Personal health device DIM .22
6.1 General .
...
INTERNATIONAL STANDARD
ISO/IEEE FDIS 11073-20601:2022(E)
ISO/TC 215
Secretariat: ANSI
Health informatics — Device interoperability —
Part 20601: Personal health device communication — Application profile —
Optimized exchange protocol
© IEEE 2019 – All rights reserved
---------------------- Page: 1 ----------------------
ISO/IEEE Std 11073-20601-2019
Health informatics—Personal health device communication
Part 20601: Application profile—Optimized Exchange Protocol:2022(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of
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The procedures used to develop this document and those intended for its further
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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 Committees of the IEEE Standards Association (IEEE-SA) Standards Board.
The IEEE develops its 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 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).
Any trade name used in this document is information given for the convenience of users and
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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.
ISO/IEEE 11073-20601 was prepared by the IEEE 11073 Standards Committee of the IEEE
Engineering in Medicine and Biology Society (as IEEE Std 11073-20601-2019) 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.
This third edition cancels and replaces the second edition (ISO/IEEE 11073-20601:2016),
which has been technically revised. It also incorporates the Technical Corrigendum
ISO/IEEE 11073-20601:2016/Cor 1:2016.
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.
Copyright © 2019 IEEE. All rights reserved.
---------------------- Page: 2 ----------------------
IEEE Std 11073-20601™-2019
(Revision of IEEE Std 11073-20601-2014)
Health informatics—Personal health device communication
Part 20601: Application profile—
Optimized Exchange Protocol
Developed by the
IEEE 11073™ Standards Committee
of the
IEEE Engineering in Medicine and Biology Society
Approved 5 September 2019
IEEE SA Standards Board
---------------------- Page: 3 ----------------------
Abstract: Within the context of the ISO/IEEE 11073 family of standards for device
communication, a common framework for making an abstract model of personal health data
available in transport-independent transfer syntax required to establish logical connections
between systems and to provide presentation capabilities and services needed to perform
communication tasks is described in this standard. The protocol is optimized to personal health
usage requirements and leverages commonly used methods and tools wherever possible.
Keywords: IEEE 11073-20601™, medical device communication, personal health devices
•
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Copyright © 2019 IEEE. All rights reserved.
---------------------- Page: 7 ----------------------
Participants
At the time this standard was completed, the Personal Health Devices Working Group had the following
membership:
Daidi Zhong, Co-Chair
Michael J. Kirwan, Co-Chair
Karsten Aalders Wenjuan Chen Rick Geimer
Charles R. Abbruscato James Cheng Igor Gejdos
Nabil Abujbara Peggy Chien Ferenc Gerbovics
Maher Abuzaid David Chiu Alan Godfrey
James Agnew Nicolae Goga
Jinyong Choi
Haidar Ahmad Chia-Chin Chong Julian Goldman
Manfred Aigner Saeed A. Choudhary Raul Gonzalez Gomez
Jorge Alberola Jinhan Chung Chris Gough
Rolf Ambuehl John A. Cogan Channa Gowda
David Aparisi John T. Collins Charles M. Gropper
Lawrence Arne Amit Gupta
Cory Condek
Diego B. Arquillo Todd H. Cooper Jeff Guttmacher
Serafin Arroyo David Cornejo Rasmus Haahr
Muhammad Asim Christian Habermann
Douglas Coup
Kit August Nigel Cox Michael Hagerty
Doug Baird Hans Crommenacker Jerry Hahn
David Baker Tomio Crosley Robert Hall
Anindya Bakshi Allen Curtis Shu Han
Ananth Balasubramanian Eyal Dassau Nathaniel Hamming
Sunlee Bang David Davenport Rickey L. Hampton
M. Jonathan Barkley Russell Davis Sten Hanke
Gilberto Barrón Sushil K. Deka Aki Harma
David Bean Ciro de la Vega Jordan Hartmann
John Bell Pedro de-las-Heras-Quiros Kai Hassing
Rudy Belliardi Jim Dello Stritto Wolfgang Heck
Kathryn M. Bennett Matthew d’Entremont Nathaniel Heintzman
Daniel Bernstein Kent Dicks Charles Henderson
George A. Bertos Hyoungho Do Jun-Ho Her
Chris Biernacki Alistair Donaldson Helen B. Hernandez
Ola Björsne Xiaolian Duan Takashi Hibino
Thomas Blackadar Brian Dubreuil Timothy L. Hirou
Marc Blanchet Sourav Dutta Allen Hobbs
Thomas Bluethner Jakob Ehrensvard Alex Holland
Douglas P. Bogia Fredrik Einberg Arto Holopainen
Xavier Boniface Michihiro Enokida Kris Holtzclaw
Shannon Boucousis Javier Escayola Calvo Xinyi Hong
Julius Broma Mark Estes Robert Hoy
Lyle G. Bullock, Jr. Leonardo Estevez Frank Hsu
Bernard Burg Hailing Feng Anne Huang
Chris Burns Bosco T. Fernandes Sen-Der Huang
Anthony Butt Christoph Fischer Zhiyong Huang
Jeremy Byford-Rew Morten Flintrup Ron Huby
Satya Calloji Joseph W. Forler
David Hughes
Xiaoying Cao Russell Foster Robert D. Hughes
Carole C. Carey Eric Freudenthal Jiyoung Huh
Craig Carlson Matthias Frohner Hugh Hunter
Santiago Carot-Nemesio Ken Fuchs Hitoshi Ikeda
Randy W. Carroll Jing Gao Yutaka Ikeda
Qi Gao
Simon Carter Philip O. Isaacson
Seungchul Chae Marcus Garbe Atsushi Ito
Rahul Chauhan John Garguilo Michael Jaffe
8
Copyright © 2019 IEEE. All rights reserved.
---------------------- Page: 8 ----------------------
Praduman Jain Jim McCain Jose A. Santos-Cadenas
Danny Jochelson László Meleg Stefan Sauermann
Phaneeth Junga Alexander Mense John Sawyer
Akiyoshi Kabe Behnaz Minaei Guillaume Schatz
Steve Kahle Jinsei Miyazaki Alois Schloegl
Tomio Kamioka Erik Moll Paul S. Schluter
James J. Kang Darr Moore Lars Schmitt
Kei Kariya Carsten Mueglitz Mark G. Schnell
Andy Kaschl Piotr Murawski Richard A. Schrenker
Junzo Kashihara Soundharya Nagasubramanian Antonio Scorpiniti
Kohichi Kashiwagi KwangSeok Seo
Jae-Wook Nah
Ralph Kent Alex Neefus Riccardo Serafin
Laurie M. Kermes Trong-Nghia Nguyen-Dobinsky Sid Shaw
Ikuo Keshi Michael E. Nidd Frank Shen
Ahmad Kheirandish Jim Niswander Min Shih
Junhyung Kim Hongliang Niu Mazen Shihabi
Minho Kim Redmond Shouldice
Hiroaki Niwamoto
Min-Joon Kim Thomas Norgall Sternly K. Simon
Taekon Kim Anand Noubade Marjorie Skubic
Tetsuya Kimura Robert Smith
Yoshiteru Nozoe
Alfred Kloos Abraham Ofek Ivan Soh
Jeongmee Koh Brett Olive Motoki Sone
Jean-Marc Koller
Begonya Otal Emily Sopensky
John Koon Marco Paleari Rajagopalan Srinivasan
Patty Krantz Bud Panjwani Nicholas Steblay
Raymond Krasinski
Carl Pantiskas Lars Steubesand
Alexander Kraus Harry P. Pappas John (Ivo) Stivoric
Ramesh Krishna Hanna Park Raymond A. Strickland
Geoffrey Kruse Jong-Tae Park Chandrasekaran Subramaniam
Falko Kuester Myungeun Park Hermanni Suominen
Rafael Lajara Soojun Park Lee Surprenant
Pierre Landau Phillip E. Pash
Ravi Swami
Jaechul Lee TongBi Pei Ray Sweidan
JongMuk Lee Lucian Pestritu Yi Tang
Kyong Ho Lee Soren Petersen Haruyuyki Tatsumi
Rami Lee James Petisce Isabel Tejero
Sungkee Lee Peter Piction John W. Thomas
Michael Pliskin
Woojae Lee Tom Thompson
Yonghee Lee Varshney Prabodh Jonas Tirén
Joe Lenart Jeff Price Alexandra Todiruta
Kathryn A. Lesh Harald Prinzhorn Janet Traub
Qiong Li Harry Qiu Jesús Daniel Trigo
Xiangchen Li Arif Rahman Gary Tschautscher
Yingsong Li Tanzilur Rahman Masato Tsuchid
Zhuofang Li Steve Ray Ken Tubman
Patrick Lichter Phillip Raymond Yoshihiro Uchida
Jisoon Lim Terrie Reed Akib Uddin
Joon-Ho Lim Tim Reilly Sunil Unadkat
John Lin Barry Reinhold Fabio Urbani
Xiaoming Liu Brian Reinhold Philipp Urbauer
Wei-Jung Lo Melvin I. Reynolds Laura Vanzago
Charles Lowe John G. Rhoads
Alpo Värri
Don Ludolph Jeffrey S. Robbins Andrei Vasilateanu
Christian Luszick Chris Roberts Dalimar Velez
Bob MacWilliams Moskowitz Robert Martha Velezis
Srikkanth Madhurbootheswaran Scott M. Robertson Rudi Voon
Miriam L. Makhlouf Timothy Robertson Barry Vornbrock
Romain Marmot Patricia Order
Isobel Walker
Sandra Martinez David Rosales David Wang
Miguel Martínez de Espronceda Fatemeh Saki Jerry P. Wang
Bill Saltzstein
Cámara Yao Wang
Peter Mayhew Giovanna Sannino Yi Wang
9
Copyright © 2019 IEEE. All rights reserved.
---------------------- Page: 9 ----------------------
Steve Warren Jia-Rong Wu Zhi Yu
Fujio Watanabe Will Wykeham Jianchao Zeng
Toru Watsuji Ariton Xhafa Jason Zhang
Mike Weng Ricky Yang Zhiqiang Zhang
Yuefeng Weng Shaoqin Ye Thomas Zhao
Kathleen Wible Melanie S. Yeung Hongyuan Zhong
Paul Williamson Qiang Yin Miha Zoubek
Jan Wittenber Done-Sik Yoo Szymon Zyskoter
The following members of the individual Standards Association balloting group voted on this standard.
Balloters may have voted for approval, disapproval, or abstention.
Juan Carreon Werner Hoelzl Beth Pumo
Randy W. Carroll Noriyuki Ikeuchi Bartien Sayogo
Lawrence Catchpole Atsushi Ito Paul S. Schluter
Keith Chow Stefan Karl Carl Singer
Malcolm Clarke Piotr Karocki Walter Struppler
Russell Davis Stuart Kerry Lai King (Anna) Tee
David Fuschi Joerg-Uwe Meyer Jan Wittenber
Randall Groves Michael Newman Oren Yuen
Nathaniel Hamming Daidi Zhong
When the IEEE SA Standards Board approved this standard on 5 September 2019, it had the following
membership:
Gary Hoffman, Chair
Ted Burse, Vice Chair
Jean-Philippe Faure, Past Chair
Konstantinos Karachalios, Secretary
Masayuki Ariyoshi David J. Law Annette Reilly
Stephen D. Dukes Joseph Levy Dorothy Stanley
J. Travis Griffith Howard Li Sha Wei
Guido Hiertz Xiaohui Liu
Phil Wennblom
Christel Hunter Kevin Lu Philip Winston
Joseph L. Koepfinger* Daleep Mohla Howard Wolfman
Thomas Koshy Andrew Myles Feng Wu
John D. Kulick Jingyi Zhou
*Member Emeritus
10
Copyright © 2019 IEEE. All rights reserved.
---------------------- Page: 10 ----------------------
Introduction
This introduction is not part of IEEE Std 11073-20601-2019, Health informatics—Personal health device
communication—Part 20601: Application profile—Optimized Exchange Protocol.
ISO and IEEE 11073 standards enable communication between medical devices and external computer
systems. This standard and corresponding IEEE 11073-104zz standards address a need for a simplified and
optimized communication approach for personal health devices, which may or may not be regulated
devices. These standards align with, and draw upon, the existing clinically focused standards to provide
easy management of data from either a clinical or personal health device.
This document addresses a need for an openly defined, independent standard for converting the collected
information into an interoperable transmission format so the information can be exchanged between agents
and managers.
Other closely related standards include the following:
1
IEEE Std 11073-00103™ [B6] provides an overview of the personal health space and defines the
underlying use cases and usage models.
ISO/IEEE 11073-10201:2004 [B17] documents the extensive domain information model (DIM)
leveraged by this standard.
ISO/IEEE 11073-104zz standards define specific device specializations. For example,
ISO/IEEE 11073-10404 [B18] defines how interoperable pulse oximeters work.
ISO/IEEE 11073-20101:2004 [B21] defines the medical device encoding rules (MDER) used in
this standard.
1
The numbers in brackets correspond to the numbers of the bibliography in Annex M.
11
Copyright © 2019 IEEE. All rights reserved.
---------------------- Page: 11 ----------------------
Contents
1. Overview .15
1.1 Scope .15
1.2 Purpose .15
1.3 Context .15
1.4 Word usage .19
2. Normative references .19
3. Definitions, acronyms, and abbreviations .20
3.1 Definitions .20
3.2 Acronyms and abbreviations .21
4. Guiding principles .22
5. Introduction to IEEE 11073 personal health devices .23
5.1 General .23
5.2 Domain information model (DIM) .23
5.3 Service model .23
5.4 Communication model.24
5.5 Compliance with other standards .24
5.6 Security .24
6. Personal health device DIM .24
6.1 General .24
6.2 Nomenclature usage .25
6.3 Personal health object class definitions .26
6.4 Information model extensibility rules .85
7. Personal health device service model .85
7.1 General .85
7.2 Association service .86
7.3 Object access services.
...
FINAL
INTERNATIONAL ISO/IEEE
DRAFT
STANDARD FDIS
11073-20601
ISO/TC 215
Health informatics — Device
Secretariat: ANSI
interoperability —
Voting begins on:
2022-06-16
Part 20601:
Voting terminates on:
Personal health device communication
2022-11-03
— Application profile — Optimized
exchange protocol
Informatique de santé — Interopérabilité des dispositifs —
Partie 20601: Communication entre dispositifs de santé personnels —
Profil d'application — Protocole d'échange optimisé
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 11073-20601:2022(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 2022
---------------------- Page: 1 ----------------------
ISO/IEEE FDIS 11073-20601:2022(E)
FINAL
INTERNATIONAL ISO/IEEE
DRAFT
STANDARD FDIS
11073-20601
ISO/TC 215
Health informatics — Device
Secretariat: ANSI
interoperability —
Voting begins on:
Part 20601:
Voting terminates on:
Personal health device communication
— Application profile — Optimized
exchange protocol
Informatique de santé — Interopérabilité des dispositifs —
Partie 20601: Communication entre dispositifs de santé personnels —
Profil d'application — Protocole d'échange optimisé
COPYRIGHT PROTECTED DOCUMENT
ISO/CEN PARALLEL PROCESSING
© IEEE 2022
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.
RECIPIENTS OF THIS DRAFT ARE INVITED TO
Institute of Electrical and Electronics Engineers, Inc
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
3 Park Avenue, New York
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
NY 10016-5997, USA
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
Email: stds.ipr@ieee.org
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
ISO/IEEE FDIS 1107320601:2022(E)
Website: www.ieee.org
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
Published in Switzerland
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN
DARDS TO WHICH REFERENCE MAY BE MADE IN
ii
© IEEE 2022 – All rights reserved
NATIONAL REGULATIONS. © IEEE 2022
---------------------- Page: 2 ----------------------
ISO/IEEE FDIS 11073-20601:2022(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
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO
collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
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
Committees of the IEEE Standards Association (IEEE-SA) Standards Board. The IEEE develops its
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
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).
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.
ISO/IEEE 11073-20601 was prepared by the IEEE 11073 Standards Committee of the IEEE Engineering in
Medicine and Biology Society (as IEEE Std 11073-20601-2019) 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.
This third edition cancels and replaces the second edition (ISO/IEEE 11073-20601:2016), which has
been technically revised. It also incorporates the Technical Corrigendum ISO/IEEE 11073-
20601:2016/Cor 1:2016.
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 2019 – All rights reserved iii
---------------------- Page: 3 ----------------------
IEEE Std 11073-20601™-2019
(Revision of IEEE Std 11073-20601-2014)
Health informatics—Personal health device communication
Part 20601: Application profile—
Optimized Exchange Protocol
Developed by the
IEEE 11073™ Standards Committee
of the
IEEE Engineering in Medicine and Biology Society
Approved 5 September 2019
IEEE SA Standards Board
---------------------- Page: 4 ----------------------
ISO/IEEE 11073-20601:2022(E)
Abstract: Within the context of the ISO/IEEE 11073 family of standards for device
communication, a common framework for making an abstract model of personal health data
available in transport-independent transfer syntax required to establish logical connections
between systems and to provide presentation capabilities and services needed to perform
communication tasks is described in this standard. The protocol is optimized to personal health
usage requirements and leverages commonly used methods and tools wherever possible.
Keywords: IEEE 11073-20601™, medical device communication, personal health devices
•
The Institute of Electrical and Electronics Engineers, Inc.
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ISO/IEEE 11073-20601:2022(E)
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ISO/IEEE 11073-20601:2022(E)
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ISO/IEEE 11073-20601:2022(E)
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ISO/IEEE 11073-20601:2022(E)
Participants
At the time this standard was completed, the Personal Health Devices Working Group had the following
membership:
Daidi Zhong, Co-Chair
Michael J. Kirwan, Co-Chair
Karsten Aalders Wenjuan Chen Rick Geimer
Charles R. Abbruscato James Cheng Igor Gejdos
Nabil Abujbara Ferenc Gerbovics
Peggy Chien
Maher Abuzaid Alan Godfrey
David Chiu
James Agnew
Jinyong Choi Nicolae Goga
Haidar Ahmad Chia-Chin Chong Julian Goldman
Manfred Aigner Saeed A. Choudhary Raul Gonzalez Gomez
Jorge Alberola Jinhan Chung Chris Gough
Rolf Ambuehl John A. Cogan Channa Gowda
David Aparisi John T. Collins Charles M. Gropper
Lawrence Arne Cory Condek Amit Gupta
Diego B. Arquillo Todd H. Cooper Jeff Guttmacher
Serafin Arroyo David Cornejo Rasmus Haahr
Muhammad Asim Douglas Coup Christian Habermann
Kit August Nigel Cox Michael Hagerty
Doug Baird Hans Crommenacker Jerry Hahn
David Baker Tomio Crosley Robert Hall
Anindya Bakshi Allen Curtis Shu Han
Ananth Balasubramanian Eyal Dassau Nathaniel Hamming
Sunlee Bang Rickey L. Hampton
David Davenport
M. Jonathan Barkley
Russell Davis Sten Hanke
Gilberto Barrón Sushil K. Deka Aki Harma
David Bean Ciro de la Vega Jordan Hartmann
John Bell Pedro de-las-Heras-Quiros Kai Hassing
Rudy Belliardi Jim Dello Stritto Wolfgang Heck
Kathryn M. Bennett Matthew d’Entremont Nathaniel Heintzman
Daniel Bernstein Kent Dicks Charles Henderson
George A. Bertos Hyoungho Do Jun-Ho Her
Chris Biernacki Alistair Donaldson Helen B. Hernandez
Ola Björsne Xiaolian Duan Takashi Hibino
Thomas Blackadar Brian Dubreuil Timothy L. Hirou
Marc Blanchet Sourav Dutta Allen Hobbs
Thomas Bluethner Jakob Ehrensvard Alex Holland
Douglas P. Bogia Fredrik Einberg Arto Holopainen
Xavier Boniface Michihiro Enokida Kris Holtzclaw
Shannon Boucousis Javier Escayola Calvo Xinyi Hong
Julius Broma Mark Estes Robert Hoy
Leonardo Estevez
Lyle G. Bullock, Jr. Frank Hsu
Hailing Feng
Bernard Burg Anne Huang
Chris Burns Bosco T. Fernandes Sen-Der Huang
Anthony Butt Christoph Fischer Zhiyong Huang
Jeremy Byford-Rew Morten Flintrup Ron Huby
Satya Calloji Joseph W. Forler David Hughes
Xiaoying Cao Russell Foster Robert D. Hughes
Carole C. Carey Eric Freudenthal Jiyoung Huh
Craig Carlson Matthias Frohner Hugh Hunter
Santiago Carot-Nemesio Ken Fuchs Hitoshi Ikeda
Randy W. Carroll Jing Gao Yutaka Ikeda
Simon Carter Qi Gao Philip O. Isaacson
Seungchul Chae Marcus Garbe Atsushi Ito
Rahul Chauhan John Garguilo Michael Jaffe
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Copyright © 2019 IEEE. All rights reserved.
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ISO/IEEE 11073-20601:2022(E)
Praduman Jain Jim McCain Jose A. Santos-Cadenas
Danny Jochelson Stefan Sauermann
László Meleg
Phaneeth Junga John Sawyer
Alexander Mense
Akiyoshi Kabe Behnaz Minaei Guillaume Schatz
Steve Kahle Jinsei Miyazaki Alois Schloegl
Tomio Kamioka Erik Moll Paul S. Schluter
James J. Kang Darr Moore Lars Schmitt
Kei Kariya Carsten Mueglitz Mark G. Schnell
Andy Kaschl Piotr Murawski Richard A. Schrenker
Junzo Kashihara Soundharya Nagasubramanian Antonio Scorpiniti
Kohichi Kashiwagi Jae-Wook Nah KwangSeok Seo
Ralph Kent Alex Neefus Riccardo Serafin
Laurie M. Kermes Trong-Nghia Nguyen-Dobinsky Sid Shaw
Ikuo Keshi Michael E. Nidd Frank Shen
Ahmad Kheirandish Jim Niswander Min Shih
Junhyung Kim Hongliang Niu Mazen Shihabi
Minho Kim Hiroaki Niwamoto Redmond Shouldice
Min-Joon Kim Sternly K. Simon
Thomas Norgall
Taekon Kim Marjorie Skubic
Anand Noubade
Tetsuya Kimura
Yoshiteru Nozoe Robert Smith
Alfred Kloos Abraham Ofek Ivan Soh
Jeongmee Koh Brett Olive Motoki Sone
Jean-Marc Koller Begonya Otal Emily Sopensky
John Koon Marco Paleari Rajagopalan Srinivasan
Patty Krantz Bud Panjwani Nicholas Steblay
Raymond Krasinski Carl Pantiskas Lars Steubesand
Alexander Kraus Harry P. Pappas John (Ivo) Stivoric
Ramesh Krishna Hanna Park Raymond A. Strickland
Geoffrey Kruse Jong-Tae Park Chandrasekaran Subramaniam
Falko Kuester Myungeun Park Hermanni Suominen
Rafael Lajara Soojun Park Lee Surprenant
Pierre Landau Phillip E. Pash Ravi Swami
Jaechul Lee TongBi Pei Ray Sweidan
JongMuk Lee Lucian Pestritu Yi Tang
Kyong Ho Lee Soren Petersen Haruyuyki Tatsumi
Rami Lee James Petisce
Isabel Tejero
Peter Piction
Sungkee Lee John W. Thomas
Michael Pliskin
Woojae Lee Tom Thompson
Yonghee Lee Varshney Prabodh Jonas Tirén
Joe Lenart Jeff Price Alexandra Todiruta
Kathryn A. Lesh Harald Prinzhorn Janet Traub
Qiong Li Harry Qiu Jesús Daniel Trigo
Xiangchen Li Arif Rahman Gary Tschautscher
Yingsong Li Tanzilur Rahman Masato Tsuchid
Zhuofang Li Steve Ray Ken Tubman
Patrick Lichter Phillip Raymond Yoshihiro Uchida
Jisoon Lim Terrie Reed Akib Uddin
Joon-Ho Lim Tim Reilly Sunil Unadkat
John Lin Barry Reinhold Fabio Urbani
Xiaoming Liu Brian Reinhold Philipp Urbauer
Wei-Jung Lo Melvin I. Reynolds Laura Vanzago
Charles Lowe John G. Rhoads
Alpo Värri
Jeffrey S. Robbins
Don Ludolph Andrei Vasilateanu
Chris Roberts
Christian Luszick Dalimar Velez
Bob MacWilliams Moskowitz Robert Martha Velezis
Srikkanth Madhurbootheswaran Scott M. Robertson Rudi Voon
Miriam L. Makhlouf Timothy Robertson Barry Vornbrock
Romain Marmot Patricia Order Isobel Walker
Sandra Martinez David Rosales David Wang
Miguel Martínez de Espronceda Fatemeh Saki Jerry P. Wang
Cámara Bill Saltzstein Yao Wang
Peter Mayhew Giovanna Sannino Yi Wang
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Copyright © 2019 IEEE. All rights reserved.
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ISO/IEEE 11073-20601:2022(E)
Steve Warren Jia-Rong Wu Zhi Yu
Fujio Watanabe Will Wykeham Jianchao Zeng
Toru Watsuji Ariton Xhafa Jason Zhang
Mike Weng Ricky Yang Zhiqiang Zhang
Yuefeng Weng Shaoqin Ye Thomas Zhao
Kathleen Wible Melanie S. Yeung Hongyuan Zhong
Paul Williamson Qiang Yin Miha Zoubek
Jan Wittenber Done-Sik Yoo Szymon Zyskoter
The following members of the individual Standards Association balloting group voted on this standard.
Balloters may have voted for approval, disapproval, or abstention.
Juan Carreon Werner Hoelzl Beth Pumo
Randy W. Carroll Noriyuki Ikeuchi Bartien Sayogo
Lawrence Catchpole Atsushi Ito Paul S. Schluter
Keith Chow Stefan Karl Carl Singer
Malcolm Clarke Piotr Karocki Walter Struppler
Russell Davis Stuart Kerry Lai King (Anna) Tee
David Fuschi Joerg-Uwe Meyer Jan Wittenber
Randall Groves Michael Newman Oren Yuen
Nathaniel Hamming Daidi Zhong
When the IEEE SA Standards Board approved this standard on 5 September 2019, it had the following
membership:
Gary Hoffman, Chair
Ted Burse, Vice Chair
Jean-Philippe Faure, Past Chair
Konstantinos Karachalios, Secretary
Masayuki Ariyoshi
David J. Law Annette Reilly
Stephen D. Dukes Joseph Levy Dorothy Stanley
J. Travis Griffith Howard Li Sha Wei
Guido Hiertz Xiaohui Liu Phil Wennblom
Christel Hunter Kevin Lu Philip Winston
Joseph L. Koepfinger* Daleep Mohla Howard Wolfman
Thomas Koshy Andrew Myles Feng Wu
John D. Kulick Jingyi Zhou
*Member Emeritus
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Copyright © 2019 IEEE. All rights reserved.
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ISO/IEEE 11073-20601:2022(E)
Introduction
This introduction is not part of IEEE Std 11073-20601-2019, Health informatics—Personal health device
communication—Part 20601: Application profile—Optimized Exchange Protocol.
ISO and IEEE 11073 standards enable communication between medical devices and external computer
systems. This standard and corresponding IEEE 11073-104zz standards address a need for a simplified and
optimized communication approach for personal health devices, which may or may not be regulated
devices. These standards align with, and draw upon, the existing clinically focused standards to provide
easy management of data from either a clinical or personal health device.
This document addresses a need for an openly defined, independent standard for converting the collected
information into an interoperable transmission format so the information can be exchanged between agents
and managers.
Other closely related standards include the following:
1
IEEE Std 11073-00103™ [B6] provides an overview of the personal health space and defines the
underlying use cases and usage models.
ISO/IEEE 11073-10201:2004 [B17] documents the extensive domain information model (DIM)
leveraged by this standard.
ISO/IEEE 11073-104zz standards define specific device specializations. For example,
ISO/IEEE 11073-10404 [B18] defines how interoperable pulse oximeters work.
ISO/IEEE 11073-20101:2004 [B21] defines the medical device encoding rules (MDER) used in
this standard.
1
The numbers in brackets correspond to the numbers of the bibliography in Annex M.
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Copyright © 2019 IEEE. All rights reserved.
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ISO/IEEE 11073-20601:2022(E)
Contents
1. Overview .13
1.1 Scope .13
1.2 Purpose .13
1.3 Context .13
1.4 Word usage .17
2. Normative references .17
3. Definitions, acronyms, and abbreviations .18
3.1 Definitions .18
3.2 Acronyms
...
Questions, Comments and Discussion
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