oSIST prEN ISO 11073-10206:2024

SLOVENSKI STANDARD
01-maj-2024
Zdravstvena informatika - Interoperabilnost naprav - 10206. del: Komunikacija
osebnih medicinskih naprav - Informacijski model abstraktne vsebine
(ISO/IEEE/FDIS 11073-10206:2024)
Health informatics - Device interoperability - Part 10206: Personal health device
communication - Abstract content information model (ISO/IEEE/FDIS 11073-
10206:2024)
Medizinische Informatik - Interoperabilität von Geräten - Teil 10206: Kommunikation
persönlicher Gesundheitsgeräte - Abstraktes Informationsmodell für Inhalte
(ISO/IEEE/FDIS 11073-10206:2024)
Informatique de santé - Interopérabilité des dispositifs - Partie 10206: Titre manque
(ISO/IEEE/FDIS 11073-10206:2024)
Ta slovenski standard je istoveten z: prEN ISO 11073-10206
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

FINAL DRAFT
International
Standard
ISO/IEEE
FDIS
11073-10206
ISO/TC 215
Health informatics — Device
Secretariat: ANSI
interoperability —
Voting begins on:
2024-02-01
Part 10206:
Personal health device
Voting terminates on:
2024-06-20
communication — Abstract content
information model
This document is circulated as received from the committee secretariat.
FAST TRACK PROCEDURE
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
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/CEN PARALLEL PROCESSING 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.
Reference number
ISO/IEEE FDIS 11073­10206:2024(en) © IEEE 2024

International
ISO/IEEE FDIS 11073-10206:2024(en)
Standard
FINAL DRAFT
ISO/IEEE
FDIS
11073-10206
ISO/TC 215
Health informatics — Device
Secretariat: ANSI
interoperability —
Voting begins on:
Part 10206:
Personal health device
Voting terminates on:
communication — Abstract content
information model
This document is circulated as received from the committee secretariat.
FAST TRACK PROCEDURE
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 SUPPORTING D OCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
© IEEE 2024
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/CEN PARALLEL PROCESSING
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
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INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
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TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
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Published in Switzerland Reference number
ISO/IEEE FDIS 11073­10206:2024(en)

© IEEE 2023
© IEEE 2024 – All rights reserved
ii
ISO/IEEE 11073-10206:2024(en)
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© IEEE 2023 – All rights reserved
iii
IEEE Std 11073-10206™-2022
Health Informatics—Device Interoperability—
Part 10206: Personal Health Device
Communication—Abstract Content
Information Model
Developed by the
IEEE 11073 Standards Committee
of the
IEEE Engineering in Medicine and Biology Society

Approved 21 September 2022
IEEE SA Standards Board
ISO/IEEE 11073-10206:2024(en)
Abstract: Within the context of the ISO/IEEE 11073 family of standards for device communication,
a simplified framework for making an abstract model of personal health data is available in this
standard. The specification addresses the structure and content of information. It does not address
communication of the information between devices.
Keywords: device interoperability, IEEE 11073-10206™, personal health device communication
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ISO/IEEE 11073-10206:2024(en)
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ISO/IEEE 11073-10206:2024(en)
Participants
At the time this standard was completed, the Personal Health Devices Working Group had the following
membership:
Daidi Zhong, Chair
Michael Kirwan, Vice Chair
Raymond Krasinski, Secretary
Karsten Aalders Todd H. Cooper Nathaniel Hamming
Charles R. Abbruscato Rickey L. Hampton
Sandra Costanzo
Nabil Abujbara Douglas Coup Sten Hanke
Maher Abuzaid Aki Harma
Nigel Cox
James Agnew Hans Crommenacker Jordan Hartmann
Manfred Aigner Tomio Crosley Kai Hassing
Jorge Alberola Allen Curtis Avi Hauser
David Aparisi David Davenport Nathaniel Heintzman
Lawrence Arne Russell Davis Charles Henderson
Diego B. Arquillo Sushil K. Deka Jun-Ho Her
Serafin Arroyo Ciro de la Vega Timothy L. Hirou
Muhammad Asim Jim Dello Stritto Allen Hobbs
Kit August Kent Dicks Alex Holland
Doug Baird Hyoungho Do Arto Holopainen
David Baker Fangjie Dong Kris Holtzclaw
Anindya Bakshi Jonathan Dougherty Robert Hoy
Ananth Balasubramanian Anne Huang
Xiaolian Duan
Sunlee Bang Sourav Dutta Guiling Huang
M. Jonathan Barkley Zhiyong Huang
Jakob Ehrensvard
Gilberto Barrón Fredrik Einberg David Hughes
David Bean Javier Escayola Calvo Robert D. Hughes
John Bell Mark Estes Jiyoung Huh
Olivia Bellamou-Huet Leonardo Estevez Hugh Hunter
Rudy Belliardi Bosco T. Fernandes Philip O. Isaacson
Daniel Bernstein Christoph Fischer Atsushi Ito
George A. Bertos Morten Flintrup Michael Jaffe
Chris Biernacki Russell Foster Praduman Jain
Ola Björsne Eric Freudenthal Hu Jin
Thomas Blackadar Matthias Frohner Danny Jochelson
Thomas Bluethner Kenneth Fuchs Akiyoshi Kabe
Douglas P. Bogia Jing Gao Steve Kahle
Xavier Boniface Tomio Kamioka
Marcus Garbe
Shannon Boucousis John Garguilo James J. Kang
Lyle G. Bullock, Jr. Liang Ge Kei Kariya
Bernard Burg Rick Geimer Andy Kaschl
Chris Burns Igor Gejdos Junzo Kashihara
Jeremy Byford-Rew Ferenc Gerbovics Ralph Kent
Satya Calloji Alan Godfrey Laurie M. Kermes
Carole C. Carey Nicolae Goga Sanjay R. Kharche
Craig Carlson Julian Goldman Ahmad Kheirandish
Santiago Carot-Nemesio Raul Gonzalez Gomez Junhyung Kim
Seungchul Chae Chris Gough Minho Kim
Yao Chen Channa Gowda Min-Joon Kim
Jing Cheng Charles M. Gropper Taekon Kim
Peggy Chien Amit Gupta Tetsuya Kimura
David Chiu Jeff Guttmacher
Alfred Kloos
Jinyong Choi Rasmus Haahr Edward Koch
Christian Habermann
Chia-Chin Chong Jeongmee Koh
Jinhan Chung Michael Hagerty Jean-Marc Koller
Jerry Hahn
John A. Cogan John Koon
John T. Collins Robert Hall Patty Krantz
Cory Condek Shu Han Alexander Kraus
ISO/IEEE 11073-10206:2024(en)
Ramesh Krishna Hanna Park Lars Steubesand
Geoffrey Kruse
Jong-Tae Park John (Ivo) Stivoric
Falko Kuester Myungeun Park Hermanni Suominen
Rafael Lajara Phillip E. Pash Lee Surprenant
Pierre Landau TongBi Pei Ravi Swami
Jaechul Lee Soren Petersen Ray Sweidan
JongMuk Lee James Petisce Na Tang
Kyong Ho Lee Peter Piction Haruyuyki Tatsumi
Rami Lee Michael Pliskin Maria Isabel Tejero del Rio
Sungkee Lee Varshney Prabodh Tom Thompson
Woojae Lee Jeff Price Jonas Tirén
Qiong Li Harald Prinzhorn Janet Traub
Xiangchen Li Jesús Daniel Trigo
Harry Qiu
Patrick Lichter Tanzilur Rahman Gary Tschautscher
Jisoon Lim Masato Tsuchid
Phillip Raymond
Wei-Jung Lo Terrie Reed Ken Tubman
Charles Lowe Barry Reinhold Akib Uddin
Don Ludolph Brian Reinhold Sunil Unadkat
Christian Luszick Melvin I. Reynolds Fabio Urbani
Bob MacWilliams John G. Rhoads Philipp Urbauer
Srikkanth Madhurbootheswaran Jeffrey S. Robbins Laura Vanzago
Miriam L. Makhlouf Chris Roberts Alpo Värri
M. Sabarimalai Manikandan Moskowitz Robert Andrei Vasilateanu
Romain Marmot Stefan Robert Dalimar Velez
Sandra Martinez Scott M. Robertson Martha Velezis
Miguel Martínez de Timothy Robertson Rudi Voon
Espronceda Cámara Sean Rocke Isobel Walker
Peter Mayhew David Wang
David Rosales
Jim McCain Bill Saltzstein Jerry P. Wang
László Meleg Shiwei Wang
Giovanna Sannino
Alexander Mense Jose A. Santos-Cadenas Yao Wang
Behnaz Minaei Stefan Sauermann Yi Wang
Jinsei Miyazaki John Sawyer Steve Warren
Madhu Mohan Alois Schloegl Fujio Watanabe
Erik Moll Paul S. Schluter Toru Watsuji
Darr Moore Mark G. Schnell Kathleen Wible
Chris Morel Richard A. Schrenker Paul Williamson
Carsten Mueglitz Antonio Scorpiniti Jia-Rong Wu
Soundharya Nagasubramanian KwangSeok Seo Will Wykeham
Alex Neefus Riccardo Serafin Ariton Xhafa
Trong-Nghia Nguyen-Dobinsky Sid Shaw Ricky Yang
Michael E. Nidd Frank Shen Melanie S. Yeung
Jim Niswander Qiang Yin
Min Shih
Mazen Shihabi
Hiroaki Niwamoto Done-Sik Yoo
Thomas Norgall Redmond Shouldice Zhi Yu
Sternly K. Simon
Yoshiteru Nozoe Jianchao Zeng
Abraham Ofek Marjorie Skubic Jason Zhang
Brett Olive Robert Smith Shiwei Zhao
Begonya Otal Ivan Soh Liang Zheng
Marco Paleari Motoki Sone Yuanhong Zhong
Bud Panjwani Emily Sopensky Qing Zhou
Carl Pantiskas Rajagopalan Srinivasan Miha Zoubek
Harry P. Pappas Nicholas Steblay Szymon Zyskoter

ISO/IEEE 11073-10206:2024(en)
The following members of the individual Standards Association balloting group voted on this standard.
Balloters may have voted for approval, disapproval, or abstention.
Robert Aiello Kenneth Fuchs Javier Luiso
Bjoern Andersen David Fuschi H. Moll
Pradeep Balachandran John Garguilo Bansi Patel
Earle Bascom III David Gregorczyk Julio Pimentel
Thomas Blackadar Charles M. Gropper Esteban Pino
Lyle G. Bullock, Jr. Werner Hoelzl Dalibor Pokrajac
Juan Carreon Raj Jain Paul S. Schluter
Pin Chang Piotr Karocki Harry Solomon
Diego Chiozzi Stuart Kerry Eugene Stoudenmire
Euclides Chuma Yongbum Kim Maria Isabel Tejero del Rio
Todd H. Cooper Edward Koch John Vergis
Allen Curtis Raymond Krasinski Lisa Ward
Kurt Elliason Jun Li
Karl Weber
Christoph Fischer Ting Li Oren Yuen
Immanuel Freedman
Juan Antonio Lloret Egea Daidi Zhong

When the IEEE SA Standards Board approved this standard on 21 September 2022, it had the following
membership:
David J. Law, Chair
Ted Burse, Vice Chair
Gary Hoffman, Past Chair
Konstantinos Karachalios, Secretary

Edward A. Addy Johnny Daozhuang Lin Mark Siira
Ramy Ahmed Fathy Kevin Lu Dorothy V. Stanley
J. Travis Griffith Daleep C. Mohla Lei Wang
Guido R. Hiertz Andrew Myles F. Keith Waters
Yousef Kimiagar Damir Novosel Karl Weber
Joseph L. Koepfinger* Annette D. Reilly Sha Wei
Thomas Koshy Robby Robson Philip B. Winston
John D. Kulick Jon Walter Rosdahl Daidi Zhong

*Member Emeritus
ISO/IEEE 11073-10206:2024(en)
Introduction
This introduction is not part of IEEE Std 11073-10206-2022, Health Informatics—Device Interoperability—Part 10206:
Personal Health Device Communication—Abstract Content Information Model.
ISO and IEEE 11073 standards enable communication between medical devices and external computer
systems. This standard addresses a need for a simplified content model that can be used for personal health
devices and is not tied to a method of communicating the content model. This standard aligns with, and draws
upon, the existing clinically focused standards as well as implementation experience gained over the past
decade.
Other closely related standards include the following:
ISO/IEEE 11073-20601:2022, Health informatics—Device interoperability—Part 20601: Personal health
device communication—Application profile—Optimized exchange protocol [B12].

The numbers in brackets correspond to those of the bibliography in Annex A.
ISO/IEEE 11073-10206:2024(en)
Contents
1. Overview . 13
1.1 Scope . 13
1.2 Purpose . 13
1.3 Word usage . 14
1.4 Context . 14
2. Normative references . 15
3. Definitions, acronyms, and abbreviations . 16
3.1 Definitions . 16
3.2 Acronyms and abbreviations . 17
4. Guiding principles . 18
5. Introduction to IEEE 11073 personal health device . 18
5.1 Content information model . 18
5.2 Compliance with other standards . 19
5.3 Security . 19
5.4 Background . 19
6. Content information model concepts . 21
6.1 Nomenclature usage . 22
6.2 Data types . 23
6.3 Time . 26
7. ACOM class definitions . 32
7.1 ACOM Base class . 32
7.2 Conceptual model . 33
7.3 ACOM PHD class . 37
7.4 ACOM SystemInfo class . 37
7.5 ACOM Clock class . 38
7.6 ACOM TimeCounter class . 39
7.7 ACOM WallClock class . 40
7.8 ACOM Power class . 40
7.9 ACOM Observation class . 41
7.10 ACOM Numeric Observation class . 44
7.11 Discrete Observation class. 45
7.12 Single Event Observation class . 46
7.13 Multiple Event observation class . 46
7.14 Multiple Boolean State observation class. 47
7.15 ACOM Sample Array Observation class . 48
7.16 ACOM String Observation class . 51
7.17 ACOM Compound observation class . 52
8. ACOM device specializations . 52
8.1 IEEE 11073-10408 thermometer . 53
8.2 IEEE 11073-10407 blood pressure . 55
8.3 IEEE 11073-10417 glucose meter . 59
8.4 IEEE 11073-10404 pulse oximeter . 65
8.5 IEEE 11073-10415 weight scale . 68
8.6 IEEE 11073-10406 basic ECG or heart rate . 71

ISO/IEEE 11073-10206:2024(en)
9. Conformance . 74
9.1 Protocol specification conformance . 74
9.2 PHD conformance . 75
9.3 PHG conformance . 76
10. Model extensions . 77
11. Protocol considerations . 77
11.1 State consistency . 77
11.2 Observation references . 77
11.3 Timelines . 78
11.4 Nomenclature . 78
12. Binary presentation of ACOM . 78
12.1 General mapping outline . 79
12.2 Example system information presentation for a thermometer . 79
13. Example JSON/FHIR presentation . 81
Annex A (informative) Bibliography . 87

ISO/IEEE 11073-10206:2024(en)
Health Informatics—Device Interoperability—
Part 10206: Personal Health Device
Communication—Abstract Content
Information Model
1. Overview
This standard defines an abstract content model (ACOM) for personal health devices (PHDs). The objective
of this work is to document the information in a PHD and the content of health observations that are sent by
the PHD so that when an observation is received from the PHD, regardless of the protocol used to perform
the communication, the health information is complete, consistent, and unambiguous. This standard does not
define a protocol by which information is exchanged between devices and hence does not make requirements
on how concepts are represented. When specific representations are made herein the purpose is to provide
clarity of concept.
1.1 Scope
This standard defines an object-oriented abstract information model to represent a PHD and the observations
generated by a PHD. It specifies what information needs to be present and the relationships between the
informational elements in the model. It models observations in a generic way by focusing on the information
content contained in the presentation of health measurements. The modeling follows the practice of
ISO/IEEE 11073-20601 [B12] where Unified Modeling Language (UML) is used to describe a set of objects
and the relationship between the objects. Tables provide descriptions of the attributes in the objects.
IEEE 11073-10101™ nomenclature terms are used to express clinical content. This standard provides
guidance as to what an exchange protocols needs to communicate to properly represent health observations,
but is not, in itself, sufficient to be an exchange protocol. However, the content model defined herein does
have sufficient detail to help organizations validate that there is no loss of the semantic content induced by
data exchanges in a protocol adhering to this standard. This standard does not define a security framework.
1.2 Purpose
This standard supports an ecosystem in which PHDs use the nomenclature and dictionary of IEEE 11073™.
When the IEEE nomenclature is used it helps to ensure that data communicated by PHDs is clearly
understood and useable by health professionals as well as intelligent systems in the wider digital health

The numbers in brackets correspond to those of the bibliography in Annex A.
Information on references can be found in Clause 2.
ISO/IEEE 11073-10206:2024(en)
IEEE Std 11073-10206-2022
IEEE Standard for Health Informatics—Device Interoperability—
Part 10206: Personal Health Device Communication—Abstract Content Information Model
ecosystem. In ISO/IEEE 11073-20601 [B12], which uses the IEEE 11073 nomenclature, the information
model is integrated with an optimized data exchange mechanism. This standard seeks to establish a new,
simplified information model that is independent of data exchange (such as physical or transport layer)
dependencies. Further it seeks to reduce the breadth of objects and attributes in the information model based
on implementation experience gained over the past ten years.
1.3 Word usage
The word shall indicates mandatory requirements strictly to be followed in order to conform to the standard
9, 10
and from which no deviation is permitted (shall equals is required to).
The word should indicates that among several possibilities one is recommended as particularly suitable,
without mentioning or excluding others; or that a certain course of action is preferred but not necessarily
required (should equals is recommended that).
The word may is used to indicate a course of action permissible within the limits of the standard (may equals
is permitted to).
The word can is used for statements of possibility and capability, whether material, physical, or causal (can
equals is able to).
1.4 Context
Figure 1 shows the categories and typical types of devices in the personal health space. Personal health
devices, or PHDs (e.g., blood pressure monitors, weighing scales, and pedometers), collect information about
a person (or persons) and transfer the information to a personal health gateway, or PHG (e.g., cell phone,
health appliance, or personal computer) for collection, display, and possible later transmission. The PHG
may also forward the data to remote support services for further analysis or to support disease management.
The PHD may also send the data directly to remote support services. The information supports a range of
domains including disease management, health and fitness, and aging independently.
The IEEE 11073 Personal Health Devices Working Group focuses on the information content and the data
exchange between the PHDs and PHG and remote support services as shown in Figure 1. Within the overall
IEEE 11073 context, this document concentrates on the information content of PHDs, with the objective of
allowing the information to be used seamlessly across the healthcare ecosystem.

The use of the word must is deprecated and cannot be used when stating mandatory requirements; must is used only to describe
unavoidable situations.
The use of will is deprecated and cannot be used when stating mandatory requirements; will is only used in statements of fact.
ISO/IEEE 11073-10206:2024(en)
IEEE Std 11073-10206-2022
IEEE Standard for Health Informatics—Device Interoperability—
Part 102
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