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ISO/IEEE 11073-10206 was prepared by the IEEE 11073 Standards Committee of the IEEE Engineering in Medicine and Biology Society (as IEEE Std 11073-10206-2022 ) 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.

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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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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

Charles R. Abbruscato

Nabil Abujbara

Maher Abuzaid

James Agnew

Manfred Aigner

Jorge Alberola

David Aparisi

Lawrence Arne

Diego B. Arquillo

Serafin Arroyo

Muhammad Asim

Kit August

Doug Baird

David Baker

Anindya Bakshi

Ananth Balasubramanian

Sunlee Bang

M. Jonathan Barkley

Gilberto Barrón

David Bean

John Bell

Olivia Bellamou-Huet

Rudy Belliardi

Daniel Bernstein

George A. Bertos

Chris Biernacki

Ola Björsne

Thomas Blackadar

Thomas Bluethner

Douglas P. Bogia

Xavier Boniface

Shannon Boucousis

Lyle G. Bullock, Jr.

Bernard Burg

Chris Burns

Jeremy Byford-Rew

Satya Calloji

Carole C. Carey

Craig Carlson

Santiago Carot-Nemesio

Seungchul Chae

Yao Chen

Jing Cheng

Peggy Chien

David Chiu

Jinyong Choi

Chia-Chin Chong

Jinhan Chung

John A. Cogan

John T. Collins

Cory Condek

Todd H. Cooper

Sandra Costanzo

Douglas Coup

Nigel Cox

Hans Crommenacker

Tomio Crosley

Allen Curtis

David Davenport

Russell Davis

Sushil K. Deka

Ciro de la Vega

Jim Dello Stritto

Kent Dicks

Hyoungho Do

Fangjie Dong

Jonathan Dougherty

Xiaolian Duan

Sourav Dutta

Jakob Ehrensvard

Fredrik Einberg

Javier Escayola Calvo

Mark Estes

Leonardo Estevez

Bosco T. Fernandes

Christoph Fischer

Morten Flintrup

Russell Foster

Eric Freudenthal

Matthias Frohner

Kenneth Fuchs

Jing Gao

Marcus Garbe

John Garguilo

Liang Ge

Rick Geimer

Igor Gejdos

Ferenc Gerbovics

Alan Godfrey

Nicolae Goga

Julian Goldman

Raul Gonzalez Gomez

Chris Gough

Channa Gowda

Charles M. Gropper

Amit Gupta

Jeff Guttmacher

Rasmus Haahr

Christian Habermann

Michael Hagerty

Jerry Hahn

Robert Hall

Shu Han

Nathaniel Hamming

Rickey L. Hampton

Sten Hanke

Aki Harma

Jordan Hartmann

Kai Hassing

Avi Hauser

Nathaniel Heintzman

Charles Henderson

Jun-Ho Her

Timothy L. Hirou

Allen Hobbs

Alex Holland

Arto Holopainen

Kris Holtzclaw

Robert Hoy

Anne Huang

Guiling Huang

Zhiyong Huang

David Hughes

Robert D. Hughes

Jiyoung Huh

Hugh Hunter

Philip O. Isaacson

Atsushi Ito

Michael Jaffe

Praduman Jain

Hu Jin

Danny Jochelson

Akiyoshi Kabe

Steve Kahle

Tomio Kamioka

James J. Kang

Kei Kariya

Andy Kaschl

Junzo Kashihara

Ralph Kent

Laurie M. Kermes

Sanjay R. Kharche

Ahmad Kheirandish

Junhyung Kim

Minho Kim

Min-Joon Kim

Taekon Kim

Tetsuya Kimura

Alfred Kloos

Edward Koch

Jeongmee Koh

Jean-Marc Koller

John Koon

Patty Krantz

Alexander Kraus

Ramesh Krishna

Geoffrey Kruse

Falko Kuester

Rafael Lajara

Pierre Landau

Jaechul Lee

JongMuk Lee

Kyong Ho Lee

Rami Lee

Sungkee Lee

Woojae Lee

Qiong Li

Xiangchen Li

Patrick Lichter

Jisoon Lim

Wei-Jung Lo

Charles Lowe

Don Ludolph

Christian Luszick

Bob MacWilliams

Srikkanth Madhurbootheswaran

Miriam L. Makhlouf

M. Sabarimalai Manikandan

Romain Marmot

Sandra Martinez

Miguel Martínez de Espronceda Cámara

Peter Mayhew

Jim McCain

László Meleg

Alexander Mense

Behnaz Minaei

Jinsei Miyazaki

Madhu Mohan

Erik Moll

Darr Moore

Chris Morel

Carsten Mueglitz

Soundharya Nagasubramanian

Alex Neefus

Trong-Nghia Nguyen-Dobinsky

Michael E. Nidd

Jim Niswander

Hiroaki Niwamoto

Thomas Norgall

Yoshiteru Nozoe

Abraham Ofek

Brett Olive

Begonya Otal

Marco Paleari

Bud Panjwani

Carl Pantiskas

Harry P. Pappas

Hanna Park

Jong-Tae Park

Myungeun Park

Phillip E. Pash

TongBi Pei

Soren Petersen

James Petisce

Peter Piction

Michael Pliskin

Varshney Prabodh

Jeff Price

Harald Prinzhorn

Harry Qiu

Tanzilur Rahman

Phillip Raymond

Terrie Reed

Barry Reinhold

Brian Reinhold

Melvin I. Reynolds

John G. Rhoads

Jeffrey S. Robbins

Chris Roberts

Moskowitz Robert

Stefan Robert

Scott M. Robertson

Timothy Robertson

Sean Rocke

David Rosales

Bill Saltzstein

Giovanna Sannino

Jose A. Santos-Cadenas

Stefan Sauermann

John Sawyer

Alois Schloegl

Paul S. Schluter

Mark G. Schnell

Richard A. Schrenker

Antonio Scorpiniti

KwangSeok Seo

Riccardo Serafin

Sid Shaw

Frank Shen

Min Shih

Mazen Shihabi

Redmond Shouldice

Sternly K. Simon

Marjorie Skubic

Robert Smith

Ivan Soh

Motoki Sone

Emily Sopensky

Rajagopalan Srinivasan

Nicholas Steblay

Lars Steubesand

John (Ivo) Stivoric

Hermanni Suominen

Lee Surprenant

Ravi Swami

Ray Sweidan

Na Tang

Haruyuyki Tatsumi

Maria Isabel Tejero del Rio

Tom Thompson

Jonas Tirén

Janet Traub

Jesús Daniel Trigo

Gary Tschautscher

Masato Tsuchid

Ken Tubman

Akib Uddin

Sunil Unadkat

Fabio Urbani

Philipp Urbauer

Laura Vanzago

Alpo Värri

Andrei Vasilateanu

Dalimar Velez

Martha Velezis

Rudi Voon

Isobel Walker

David Wang

Jerry P. Wang

Shiwei Wang

Yao Wang

Yi Wang

Steve Warren

Fujio Watanabe

Toru Watsuji

Kathleen Wible

Paul Williamson

Jia-Rong Wu

Will Wykeham

Ariton Xhafa

Ricky Yang

Melanie S. Yeung

Qiang Yin

Done-Sik Yoo

Zhi Yu

Jianchao Zeng

Jason Zhang

Shiwei Zhao

Liang Zheng

Yuanhong Zhong

Qing Zhou

Miha Zoubek

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.

Robert Aiello

Bjoern Andersen

Pradeep Balachandran

Earle Bascom III

Thomas Blackadar

Lyle G. Bullock, Jr.

Juan Carreon

Pin Chang

Diego Chiozzi

Euclides Chuma

Todd H. Cooper

Allen Curtis

Kurt Elliason

Christoph Fischer

Immanuel Freedman

Kenneth Fuchs

David Fuschi

John Garguilo

David Gregorczyk

Charles M. Gropper

Werner Hoelzl

Raj Jain

Piotr Karocki

Stuart Kerry

Yongbum Kim

Edward Koch

Raymond Krasinski

Jun Li

Ting Li

Juan Antonio Lloret Egea

Javier Luiso

H. Moll

Bansi Patel

Julio Pimentel

Esteban Pino

Dalibor Pokrajac

Paul S. Schluter

Harry Solomon

Eugene Stoudenmire

Maria Isabel Tejero del Rio

John Vergis

Lisa Ward

Karl Weber

Oren Yuen

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

Ramy Ahmed Fathy

J. Travis Griffith

Guido R. Hiertz

Yousef Kimiagar

Joseph L. Koepfinger ^*

Thomas Koshy

John D. Kulick

Johnny Daozhuang Lin

Kevin Lu

Daleep C. Mohla

Andrew Myles

Damir Novosel

Annette D. Reilly

Robby Robson

Jon Walter Rosdahl

Mark Siira

Dorothy V. Stanley

Lei Wang

F. Keith Waters

Karl Weber

Sha Wei

Philip B. Winston

Daidi Zhong

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]. ⁶

1 Overview

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. ⁷ Tables provide descriptions of the attributes in the objects. IEEE 11073-10101 ™ nomenclature terms are used to express clinical content. ⁸ 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

1.3 Word usage

1.4 Context

2 Normative references

3 Definitions, acronyms, and abbreviations

3.1 Definitions

3.2 Acronyms and abbreviations

4 Guiding principles

5 Introduction to IEEE 11073 personal health device

5.1 Content information model

5.2 Compliance with other standards

5.3 Security

5.4 Background

6 Content information model concepts

6.1 Nomenclature usage

6.2 Data types

6.3 Time

7 ACOM class definitions

7.1 ACOM Base class

7.2 Conceptual model

7.3 ACOM PHD class

7.4 ACOM SystemInfo class

7.5 ACOM Clock class

7.6 ACOM TimeCounter class

7.7 ACOM WallClock class

7.8 ACOM Power class

7.9 ACOM Observation class

7.10 ACOM Numeric Observation class

7.11 Discrete Observation class

7.12 Single Event Observation class

7.13 Multiple Event observation class

7.14 Multiple Boolean State observation class

7.15 ACOM Sample Array Observation class

7.16 ACOM String Observation class

7.17 ACOM Compound observation class

8 ACOM device specializations

8.1 IEEE 11073-10408 thermometer

8.2 IEEE 11073-10407 blood pressure

8.3 IEEE 11073-10417 glucose meter

8.4 IEEE 11073-10404 pulse oximeter

8.5 IEEE 11073-10415 weight scale

8.6 IEEE 11073-10406 basic ECG or heart rate

9 Conformance

9.1 Protocol specification conformance

9.2 PHD conformance

9.3 PHG conformance

10 Model extensions

11 Protocol considerations

11.1 State consistency

11.2 Observation references

11.3 Timelines

11.4 Nomenclature

12 Binary presentation of ACOM

12.1 General mapping outline

12.2 Example system information presentation for a thermometer

13 Example JSON/FHIR presentation

13.1 JSON encoded FHIR resources for commonly used personal health devices

13.2 ACOM thermometer presented using JSON/FHIR

ISO/IEEE 11073-10206:2024

Health informatics. Device interoperability - Personal health device communication. Abstract content information model

Current

Published:

1 Jul 2024