Health informatics — Device interoperability — Part 10421: Personal Health Device Communication — Device Specialization- Peak expiratory flow monitor (peak flow)

Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of communication is established in ISO/IEEE 11073-10421:2012 between personal telehealth peak expiratory flow monitor devices and compute engines (e.g. cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability. Appropriate portions of existing standards are leveraged, including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. The use of specific term codes, formats, and behaviors is specified in telehealth environments restricting optionality in base frameworks in favor of interoperability. A common core of communication functionality is defined for personal telehealth peak expiratory flow monitor devices.

Informatique de santé — Interopérabilité des dispositifs — Partie 10421: Communication entre dispositifs de santé personnels — Spécialisation des dispositifs — Moniteur de surveillance du débit expiratoire de pointe (débit de pointe)

Dans le contexte de la famille de Normes ISO/IEEE 11073 relatives à la communication de dispositifs, l'ISO/IEEE 11073-10421:2012 établit une définition normative de la communication entre les dispositifs personnels d'analyse de composition corporelle et des gestionnaires (par exemple, des téléphones cellulaires, des ordinateurs personnels, des équipements personnels de santé, des boîtiers décodeurs) d'une manière qui permet une interopérabilité du type prêt à l'emploi. Elle s'appuie sur un travail effectué dans d'autres normes ISO/IEEE 11073, y compris la terminologie, les profils d'informations, les normes de profils d'applications et les normes de transports existants. Elle spécifie l'utilisation de codes, de formats et de comportements en termes spécifiques dans les environnements de télésanté, en limitant les choix à des cadres de travail de base en faveur de l'interopérabilité. Elle définit un noyau commun de fonctionnalités d'un dispositif de surveillance de débit de pointe.

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FINAL DRAFT
International
Standard
ISO/IEEE
FDIS
11073-10421
ISO/TC 215
Health informatics — Device
Secretariat: ANSI
interoperability —
Voting begins on:
2024-03-15
Part 10421:
Personal Health Device
Voting terminates on:
2024-08-02
Communication — Device
Specialization- Peak expiratory flow
monitor (peak flow)
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
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TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
ISO/IEEE FDIS 11073­10421:2024(en) © IEEE 2024

FINAL DRAFT
International
Standard
ISO/IEEE
FDIS
11073-10421
ISO/TC 215
Health informatics — Device
Secretariat: ANSI
interoperability —
Voting begins on:
Part 10421:
Personal Health Device
Voting terminates on:
Communication — Device
Specialization- Peak expiratory flow
monitor (peak flow)
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
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
the internet or an intranet, without prior written permission. Permission can be requested from IEEE at the address below.
TO BECOME STAND ARDS TO WHICH REFERENCE MAY BE
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Published in Switzerland Reference number
ISO/IEEE FDIS 11073­10421:2024(en)

© IEEE 2023
© IEEE 2024 – All rights reserved
ii
ISO/IEEE 11073-10421:2024(en)
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ISO/IEEE 11073-10421 was prepared by the IEEE 11073 Standards Committee of the IEEE Engineering in
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This second edition cancels and replaces the first edition (ISO/IEEE 11073-10421:2012), which has been
technically revised.
The main changes are as follows:
— added support for Base-Offset-Time;
— defined new standard configuration 0x0835;
— updated normative references, to refer to ISO/IEEE 11703-20601;
— updated version of this device specialization;
© IEEE 2023 – All rights reserved
iii
ISO/IEEE 11073-10421:2024(en)
— updated the association details based on the new version;
— updated the wording in 6.3 regarding the Observational;
— updated the examples in 8.4.2 and Annex E to indicate the support of BaseOffsetTime;
— updated the qualifier in MDS and other objects to recommend BaseOffsetTime; also updated the
description of the qualifiers in 6.5;
— added some text to 6.12 to further elaborate the DIM extensibility rule;
— corrected the use condition of GET MDS at E.4.1;
— updated the text in 8.5.2 regarding attribute-id-list, in order to be compliant with 20601-V4;
— added subclause 3.4 ‒ Compliance with other standards;
— removed the year in the bibliography to represent the latest version;
— extended Table 1 to specify qualifier details for all possible configurations;
— made the IEEE std 11073-10101 as normative reference;
— updated the wording at 1.3 and 4.1 regarding the precedence of nomenclature between 10101, 20601,
104xx, and this standard;
— updated the usage of nomenclature-version. Tied it with the corresponding protocol-version.
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 2023 – All rights reserved
iv
IEEE Std 11073-10421™-2023
(Revision of IEEE Std 11073-10421-2010)
Health Informatics—Device Interoperability
Part 10421: Personal Health Device
Communication—Device
Specialization—Peak Expiratory Flow
Monitor (Peak Flow)
Developed by the
IEEE 11073™ Standards Committee
of the
IEEE Engineering in Medicine and Biology Society
Approved 30 March 2023
IEEE SA Standards Board
ISO/IEEE 11073-10421:2024(en)
Abstract: Within the context of the ISO/IEEE 11073 family of standards for device
communication, a normative definition of communication is established in this standard between
personal telehealth peak expiratory flow monitor devices and compute engines (e.g., cell phones,
personal computers, personal health appliances, and set-top boxes) in a manner that enables
plug-and-play interoperability. Appropriate portions of existing standards are leveraged, including
ISO/IEEE 11073 terminology, information models, application profile standards, and transport
standards. The use of specific term codes, formats, and behaviors is specified in telehealth
environments restricting optionality in base frameworks in favor of interoperability. A common
core of communication functionality is defined for personal telehealth peak expiratory flow monitor
devices.
Keywords: forced expiratory volume, IEEE 11073-10421™, medical device communication,
peak expiratory flow, peak expiratory flow monitor, peak flow, personal health devices

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ISO/IEEE 11073-10421:2024(en)
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