Health informatics - Personal health device communication - Part 00103: Overview (ISO/IEEE 11073-00103:2015)

Within the context of the ISO/IEEE 11073 family of standards for device communication, this guide describes the landscape of transport-independent applications and information profiles for personal telehealth devices. These profiles define data exchange, data representation, and terminology for communication between personal health devices and compute engines (e.g., health appliances, set top boxes, cell phones, and personal computers). The guide provides a definition of personal telehealth devices as devices used for life activity, wellness monitoring, and/or health monitoring in domestic home, communal home, and/or mobile applications as well as professional medical usage. Use cases relevant to these scenarios and environments are also presented.

Medizinische Informatik - Kommunikation von Geräten für die persönliche Gesundheit- Teil 00103: Überblick (ISO/IEEE 11073-00103:2015)

Informatique de santé - Communication entre dispositifs de santé personnels - Partie 00103: Aperçu général (ISO/IEEE 11073-00103:2015)

Dans le contexte de la famille de normes ISO/IEEE 11073 pour la communication entre dispositifs, ISO/IEEE 11073-00103:2015 décrit l'environnement des applications indépendantes du transport et des profils d'information pour les dispositifs personnels de télésanté. Ces profils définissent l'échange de données, la représentation des données et la terminologie pour la communication entre les dispositifs personnels de télésanté et les moteurs informatiques (par exemple équipements de santé, boîtiers décodeurs, téléphones cellulaires et ordinateurs personnels). Le guide donne une définition des dispositifs personnels de télésanté en tant que dispositifs utilisés pour l'activité quotidienne, la surveillance du bien-être et/ou la surveillance de la santé à domicile, dans des lieux publics et/ou sur des applications mobiles. Des cas d'utilisation relevant de ces scénarios et de ces environnements sont également présentés.

Zdravstvena informatika - Komunikacija osebnih medicinskih naprav - 00103. del: Pregled (ISO/IEEE 11073-00103:2015)

Ta smernica v okviru skupine standardov za komunikacijo naprav ISO/IEEE 11073 opisuje območja aplikacij, neodvisnih od oblike prenosa, in informacijske profile za osebne telemedicinske naprave. Ti profili določajo izmenjavo podatkov, predstavitev podatkov in terminologijo za komunikacijo med osebnimi medicinskimi napravami in upravljalnimi napravami (npr. medicinskimi pripomočki, digitalnimi sprejemniki, mobilnimi telefoni in osebnimi računalniki). Vodilo podaja definicijo osebnih telemedicinskih naprav kot naprav, ki se uporabljajo za življenjsko dejavnost, spremljanje dobrega počutja in/ali zdravja doma, v ustanovah, in/ali mobilne aplikacije kot tudi za profesionalno medicinsko uporabo. Predstavljeni so tudi primeri uporabe, ki zadevajo te scenarije in okolja.

General Information

Status
Published
Public Enquiry End Date
30-Dec-2016
Publication Date
15-Aug-2017
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
02-Mar-2017
Due Date
07-May-2017
Completion Date
16-Aug-2017
Standard
SIST EN ISO 11073-00103:2017
English language
87 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (Sample)


SLOVENSKI STANDARD
01-september-2017
Zdravstvena informatika - Komunikacija osebnih medicinskih naprav - 00103. del:
Pregled (ISO/IEEE 11073-00103:2015)
Health informatics - Personal health device communication - Part 00103: Overview
(ISO/IEEE 11073-00103:2015)
Medizinische Informatik - Kommunikation von Geräten für die persönliche Gesundheit-
Teil 00103: Überblick (ISO/IEEE 11073-00103:2015)
Informatique de santé - Communication entre dispositifs de santé personnels - Partie
00103: Aperçu général (ISO/IEEE 11073-00103:2015)
Ta slovenski standard je istoveten z: EN ISO 11073-00103:2017
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD 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.

EN ISO 11073-00103
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2017
EUROPÄISCHE NORM
ICS 11.040.55; 35.240.80
English Version
Health informatics - Personal health device
communication - Part 00103: Overview (ISO/IEEE 11073-
00103:2015)
Informatique de santé - Communication entre Medizinische Informatik - Kommunikation von Geräten
dispositifs de santé personnels - Partie 00103: Aperçu für die persönliche Gesundheit- Teil 00103: Überblick
général (ISO/IEEE 11073-00103:2015) (ISO/IEEE 11073-00103:2015)
This European Standard was approved by CEN on 16 January 2017.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11073-00103:2017 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
The text of ISO/IEEE 11073-00103:2015 has been prepared by Technical Committee ISO/TC 215
“Health informatics” of the International Organization for Standardization (ISO) and has been taken
over as EN ISO 11073-00103:2017 by Technical Committee CEN/TC 251 “Health informatics” the
secretariat of which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by August 2017, and conflicting national standards shall
be withdrawn at the latest by August 2017.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia,
Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands,
Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
the United Kingdom.
Endorsement notice
The text of ISO 11073-00103:2015 has been approved by CEN as EN ISO 11073-00103:2017 without
any modification.
INTERNATIONAL ISO/IEEE
STANDARD 11073-00103
First edition
2015-03-01
Health informatics — Personal health
device communication —
Part 00103:
Overview
Informatique de santé — Communication entre dispositifs de santé
personnels —
Partie 00103: Aperçu général
Reference number
ISO/IEEE 11073-00103:2015(E)
©
IEEE 2012
ISO/IEEE 11073-00103:2015(E)
©  IEEE 2012
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO or IEEE at the respective
address below.
ISO copyright office Institute of Electrical and Electronics Engineers, Inc.
Case postale 56  CH-1211 Geneva 20 3 Park Avenue, New York  NY 10016-5997, USA
Tel. + 41 22 749 01 11 E-mail stds.ipr@ieee.org
Fax + 41 22 749 09 47 Web www.ieee.org
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © IEEE 2012 – All rights reserved

ISO/IEEE 11073-00103:2015(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.
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.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is called to the possibility that implementation of this standard may require the use of subject matter
covered by patent rights. By publication of this standard, no position is taken with respect to the existence or
validity of any patent rights in connection therewith. ISO/IEEE is not responsible for identifying essential
patents or patent claims for which a license may be required, for conducting inquiries into the legal validity or
scope of patents or patent claims or determining whether any licensing terms or conditions provided in
connection with submission of a Letter of Assurance or a Patent Statement and Licensing Declaration Form, if
any, or in any licensing agreements are reasonable or non-discriminatory. Users of this standard are expressly
advised that determination of the validity of any patent rights, and the risk of infringement of such rights, is
entirely their own responsibility. Further information may be obtained from ISO or the IEEE Standards
Association.
ISO/IEEE 11073-00103 was prepared by the 11073 Committee of the Engineering in Medicine and Biology
Society of the IEEE (as IEEE 11073-00103-2012). It was adopted by Technical Committee ISO/TC 215,
Health informatics, in parallel with its approval by the ISO member bodies, under the “fast-track procedure”
defined in the Partner Standards Development Organization cooperation agreement between ISO and IEEE.
IEEE is responsible for the maintenance of this document with participation and input from ISO member
bodies.
ISO/IEEE 11073 consists of the following parts, under the general title Health informatics — Personal health
device communication (text in parentheses gives a variant of subtitle):
 Part 00103: Overview
 Part 10101: (Point-of-care medical device communication) Nomenclature
 Part 10102: (Point-of-care medical device communication) Nomenclature — Annotated ECG
 Part 10103: (Point-of-care medical device communication) — Nomenclature — Implantable device,
cardiac
 Part 10201: (Point-of-care medical device communication) Domain information model
 Part 10404: Device specialization — Pulse oximeter
© IEEE 2012 – All rights reserved iii

ISO/IEEE 11073-00103:2015(E)
 Part 10406: Device specialization — Basic electrocardiograph (ECG) (1- to 3-lead ECG)
 Part 10407: Device specialization — Blood pressure monitor
 Part 10408: Device specialization — Thermometer
 Part 10415: Device specialization — Weighing scale
 Part 10417: Device specialization — Glucose meter
 Part 10418: Device specialization — International Normalized Ratio (INR) monitor
 Part 10420: Device specialization — Body composition analyzer
 Part 10421: Device specialization — Peak expiratory flow monitor (peak flow)
 Part 10441: Device specialization — Cardiovascular fitness and activity monitor
 Part 10442: (Point-of-care medical device communication) Device specialization — Strength fitness
equipment
 Part 10471: Device specialization — Independent living activity hub
 Part 10472: Device specialization — Medication monitor
 Part 20101: (Point-of-care medical device communication) Application profiles — Base standard
 Part 20601: Application profile — Optimized exchange protocol
 Part 30200: (Point-of-care medical device communication) Transport profile — Cable connected
 Part 30300: (Point-of-care medical device communication) Transport profile — Infrared wireless
 Part 30400: (Point-of-care medical device communication) Interface profile — Cabled Ethernet
 Part 90101: (Point-of-care medical device communication) Analytical instruments — Point-of-care test
 Part 91064: (Standard communication protocol) Computer-assisted electrocardiography
— Part 92001: (Medical waveform format) — Encoding rules
iv © IEEE 2012 – All rights reserved

Health Informatics—Personal health device communication

Part 00103: Overview
IEEE Engineering in Medicine and Biology Society

Sponsored by the
IEEE 11073™ Standard Committee

IEEE
IEEE Std 11073-00103™-2012
3 Park Avenue
New York, NY 10016-5997
USA
31 August 2012
TM
IEEE Std 1173-00103 -2012
Health informatics—Personal health device communication
Part 00103: Overview
Sponsor
TM
IEEE 11073 Standards Committee
of the
IEEE Engineering in Medicine and Biology Society

Approved 14 May 2012
IEEE-SA Standards Board
Abstract: Within the context of the ISO/IEEE 11073 family of standards for device
communication, the landscape of transport-independent applications and information profiles for
personal telehealth devices is described in this guide. Defined in these profiles are data exchange,
data representation, and terminology for communication between personal telehealth devices and
compute engines (e.g., health appliances, set top boxes, cell phones, and personal computers). A
definition of personal telehealth devices as devices used for life activity, wellness monitoring,
and/or health monitoring in domestic home, communal home, and/or mobile applications is
provided in this guide. Use cases relevant to these scenarios and environments are also
presented.
Keywords: IEEE 11073-00103, medical device communication, personal health devices


The Institute of Electrical and Electronics Engineers, Inc.
3 Park Avenue, New York, NY 10016-5997, USA

All rights reserved. Published 31 August 2012. Printed in the United States of America.

IEEE is a registered trademark in the U.S. Patent & Trademark Office, owned by The Institute of Electrical and Electronics
Engineers, Incorporated.
PDF: ISBN 978-0-7381-7280-4 STD97255
Print: ISBN 978-0-7381-7386-3 STDPD97255

IEEE prohibits discrimination, harassment, and bullying. For more information, visit http://www.ieee.org/web/aboutus/whatis/policies/p9-26.html.
No part of this publication may be reproduced in any form, in an electronic retrieval system or otherwise, without the prior written permission
of the publisher.
Notice and Disclaimer of Liability Concerning the Use of IEEE Documents: IEEE Standards documents are developed
within the IEEE Societies and the Standards Coordinating Committees of the IEEE Standards Association (IEEE-SA)
Standards Board. 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 IEEE administers the process
and establishes rules to promote fairness in the consensus development process, IEEE does not independently evaluate, test, or
verify the accuracy of any of the information or the soundness of any judgments contained in its standards.
Use of an IEEE Standard is wholly voluntary. IEEE disclaims liability for any personal injury, property or other damage, of
any nature whatsoever, whether special, indirect, consequential, or compensatory, directly or indirectly resulting from the
publication, use of, or reliance upon any IEEE Standard document.
IEEE does not warrant or represent the accuracy or content of the material contained in its standards, and expressly disclaims
any express or implied warranty, including any implied warranty of merchantability or fitness for a specific purpose, or that
the use of the material contained in its standards is free from patent infringement. IEEE Standards documents are supplied "AS
IS."
The existence of an IEEE Standard does not imply that there are no other ways to produce, test, measure, purchase, market, or
provide other goods and services related to the scope of the IEEE standard. Furthermore, the viewpoint expressed at the time a
standard is approved and issued is subject to change brought about through developments in the state of the art and comments
received from users of the standard. Every IEEE standard is subjected to review at least every ten years. When a document is
more than ten years old and has not undergone a revision process, it is reasonable to conclude that its contents, although still of
some value, do not wholly reflect the present state of the art. Users are cautioned to check to determine that they have the
latest edition of any IEEE standard.
In publishing and making its standards available, IEEE is not suggesting or rendering professional or other services for, or on
behalf of, any person or entity. Nor is IEEE undertaking to perform any duty owed by any other person or entity to another.
Any person utilizing any IEEE Standards document, should rely upon his or her own independent judgment in the exercise of
reasonable care in any given circumstances or, as appropriate, seek the advice of a competent professional in determining the
appropriateness of a given IEEE standard.
Translations: The IEEE consensus development process involves the review of documents in English only. In the event that
an IEEE standard is translated, only the English version published by IEEE should be considered the approved IEEE standard.
Official Statements: A statement, written or oral, that is not processed in accordance with the IEEE-SA Standards Board
Operations Manual shall not be considered the official position of IEEE or any of its committees and shall not be considered to
be, nor be relied upon as, a formal position of IEEE. At lectures, symposia, seminars, or educational courses, an individual
presenting information on IEEE standards shall make it clear that his or her views should be considered the personal views of
that individual rather than the formal position of IEEE.
Comments on Standards: Comments for revision of IEEE Standards documents are welcome from any interested party,
regardless of membership affiliation with IEEE. However, IEEE does not provide consulting information or advice pertaining
to IEEE Standards documents. Suggestions for changes in documents should be in the form of a proposed change of text,
together with appropriate supporting comments. Since IEEE standards represent a consensus of concerned interests, it is
important to ensure that any responses to comments and questions also receive the concurrence of a balance of interests. For
this reason, IEEE and the members of its societies and Standards Coordinating Committees are not able to provide an instant
response to comments or questions except in those cases where the matter has previously been addressed. Any person who
would like to participate in evaluating comments or revisions to an IEEE standard is welcome to join the relevant IEEE
working group at http://standards.ieee.org/develop/wg/.
Comments on standards should be submitted to the following address:
Secretary, IEEE-SA Standards Board
445 Hoes Lane
Piscataway, NJ 08854-4141
USA
Photocopies: Authorization to photocopy portions of any individual standard for internal or personal use is granted by The
Institute of Electrical and Electronics Engineers, Inc., provided that the appropriate fee is paid to Copyright Clearance Center.
To arrange for payment of licensing fee, please contact Copyright Clearance Center, Customer Service, 222 Rosewood Drive,
Danvers, MA 01923 USA; +1 978 750 8400. Permission to photocopy portions of any individual standard for educational
classroom use can also be obtained through the Copyright Clearance Center.

Notice to users
Laws and regulations
Users of IEEE Standards documents should consult all applicable laws and regulations. Compliance with
the provisions of any IEEE Standards document does not imply compliance to any applicable regulatory
requirements. Implementers of the standard are responsible for observing or referring to the applicable
regulatory requirements. IEEE does not, by the publication of its standards, intend to urge action that is not
in compliance with applicable laws, and these documents may not be construed as doing so.
Copyrights
This document is copyrighted by the IEEE. It is made available for a wide variety of both public and
private uses. These include both use, by reference, in laws and regulations, and use in private self-
regulation, standardization, and the promotion of engineering practices and methods. By making this
document available for use and adoption by public authorities and private users, the IEEE does not waive
any rights in copyright to this document.
Updating of IEEE documents
Users of IEEE Standards documents should be aware that these documents may be superseded at any time
by the issuance of new editions or may be amended from time to time through the issuance of amendments,
corrigenda, or errata. An official IEEE document at any point in time consists of the current edition of the
document together with any amendments, corrigenda, or errata then in effect. In order to determine whether
a given document is the current edition and whether it has been amended through the issuance of
amendments, corrigenda, or errata, visit the IEEE-SA Website at http://standards.ieee.org/index.html or
contact the IEEE at the address listed previously. For more information about the IEEE Standards
Association or the IEEE standards development process, visit IEEE-SA Website at
http://standards.ieee.org/index.html.
Errata
Errata, if any, for this and all other standards can be accessed at the following URL:
http://standards.ieee.org/findstds/errata/index.html. Users are encouraged to check this URL for errata
periodically.
iv
Patents
Attention is called to the possibility that implementation of this standard may require use of subject matter
covered by patent rights. By publication of this standard, no position is taken by the IEEE with respect to
the existence or validity of any patent rights in connection therewith. If a patent holder or patent applicant
has filed a statement of assurance via an Accepted Letter of Assurance, then the statement is listed on the
IEEE-SA Website at http://standards.ieee.org/about/sasb/patcom/patents.html. Letters of Assurance may
indicate whether the Submitter is willing or unwilling to grant licenses under patent rights without
compensation or under reasonable rates, with reasonable terms and conditions that are demonstrably free of
any unfair discrimination to applicants desiring to obtain such licenses.
Essential Patent Claims may exist for which a Letter of Assurance has not been received. The IEEE is not
responsible for identifying Essential Patent Claims for which a license may be required, for conducting
inquiries into the legal validity or scope of Patents Claims, or determining whether any licensing terms or
conditions provided in connection with submission of a Letter of Assurance, if any, or in any licensing
agreements are reasonable or non-discriminatory. Users of this standard are expressly advised that
determination of the validity of any patent rights, and the risk of infringement of such rights, is entirely
their own responsibility. Further information may be obtained from the IEEE Standards Association.
v
Participants
At the time this guide was submitted to the IEEE-SA Standards Board for approval, the Personal Health
Devices Working Group had the following membership:
Douglas P. Bogia, Chair    Daidi Zhong, Chair    Michael J. Kirwan, Chair
Stefan Sauermann, Vice Chair  Jan Wittenber, Vice Chair  Benedikt Salzbrunn, Vice Chair

Charles R. Abbruscato Jinhan Chung Charles Gropper
Nabil Abujbara Malcolm Clarke Amit Gupta

Maher Abuzaid John A. Cogan Jeff Guttmacher
Manfred Aigner John T. Collins Rasmus Haahr
Jorge Alberola Cory Condek Christian Habermann
Karsten Alders Todd H. Cooper Michael Hagerty
Murtaza Ali David Cornejo Jerry Hahn
Prasad Alva Douglas Coup Robert Hall
Rolf Ambuehl Nigel Cox Nathaniel Hamming
David Aparisi Tomio Crosley Rickey L. Hampton
Lawrence Arne Allen Curtis Sten Hanke
Serafin Arroyo Jesús Daniel Trigo Kai Hassing
Muhammad Asim Eyal Dassau Marc Daniel Haunschild
Merat Bagha Russell Davis Charles Henderson
Doug Baird Ed Day Jun-Ho Her
David Baker Sushil K. Deka Takashi Hibino
Anindya Bakshi Pedro de-las-Heras-Quiros Timothy L. Hirou
Ananth Balasubramanian Jim DelloStritto Allen Hobbs
Sunlee Bang Matthew d'Entremont Alex Holland
M. Jonathan. Barkley Kent Dicks Arto Holopainen
Gilberto Barrón Hyoungho Do Robert Hoy
David Bean Xiaolian Duan Frank Hsu
John Bell Brian Dubreuil Anne Huang
Rudy Belliardi Jakob Ehrensvard Sen-Der Huang
Kathryn M. Bennett Fredrik Einberg Ron Huby
Daniel Bernstein Roger M. Ellingson Robert D. Hughes
George A. Bertos Michihiro Enokida David Hughes
Ola Björsne Javier Escayola Calvo Jiyoung Huh
Thomas Blackadar Leonardo Estevez Hugh Hunter
Marc Blanchet Roger Feeley Hitoshi Ikeda
Thomas Bluethner Bosco T. Fernandes Yutaka Ikeda
Douglas P. Bogia Christoph Fischer Philip O. Isaacson
Xavier Boniface Morten Flintrup Atsushi Ito
Shannon Boucousis Joseph W. Forler Praduman Jain
Kevin Braun Michael Fortner Danny Jochelson
Julius Broma Russell Foster Chris Johnson
Lyle G. Bullock, Jr. Eric Freudenthal Phaneeth Junga
Bernard Burg Matthias Frohner Akiyoshi Kabe
Chris Burns Ken Fuchs Steve Kahle
Anthony Butt Jing Gao Tomio Kamioka
Jeremy Byford-Rew Marcus Garbe Kei Kariya
Satya Calloji Gracinda García Lago Andy Kaschl
Carole C. Carey John Garguilo Junzo Kashihara
Santiago Carot-Nemesio Rick Geimer Kohichi Kashiwagi
Randy W. Carroll Igor Gejdos Ralph Kent
Seungchul Chae Ferenc Gerbovics Laurie M. Kermes
Rahul Chauhan Nicolae Goga Ikuo Keshi
James Cheng Julian Goldman Junhyung Kim
Peggy Chien Raul Gonzalez Gomez Min-Joon Kim
Silviu Chiricescu Chris Gough Minho Kim
Chia-Chin Chong Channa Gowda Taekon Kim
Saeed A. Choudhary Niclas Granqvist Tetsuya Kimura
vi
Alfred Kloos Bud Panjwani Andreas Staubert
Jeongmee Koh Carl Pantiskas Nicholas Steblay
Jean-Marc Koller Mikey Paradis Lars Steubesand
Patty Krantz Hanna Park John (Ivo). Stivoric
Alexander Kraus Jong-Tae Park Raymond A. Strickland
Ramesh Krishna Myungeun Park Hermanni Suominen
Falko Kuester Soojun Park Lee Surprenant
Rafael Lajara Phillip E. Pash Ravi Swami
Pierre Landau TongBi Pei Ray Sweidan
Jaechul Lee Soren Petersen Kunihiro Takiuchi
Kyong Ho Lee Peter Piction Francis Tam
Rami Lee Jeff Price Haruyuyki Tatsumi
Sungkee Lee John Quinlan John W. Thomas
Woojae Lee Arif Rahman Brad Tipler
Yonghee Lee Tanzilur Rahman Jonas Tirén
Joe Lenart Steve Ray James Tomcik
Kathryn A. Lesh Tim Reilly Janet Traub
Qiong Li Barry Reinhold Gary Tschautscher
Patrick Lichter Brian Reinhold Masato Tsuchid
Jisoon Lim Melvin I. Reynolds Ken Tubman
Joon-Ho Lim John G. Rhoads Yoshihiro Uchida
John Lin Jeffrey S. Robbins Sunil Unadkat
Wei-Jung Lo Timothy Robertson Philipp Urbauer
Charles Lowe David Rosales Laura Vanzago
Don Ludolph Bill Saltzstein Alpo Värri
Bob MacWilliams Giovanna Sannino Dalimar Velez
Sandra Martinez Jose A. Santos-Cadenas Naveen Verma
Miguel Martínez de Espronceda Stefan Sauermann Daniel von Büren
Cámara John Sawyer Rudi Voon
Peter Mayhew Guillaume Schatz Isobel Walker
Jim McCain Alois Schloegl David Wang
Richard McPartland Paul S. Schluter Jerry P. Wang
Chris Mcvay Johannes Schmidt Yao Wang
László Meleg Lars Schmitt Yi Wang
Ethan Metsger Mark G. Schnell Steve Warren
Jinsei Miyazaki Richard A. Schrenker Fujio Watanabe
Darr Moore Antonio Scorpiniti Toru Watsuji
Piotr Murawski Jungmin Seo Mike Weng
Soundharya Nagasubramanian Kwang Seok Seo Kathleen Wible
Jae-Wook Nah Riccardo Serafin Paul Williamson
Alex Neefus Sid Shaw Jia-Rong Wu
Trong-Nghia Nguyen-Dobinsky Frank Shen Will Wykeham
Michael E. Nidd Min Shih Ariton Xhafa
Tetsu Nishimura Mazen Shihabi Ricky Yang
Jim Niswander Krishna Shingala Melanie Yeung
Hiroaki Niwamoto Redmond Shouldice Done-Sik Yoo
Thomas Norgall Marjorie Skubic Jason Zhang
Yoshiteru Nozoe Robert Smith Zhiqiang Zhang
Brett Olive Ivan Soh Thomas Zhao
Begonya Otal Motoki Sone Miha Zoubek
Charles Palmer Emily Sopensky Szymon Zysko
Rajagopalan Srinivasan
vii
The following members of the individual balloting committee voted on this guide. Balloters may have
voted for approval, disapproval, or abstention.
Thomas Blackadar Werner Hoelzl Lars Schmitt
Douglas P. Bogia Tetsushi Ikegami Gil Shultz
Lyle G. Bullock, Jr. Atsushi Ito Kapil Sood
William Byrd Piotr Karocki Walter Struppler
Keith Chow Greg Luri Mark Sturza
Malcolm Clarke Wayne W. Manges Thomas Tullia
Randall Groves Michael S. Newman John Vergis
John Harauz Melvin I. Reynolds Jan Wittenber
Kai Hassing Bartien Sayogo Oren Yuen

When the IEEE-SA Standards Board approved this guide on 14 May 2012, it had the following
membership:
Richard H. Hulett, Chair
John Kulick, Vice Chair
Robert Grow, Past Chair
Satish Aggarwal Alexander Gelman Oleg Logvinov
Masayuki Ariyoshi Paul Houzé Ted Olsen
Peter Balma Jim Hughes Gary Robinson
William Bartley Young Kyun Kim Jon Walter Rosdahl
Ted Burse Joseph L. Koepfinger* Mike Seavey
Clint Chaplin David J. Law Yatin Trivedi
Wael Diab Thomas Lee Phil Winston
Jean-Philippe Faure Hung Ling Yu Yuan

*Member Emeritus
Also included are the following nonvoting IEEE-SA Standards Board liaisons:
Richard DeBlasio, DOE Representative
Michael Janezic, NIST Representative

Don Messina
IEEE Standards Program Manager, Document Development

Kathryn Bennett
IEEE Client Services Manager, Professional Services
viii
Introduction
This introduction is not part of IEEE Std 11073-00103-2012, Health informatics—Personal health device
communication—Part 00103: Overview.
Within the context of the ISO/IEEE 11073 family of standards for device communication, this guide
describes the landscape of transport-independent applications and information profiles for personal
telehealth devices. These profiles define data exchange, data representation, and terminology for
communication between personal telehealth devices and compute engines (e.g., health appliances, set top
boxes, cell phones, and personal computers). The guide provides a definition of personal telehealth devices
as devices used for life activity, wellness monitoring, and/or health monitoring in domestic home,
communal home, and/or mobile applications. Use cases relevant to these scenarios and environments are
also presented.
ix
Contents
1. Overview . 1
1.1 Scope . 1
1.2 Purpose . 1
1.3 The standards within 11073 standards applicable for the personal health devices (PHD) domain . 2
1.4 Audience . 3
1.5 Document organization . 3
2. Definitions, acronyms, and abbreviations . 3
2.1 Definitions . 3
2.2 Acronyms and abbreviations . 4
3. PHD environment overview . 5
3.1 General . 5
3.2 Topology of PHD systems . 6
3.3 Use contexts . 7
3.4 Health and fitness . 9
3.5 Independent living (aging independently) . 11
3.6 Disease management . 13
3.7 Device examples . 20
4. Introduction into IEEE 11073 PHD standards (tutorial) . 23
4.1 General description of the IEEE 11073 context . 23
4.2 Domain information model . 27
4.3 Nomenclature. 29
4.4 Service model . 30
4.5 Communication model. 33
5. Utilizing IEEE 11073 PHD standards in the development process . 35
5.1 Example implementation: Introduction, how to use ISO/IEEE 11073-20601:2010(E) [B48]. 35
5.2 Customer needs analysis, use knowledge from the IEEE 11073 PHD standards . 36
5.3 Risk management . 37
5.4 Security . 39
5.5 Quality of service (QoS) . 43
5.6 Regulatory issues—what is a medical device? . 43
5.7 System development planning: Using available IEEE 11073 PHD conformant components may
speed things up . 47
5.8 System requirements analysis: Drawing from the ISO/IEEE 11073-20601 blueprints . 48
5.9 Software architectural design: Using the ISO/IEEE 11073-20601 building blocks . 49
5.10 Software detailed design: Using the ISO/IEEE 11073-20601 engineering elements . 50
5.11 Software unit implementation and verification . 50
5.12 System integration and testing, validation . 50
5.13 System release . 50
5.14 Configuration management . 51
5.15 Maintenance. 51
6. Conformance and interoperability . 51
x
Annex A (informative) Example use case regular blood pressure control, detailed description . 53
Annex B (informative) Example transaction profiles . 55
Annex C (informative) Transport layer details . 60
Annex D (informative) Bibliography . 63

xi
ISO/IEEE 11073-00103:2015(E)
Health informatics—Personal health device communication
Part 00103: Overview
IMPORTANT NOTICE: IEEE Standards documents are not intended to ensure safety, health, or
environmental protection, or ensure against interference with or from other devices or networks.
Implementers of IEEE Standards documents are responsible for determining and complying with all
appropriate safety, security, environmental, health, and interference protection practices and all
applicable laws and regulations.
This IEEE document is made available for use subject to important notices and legal disclaimers.
These notices and disclaimers appear in all publications containing this document and may
be found under the heading “Important Notice” or “Important Notices and Disclaimers
Concerning IEEE Documents.” They can also be obtained on request from IEEE or viewed at
http://standards.ieee.org/IPR/disclaimers.html.
1. Overview
1.1 Scope
Within the context of the ISO/IEEE 11073 family of standards for device communication, this guide
describes the landscape of transport-independent applications and information profiles for personal
telehealth devices. These profiles define data exchange, data representation, and terminology for
communication between personal health devices and compute engines (e.g., health appliances, set top
boxes, cell phones, and personal computers). The guide provides a definition of personal telehealth devices
as devices used for life activity, wellness monitoring, and/or health monitoring in domestic home,
communal home, and/or mobile applications as well as professional medical usage. Use cases relevant to
these scenarios and environments are also presented.
1.2 Purpose
This guide sets a context for other personal telehealth standards in the ISO/IEEE 11073 framework of
standards and describes the need for interoperability in personal telehealth environments. Interoperability is
the key to growing the potential market for these devices and to enabling people to manage their own
health independently.
ISO/IEEE 11073-00103:2015(E)
IEEE Std 11073-00103-2012
Health informatics—Personal health device communication
Part 00103: Overview
1.3 The standards within 11073 standards applicable for the personal health
devices (PHD) domain
The IEEE 11073 series of standards date back to the 1990s. It was initially intended for connecting point-
of-care medical devices in professional healthcare provider organizations. Examples of these devices are
vital signs monitors, blood pressure monitors, and other “medical” devices. Initially, medical devices were
in most cases used in healthcare organizations by medical experts. However, the use of medical devices at
home increased over time. Additionally, fitness and health devices reached the market. The intended use of
these devices is generally not by clinicians directly, but derived data may have clinical significance. The
term PHD evolved for medical devices as well as for health and fitness devices used out of professional
healthcare organizations, by users at home. Today, PHDs are commonly sold together with consumer
electronics products. They are used in home and mobile environments. Most devices provide digital
displays and local storage of readings. Because of their small size and limited power supply, many devices
have low computational limits. Users increasingly find it cumbersome to read data from displays and to
enter it manually into online forms. Any manual interference adds to the probability of error.
Communicating the recorded data is therefore gaining importance, with the additional advantage of
avoiding media breaches. This development was also reflected in standardization work.
The following standards have been developed within the IEEE 11073 PHD standards series so far.
⎯ ISO/IEEE 11073-20601:2010(E) [B48] and its amendment IEEE Std 11073-20601a:2010
[B36]: The Optimized Exchange Protocol defines the core elements: the domain information
model, the service model, and the communication model.
A further series of “device specialization” standards then tailor the broad toolkit provided in
ISO/IEEE 11073-20601:2010(E) [B48] and IEEE Std 11073-20601a:2010 [B36] to specific usages to meet
the needs to the device type being specialized. The following device specializations are currently available:
⎯ ISO/IEEE 11073-10404:2010(E) [B43]
TM
⎯ IEEE Std 11073-10406 -2011 [B27]
⎯ ISO/IEEE 11073-10407:2010(E) [B44]
⎯ ISO/IEEE 11073-10408:2010(E) [B45]
⎯ ISO/IEEE 11073-10415:2010(E) [B46]
TM
⎯ IEEE Std 11073-10417 -2011 [B28]
TM
⎯ IEEE Std 11073-10418 -2011 [B29]
TM
⎯ IEEE Std 11073-10420 -2010 [B30]
TM
⎯ IEEE Std 11073-10421 -2010 [B31]
TM
⎯ IEEE Std 11073-10441 -2008 [B32]
TM
⎯ IEEE Std 11073-10442 -2008 [B33]
TM
⎯ IEEE Std 11073-10471 -2008 [B34]
TM
⎯ IEEE Std 11073-10472 -2010 [B35]
Work is in progress to add further device specializations.
The numbers in brackets correspond to those of the bibliography in Annex D.
ISO/IEEE 11073-00103:2015(E)
IEEE Std 11073-00103-2012
Health informatics—Personal health device communication
Part 00103: Overview
An attempt has been made to ensure that the device specialization documents together with the base
standard are self-contained and complete. For example, ISO/IEEE 11073-10101:2004(E) [B41] provides an
extensive list of terms for coding data elements in the domain information model. For convenience of use,
the terms are repeated where they are used, so that the reader does not need to consult
ISO/IEEE 11073-10101:2004(E). Equally, key concepts such as the information and communication
models are reproduced.
1.4 Audience
This overview is intended for readers who are interested in standardization for interoperability in the PHD
field. It targets readers, engineers, and noneng
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.

Loading comments...