Health informatics -- Personal health device communication

The scope of this standard is the definition and structuring of information that is communicated in a distributed system of point-of-care medical devices and medical information technology (IT) systems in which medical data needs to be exchanged or networked point-of-care medical devices need to be controlled. The standard provides a Participant Model and Communication Model derived from the IEEE 11073? Domain Information Model (IEEE 11073-10201? DIM). Furthermore, it utilizes the IEEE 11073 Nomenclature (IEEE 11073-10101?) and supports other coding systems to convey the semantics of any information elements.[1] The definition of network transport mechanisms is outside the scope of this standard. [1] Information on normative references can be found in Clause 2.

Informatique de santé -- Communication entre dispositifs de santé personnels

General Information

Status
Published
Publication Date
07-Mar-2019
Current Stage
6060 - International Standard published
Start Date
12-Jan-2019
Completion Date
08-Mar-2019
Ref Project

Buy Standard

Standard
ISO/IEEE 11073-10207:2019 - Health informatics -- Personal health device communication
English language
435 pages
sale 15% off
Preview
sale 15% off
Preview

Standards Content (sample)

ISO/IEEE
INTERNATIONAL
11073-10207
STANDARD
First edition
2019-03
Health informatics — Personal health
device communication —
Part 10207:
Domain information and service
model for service-oriented point-of-
care medical device communication
Informatique de santé — Communication entre dispositifs de santé
personnels —
Partie 10207: Informations de domaine et modèle de services pour la
communication orientée services entre dispositifs médicaux sur le site
des soins
Reference number
ISO/IEEE 11073-10207:2019(E)
IEEE 2018
---------------------- Page: 1 ----------------------
ISO/IEEE 11073-10207:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© IEEE 2018

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.

Institute of Electrical and Electronics Engineers, Inc
3 Park Avenue, New York
NY 10016-5997, USA
Email: stds.ipr@ieee.org
Website: www.ieee.org
Published in Switzerland
ii © IEEE 2018 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/IEEE 11073-10207:2019(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 11073-10207 was prepared by the IEEE 11073 Standards Committee of the IEEE

Engineering in Medicine and Biology Society (as IEEE Std 11073-10207-2017) 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.
A list of all parts in the ISO 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 2018 – All rights reserved
iii
---------------------- Page: 3 ----------------------
ISO/IEEE 11073-10207:2019(E)

Abstract: Within the context of the ISO/IEEE 11073™ family of standards for point-of-care

medical device communication, a Participant Model derived from the ISO/IEEE11073-10201

Domain Information Model is provided in this standard. The Participant Model specifies the

structure of medical information objects. This standard also defines an abstract Communication

Model to support the exchange of medical information objects. All elements of the Participant

Model and Communication Model are specified using XML Schema. Core subjects of the

Participant Model comprise modelling of medical device-related data, e.g., measurements and

settings, alert systems, contextual information (e.g., patient demographics and location

information), remote control, and archival information. Model extensibility is provided inherently

through the use of XML Schema.

Keywords: alert systems, IEEE 11073-10207™, medical device communication, patient, point-

of-care, remote control, service-oriented architecture, XML Schema
The Institute of Electrical and Electronics Engineers, Inc.
3 Park Avenue, New York, NY 10016-5997, USA
Copyright © 2018 by The Institute of Electrical and Electronics Engineers, Inc.

All rights reserved. Published 21 February 2018. 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 978-1-5044-4627-3 STD22961
Print: ISBN 978-1-5044-4628-0 STDPD22961
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.
Copyright © 2018 IEEE. All rights reserved.
---------------------- Page: 4 ----------------------
ISO/IEEE 11073-10207:2019(E)
Important Notices and Disclaimers Concerning IEEE Standards Documents

IEEE documents are made available for use subject to important notices and legal disclaimers. These

notices and disclaimers, or a reference to this page, appear in all standards and may be found under the

heading “Important Notices and Disclaimers Concerning IEEE Standards Documents.” They can also be

obtained on request from IEEE or viewed at http://standards.ieee.org/IPR/disclaimers.html.

Notice and Disclaimer of Liability Concerning the Use of IEEE Standards
Documents

IEEE Standards documents (standards, recommended practices, and guides), both full-use and trial-use, are

developed within IEEE Societies and the Standards Coordinating Committees of the IEEE Standards

Association (“IEEE-SA”) Standards Board. IEEE (“the Institute”) develops its standards through a

consensus development process, approved by the American National Standards Institute (“ANSI”), which

brings together volunteers representing varied viewpoints and interests to achieve the final product.

Volunteers are not necessarily members of the Institute and participate without compensation from IEEE.

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.

IEEE does not warrant or represent the accuracy or content of the material contained in its standards, and

expressly disclaims all warranties (express, implied and statutory) not included in this or any other

document relating to the standard, including, but not limited to, the warranties of: merchantability; fitness

for a particular purpose; noninfringement; and quality, accuracy, effectiveness, currency, or completeness

of material. In addition, IEEE disclaims any and all conditions relating to: results; and workmanlike effort.

IEEE standards documents are supplied “AS IS” and “WITH ALL FAULTS.”

Use of an IEEE standard is wholly voluntary. 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.

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.
IN NO EVENT SHALL IEEE BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL,
EXEMPLARY, OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT LIMITED TO:
PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES; LOSS OF USE, DATA, OR PROFITS;
OR BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY,
WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR
OTHERWISE) ARISING IN ANY WAY OUT OF THE PUBLICATION, USE OF, OR RELIANCE
UPON ANY STANDARD, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE AND
REGARDLESS OF WHETHER SUCH DAMAGE WAS FORESEEABLE.
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.
Copyright © 2018 IEEE. All rights reserved.
---------------------- Page: 5 ----------------------
ISO/IEEE 11073-10207:2019(E)
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 or inferred to be the official position of IEEE or any of its

committees and shall not be considered to be, or 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 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. For the same reason, IEEE does not

respond to interpretation requests. Any person who would like to participate in revisions to an IEEE

standard is welcome to join the relevant IEEE working group.
Comments on standards should be submitted to the following address:
Secretary, IEEE-SA Standards Board
445 Hoes Lane
Piscataway, NJ 08854 USA
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

IEEE draft and approved standards are copyrighted by IEEE under U.S. and international copyright laws.

They are made available by IEEE and are adopted 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 these documents available for use and

adoption by public authorities and private users, IEEE does not waive any rights in copyright to the

documents.
Photocopies

Subject to payment of the appropriate fee, IEEE will grant users a limited, nonexclusive license to

photocopy portions of any individual standard for company or organizational internal use or individual,

noncommercial use only. To arrange for payment of licensing fees, 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.
Copyright © 2018 IEEE. All rights reserved.
---------------------- Page: 6 ----------------------
ISO/IEEE 11073-10207:2019(E)
Updating of IEEE Standards 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.

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 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://ieeexplore.ieee.org/xpl/standards.jsp or contact IEEE at the address listed previously. For more

information about the IEEE SA or IEEE’s standards development process, visit the IEEE-SA Website at

http://standards.ieee.org.
Errata

Errata, if any, for all IEEE standards can be accessed on the IEEE-SA Website at the following URL:

http://standards.ieee.org/findstds/errata/index.html. Users are encouraged to check this URL for errata

periodically.
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 nondiscriminatory. 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.

Copyright © 2018 IEEE. All rights reserved.
---------------------- Page: 7 ----------------------
ISO/IEEE 11073-10207:2019(E)
Participants

At the time this standard was submitted to the IEEE-SA Standards Board for approval, the Point of Care

Devices Working Group had the following membership:
Jan Wittenber, Chair
Stefan Schlichting, Subgroup Chair
Bjoern Anderson Frank Golatowski Stephan Poehlsen
Malcolm Clarke David Gregorczyk Tracy Rausch
Todd Cooper Kai Hassing John Rhoads
Chris Courville John Hatcliff Paul Schluter
Michael Faughn Stefan Karl Masato Tanaka
Kenneth Fuchs Martin Kasparick Eugene Vasserman
John Garguilo Koichiro Matsumoto Stan Wiley
Joerg-Uwe Meyer

The following members of the individual balloting committee voted on this standard. Balloters may have

voted for approval, disapproval, or abstention.
Bjoern Andersen David Gregorczyk Martin Kasparick
Susan Burgess Randall Groves Joerg-Uwe Meyer
Craig Carlson Kai Hassing Stephan Poehlsen
Keith Chow Robert Heile Beth Pumo
Malcolm Clarke Werner Hoelzl Stefan Schlichting
Todd Cooper Noriyuki Ikeuchi Eugene Stoudenmire
Sourav Dutta Atsushi Ito Walter Struppler
Kenneth Fuchs Stefan Karl J. Wiley
Joel Goergen Piotr Karocki Jan Wittenber
Frank Golatowski Oren Yuen

When the IEEE-SA Standards Board approved this standard on 6 December 2017, it had the following

membership:
Jean-Philippe Faure, Chair
Gary Hoffman, Vice Chair
John D. Kulick, Past Chair
Konstantinos Karachalios, Secretary
Chuck Adams
Thomas Kochy Robby Robson
Masayuki Ariyoshi Joseph L. Koepfinger* Dorothy Stanley
Ted Burse Kevin Lu Adrian Stephens
Stephen Dukes Daleep Mohla Mehmet Ulema
Doug Edwards Damir Novosel Phil Wennblom
J. Travis Griffith Ronald C. Petersen Howard Wolfman
Michael Janezic Annette D. Reilly Yu Yuan
*Member Emeritus
Copyright © 2018 IEEE. All rights reserved.
---------------------- Page: 8 ----------------------
ISO/IEEE 11073-10207:2019(E)
Introduction

This introduction is not part of IEEE Std 11073-10207-2017, Health informatics—Point-of-care medical device

communication—Part 10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical

Device Communication.

ISO/IEEE 11073 standards enable communication between medical devices and external computer

systems. They provide automatic and detailed electronic data capture of patient vital signs information and

device operational data. The primary goals of these standards are to

 Provide real-time, plug-and-play interoperability for patient-connected medical devices.

 Facilitate the efficient exchange of vital signs and medical device data, acquired at the point of

care, in all health care environments.

“Real-time” means that data from multiple devices can be retrieved, time correlated, and displayed or

processed in fractions of a second. “Plug-and-play” means that all the clinician has to do is make the

connection—the systems automatically detect, configure, and communicate without any other human

interaction.

“Efficient exchange of medical device data” means that information that is captured at the point of care

(e.g., patient vital signs data) can be archived, retrieved, and processed by many different types of

applications without extensive software and equipment support and without needless loss of information.

The standards are especially targeted at acute and continuing care devices, such as patient monitors,

ventilators, infusion pumps, and electrocardiogram (EKG) devices. This family of standards can be layered

together to provide connectivity optimized for the specific devices being interfaced.

Note that normative statements of requirements are presented in this standard in the following manner:

Rnnnn: Statement text here.

where "nnnn" is replaced by a number that is unique among the requirements in this standard and thereby

forms a unique requirement identifier, for example,

R0007: All HANDLEs SHALL be unique within one MDIB sequence of a SERVICE PROVIDER.

Copyright © 2018 IEEE. All rights reserved.
---------------------- Page: 9 ----------------------
ISO/IEEE 11073-10207:2019(E)
Contents

1. Overview ...................................................................................................................................................21

1.1 Scope ..................................................................................................................................................21

1.2 Purpose ...............................................................................................................................................21

2. Normative references .................................................................................................................................22

3. Definitions and notational conventions .....................................................................................................23

3.1 Definitions ..........................................................................................................................................23

3.2 Notational conventions .......................................................................................................................25

4. Introduction to BICEPS .............................................................................................................................28

5. Participant Model ......................................................................................................................................30

5.1 Overview ............................................................................................................................................30

5.2 Background .........................................................................................................................................30

5.3 Descriptive part...................................................................................................................................34

5.4 State part .............................................................................................................................................41

6. Alert signal delegation ...............................................................................................................................49

6.1 General ...............................................................................................................................................49

6.2 Delegable alert signals ........................................................................................................................49

6.3 Fallback alert signals ..........................................................................................................................52

7. Communication Model ..............................................................................................................................53

7.1 General ...............................................................................................................................................53

7.2 Message exchange patterns .................................................................................................................53

7.3 Service Model .....................................................................................................................................54

7.4 Message Model ...................................................................................................................................59

8. Extension Model ........................................................................................................................................62

9. Discovery Model .......................................................................................................................................63

9.1 General ...............................................................................................................................................63

9.2 Implicit discovery ...............................................................................................................................63

9.3 Explicit discovery ...............................................................................................................................63

10. Nonfunctional requirements ....................................................................................................................64

10.1 General .............................................................................................................................................64

10.2 Patient safety considerations .............................................................................................................64

10.3 Cybersecurity considerations ............................................................................................................64

10.4 Clinical effectiveness ........................................................................................................................65

10.5 Regulatory considerations ................................................................................................................65

11. Conformance ...........................................................................................................................................66

11.1 Overview ..........................................................................................................................................66

11.2 General format ..................................................................................................................................66

11.3 ICS tables ..........................................................................................................................................67

Annex A (normative) Extension Model ........................................................................................................70

A.1 Extension ...........................................................................................................................................70

A.2 ExtensionType ...................................................................................................................................71

Copyright © 2018 IEEE. All rights reserved.
---------------------- Page: 10 ----------------------
ISO/IEEE 11073-10207:2019(E)

A.3 MustUnderstand .................................................................................................................................71

Annex B (normative) Participant Model .......................................................................................................72

B.1 AbstractAlertDescriptor .....................................................................................................................74

B.2 AbstractAlertState ..............................................................................................................................74

B.3 AbstractAlertState/@ActivationState ................................................................................................75

B.4 AbstractComplexDeviceComponentDescriptor .................................................................................75

B.5 AbstractComplexDeviceComponentDescriptor/AlertSystem ............................................................76

B.6 AbstractComplexDeviceComponentDescriptor/Sco ..........................................................................77

B.7 AbstractComplexDeviceComponentState ..........................................................................................78

B.8 AbstractContextDescriptor .................................................................................................................79

B.9 AbstractContextState .........................................................................................................................80

B.10 AbstractContextState/@ContextAssociation ...................................................................................81

B.11 AbstractContextState/@BindingMdibVersion .................................................................................81

B.12 AbstractContextState/@UnbindingMdibVersion.............................................................................81

B.13 AbstractContextState/@BindingStartTime ......................................................................................82

B.14 AbstractContextState/@BindingEndTime .......................................................................................82

B.15 AbstractContextState/V
...

Questions, Comments and Discussion

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