ISO/TR 28380-1:2014
(Main)Health informatics — IHE global standards adoption — Part 1: Process
Health informatics — IHE global standards adoption — Part 1: Process
ISO/TR 28380-1:2014 describes how the Integrating the Healthcare Enterprise (IHE) process specifies and facilitates profiles of selected standards to support carefully defined healthcare tasks that depend on electronic information exchange. It accelerates the worldwide adoption of standards targeted at achieving interoperability between software applications within healthcare enterprises and across healthcare settings. The Integration and Content Profiles are specified in ISO 28380-2.
Informatique de santé — Adoption des normes globales IHE — Partie 1: Procédé
General Information
Standards Content (Sample)
TECHNICAL ISO/TR
REPORT 28380-1
First edition
2014-02-15
Health informatics — IHE global
standards adoption —
Part 1:
Process
Informatique de santé — Adoption des normes globales IHE —
Partie 1: Procédé
Reference number
©
ISO 2014
© ISO 2014
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ii © ISO 2014 – All rights reserved
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Terms and definitions . 1
3 Abbreviations. 3
4 Global standards adoption process overview . 3
4.1 General . 3
4.2 Development and deployment process . 4
4.3 Levels of requirements. 5
4.4 Stakeholder participation and overall structure . 7
5 Development process . 8
6 Deployment-validation process .10
7 Principle and policies .12
8 Overview of the Technical Framework .12
8.1 Relationship to real-world architectures .12
8.2 Structure of the Technical Frameworks .13
8.3 Relationship to base standards .13
8.4 IHE Technical Framework development and maintenance process .14
8.5 Implementation of the Technical Framework .14
Annex A (informative) IHE Integration Statement template .15
Annex B (informative) IHE sponsoring organizations .17
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. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
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 on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT) see the following URL: Foreword - Supplementary information.
The committee responsible for this document is ISO/TC 215, Health informatics.
ISO/TR 28380 consists of the following parts, under the general title Health informatics — IHE global
standards adoption:
— Part 1: Process
— Part 2: Integration and content profiles
The following parts are under preparation:
— Part 3: Deployment
iv © ISO 2014 – All rights reserved
Introduction
1)
This part of ISO/TR 28380 describes how the Integrating Healthcare Enterprise (IHE ) process specifies
and facilitates adoption of profiles of selected standards to support carefully defined healthcare tasks
that depend on electronic information exchange. It accelerates the worldwide adoption of standards
targeted to achieving the interoperability of healthcare information between software applications
within healthcare enterprises and across various care settings.
IHE is an initiative designed to stimulate the integration of electronic information systems that support
the delivery of modern healthcare. Its fundamental objective is to facilitate the standards-based
exchange of authorized and relevant health information for citizens as consumers of health services and
for healthcare professionals in the care of their patients. Integrating these systems and devices both
within the healthcare enterprise, across a variety of care settings, and personal health management
services will empower patients and health professionals with efficient access to necessary health
information.
The information exchange between IT systems, applications, and devices in healthcare is a complex
process due to the wide range of medical specialities, the rapid evolution of knowledge, use of technology
in the delivery service, and the broad range of stakeholders that need to cooperate.
Stakeholders include legislative institutions, governmental entities, insurers, vendors, employers, and
care providers organized in a variety of entities ranging from the small physician practice to large
hospital networks. Interoperability standards have proven quite complex to develop, driven by a
wide range of standard development organizations each effective at engaging a subset of these many
stakeholders.
In such a complex environment, standards require flexibility to account for a variety of environments
within which they can be used. Removing this flexibility would only result in further fragmentation. An
agreed upon process to rationalize the implementation of combined sets of these standards is required
in order to address some of the most common cases of information exchange in a defined manner that
can be tested.
This part of ISO/TR 28380 summarizes the successful work done by the IHE initiative, in which several
of the ISO/TC 215 member countries are engaged. This part of ISO/TR 28380 is intended to provide all
ISO members with an understanding of the valuable experience gained, as well as access to the results
achieved. The IHE is both a process and a forum that rationalizes at a multi-national level the adoption
of interoperability standards that can be profiled and combined to meet healthcare needs.
IHE draws on established healthcare-specific standards such as those developed by ISO/TC 215, as well
as general purpose IT standards, to define technical frameworks for the implementation of information
exchange to further address specific healthcare improvement or clinical goals. It includes a rigorous
testing process for the implementation of these technical frameworks. It also organizes educational
sessions and exhibits at major meetings of healthcare professionals to demonstrate the benefits of these
frameworks and encourages their adoption by the healthcare industry, the technology industry, and
other stakeholders worldwide. These elements are further discussed in this part of ISO/TR 28380.
By facilitating the adoption of internationally recognized standards (e.g. ISO, HL7, DICOM, IEEE, IETF,
and OASIS) in healthcare, IHE is doing what “Wi-Fi” has done in the field of wireless networking to the
adoption and deployment of the IEEE 802.11 standard. The IHE process produces detailed implementation
guides called “Integration Profiles or Content Profiles”.
Each profile references foundation standards from Standards Development Organizations (SDOs) and
constrains them as allowed by the parent SDO.
IHE makes configuration choices where necessary in these standards to ensure that IT systems or
devices commonly used in healthcare can easily exchange information in the context of the specific
but broadly required use case. When clarifications or gaps are identified in the standards, IHE refers
1) Information on IHE may be found at www.ihe.net.
recommendations to the relevant standards bodies. To this end, IHE maintains liaison relationships
with all major SDOs involved in healthcare (e.g. ISO, HL7, CEN, DICOM and IEEE).
The intended audience for this part of ISO/TR 28380 includes, but is not limited to, the following:
— IT departments of healthcare institutions;
— technical and marketing staff in the healthcare information technology industry;
— experts involved in standards development;
— those interested in integrating healthcare information systems and workflows;
— leadership in national and regional healthcare information exchange projects.
vi © ISO 2014 – All rights reserved
TECHNICAL REPORT ISO/TR 28380-1:2014(E)
Health informatics — IHE global standards adoption —
Part 1:
Process
1 Scope
This part of ISO/TR 28380 describes how the Integrating the Healthcare Enterprise (IHE) process
specifies and facilitates profiles of selected standards to support carefully defined healthcare tasks that
depend on electronic information exchange. It accelerates the worldwide adoption of standards targeted
at achieving interoperability between software applications within healthcare enterprises and across
healthcare settings. The Integration and Content Profiles are specified in ISO 28380-2.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
actor
functional component of a system that exchanges transactions with other actors as defined in an IHE
Integration Profile
2.2
Content Profile
coordinated set of standards-based information content exchanged between the functional components
of communicating healthcare IT systems and devices
Note 1 to entry: It also specifies a specific element of content (e.g. a document) that can be conveyed through the
transactions of one or more associated Integration Profile(s).
2.3
Connectathon
testing event at which developers have registered their system implementations for supervised
interoperability testing with other systems implementations
Note 1 to entry: Each participating system is tested for each registered combination of an IHE Actor and IHE
Integration or Content Profile.
2.4
deployment-production process
part of the IHE process that deploys into production healthcare delivery systems that effectively support
end users with standards-based interoperability as specified by IHE
Note 1 to entry: Although the IHE process is not directly responsible to conduct these deployment projects in
production, it expects that such projects will continuously provide feedback to the development process.
2.5
deployment-validation process
part of the IHE process that builds upon IHE Profile specifications produced by the development process
Note 1 to entry: The process starts with the testing of working implementations of these profiles, demonstrates
successful interoperability between independent implementations, and concludes with the means for developers
of IT products to state their compliance to one or more profiles.
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