1、BSI Standards Publication PD ISO/TR 28380-2:2014 Health informatics IHE global standards adoption Part 2: Integration and content profilesPD ISO/TR 28380-2:2014 PUBLISHED DOCUMENT National foreword This Published Document is the UK implementation of ISO/TR 28380-2:2014. The UK participation in its p
2、reparation was entrusted to Technical Committee IST/35, Health informatics. A list of organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correc
3、t application. The British Standards Institution 2014. Published by BSI Standards Limited 2014 ISBN 978 0 580 63574 8 ICS 35.240.80 Compliance with a British Standard cannot confer immunity from legal obligations. This Published Document was published under the authority of the Standards Policy and
4、Strategy Committee on 28 February 2014. Amendments issued since publication Date Text affectedPD ISO/TR 28380-2:2014 ISO 2014 Health informatics IHE global standards adoption Part 2: Integration and content profiles Informatique de sant Adoption des normes globales IHE - Partie 2: Intgration et prof
5、ils de contenu TECHNICAL REPORT ISO/TR 28380-2 First edition 2014-02-15 Reference number ISO/TR 28380-2:2014(E)PD ISO/TR 28380-2:2014ISO/TR 28380-2:2014(E)ii ISO 2014 All rights reserved COPYRIGHT PROTECTED DOCUMENT ISO 2014 All rights reserved. Unless otherwise specified, no part of this publicatio
6、n 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 either ISO at the address below or ISOs member body in the country of
7、 the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in SwitzerlandPD ISO/TR 28380-2:2014ISO/TR 28380-2:2014(E) ISO 2014 All rights reserved iii Contents Page Foreword iv Introduction v 1
8、 Scope . 1 2 Terms and definitions . 1 3 Symbols and abbreviated terms . 3 4 Overview of IHE Profiles . 3 5 Anatomic Pathology (AP) Domain 4 5.1 AP Domain Scope 4 5.2 AP Infrastructure and Content Profiles . 5 6 Cardiology (CARD) Domain . 5 6.1 CARD Domain Scope 5 6.2 CARD Domain Integration and Con
9、tent Profiles 5 7 Eye Care Domain . 5 7.1 Eye Care Domain Scope . 5 7.2 Eye Care Domain Integration and Content Profiles . 6 8 Information Technology Infrastructure (ITI) Domain 6 8.1 ITI Domain Scope 6 8.2 IT Infrastructure Integration and Content Profiles . 6 9 Laboratory (LAB) Domain 6 9.1 LAB Do
10、main Scope . 6 9.2 LAB Integration and Content Profiles . 6 10 Patient Care Coordination (PCC) Domain . 7 10.1 PCC Domain Scope . 7 10.2 PCC Integration and Content Profiles 7 11 Patient Care Device (PCD) Domain 7 11.1 PCD Scope 7 11.2 PCD Integration and Content Profiles . 7 12 Pharmacy (PHARM) Dom
11、ain 7 12.1 PHARM Scope . 7 12.2 PHARM Integration and Content Profiles 7 13 Quality, Research, and Public Health (QRPH) Domain 8 13.1 QRPH Domain Scope 8 13.2 QRPH Integration and Content profiles . 8 14 Radiation Oncology (RO) Domain . 8 14.1 RO Domain Scope 8 14.2 RO Domain Integration and Content
12、 Profiles . 8 15 Radiology (RAD) Domain . 9 15.1 RAD Domain Scope 9 15.2 RAD Domain Integration and Content Profiles . 9 16 Other Domains 9 16.1 Endoscopy . 9 16.2 Dental 9 16.3 Surgery . 9 Bibliography .10PD ISO/TR 28380-2:2014ISO/TR 28380-2:2014(E) Foreword ISO (the International Organization for
13、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 r
14、ight 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 procedu
15、res 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
16、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 id
17、entified 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 explanat
18、ion on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information. The committee responsible for this docume
19、nt 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: Deploymentiv ISO 2014 All rights r
20、eservedPD ISO/TR 28380-2:2014ISO/TR 28380-2:2014(E) Introduction This part of ISO/TR 28380 describes the most recent Integrating the Healthcare Enterprise (IHE) Profiles developed by IHE. IHE specifies and facilitates adoption of profiles of selected standards to support carefully defined healthcare
21、-related tasks that depend on information exchange. Use of IHE processes and of the resulting profiles accelerates the worldwide adoption of standards targeted to achieving the interoperability of health information between software applications within enterprises and across various care settings. I
22、HE 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 servic
23、es 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
24、 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
25、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,
26、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 resul
27、t 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 w
28、ork done by the IHE initiative, in which several of the ISO/TC215 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 t
29、hat 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
30、 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 healt
31、hcare 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
32、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
33、 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 ea
34、sily exchange information in the context of the specific but broadly required use case. When clarifications or gaps are identified in the standards, IHE refers recommendations to the relevant standards bodies. To this end, IHE maintains liaison relationships with all major SDOs involved in healthcar
35、e (e.g. ISO, HL7, CEN, DICOM, and IEEE). ISO 2014 All rights reserved vPD ISO/TR 28380-2:2014ISO/TR 28380-2:2014(E) 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 heal
36、thcare 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 reservedPD ISO/TR 28380-2:2014TECHNICAL
37、 REPORT ISO/TR 28380-2:2014(E) Health informatics IHE global standards adoption Part 2: Integration and content profiles 1 Scope This part of ISO/TR 28380 describes the most recent Integrating the Healthcare Enterprise (IHE) Profiles developed by IHE. These profiles of selected standards support car
38、efully defined healthcare- related tasks that depend on information exchange. It accelerates the worldwide adoption of standards targeted to achieving the interoperability of health information between software applications within enterprises and across various care settings. Each available Integrat
39、ion or Content Profile is described with reference to the specification provided. ISO/TR 28380-1 is a companion to this part of ISO/TR 28380. The reader is encouraged to be familiar with the process followed by IHE in developing the Integration and Content Profiles described in this part of ISO/TR 2
40、8380. 2 Terms and definitions For the purposes of this document, the terms and definitions given in ISO/TR 28380-1 and the following 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 coordinate
41、d 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 Integ
42、ration 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 I
43、ntegration 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 res
44、ponsible to conduct these deployment projects in production, it expects that such projects will continuously provide feedback to the development process. ISO 2014 All rights reserved 1PD ISO/TR 28380-2:2014ISO/TR 28380-2:2014(E) 2.5 deployment-validation process part of the IHE process that builds u
45、pon 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 produc
46、ts to state their compliance to one or more Profiles. 2.6 development process part of the IHE process that identifies and prioritizes use cases, selects interoperability standards, defines the necessary constraints and documents these specifications in the form of either an Integration Profile or a
47、Content Profile 2.7 Domain field of clinical or healthcare technology-related activities 2.8 draft supplement for public comment specification candidate for addition to an IHE Domain Technical Framework (e.g. a new Profile) that is issued for comment by any interested party 2.9 Integration Profile I
48、HE Integration Profile specifies the information exchanges to support a specific business process Note 1 to entry: It is a coordinated set of interactions exchanged between the functional components of communicating healthcare IT systems and devices. These functional components are called IHE Actors
49、. An IHE Integration Profile specifies their interactions in terms of a set of coordinated, standards-based transactions. 2.10 Technical Framework collection of Profile specifications related to an IHE Domain and its specific clinical or technological focus Note 1 to entry: Profiles within a Technical Framework and across Technical Frameworks can be combined. 2.11 transaction specification for a set of messages exchanged between pairs of actors in support of an Integration Profile 2.12 Trial Implementation Supplement specifica
