BS PD ISO TR 28380-1-2014 Health informatics IHE global standards adoption Process《健康信息学 IHE全球标准采用 过程》.pdf

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1、BSI Standards Publication PD ISO/TR 28380-1:2014 Health informatics IHE global standards adoption Part 1: ProcessPD ISO/TR 28380-1:2014 PUBLISHED DOCUMENT National foreword This Published Document is the UK implementation of ISO/TR 28380-1:2014. The UK participation in its preparation was entrusted

2、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 correct application. The Britis

3、h Standards Institution 2014. Published by BSI Standards Limited 2014 ISBN 978 0 580 81873 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 Strategy Committee on 28

4、February 2014. Amendments issued since publication Date Text affectedPD ISO/TR 28380-1:2014 ISO 2014 Health informatics IHE global standards adoption Part 1: Process Informatique de sant Adoption des normes globales IHE Partie 1: Procd TECHNICAL REPORT ISO/TR 28380-1 First edition 2014-02-15 Referen

5、ce number ISO/TR 28380-1:2014(E)PD ISO/TR 28380-1:2014ISO/TR 28380-1:2014(E)ii ISO 2014 All rights reserved COPYRIGHT PROTECTED DOCUMENT ISO 2014 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electron

6、ic 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 the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 4

7、1 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in SwitzerlandPD ISO/TR 28380-1:2014ISO/TR 28380-1:2014(E) ISO 2014 All rights reserved iii Contents Page Foreword iv Introduction v 1 Scope . 1 2 T erms and definitions . 1 3 Abbreviations. 3 4 Global standards a

8、doption 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 .

9、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

10、template 15 Annex B (informative) IHE sponsoring organizations .17PD ISO/TR 28380-1:2014ISO/TR 28380-1:2014(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 i

11、s 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 par

12、t 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 particu

13、lar 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 thi

14、s 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.

15、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 ISOs adherence to th

16、e 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 st

17、andards adoption: Part 1: Process Part 2: Integration and content profiles The following parts are under preparation: Part 3: Deploymentiv ISO 2014 All rights reservedPD ISO/TR 28380-1:2014ISO/TR 28380-1:2014(E) Introduction This part of ISO/TR 28380 describes how the Integrating Healthcare Enterpri

18、se (IHE 1) ) 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 informat

19、ion 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-base

20、d 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 ma

21、nagement 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 know

22、ledge, 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 pra

23、ctice 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

24、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 exc

25、hange 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 e

26、xperience 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

27、 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

28、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

29、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.

30、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

31、 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 .

32、 ISO 2014 All rights reserved vPD ISO/TR 28380-1:2014ISO/TR 28380-1:2014(E) 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/T

33、R 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;

34、 leadership in national and regional healthcare information exchange projects.vi ISO 2014 All rights reservedPD ISO/TR 28380-1:2014TECHNICAL 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

35、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 ap

36、plications within healthcare enterprises and across healthcare settings. The Integration and Content Profiles are specified in ISO 28380-2. 2 T erms a nd definiti ons For the purposes of this document, the following terms and definitions apply. 2.1 actor functional component of a system that exchang

37、es transactions with other actors as defined in an IHE Integration Profile 2.2 C ont ent P r o f i le 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 el

38、ement 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 implementation

39、s 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 st

40、andards-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

41、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

42、the means for developers of IT products to state their compliance to one or more profiles. ISO 2014 All rights reserved 1PD ISO/TR 28380-1:2014ISO/TR 28380-1:2014(E) 2.6 development process part of the IHE process that identifies and prioritizes use cases, selects interoperability standards, defines

43、 the necessary constraints and documents these specifications in the form of either an Integration Profile or a 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 Techn

44、ical Framework (e.g. a new profile) that is issued for comment by any interested party 2.9 In teg ra t i o n Pro f il e IHE 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 fu

45、nctional components of communicating healthcare IT systems and devices. These functional components are called IHE Actors. An IHE Integration Profile specifies their interactions in terms of a set of coordinated, standards-based transactions. 2.10 Technical Framework collection of profile specificat

46、ions 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 P

47、rofile 2.12 Trial Implementation Supplement specification candidate for addition to an IHE Domain Technical Framework (e.g. a new profile) that is issued for early implementation by any interested party Note 1 to entry: The authoring Technical Committee expects developers feedback. 2.13 use case tex

48、tual and graphical depiction of the actors and operations that address information exchange in the context of a set of specific tasks for a workflow performed by different systems or devices2 ISO 2014 All rights reservedPD ISO/TR 28380-1:2014ISO/TR 28380-1:2014(E) 3 Abbreviations ANSI American Natio

49、nal Standards Institute ASTM American Society for Testing and Materials CDA Clinical Document Architecture CDISC Clinical Data Interchange Standards Consortium CEN European Committee for Standardization DICOM Digital and Imaging Communications in Medicine EHR Electronic Health Record HIS Hospital Information System HL7 Health Level Seven IETF Internet Engineering Task Force IEEE Institute of Electrical and Electronics Engineers IHE Integrating the Healthcare Enterprise IHTSDO International Health Terminology St