1、 ISO 2014 Health informatics IHE global standards adoption Part 3: Deployment Informatique de sant Adoption des normes globales IHE Partie 3: Dploiement TECHNICAL REPORT ISO/TR 28380-3 Reference number ISO/TR 28380-3:2014(E) First edition 2014-12-15 ISO/TR 28380-3:2014(E)ii ISO 2014 All rights reser
2、ved 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, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior writt
3、en 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. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland IS
4、O/TR 28380-3:2014(E)Contents Page Foreword iv Introduction v 1 Scope . 1 2 Normative References . 1 3 T erms and definitions . 1 4 Abbreviations. 4 5 General approach to analyse the interoperability requirements in support of an interoperability use case . 4 5.1 Concept of an Interoperability Use Ca
5、se . 4 5.2 Decomposition of an Interoperability Use Case into Technical Use Cases 5 6 Pr oject Int er oper ability Specification 7 6.1 Scope of Interoperability 7 6.2 Selection and combination of the appropriate Profiles . 7 6.3 Establishing a Jurisdictional Interoperability Framework 10 6.4 Example
6、s to illustrate the application of the above methodology to specific Interoperability Use Cases .10 7 Deplo yment benefits of pr ofile-based int er oper ability specifications.11 7.1 Alternatives and Deployment benefits 11 8 Approach to testing for interoperability 14 8.1 Four phases of Testing for
7、Interoperability.14 8.2 Responsibilities and Entrance/Exit Criteria .15 8.3 Test Management Processes and Certification .16 Bibliography .18 ISO 2014 All rights reserved iii ISO/TR 28380-3:2014(E) Foreword ISO (the International Organization for Standardization) is a worldwide federation of national
8、 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. Internationa
9、l 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 f
10、or 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. www.iso.org/d
11、irectives 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 t
12、he Introduction and/or on the ISO list of patent declarations received. 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 t
13、o 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 document is ISO/TC 215, Health Informatics, WG 2, Systems and Device Int
14、eroperability. ISO 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 Part 3: Deployment Part 1 and 2 have been approved by the TC 215 and have been published. This technical report
15、 will complement and support the general requirements for the adoption of global standards towards increasing the efficiency of deploying interoperability in health.iv ISO 2014 All rights reserved ISO/TR 28380-3:2014(E) Introduction The purpose of this Technical Report is to structure and facilitate
16、 adoption and deployment of health interoperability standards in a broad range of eHealth projects, including regional and national programs. A solid standards adoption process is a critical element that complements standards development and ensures that timely and effective implementation of standa
17、rds is realized for health information exchange. This technical report is intended to help and guide eHealth projects in the way to specify their use of interoperability standards in health information exchange by reusing IHE Profiles to support specific business use cases chosen by the project. Thi
18、s technical report is the third part of a multi-part Technical Report on IHE Global Standards Adoption. It builds upon: TR 28380-1, Health Informatics IHE Global Standards Adoption Part 1: Process TR 28380-2, Health Informatics IHE Global Standards Adoption Part 2: Integration and Content Profiles.
19、This Technical Report uses the term Profile as defined by TR 28380. A Profile is intended to guide implementers in a detailed manner and to ensure that implementations may be tested for compliance. For each use case, a Profile selects from a number of interoperability standards specific to healthcar
20、e (ISO TC215, HL7, DICOM, CEN, etc.) as well as general IT standards from ISO, or Internet related standards bodies (e.g. W3C, IETF, OASIS). Such Profiles are intended to guide implementers in a detailed manner and ensure that implementation may be tested for compliance and interoperability among im
21、plementations of like profiles achieved. For each standard it profiles, i.e. defines a specific and proper subset of each selected standard; IHE leverages implementation guides produced by the source standard development organizations (SDO), if they exist, and specifies the integration of these stan
22、dards. This coordinated process has been developed by Integrating the Healthcare Enterprise (IHE) and has been in effective use since 1998 to address a rapidly increasing number of healthcare interoperability problems for citizens as consumers of health services and for health professionals in the c
23、are of their patients. Integrating the information systems and devices within healthcare institutions, across a variety of care settings, and personal health management services will empower patients and healthcare professionals with a more efficient access to accurate information. IHE has a formal
24、Type-A Liaison relationship with ISO TC215. It is sponsored by a large number of healthcare user organizations world-wide and has engaged over 300 vendors in healthcare IT (). 16 countries are directly engaged in IHE at the time of writing this Technical Report. The information exchange among IT sys
25、tems, applications and devices in healthcare is a complex challenge. In particular, it needs to account for the wide range of medical specialities, for the rapid evolution of knowledge and for the use of technology in the delivery services, among the broad range of stakeholders that need to cooperat
26、e ranging from democratic institutions, governmental entities, insurers and employers, to care providers organized in a variety of entities of all sizes (single doctors practice to large hospital networks). Interoperability standards have proven quite complex to develop and are driven by a wide rang
27、e of standard development organizations (SDO) each effective at engaging a subset of these many stakeholders. In such a complex environment, standards have to incorporate much flexibility and optionality to account for a variety of environments in which they could be used. Removing the need for flex
28、ibility and optionality in these standards would only result in further fragmentation. An agreed upon process to rationalize and constrain 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 definite manner
29、 that can be tested. ISO 2014 All rights reserved v ISO/TR 28380-3:2014(E) This Technical Report is based on the valuable work done by the IHE initiatives in which several of the ISO/TC 215 member countries are engaged. This T echnical Report is intended to provide all ISO members with an understand
30、ing of the practical experience gained as well as access to the results achieved. 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 s
31、pecific standards such as those developed by ISO/TC 215 and HL7, as well as general purpose IT standards, in order to define a technical framework for the implementation of information exchange to address specific health improvement or clinical goals. It includes a rigorous interoperability testing
32、process for the implementation of this technical framework. IHE also organizes educational sessions and exhibits at major meetings of health professionals to demonstrate the benefits of this framework and encourage its adoption by the healthcare industry, the technology industry, and other stakehold
33、ers worldwide. These elements are further discussed in Part 1 of this technical report. The intended audience of this ISO Technical Report is: IT departments of healthcare institutions; Technical and marketing staff in the healthcare technology industry; Experts involved in standards development; He
34、alth Professionals interested in integrating healthcare information systems and workflows; National and regional healthcare information exchange projects leadership.vi ISO 2014 All rights reserved Health informatics IHE global standards adoption Part 3: Deployment 1 Scope This part of this Technical
35、 Report describes the general methodology to analyse interoperability requirements in support of a use case to produce the selection and combination of the relevant Profiles specified in TR 28380-2. It is illustrated by applying this methodology to a small number of examples. It also identifies and
36、proposes a high-level quantification of the benefits gained by the use of a profile based specification of interoperability. Finally this technical report will discuss the approach to effectively test interoperability from the specific of the standards and profiles, up to the level of business use c
37、ases. ISO/TR 28380-1 is a companion to this part of this Technical Report. ISO/TR 28380-1 describes how the IHE process identifies technical use cases for interoperability and specifies profiles of selected standards to support these carefully defined healthcare tasks that depend on electronic infor
38、mation exchange. The reader is encouraged to be familiar with this process followed by IHE in developing its Profiles. A wide portfolio of such profiles for Integration, Security, and Semantic Content is now available across various domains of healthcare clinical specialities and technologies, as de
39、scribed in ISO/TR 28380-2. The reader of this part of this Technical Report is encouraged to be familiar with this process followed by IHE in developing its Profiles as it builds upon ISO/TR 28380-1 and ISO/TR 28380-2 by addressing a number of key issues to support eHealth projects across all sector
40、s of health to more effectively deploy standards-based interoperability between software applications and devices, including within healthcare organizations and across healthcare and home settings. 2 Normative References ISO/TR 28380-1, Health informatics IHE global standards adoption Part 1: Proces
41、s ISO/TR 28380-2, He alt h inf or mat ic s IHE glob al s t andar d s adopt ion Par t 2: Int e gr at ion and c ont e nt pr o f ile s ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories 3 T erms a nd definiti ons For the purposes of this document, the terms a
42、nd definitions of ISO/TR 28380-1 and the following apply. 3.1 actors actors are information systems or components of information systems that produce, transmit or act on health information exchanged to support operational activities 3.2 eHealth refers to the combined use of electronic communication
43、and information technology in the health sector to enable better health and healthcare SOURCE: WHO TECHNICAL REPORT ISO/TR 28380-3:2014(E) ISO 2014 All rights reserved 1 ISO/TR 28380-3:2014(E) 3.3.1 electronic health record EHR information relevant to the wellness, health and healthcare of an indivi
44、dual, in computer-processable form and represented according to a standardized information model SOURCE: ISO 18308:2011, 3.20 3.3.2 electronic health record EHR longitudinal electronic record of an individual that contains or virtually interlinks to data in multiple EMRs and EPRs, which is to be sha
45、red and/or interoperable across healthcare settings and is patient-centric Note 1 to entry: Adapted from the European 2011 eHealth Strategies Final Report, January 2011. 3.4 health state of complete physical, mental and social well-being and not merely the absence of disease or infirmity SOURCE: WHO
46、 1948 3.5 health information information about a person relevant to his or her health SOURCE: ISO 18308:2011, 3.28 3.6 healthcare activities, services, or supplies related to the health of an individual SOURCE: EN 13940-1:2007 3.7 healthcare activity activity performed for a subject of care with the
47、 intention of directly or indirectly improving or maintaining the health of that subject of care SOURCE: EN 13940-1:2007 3.8 healthcare professional person authorized to be involved in the direct provision of certain healthcare provider activities in a jurisdiction according to a mechanism recognize
48、d in that jurisdiction Note 1 to entry: Adapted from EN 139401:2007. 3.9 healthcare provider healthcare organization or healthcare professional involved in the direct provision of healthcare SOURCE: EN 13940-1:2007 3.10 patient individual who is a subject of care SOURCE: ISO/TR 20514:2005, 2.302 ISO
49、 2014 All rights reserved ISO/TR 28380-3:2014(E) 3.11 policy set of rules such as legal, political or organizational which can be expressed as obligations, permissions or prohibitions Note 1 to entry: Adapted from ISO/TS 22600-1:2006, 2.13. 3.12 privacy freedom from intrusion into the private life or affairs of an individual when that intrusion results from undue or illegal gathering and use of data about that individual SOURCE: ISO/IEC 2382-8:1998, 08.01.23 3.13 registry serve
