BS PD ISO TR 17522-2015 Health informatics Provisions for health applications on mobile smart devices《健康信息学 移动 智能设备上健康应用的规定》.pdf

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1、BSI Standards Publication PD ISO/TR 17522:2015 Health informatics Provisions for health applications on mobile/smart devicesPD ISO/TR 17522:2015 PUBLISHED DOCUMENT National foreword This Published Document is the UK implementation of ISO/TR 17522:2015. The UK participation in its preparation was ent

2、rusted 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

3、 British Standards Institution 2015. Published by BSI Standards Limited 2015 ISBN 978 0 580 82179 0 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

4、 on 31 August 2015. Amendments issued since publication Date Text affectedPD ISO/TR 17522:2015 ISO 2015 Health informatics Provisions for health applications on mobile/smart devices Informatique de sant Provisions pour les applications de sant sur les dispositifs smart/mobiles TECHNICAL REPORT ISO/T

5、R 17522 Reference number ISO/TR 17522:2015(E) First edition 2015-08-01PD ISO/TR 17522:2015ISO/TR 17522:2015(E)ii ISO 2015 All rights reserved COPYRIGHT PROTECTED DOCUMENT ISO 2015, Published in Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced

6、 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 the requester. ISO

7、 copyright office Ch. de Blandonnet 8 CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 copyrightiso.org www.iso.orgPD ISO/TR 17522:2015ISO/TR 17522:2015(E)Foreword iv Introduction v 1 Scope . 1 2 Normative references 1 3 T erms and definitions . 1 4 Symbols and

8、abbreviated terms . 3 5 Mobile health applications based on Registry and Repository (Reg/Rep) 5 5.1 Transportation of emergency patient . 6 5.2 Manage medication . 7 5.3 Telehealth 7 5.4 Referenced Standards . 7 6 Mobile health applications in a health provider . 8 6.1 Mobile electronic medical reco

9、rd system 8 6.2 Scheduling medical examination . 8 6.3 Manage chronic diseases patient 9 6.4 Nursing home . 9 6.5 Mobile PACS architecture . 9 6.6 Veterans personal electronic health record 10 7 Mobile medical application 10 7.1 Mobile application for the purpose of processing patient medical device

10、 data 11 7.2 Mobile application to function as a medical device .11 8 Analysis of required architectures for mHealth .12 8.1 IHE MHD 12 8.2 Mobile EMR .12 8.3 Mobile Medical Application 13 Bibliography .16 ISO 2015 All rights reserved iii Contents PagePD ISO/TR 17522:2015ISO/TR 17522:2015(E) Forewor

11、d 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 technica

12、l 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 ele

13、ctrotechnical 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

14、 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 pate

15、nt 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

16、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 the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information

17、The committee responsible for this document is ISO/TC 215, Health informatics.iv ISO 2015 All rights reservedPD ISO/TR 17522:2015ISO/TR 17522:2015(E) Introduction Development and implementation of smart devices are rapidly progressing around world. An appropriate deployment of smart health applicati

18、ons and services on smart device platforms will enhance various aspects of healthcare delivery. Smart devices will also enable health organizations to provide essential care and health information anytime, anywhere through information and telecommunications technologies. This includes a broad spectr

19、um of capabilities including health sensors, devices, manager, server, health information systems, and call centre services of patient information. Recent development of smart devices such as smart phone, TV, and electronic book where the patients services are stored and distributed securely wheneve

20、r necessary (sharing EHR information at point of care) requires a robust architecture to be able to manage the mobile data effectively. This Technical Report describes the status and requirements of health applications and services on smart devices platforms and suggests the reference architecture f

21、or these. The report is not intended to be prescriptive either from a methodological or technological perspective. ISO 2015 All rights reserved vPD ISO/TR 17522:2015PD ISO/TR 17522:2015Health informatics Provisions for health applications on mobile/smart devices 1 Scope This Technical Report is appl

22、icable to the developments of smart health applications available anywhere, anytime and supporting new health businesses based on the smart devices. This Technical Report is to investigate the areas of ongoing developments and analyses of emerging interoperability standards for smart mobile devices.

23、 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amen

24、dments) applies. There are no normative references. 3 T erms a nd definiti ons For the purposes of this document, the following terms and definitions apply. 3.1 accelerometer device that measures proper acceleration 3.2 access provision of an opportunity to approach, inspect, review, make use of dat

25、a, or information 3.3 android open source operating system for mobile devices developed by a group of organizations led by Google 3.4 application software program or set of related programs that provide some useful healthcare capability or functionality 3.5 Apple iOS previously iPhone OS mobile oper

26、ating system developed by Apple Inc. and distributed exclusively for Apple hardware Note 1 to entry: It is the operating system (3.12) that powers iPhone, iPad, iPod Touch, and Apple TV. 3.6 BlackBerry line of wireless handheld devices and services (3.20) designed and marketed by BlackBerry Limited,

27、 formerly known as Research In Motion Limited 3.7 bluetooth standard for sending information wirelessly over short distances TECHNICAL REPORT ISO/TR 17522:2015(E) ISO 2015 All rights reserved 1PD ISO/TR 17522:2015ISO/TR 17522:2015(E) 3.8 healthcare professional person entrusted with the direct or in

28、direct provision of defined healthcare services to a subject of care or population of subjects of care 3.9 electronic health record health record with data structured and represented in a manner suited to computer calculation and presentation 3.10 medical device instrument, apparatus, implant, in vi

29、tro reagent, or similar or related article that is used to diagnose, prevent, or treat disease or other conditions and does not achieve its purposes through chemical action within or on the body 3.11 metadata “data about data” Note 1 to entry: The term is ambiguous, as it is used for two fundamental

30、ly different concepts. 3.12 operating system set of programs that provide basic operating functions for hardware devices EXAMPLE Starting up the device and running other software applications. 3.13 out-of-the-box functions used to describe the functions of a device that run when you first buy it and

31、 start it up without the need to purchase or install any additional software or hardware 3.14 patient individual person that is a subject of care 3.15 personal health record may have contributions from providers of healthcare and the person or their carer/s Note 1 to entry: The legal rules for a hea

32、lth record still apply to this record. 3.16 picture archiving and communication system PACS application system that uses an image server to exchange X-rays, CT scans, and other medical images over a network 3.17 registry collection of all the official records relating to something or the place where

33、 they are kept 3.18 repository place where something is kept safely 3.19 security combination of confidentiality, integrity, and availability2 ISO 2015 All rights reservedPD ISO/TR 17522:2015ISO/TR 17522:2015(E) 3.20 service specific behaviour that a communication party in a specific role is respons

34、ible for exhibiting 3.21 smartphone additional features usually include media player and the ability to run mobile apps Note 1 to entry: There is no single fixed definition of a smartphone. 3.22 standard technical specification which addresses a business requirement, has been implemented in viable c

35、ommercial products, and, to the extent practical, complies with recognized standards organizations such as ISO 3.23 tablet computer mobile computer based around a flat touchscreen operated by finger or stylus 3.24 Windows phone Windows mobile proprietary smartphone operating system developed by Micr

36、osoft 3.25 data carrier all-encompassing term covering the different encoding modalities for machine readable data applied to the product packaging or directly to the product Note 1 to entry: The possibilities include barcodes both 1 and 2 dimensions and radio frequency identification tags. It is cr

37、itical to standards based mobile applications that the data is represented in symbol using ISO based standards such as GS1 and industry adopted guidelines. 3.26 vital sign clinical information relating to one or more patients (3.14) that is measured by or derived from apparatus connected to the pati

38、ent, or otherwise gathered from the patient 3.27 healthcare provider healthcare organization or healthcare professional (3.8) responsible for the provision of healthcare to a subject of care or to a population 4 Symbols and abbreviated terms AAC Augmentative and Alternative Communication: Communicat

39、ion methods such as use of signs, symbols, or software tools to help people who have problems with the use of speech or written language to express themselves and communicate API Application Programming Interface: An interface that allows one piece of software to interact with another allowing devel

40、opers to add new functions on top of existing software BECS Blood Establishment Computer Software CDA Clinical Document Architecture DOC Document query ISO 2015 All rights reserved 3PD ISO/TR 17522:2015ISO/TR 17522:2015(E) ebXML Electronic Business Extensible Markup Language ECG Electrocardiogram EC

41、G/EKG Electrocardiography is the recording of the electrical activity of the heart EHR Electronic Health Record FDA Food and Drug Administration FHIR Fast Healthcare Interoperability Resources GS1 General Specifications and Standards HL7 Health Level 7 HIE Health Information Exchange HTTP Hypertext

42、Transfer Protocol IHE Integrating the Healthcare Enterprise ISO International Organization for Standardization JSON JavaScript Object Notation MHD 38 Mobile Access to Health Documents OASIS Organization for the Advancement of Structured Information Standards OS Operating System PACS Picture Archivin

43、g and Communication System PCD Patient Care Device PDQ Patient Demographics Query PHR Personal Health Record PIX 37 Patient Identifier Cross Referencing PMA Premarket Approval QPB Query by Parameter/Segment Pattern Response QRY Query, original mode RHEx RESTful Health Exchange RIM Reference Informat

44、ion Model RS Registry Service RSP Segment Pattern Response RTB Tabular Response SDK Software Development Kit: A set of software tools that enable a developer to create applications for a specific operating system or other software environment4 ISO 2015 All rights reservedPD ISO/TR 17522:2015ISO/TR 1

45、7522:2015(E) WAI Web Accessibility Initiative: A project of workstream of the W3C (see below) that develops guidelines and techniques to make the web more accessible. Website: www.w3.org/WAI W3C World Wide Web Consortium: An open, collaborative international community of technology organizations, ac

46、ademic bodies, and others which creates and maintains the webs core technical standards. Website: www.w3.org XDS Cross Enterprise Document Sharing XDW 36 Cross-Enterprise Document Workflow XML Extensible Markup Language 5 Mobile health applications based on Registry and Repository (Reg/Rep) The mobi

47、le access to health documents (MHD) profile a) defines a simple HTTP interface to an XDS like environment, and b) defines transactions to 1) submit a new document and metadata from the mobile device to a document receiver, 2) get the metadata for an identified document, 3) find document entries cont

48、aining metadata based on query parameters, and 4) retrieve a copy of a specific document. The above four transactions leverage the document content and format agnostic metadata concepts from XDS, but simplify them for access by constrained environments such as mobile devices. The MHD profile does no

49、t replace XDS. It can be used to allow mobile devices constrained access to an XDS health information exchange. Figure 1 shows one possible way to implement the MHD with a document sharing environment (that may, but is not necessarily, XDS based). NOTE From Reference 38, Figure 1. Figure 1 Mobile access to a document sharing environment ISO 2015 All rights reserved 5PD ISO/TR 17522:2015ISO/TR 17522:2015(E) The MHD profile supports a broad set of the XDS use cases and functionality while keeping the technology as simple as possib