ISO TS 13131-2014 Health informatics - Telehealth services - Quality planning guidelines《健康信息学 远程医疗服务 质量计划指南》.pdf

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1、 ISO 2014 Health informatics Telehealth services Quality planning guidelines Informatique de sant Services de tlsant Lignes directrices pour la planification de la qualit TECHNICAL SPECIFICATION ISO/TS 13131 Reference number ISO/TS 13131:2014(E) First edition 2014-12-15 ISO/TS 13131:2014(E)ii ISO 20

2、14 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, electronic or mechanical, including photocopying, or posting on the internet or an intranet,

3、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. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Publishe

4、d in Switzerland ISO/TS 13131:2014(E)Contents Page Foreword v Introduction vi 1 Scope . 1 2 Normative references 1 3 T erms and definitions . 1 3.1 Quality characteristics 1 3.2 Actors 3 3.3 Care . 5 3.4 Quality 7 3.5 Risk 8 3.6 Telehealth 9 4 Conformance 10 5 Quality and risk management .10 5.1 Tel

5、ehealth risk, safety and quality assessment 10 5.2 Telehealth quality characteristics 10 5.3 Management of quality characteristics .11 5.4 Establishing the context for telehealth services .12 5.5 Risk assessment Identification .12 5.6 Risk assessment Analysis 12 5.7 Risk assessment Evaluation 12 5.8

6、 Risk treatment and quality 13 6 Quality management of telehealth services 13 6.1 Quality characteristics .13 6.2 Services description 13 6.3 Processes description 14 6.4 Quality planning 14 6.5 Risk assessment 14 6.6 Risk treatment 15 6.7 Service improvement .15 6.8 Safety improvement 15 7 Financia

7、l management 15 7.1 Quality characteristics .15 7.2 Sustainability .16 7.3 Healthcare funds 16 8 Service planning 16 8.1 Quality characteristics .16 8.2 Service design .17 8.3 Service levels .17 8.4 Duration of care .17 9 Workforce planning17 9.1 Quality characteristics .17 9.2 Workforce skills and

8、training 18 9.3 Consultation with workforce .18 ISO 2014 All rights reserved iii ISO/TS 13131:2014(E)10 Healthcare planning 18 10.1 Quality characteristics .18 10.2 Healthcare processes 18 10.3 Healthcare plans .19 10.4 Healthcare continuity .19 10.5 Unavailable clinical guidelines and protocols .19

9、 10.6 Adverse event management .19 10.7 Professional health record management 20 11 Responsibilities 20 11.1 Quality characteristics .20 11.2 Healthcare mandate 20 11.3 Informed consent .21 11.4 Care recipient preferences .21 11.5 Care recipients expenses .22 11.6 Appropriate healthcare services 22

10、11.7 Competence of care recipients .22 11.8 Execution of healthcare plan 23 12 Facilities management 23 12.1 Quality characteristics .23 12.2 Healthcare organization facilities 23 12.3 Care recipient facilities .24 13 Technology management 24 13.1 Quality characteristics .24 13.2 Service support 25

11、13.3 Service delivery .25 13.4 Infrastructure management .25 13.5 Deployment management 26 13.6 Operations management .26 13.7 Technical support 27 14 Information management 27 14.1 Quality characteristics .27 14.2 Privacy .27 14.3 Care recipient identity .28 14.4 Confidentiality of health records 2

12、8 14.5 Consultations, ordering and prescribing .28 14.6 Coordination and scheduling .28 14.7 Data quality .29 Annex A (informative) Examples of telehealth risk assessments 30 Bibliography .32 iv ISO 2014 All rights reserved ISO/TS 13131:2014(E) Foreword ISO (the International Organization for Standa

13、rdization) 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 t

14、o 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 us

15、ed 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

16、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 identifi

17、ed 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

18、 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 document is I

19、SO/TC 215, Health Informatics. ISO 2014 All rights reserved v ISO/TS 13131:2014(E) Introduction Aging populations are driving the demand for healthcare in many countries. Extended life expectancy will bring increased health issues for many people. Health systems are seeking to lower the demand for h

20、ospital beds by shortening the periods of hospitalization and providing more health care outside of the acute sector. The acute sector can also be geographically concentrated in capital cities which increases the potential demand for health services in primary care, community care settings, and prev

21、entative health care. Despite such measures, the demand for healthcare professionals and resources is likely to increase across all these care settings. The use of information and communication technologies (ICT) is growing within the healthcare sector. The applications for ICT include devices and e

22、quipment that have embedded software. Originally, ICT was mainly used only within larger healthcare organizations, but has now spread throughout the healthcare sector. Applications and devices that use many types of information and communication technologies, including embedded software are now wide

23、ly available for use in hospital clinics and the homes of patients or clients. Healthcare organizations and healthcare supporting organizations can provide or support healthcare services using information and communications technologies (ICTs) to deliver health services and transmit health informati

24、on over both long and short distances. The use of ICT in this way is known as telehealth or telemedicine services. Although the use of ICT applications to deliver health care in community settings, in patients homes, and connect healthcare professionals is seen as advantageous, there are additional

25、risks to the quality of health care services when delivered at a distance using ICT. This Technical Specification provides guidelines on the development of quality plans to manage these risks. These guidelines are intended for use by healthcare organizations and healthcare supporting organizations.

26、A quality plan identifies the desired quality characteristics, related quality objectives, and quality procedures. This Technical Specification provides examples of generally applicable quality plans applicable to telehealth services.vi ISO 2014 All rights reserved Health informatics Telehealth serv

27、ices Quality planning guidelines 1 Scope A growing number of initiatives in various countries around the world, most of them small-scale, are described as telehealth or telemedicine or m-health projects. It is not yet clear when the term telehealth or telemedicine should be used to describe such ini

28、tiatives, because these terms can be described and interpreted in different ways in the absence of a unifying concept. Telehealth is the use of information and communications technologies to deliver healthcare and transmit health information over both long and short distances. Telehealth is a form o

29、f care provision that extends the reach of care, reduces the need for care recipient or client travel and mobility, supports choice in healthcare service delivery, preventative care, individual self-care, and may also increase the efficiency of care. Currently telemedicine is seen as a providing a s

30、ubset of a broader suite of telehealth services. Telehealth also includes ICT applications that support a wider set of activities including educational and administrative use. This Technical Specification provides advice and recommendations on how to develop quality objectives and guidelines for tel

31、ehealth services that that use information and communications technologies (ICTs) to deliver healthcare over both long and short distances by using a risk management process. The following key requirements are considered when developing quality objectives and guidelines for telehealth services: mana

32、gement of telehealth quality processes by the healthcare organization; management of financial resources to support telehealth services; processes relating to people such as workforce planning, healthcare planning, and responsibilities; provision of infrastructure and facilities resources for telehe

33、alth services; management of information and technology resources used in telehealth services. 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 appl

34、ies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 31000:2009, Risk management Principles and guidelines 3 T erms a nd definiti ons For the purposes of this document, the following terms and definitions apply. 3.1 Quality characteristic

35、s 3.1.1 accessibility usability of a product, service, environment, or facility by people within the widest range of capabilities EXAMPLE Accessibility of healthcare for recipients. SOURCE: Based on ISO 9241-20 TECHNICAL SPECIFICATION ISO/TS 13131:2014(E) ISO 2014 All rights reserved 1 ISO/TS 13131:

36、2014(E) 3.1.2 accountability responsibility of an organization for its decisions and activities, and state of being answerable to its governing bodies, legal authorities, and, more broadly, its other stakeholders regarding these decisions and activities EXAMPLE Accountability for healthcare activiti

37、es delivered by a healthcare organization. SOURCE: ISO 26000, 2.1, modified 3.1.3 appropriateness extent to which healthcare activities enable care recipients to achieve specified objectives EXAMPLE Appropriateness of a healthcare activity for care recipients and healthcare organizations. SOURCE: IS

38、O/IEC 25010, modified 3.1.4 competency ability to apply knowledge and skills to achieve intended results EXAMPLE Competency to participate in healthcare activities of care recipients or healthcare professionals. SOURCE: ISO/IEC 17021:2011, 3.7 3.1.5 c on f ide nt i a l i t y extent to which informat

39、ion is not made available or disclosed to unauthorized entities Note 1 to entry: In this context, entities include individuals, processes, and healthcare actors. EXAMPLE Confidentiality of information to maintain the privacy of the care recipient in society or social life. SOURCE: ISO/IEC 27000:2014

40、, modified 3.1.6 continuity component of patient care quality consisting of the degree to which the care needed by a patient is coordinated among practitioners and across organizations and time EXAMPLE Continuity of healthcare especially when several healthcare professionals or organizations share t

41、he delivery of services to a single care recipient. SOURCE: ISO/TR 18307:2001 3.1.7 dependability collective term used to describe the availability performance and its influencing factors, reliability performance, maintainability performance, and maintenance support performance EXAMPLE Dependability

42、 of healthcare for care recipients and healthcare organizations. SOURCE: ISO 9000:2005, 3.5.3 3.1.8 effectiveness extent to which planned activities are realized and planned results achieved EXAMPLE Effectiveness of healthcare activities in improving the quality of life and health outcomes of care r

43、ecipients and their informal caregivers. SOURCE: ISO 9000:2005, 3.2.142 ISO 2014 All rights reserved ISO/TS 13131:2014(E) 3.1.9 ef f ic ienc y relationship between the results achieved and how well the resources have been used EXAMPLE Efficiency of healthcare activities in improving the quality of l

44、ife and health outcomes of care recipients and healthcare providers. SOURCE: ISO/IEC 27000:2014, 2.14 3.1.10 inclusivity intention or policy of including people who might otherwise be excluded or marginalized, such as the handicapped, learning-disabled, or racial and sexual minorities EXAMPLE Inclus

45、ivity of the care recipient in society or social life. Note 1 to entry: Refer to ISO 26000 for further discussion of this concept. SOURCE: The Oxford Pocket Dictionary of Current English, 2009 3.1.11 safety freedom from unacceptable risk or harm EXAMPLE Safety measures that maintain the health of ca

46、re recipients and healthcare professionals. SOURCE: ISO/IEC Guide 51:1999, modified 3.1.12 transparency openness about decisions and activities that affect the care recipient, and willingness to communicate these in a clear, accurate, timely, honest, and complete manner EXAMPLE Transparency of healt

47、hcare activities. SOURCE: ISO 26000:2010, 2.1.24, modified 3.1.13 usability extent to which a product can be used by specified users to achieve specified goals with effectiveness, efficiency, and satisfaction in a specified context of use EXAMPLE Usability of the systems providing healthcare for car

48、e recipients and healthcare professionals. SOURCE: ISO 9241:2011 3.2 Actors 3.2.1 care recipient person seeking to receive, receiving, or having received healthcare Note 1 to entry: Based on ISO 13940:, 5.2.1 definition of subject of care 3.2.2 client person seeking to receive, receiving, or having

49、received healthcare EXAMPLE A client may have a contract or agreement for the provision of healthcare using telehealth. If the subject of care is not capable of engaging in an agreement, a subject of care proxy or a legally authorized proxy may act on behalf of the client. SOURCE: Based on ISO 13940:, 5.2.1 ISO 2014 All rights reserved 3 ISO/TS 13131:2014(E) 3.2.3 healthcare actor organization or person participating in healthcare Note 1 to entry: An individual person may be regarded as a le