BS EN ISO 13940-2016 Health informatics System of concepts to support continuity of care《保健信息学 保障保健持续性概念系统》.pdf

1、BSI Standards Publication BS EN ISO 13940:2016 Health informatics System of concepts to support continuity of careBS EN ISO 13940:2016 BRITISH STANDARD National foreword This British Standard is the UK implementation of EN ISO 13940:2016. It is identical to ISO 13940:2015. It supersedes BS EN 13940-

2、1:2007 which is withdrawn. The UK participation in its preparation 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 provis

3、ions of a contract. Users are responsible for its correct application. The British Standards Institution 2016. Published by BSI Standards Limited 2016 ISBN 978 0 580 77253 5 ICS 35.240.80 Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was publ

4、ished under the authority of the Standards Policy and Strategy Committee on 29 February 2016. Amendments/corrigenda issued since publication Date T e x t a f f e c t e d EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 13940 January 2016 ICS 35.240.80 Supersedes EN 13940-1:2007 English Versi

5、on Health informatics - System of concepts to support continuity of care (ISO 13940:2015) Informatique de sant - Systme de concepts en appui de la continuit des soins (ISO 13940:2015) Medizinische Informatik - Begriffssystem zur Untersttzung der Kontinuitt der Versorgung (ISO 13940:2015) This Europe

6、an Standard was approved by CEN on 19 September 2015. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references c

7、oncerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member

8、 into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, Franc

9、e, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOM

10、ITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 13940:2016 EBS EN ISO 13940:2016 EN ISO 13940:2016 (E) 3 European foreword This document (EN

11、ISO 13940:2016) has been prepared by Technical Committee ISO/TC 215 “Health informatics“ in collaboration with Technical Committee CEN/TC 251 “Health informatics” the secretariat of which is held by NEN. This European Standard shall be given the status of a national standard, either by publication o

12、f an identical text or by endorsement, at the latest by July 2016, and conflicting national standards shall be withdrawn at the latest by July 2016. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be h

13、eld responsible for identifying any or all such patent rights. This document supersedes EN 13940-1:2007. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croat

14、ia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and th

15、e United Kingdom. Endorsement notice The text of ISO 13940:2015 has been approved by CEN as EN ISO 13940:2016 without any modification. BS EN ISO 13940:2016ISO 13940:2015(E)Foreword vi 0 Introduction .vii 1 Scope . 1 2 Normative references 1 3 T erms and definitions . 1 3.1 Healthcare . 1 3.2 Concep

16、ts and terms 2 3.3 Actors 2 3.4 Resources . 3 3.5 Management 4 3.6 Process management . 5 3.7 Time 6 3.8 Responsibility 7 3.9 Information management 7 4 Symbols and abbreviations . 8 5 Concepts related to healthcare actors 9 5.1 General . 9 5.2 Healthcare actor 10 5.2.1 Subject of care .12 5.2.2 Nex

17、t of kin .14 5.2.3 Healthcare provider .15 5.2.4 Healthcare third party . .21 6 Concepts related to healthcare matters 24 6.1 General 24 6.2 Healthcare matter25 6.3 Health issue .27 6.4 Health condition .28 6.4.1 Observed condition 29 6.4.2 Potential health condition 31 6.5 Health state .37 6.5.1 In

18、put health state .38 6.5.2 Output health state .39 6.5.3 Health need 39 6.6 Health thread .40 6.6.1 Clinical process interest 41 6.6.2 Health problem list .42 6.6.3 Health condition evolution.42 7 Concepts related to activities .44 7.1 General 44 7.2 Healthcare activity 45 7.2.1 Healthcare provider

19、activity .47 7.2.2 Healthcare activity directory 48 7.2.3 Self-care activity 48 7.2.4 Prescribed self-care 49 7.2.5 Healthcare third party activity .50 7.2.6 Prescribed third party activity 51 7.2.7 Healthcare activity element.51 7.2.8 Automated healthcare 60 7.2.9 Healthcare resource .61 7.2.10 Hea

20、lthcare funds .63 8 Concepts related to process .65 ISO 2015 All rights reserved iii Contents PageBS EN ISO 13940:2016ISO 13940:2015(E)8.1 General 65 8.2 Healthcare process .65 8.2.1 Clinical process .66 8.2.2 Healthcare quality management .68 8.2.3 Healthcare administration .68 8.2.4 Adverse event

21、69 8.2.5 Adverse event management 69 8.2.6 Healthcare service .70 8.2.7 Healthcare service directory 70 9 Concepts related to healthcare planning .72 9.1 General 72 9.2 Care plan 73 9.2.1 Uniprofessional care plan .74 9.2.2 Multi-professional care plan .75 9.2.3 Core care plan 75 9.2.4 Clinical guid

22、eline.76 9.2.5 Health objective .78 9.2.6 Healthcare goal .79 9.2.7 Healthcare activities bundle .79 9.2.8 Needed healthcare activity .80 10 Concepts related to time 82 10.1 General 82 10.2 Health related period .82 10.2.1 Mandated period of care 83 10.2.2 Healthcare activity period 84 10.2.3 Health

23、care activity delay90 10.2.4 Clinical process episode .93 10.2.5 Health condition period 93 10.2.6 Episode of care .94 11 Concepts related to responsibilities .97 11.1 General 97 11.2 Healthcare mandate 97 11.2.1 Demand mandate .99 11.2.2 Care period mandate 100 11.2.3 Healthcare activity mandate 10

24、1 11.2.4 Continuity facilitator mandate .102 11.2.5 Mandate to export personal information .102 11.2.6 Informed consent 103 11.2.7 Dissent 104 11.2.8 Consent competence.104 11.2.9 Authorization by law 105 11.2.10 Healthcare commitment 105 11.2.11 Subject of care desire .106 11.3 Demand for care.106

25、11.3.1 Demand for initial contact .108 11.3.2 Referral .108 11.3.3 Request .109 11.3.4 Reason for demand for care .110 12 Concepts related to information management 111 12.1 General .111 12.2 Health record 111 12.2.1 Professional health record 113 12.2.2 Personal health record 114 12.2.3 Health reco

26、rd component 114 12.2.4 Electronic health record component 115 12.3 Sharable data repository 116 iv ISO 2015 All rights reservedBS EN ISO 13940:2016ISO 13940:2015(E)12.4 Summarized healthcare information repository .117 12.5 Health record extract .117 12.5.1 Electronic health record extract .118 12.

27、5.2 Electronic patient summary.119 12.5.3 Clinical Report 120 12.5.4 Health concern .123 12.5.5 Healthcare information request .124 12.6 Certificate related to a healthcare matter 125 13 Conformance 126 Annex A (informative) Framework for the normative concepts in this International Standard 127 Bib

28、liography .142 ISO 2015 All rights reserved vBS EN ISO 13940:2016ISO 13940:2015(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 is normally carried out throu

29、gh 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 part in the work. ISO collabora

30、tes 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 particular the different approval c

31、riteria 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 this document may be the subjec

32、t 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.iso.org/patents). Any trade

33、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 the WTO principles in the Tech

34、nical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information The committee responsible for this document is ISO/TC 215, Health informatics. vi ISO 2015 All rights reservedBS EN ISO 13940:2016ISO 13940:2015(E) 0 Introduction 0.1 General The purpose of this International S

35、tandard is to define the generic concepts needed to achieve continuity of care. Continuity of care is an important aspect of quality and safety in healthcare and semantic interoperability is a basic requirement for continuity of care. The concepts that are needed for these should represent both the

36、content and context of the healthcare services. Healthcare is provided through activities in healthcare and clinical processes. These types of processes reflect the interaction between a subject of care and healthcare professionals. A clinical process provides continuity from the subject of cares pe

37、rspective. To complete the concepts representing continuity of care, a number of basic premises for management, resource handling and administration are also needed. The system of concepts for continuity of care defined in this International Standard is based upon the clinical perspective with the c

38、linical process as focus, it defines its component concepts and their descriptive terms regarding all types of healthcare and especially considering patient-centred continuity of care. This International Standard will establish a common conceptual framework across national, cultural and professional

39、 barriers. 0.2 Aims for this International Standard The general aim for this International Standard is to provide a comprehensive, conceptual basis for content and context in healthcare services. It should be the foundation for interoperability at all levels in healthcare organizations and for devel

40、opment of information systems in healthcare. The concepts aim to support the continuity of care in healthcare with clinical processes as the focus, enabling the use of healthcare information for other purposes such as secondary use for follow-up and knowledge management. The core business in healthc

41、are is the interaction between subjects of care and healthcare professionals, such interactions occur in healthcare and clinical processes and are the justification for the process approach of this International Standard. To be able to represent both clinical content and clinical context, this Inter

42、national Standard is based upon the clinical perspective and has focus upon the clinical process as a main concept for achieving continuity of care. To be able to support continuity of care, the standard also aims to include comprehensive concept definitions and concept relations for the clinical, m

43、anagement and resource aspects of healthcare. In practice this International Standard aims to be used whenever requirements for information in healthcare are specified. This will cover all levels of specifications in the development of, enterprise models as a common basis for interoperability on int

44、ernational, national or local levels, information systems, and structured information for specified types of clinical processes. 0.3 About the concept of health This International Standard is based on the World Health Organizations (WHO) declaration of health from 1948: “. a state of complete physic

45、al, mental and social well-being and not merely the absence of disease or infirmity”. In 1986 WHO made two amendments to the above definition: “resource for everyday life, not the objective of living” and “health is a positive concept emphasizing social and personal resources, as well as physical ca

46、pacities”. In the International Classification of Functioning, Disability and Health (ICF) of WHO, the concept of health is categorized in a more specified way. The theoretical model in ICF identifies health components; body function, body structure, activity and participation, personal and environm

47、ental factors respectively. This International Standard applies the ICF model of health based on the health declaration. ISO 2015 All rights reserved viiBS EN ISO 13940:2016ISO 13940:2015(E) In this International Standard, the word “health” is not used as an isolated term designating any concept wit

48、hin the scope of the standard. The word “health” is merely used as prefix in several terms. The meaning of this prefix is that the concept represented by the term has to do with the subject of cares health state or health condition, often in relation to a healthcare/clinical process. 0.4 Healthcare

49、versus social care Healthcare as well as social care has the objective to influence, restore and maintain health in the WHO sense. All kinds of activities that have the potential to influence any one of the five components of health mentioned in the ICF model can be a part of such care. There is an evident overlap between healthcare activities and social care activities. This International Standard is focused upon the part of healthcare that (in most cultures) does not include social care. The role of the subject of care is defined with respect t