EN ISO 13940-2016 en Health informatics - System of concepts to support continuity of care《健康信息学 支持连续性护理的概念系统(ISO 13940 2015)》.pdf

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1、BSI Standards PublicationBS EN ISO 13940:2016Health informatics System of concepts to support continuity of careBS EN ISO 13940:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 13940:2016. It is identical to ISO 13940:2015. It supersedes BS EN 13940-1:20

2、07 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee IST/35, Health informatics.A list of organizations represented on this committee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 provisions of

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

4、r the authority of the Standards Policy and Strategy Committee on 29 February 2016.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 13940 January 2016 ICS 35.240.80 Supersedes EN 13940-1:2007English Version Health info

5、rmatics - 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 European Standard wa

6、s 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 concerning such

7、 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 into its own

8、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, France, Germany, Gr

9、eece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG

10、 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 13940:2016EN ISO 13940:2016 (E) 3 European foreword This document (EN ISO 13940:2016)

11、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 of an identical t

12、ext 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 held responsible

13、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, Croatia, Cyprus, Czec

14、h 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 the United Kingdom

15、. 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 vi0 Introduction .vii1 Scope . 12 Normative references 13 Terms and definitions . 13.1 Healthcare . 13.2 Concepts and terms 23.3 Actor

16、s 23.4 Resources . 33.5 Management 43.6 Process management . 53.7 Time 63.8 Responsibility 73.9 Information management 74 Symbols and abbreviations . 85 Concepts related to healthcare actors 95.1 General . 95.2 Healthcare actor 105.2.1 Subject of care .125.2.2 Next of kin . 145.2.3 Healthcare provid

17、er .155.2.4 Healthcare third party 216 Concepts related to healthcare matters 246.1 General 246.2 Healthcare matter 256.3 Health issue . 276.4 Health condition . 286.4.1 Observed condition 296.4.2 Potential health condition 316.5 Health state . 376.5.1 Input health state .386.5.2 Output health state

18、 .396.5.3 Health need 396.6 Health thread . 406.6.1 Clinical process interest 416.6.2 Health problem list .426.6.3 Health condition evolution. 427 Concepts related to activities .447.1 General 447.2 Healthcare activity 457.2.1 Healthcare provider activity . 477.2.2 Healthcare activity directory 487.

19、2.3 Self-care activity 487.2.4 Prescribed self-care 497.2.5 Healthcare third party activity . 507.2.6 Prescribed third party activity 517.2.7 Healthcare activity element. 517.2.8 Automated healthcare 607.2.9 Healthcare resource .617.2.10 Healthcare funds .638 Concepts related to process .65 ISO 2015

20、 All rights reserved iiiContents PageBS EN ISO 13940:2016ISO 13940:2015(E)8.1 General 658.2 Healthcare process . 658.2.1 Clinical process .668.2.2 Healthcare quality management . 688.2.3 Healthcare administration . 688.2.4 Adverse event 698.2.5 Adverse event management 698.2.6 Healthcare service .70

21、8.2.7 Healthcare service directory 709 Concepts related to healthcare planning .729.1 General 729.2 Care plan 739.2.1 Uniprofessional care plan . 749.2.2 Multi-professional care plan . 759.2.3 Core care plan 759.2.4 Clinical guideline.769.2.5 Health objective .789.2.6 Healthcare goal .799.2.7 Health

22、care activities bundle . 799.2.8 Needed healthcare activity . 8010 Concepts related to time 8210.1 General 8210.2 Health related period . 8210.2.1 Mandated period of care 8310.2.2 Healthcare activity period 8410.2.3 Healthcare activity delay 9010.2.4 Clinical process episode . 9310.2.5 Health condit

23、ion period 9310.2.6 Episode of care .9411 Concepts related to responsibilities .9711.1 General 9711.2 Healthcare mandate 9711.2.1 Demand mandate .9911.2.2 Care period mandate 10011.2.3 Healthcare activity mandate 10111.2.4 Continuity facilitator mandate .10211.2.5 Mandate to export personal informat

24、ion .10211.2.6 Informed consent 10311.2.7 Dissent 10411.2.8 Consent competence.10411.2.9 Authorization by law 10511.2.10 Healthcare commitment 10511.2.11 Subject of care desire .10611.3 Demand for care.10611.3.1 Demand for initial contact .10811.3.2 Referral .10811.3.3 Request .10911.3.4 Reason for

25、demand for care .11012 Concepts related to information management 11112.1 General .11112.2 Health record 11112.2.1 Professional health record 11312.2.2 Personal health record 11412.2.3 Health record component 11412.2.4 Electronic health record component 11512.3 Sharable data repository 116iv ISO 201

26、5 All rights reservedBS EN ISO 13940:2016ISO 13940:2015(E)12.4 Summarized healthcare information repository .11712.5 Health record extract .11712.5.1 Electronic health record extract .11812.5.2 Electronic patient summary.11912.5.3 Clinical Report 12012.5.4 Health concern .12312.5.5 Healthcare inform

27、ation request .12412.6 Certificate related to a healthcare matter 12513 Conformance 126Annex A (informative) Framework for the normative concepts in this International Standard 127Bibliography . 142 ISO 2015 All rights reserved vBS EN ISO 13940:2016ISO 13940:2015(E)ForewordISO (the International Org

28、anization 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 technical committee has been establi

29、shed 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 electrotechnical standardizatio

30、n.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 drafted in accordance with t

31、he 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 patent rights. Details of any pat

32、ent 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 constitute an endorsement.For

33、 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 informationThe committee responsible for t

34、his document is ISO/TC 215, Health informatics. vi ISO 2015 All rights reservedBS EN ISO 13940:2016ISO 13940:2015(E)0 Introduction0.1 GeneralThe purpose of this International Standard is to define the generic concepts needed to achieve continuity of care. Continuity of care is an important aspect of

35、 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 content and context of the healthcare services.Healthcare is provided through activities in healthcare and clinical processe

36、s. 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 perspective. To complete the concepts representing continuity of care, a number of basic premises for management, resource hand

37、ling 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 clinical process as focus, it defines its component concepts and their descriptive terms regarding all types of healthcare and

38、especially considering patient-centred continuity of care. This International Standard will establish a common conceptual framework across national, cultural and professional barriers.0.2 Aims for this International StandardThe general aim for this International Standard is to provide a comprehensiv

39、e, conceptual basis for content and context in healthcare services. It should be the foundation for interoperability at all levels in healthcare organizations and for development of information systems in healthcare.The concepts aim to support the continuity of care in healthcare with clinical proce

40、sses 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 healthcare is the interaction between subjects of care and healthcare professionals, such interactions occur in healthcare and clinical

41、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 International Standard is based upon the clinical perspective and has focus upon the clinical process as a main concept for achieving

42、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, management and resource aspects of healthcare.In practice this International Standard aims to be used whenever requirements for inf

43、ormation in healthcare are specified. This will cover all levels of specifications in the development of, enterprise models as a common basis for interoperability on international, national or local levels, information systems, and structured information for specified types of clinical processes.0.3

44、 About the concept of healthThis International Standard is based on the World Health Organizations (WHO) declaration of health from 1948: “. a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity”. In 1986 WHO made two amendments to the above de

45、finition: “resource for everyday life, not the objective of living” and “health is a positive concept emphasizing social and personal resources, as well as physical capacities”.In the International Classification of Functioning, Disability and Health (ICF) of WHO, the concept of health is categorize

46、d in a more specified way. The theoretical model in ICF identifies health components; body function, body structure, activity and participation, personal and environmental factors respectively. This International Standard applies the ICF model of health based on the health declaration. ISO 2015 All

47、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 within the scope of the standard. The word “health” is merely used as prefix in several terms. The meaning of this prefix is that the conc

48、ept 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 versus social careHealthcare as well as social care has the objective to influence, restore and maintain health in the WHO sense. All ki

49、nds 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 to healthcare and the terms chosen are from this sector. However, many of the concepts are relevant for the social care sector and through the c