1、BSI Standards PublicationBS EN ISO 10781:2015Health Informatics HL7Electronic Health Records-System Functional Model,Release 2 (EHR FM) (ISO10781:2015)BS EN ISO 10781:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO10781:2015. It supersedes BS EN ISO 107
2、81:2009 which is withdrawn.BSI, as a member of CEN, is obliged to publish EN ISO 10781 as aBritish Standard. However, attention is drawn to the fact that duringthe development of this European Standard, the UK committeevoted against its approval as a European Standard.The UK committee vote was not a
3、 comment on the quality ofthe specification, nor on its value in those situations where it isbeing used. Rather, the vote reflects the dual concerns that boththe method and the content are too specific, based primarily onrequirements from the US. The UK proposal was that this document should have be
4、en broughtforward within ISO/CEN as a Technical Specification, and not anInternational Standard, for the following reasons:a) While this is one reasonable way to specify Electronic HealthRecord (EHR) systems, it is not the only way or the best way in allsituations.b) The roles and functions of EHR s
5、ystems are evolving fast andso while it is useful to collaborate internationally on TechnicalSpecifications, it is not yet an area where international regulation orInternational Standards are helpful or appropriate.c) The boundary between EHR systems and Personal Health Records(PHR) systems is not c
6、lear cut, nor is the boundary between EHRsystems and Social Care. This is particularly important for the UK,where the direction is for integration across health and social care.The UK participation in its preparation was entrusted to TechnicalCommittee IST/35, Health informatics.A list of organizati
7、ons represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2015. Published by BSI StandardsLimited 2015ISBN 97
8、8 0 580 78183 4ICS 35.240.80Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 September 2015.Amendments/corrigenda issued since publicationDate Text affectedEUROP
9、EAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10781 August 2015 ICS 35.240.80 Supersedes EN ISO 10781:2009English Version Health Informatics - HL7 Electronic Health Records-System Functional Model, Release 2 (EHR FM) (ISO 10781:2015) Informatique de sant - Modle fonctionnel dun systme de dossi
10、er de sant lectronique, publication 2 (EHR FM) (ISO 10781:2015) Funktionales Modell fr ein elektronisches Gesundheitsaktensystem (EHRS FM), Ausgabe 2 (ISO 10781:2015) This European Standard was approved by CEN on 30 April 2015. CEN members are bound to comply with the CEN/CENELEC Internal Regulation
11、s 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 national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. Th
12、is 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 language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN mem
13、bers are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, 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, Portu
14、gal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any fo
15、rm and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 10781:2015 EBS EN ISO 10781:2015EN ISO 10781:2015 (E) 3 European foreword This document (EN ISO 10781:2015) has been prepared by Technical Committee ISO/TC 215 “Health informatics“ in collaboration with Technical Commit
16、tee CEN/TC 251 “Health informatics“, the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by February 2016, and conflicting national standards shall be withdrawn a
17、t the latest by February 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 for identifying any or all such patent rights. This document supersedes EN ISO 10781:2009. According t
18、o 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, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greec
19、e, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 10781:2015 has been approved by CEN as EN ISO 10781:2015 withou
20、t any modification. BS EN ISO 10781:2015ISO 10781:2015(E)Foreword vIntroduction vi1 Scope . 12 Normative references 23 Terms and definitions . 24 Overview and definition of the Functional Model (Normative). 34.1 Sections of the Function List . 44.2 Functional Profiles . 54.3 EHR-S Function List Comp
21、onents . 64.3.1 Function ID (Normative) . 74.3.2 Function Type (Reference) 74.3.3 Function Name (Normative) 74.3.4 Function Statement (Normative) . 84.3.5 Description (Reference) 84.3.6 Conformance Criteria (Normative) 85 Anticipated Uses (Reference) 85.1 Anticipated Development Approach: Functional
22、 Profiles . 85.1.1 Scenario 1 Group Practice . 95.1.2 Scenario 2 - Hospital . 95.1.3 Scenario 3 - IT Vendor . 95.2 Examples of Current Use . 105.2.1 Functional Profile for Clinical Research based on the EHR-S FM 105.2.2 AHRQ Announces Childrens Electronic Health Record Format 105.2.3 Linking clinica
23、l content descriptions to the EHR-S FM (Reference) 116 Conformance Clause 116.1 Introduction (Reference) 116.2 Scope and Field of Application (Normative) 116.3 Concepts (Normative) 126.3.1 Functional Profiles 126.3.2 Conformance Model .136.3.3 Profile Traceability 136.4 Normative Language (Normative
24、) 146.5 Conformance Criteria (Normative) 146.5.1 Criteria in the Functional Profile 146.5.2 Dependent SHALL Criteria . 146.5.3 Referencing Other Criteria or Functions 156.6 Functional Model Structure and Extensibility (Normative) .156.6.1 Hierarchical Structure 156.6.2 Naming Convention 176.6.3 Prio
25、rities 176.6.4 Extensibility 176.7 Functional Profile Conformance (Normative) 176.7.1 Rules for Functional Domain Profiles .176.7.2 Rules for Creating New Functions in Functional Profiles 196.7.3 Rules for Derived Functional Profiles .216.7.4 Conformance Statement . 226.7.5 Rules for Functional Comp
26、anion Profiles 226.8 Use Cases and Samples (Reference) 236.8.1 Functional Profile Use Cases . 236.8.2 Sample Functional Domain Profile Conformance Clauses 246.8.3 Interpreting and Applying a Conditional SHALL (Reference) .256.8.4 General Concepts 25 ISO 2015 All rights reserved iiiContents PageBS EN
27、 ISO 10781:2015ISO 10781:2015(E)6.8.5 Rationale for Dependent SHALL 266.8.6 How to Apply the Dependent SHALL 267 Glossary 287.1 Preface (Reference) 287.2 Introduction (Normative) . 287.3 Overview (Reference) 287.3.1 Known Issues (Reference) 297.4 The Action-Verb Structure (Normative) . 297.4.1 Secur
28、e (System) Category . 297.4.2 Data Management Category 307.4.3 How Action-Verbs are defined 307.4.4 Deprecated Verbs .317.5 Guidelines for Use (Reference) 317.5.1 General Guidance317.5.2 Constructing Rigorous Conformance Criteria .327.5.3 Examples of Rewording Conformance Criteria using the Proper A
29、ction-Verbs .33Annex A (normative) Function List .35Annex B (informative) Glossary of Terms for EHR-S FM 36Annex C (informative) History of the Action-Verb Hierarchy .60Annex D (informative) Contributing Organizations 63Annex E (informative) Background .64Annex F (informative) Acknowledgements 66Ann
30、ex G (informative) Other Offerings and Requests from the EHR Work Group .68Bibliography .69iv ISO 2015 All rights reservedBS EN ISO 10781:2015ISO 10781:2015(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies).
31、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. International organizations, governmental and non-g
32、overnmental, 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.International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
33、The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vo
34、te.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.ISO/HL7 10781 was prepared by Technical Committee ISO/TC 215, Health informatics.This second editio
35、n cancels and replaces the first edition (ISO/HL7 10781:2009), which has been technically revised. ISO 2015 All rights reserved vBS EN ISO 10781:2015ISO 10781:2015(E)IntroductionInformation for readersEHR System Functional Model Release 2.0 is based on a series of predecessors, starting in 2004 with
36、 the release of the first consensus Draft Standard, followed in 2007 by Release 1, then in 2009 with Release 1.1, jointly balloted with ISO/TC 215 and CEN/TC 251. Release 2.0 reflects many changes, including ballot comments that had been made on past ballots and where the HL7 EHR Work Group had comm
37、itted to bringing consideration of requested changes forward. It also includes comments that were considered for future use from the ISO ballot of 2009 as well as considerations of the Comment Only ballot that was circulated in May 2011.Other inclusions were made as a result of the multiple EHR Syst
38、em Functional Profiles that have been written on Functional Model Releases 1 and 1.1. There was great learning in those various domain as well as companion profiles. The EHR-S FM also incorporated two other Draft Standards for Trial Use: HL7 EHR Lifecycle Model and HL7 EHR Interoperability Model.Cha
39、nges from previous ReleaseThe HL7 EHR-System Functional Model Release 2 had its first normative ballot in May 2012. The key changes as a result of the first normative ballot included the following. Moved the normative parts of the Glossary into the Conformance clause section as use of glossary consi
40、stently is key to ease in reading and understanding the model. Improved consistency in representation of Headers, Functions and Conformance Criteria throughout the model. Updated the conformance clause for ease of reading especially as it related to the different types of profiles: domain profiles a
41、nd companion profiles. Provided clarity for functional description and related conformance criteria. Updated the content to be more current.To see all of the comments and reconciliation of the Normative 1 ballot, please see the HL7 Ballot Website for the ballot cycle of May 2012.BackgroundWhat are E
42、lectronic Health Record Systems?The effective use of information technology is a key focal point for improving healthcare in terms of patient safety, quality outcomes, and economic efficiency. A series of reports from the US Institute of Medicine (IOM) identifies a crisis of “system” failure and cal
43、ls for “system” transformation enabled by the use of information technology. Such a change is possible by “an infrastructure that permits fully interconnected, universal, secure network of systems that can deliver information for patient care anytime, anywhere.”(HHS Goals in “Pursuing HL7 EHR Functi
44、onal Standard” in Memorandum to HIMSS from C. Clancy and W. Raub co-chairs of HHS Council on the Application of Health Information Technology, dated November 12, 2003.) A critical foundational component for resolving these system and infrastructure issues is the Electronic Health Record System (EHR-
45、S).In developing this EHR-S Functional Model, HL7 relied on three well-accepted definitions: two provided by the US. Institute of Medicine and one developed by the European Committee for Standardization/ Comit Europen de Normalization (CEN). This Functional Model leverages these existing EHR-S defin
46、itions and does not attempt to create a redundant definition of an EHR-S.vi ISO 2015 All rights reservedBS EN ISO 10781:2015ISO 10781:2015(E)Existing EHR System DefinitionsThe IOMs 1991 report, The Computer-Based Patient Record: An Essential Technology, and updated in 1997 (Dick, R.S, Steen, E.B., a
47、nd Detmer, D.E. (Editors), National Academy Press: Washington, DC) defined an EHR System as follows. The set of components that form the mechanism by which patient records are created, used, stored, and retrieved. A patient record system is usually located within a health care provider setting. It i
48、ncludes people, data, rules and procedures, processing and storage devices (e.g. paper and pen, hardware and software), and communication and support facilities. The 2003 IOM Letter Report, Key Capabilities of an Electronic Health Record System, defined the EHR System as including: Longitudinal coll
49、ection of electronic health information for and about persons, where health information is defined as information pertaining to the health of an individual or health care provided to an individual. Immediate electronic access to person- and population-level information by authorized, and only authorized, users. Provision of knowledge and decision-support that enhance the quality, safety, and efficiency of patient care. Support of efficient processes for health care delivery.The 2003 ISO/TS 18308 references the IOM 1991 definition abov
