Appendix C5 HL7 EHR System Functional Model

232 Pages·2017·1.97 MB·English

INVITATION TO DIALOGUE

Procurement of an
EHR solution
with adjacent systems and services

***

Invitation to Dialogue

Appendix C5 HL7 EHR-S Functional Model R2

Case number: 2016/238

HELSE MIDT-NORGE RHF (983 658 776) PAGE 1 of 3

Appendix C5 HL7 EHR System Functional Model v1.0
INVITATION TO DIALOGUE

History
Version Responsibility Date Comments/Changes
v1.0 Helseplattformen 02.02.2017 Version v1.0 sent to the Contractors

HELSE MIDT-NORGE RHF (983 658 776) PAGE 2 of 3

Appendix C5 HL7 EHR System Functional Model v1.0
INVITATION TO DIALOGUE

1 THE CUSTOMER’S USE OF THE HL7 EHR-S FUNCTIONAL
MODEL, RELEASE 2
This Appendix contains the HL7 Electronic Health Records System (EHR-S) Functional Model,
Release 2, which the Customer has used to define the ICT functionalities that the EHR solution must
include.
The Contractor should note that the Customer has chosen not to create Functional Profiles, but to
relate the EHR-S FM functions to the enterprise capabilities and the areas of particular focus to
Helseplattformen. The Customers’ additional requirements are not constructed in the same rigorous
way as the EHR-S FM conformance criteria. The Customer has nevertheless obtained some
inspiration from the syntax and language used in the EHR-S FM conformance criteria when
developing additional requirements, however this is not been carried out completely.
When the Customer refers to the HL7 EHR-S FM conformance criteria in the requirements table, the
requirements are expressed with different levels of importance, overriding the HL7 EHR-S
Functional Model’s SHALL/SHOULD/MAY keyword.

HELSE MIDT-NORGE RHF (983 658 776) PAGE 3 of 3

Appendix C5 HL7 EHR System Functional Model v1.0
Annex A

ANSI/HL7 EHR, R2-2014
4/21/2014
(revision of ANSI/HL7 EHR, R1-2007)

HL7 EHR-System Functional Model,
Release 2

April 2014

Sponsored by:
Electronic Health Records Working Group

Copyright © 2014 Health Level Seven International ® ALL RIGHTS RESERVED. The reproduction of this material in any form is
strictly forbidden without the written permission of the publisher. HL7 and Health Level Seven are registered trademarks of Health
Level Seven International. Reg. U.S. Pat & TM Off.
Document type: International Standard
Document subtype:
Document stage: (60) Publication
Document language: E
IMPORTANT NOTES:

HL7 licenses its standards and select IP free of charge. If you did not acquire a free license from HL7
for this document, you are not authorized to access or make any use of it. To obtain a free license, please
visit http://www.HL7.org/implement/standards/index.cfm.

If you are the individual that obtained the license for this HL7 Standard, specification or other freely
licensed work (in each and every instance "Specified Material"), the following describes the permitted uses
of the Material.

A. HL7 INDIVIDUAL, STUDENT AND HEALTH PROFESSIONAL MEMBERS, who register and agree to the
terms of HL7’s license, are authorized, without additional charge, to read, and to use Specified Material to
develop and sell products and services that implement, but do not directly incorporate, the Specified Material in
whole or in part without paying license fees to HL7.

INDIVIDUAL, STUDENT AND HEALTH PROFESSIONAL MEMBERS wishing to incorporate additional items of
Special Material in whole or part, into products and services, or to enjoy additional authorizations granted to
HL7 ORGANIZATIONAL MEMBERS as noted below, must become ORGANIZATIONAL MEMBERS of HL7.

B. HL7 ORGANIZATION MEMBERS, who register and agree to the terms of HL7's License, are authorized,
without additional charge, on a perpetual (except as provided for in the full license terms governing the
Material), non-exclusive and worldwide basis, the right to (a) download, copy (for internal purposes only) and
share this Material with your employees and consultants for study purposes, and (b) utilize the Material for the
purpose of developing, making, having made, using, marketing, importing, offering to sell or license, and selling
or licensing, and to otherwise distribute, Compliant Products, in all cases subject to the conditions set forth in
this Agreement and any relevant patent and other intellectual property rights of third parties (which may include
members of HL7). No other license, sublicense, or other rights of any kind are granted under this Agreement.

C. NON-MEMBERS, who register and agree to the terms of HL7’s IP policy for Specified Material, are
authorized, without additional charge, to read and use the Specified Material for evaluating whether to
implement, or in implementing, the Specified Material, and to use Specified Material to develop and sell
products and services that implement, but do not directly incorporate, the Specified Material in whole or in part.

NON-MEMBERS wishing to incorporate additional items of Specified Material in whole or part, into products
and services, or to enjoy the additional authorizations granted to HL7 ORGANIZATIONAL MEMBERS, as noted
above, must become ORGANIZATIONAL MEMBERS of HL7.

Please see http://www.HL7.org/legal/ippolicy.cfm for the full license terms governing the Material.
ISO TC 215/SC
Date: 2014-02-19
ISO 10781:2014(E)
ISO TC 215/SC /WG 1
Secretariat: ISO
Health Informatics — HL7 Electronic Health Records-System Functional
Model, Release 2
Informatic de santé — Modele fontionnel d'un systeme d'enreistrement de la santé HL7, version 2

Copyright notice
This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as permitted
under the applicable laws of the user's country, neither this ISO draft nor any extract from it may be
reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, photocopying,
recording or otherwise, without prior written permission being secured.
Requests for permission to reproduce should be addressed to either ISO at the address below or ISO's
member body in the country of the requester.
ISO copyright office Health Level 7 International
Case postale 56 • CH-1211 Geneva 20 3300 Washtenaw Ave., Suite 227, Ann Arbor, MI 48104 USA
Tel. + 41 22 749 01 11 Tel. + 1 734-677-7777
Fax + 41 22 749 09 47 Fax + 1 734-677-6622
E-mail [email protected] E-mail [email protected]
Web www.iso.org Web www.hl7.org
Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.
Contents
0.1 Notes to Readers ............................................................................................................................ 1
0.2 Changes from Previous Release .................................................................................................. 1
0.3 Background .................................................................................................................................... 1
0.3.1 What are Electronic Health Record Systems? ............................................................................ 1
0.3.2 Existing EHR System Definitions ................................................................................................. 2
0.3.3 How were the Functions Identified and Developed? .................................................................. 2
1 Scope ............................................................................................................................................... 2
1.1 EHR-S Functional Model Scope ................................................................................................... 3
2 Normative References ................................................................................................................... 4
3 Terms and Definitions ................................................................................................................... 4
4 Overview and Definition of the Functional Model (Normative) ................................................. 5
4.1 Sections of the Function List ........................................................................................................ 5
4.2 Functional Profiles ......................................................................................................................... 6
4.3 EHR-S Function List Components ............................................................................................... 6
4.3.1 Function ID (Normative) ................................................................................................................ 7
4.3.2 Function Type (Reference) ............................................................................................................ 7
4.3.3 Function Name (Normative) .......................................................................................................... 7
4.3.4 Function Statement (Normative) .................................................................................................. 8
4.3.5 Description (Reference) ................................................................................................................. 8
4.3.6 Conformance Criteria (Normative) ............................................................................................... 8
5 Anticipated Uses (Reference) ....................................................................................................... 8
5.1 Anticipated Development Approach: Functional Profiles ......................................................... 8
5.1.1 Scenario 1 – Group Practice ......................................................................................................... 9
5.1.2 Scenario 2 - Hospital ...................................................................................................................... 9
5.1.3 Scenario 3 - IT Vendor ................................................................................................................... 9
5.2 Examples of Current Use .............................................................................................................. 9
5.2.1 Functional Profile for Clinical Research based on the EHR-S FM ............................................ 9
5.2.2 AHRQ Announces Children’s Electronic Health Record Format ............................................ 10
5.3 Linking clinical content descriptions to the EHR-S FM (Reference) ...................................... 10
6 Conformance Clause ................................................................................................................... 11
6.1 Introduction (Reference) ............................................................................................................. 11
6.2 Scope and Field of Application (Normative) ............................................................................. 11
6.3 Concepts (Normative) .................................................................................................................. 11
6.3.1 Functional Profiles ....................................................................................................................... 11
6.3.2 Conformance Model ..................................................................................................................... 12
6.3.3 Profile Traceability ....................................................................................................................... 12
6.4 Normative Language (Normative) .............................................................................................. 13
6.5 Conformance Criteria (Normative) ............................................................................................. 13
6.5.1 Criteria in the Functional Profile ................................................................................................ 13
6.5.2 ‘Dependent SHALL’ Criteria ........................................................................................................ 13
6.5.3 Referencing Other Criteria or Functions ................................................................................... 13
6.6 Functional Model Structure and Extensibility (Normative) ...................................................... 14
6.6.1 Hierarchical Structure .................................................................................................................. 14
6.6.2 Naming Convention ..................................................................................................................... 15
6.6.3 Priorities ........................................................................................................................................ 15
6.6.4 Extensibility .................................................................................................................................. 15
6.7 Functional Profile Conformance (Normative) ........................................................................... 15
6.7.1 Rules for Functional Domain Profiles ........................................................................................ 15
6.7.2 Rules for Creating New Functions in Functional Profiles ....................................................... 16
6.7.3 Rules for Derived Functional Profiles ........................................................................................ 18
6.7.4 Conformance Statement .............................................................................................................. 18
6.7.5 Rules for Functional Companion Profiles ................................................................................. 18
6.8 Use Cases and Samples (Reference) ......................................................................................... 19
6.8.1 Functional Profile Use Cases ..................................................................................................... 19
6.8.2 Sample Functional Domain Profile Conformance Clauses ..................................................... 20
6.9 Interpreting and Applying a Conditional ‘SHALL’ (Reference) ............................................... 21
6.9.1 General Concepts ........................................................................................................................ 21
6.9.2 Rationale for ‘Dependent SHALL’ .............................................................................................. 22
6.9.3 How to Apply the ‘Dependent SHALL’ ....................................................................................... 22
7 Glossary ........................................................................................................................................ 23
7.1 Preface (Reference) ..................................................................................................................... 23
7.2 Introduction (Normative) ............................................................................................................. 24
7.3 Overview (Reference) .................................................................................................................. 24
7.4 Known Issues (Reference) .......................................................................................................... 24
7.5 The Action-Verb Structure (Normative) ..................................................................................... 24
7.5.1 Secure (System) Category .......................................................................................................... 25
7.5.2 Data Management Category ....................................................................................................... 25
7.5.3 How Action-Verbs are defined .................................................................................................... 26
7.5.4 Deprecated Verbs ........................................................................................................................ 26
7.6 Guidelines for Use (Reference) .................................................................................................. 26
7.6.1 General Guidance ........................................................................................................................ 26
7.6.2 Constructing Rigorous Conformance Criteria .......................................................................... 27
7.6.3 Examples of Rewording Conformance Criteria using the Proper Action-Verbs ................... 28
7.6.4 Clarification of Terms .................................................................................................................. 28
Annex A (normative) Function List ........................................................................................................ 30
Annex B (informative) Glossary of Terms for EHR-S FM .................................................................... 31
Annex C (informative) History of the Action-Verb Hierarchy .............................................................. 80
C.1 Original Trigger ............................................................................................................................ 80
C.2 How the first version of the Glossary was developed ............................................................. 80
C.3 Second version of the Glossary ................................................................................................. 80
C.4 Current version of the Glossary ................................................................................................. 80
Annex D (informative) Contributing Organizations .............................................................................. 82
Annex E (informative) Background ........................................................................................................ 83
E.1 What is HL7? ................................................................................................................................ 83
E.2 The HL7 Electronic Health Records Work Group ..................................................................... 83
E.3 What is the EHR-S Functional Model Package? ....................................................................... 83
Annex F (informative) Acknowledgements ........................................................................................... 85
F.1 General Acknowledgements ....................................................................................................... 85
F.2 Glossary Acknowledgements ..................................................................................................... 85
Annex G (informative) Other Offerings and Requests from the EHR Work Group ........................... 86