EN ISO 10781:2015

SLOVENSKI STANDARD
01-december-2015
Nadomešča:
SIST EN ISO 10781:2010
Funkcionalni model za sistem elektronskih zdravstvenih zapisov (ISO 10781:2015)
Electronic health record-system functional model (ISO 10781:2015)
Funktionales Modell für ein elektronisches Gesundheitsaktensystem (ISO 10781:2015)
Modèle fonctionnel d'un système de dossier informatisé de santé (ISO 10781:2015)
Ta slovenski standard je istoveten z: EN ISO 10781:2015
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 10781
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2015
ICS 35.240.80 Supersedes EN ISO 10781:2009
English Version
Health Informatics - HL7 Electronic Health Records-System
Functional Model, Release 2 (EHR FM) (ISO 10781:2015)
Informatique de santé - Modèle fonctionnel d'un système de Funktionales Modell für ein elektronisches
dossier de santé électronique, publication 2 (EHR FM) (ISO Gesundheitsaktensystem (EHRS FM), Ausgabe 2 (ISO
10781:2015) 10781:2015)
This European Standard was approved by CEN on 30 April 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 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 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, 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
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10781:2015 E
worldwide for CEN national Members.

Contents Page
European foreword .3
European foreword
This document (EN ISO 10781:2015) 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 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
at 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 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, 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 the United Kingdom.
Endorsement notice
The text of ISO 10781:2015 has been approved by CEN as EN ISO 10781:2015 without any modification.
INTERNATIONAL ISO
STANDARD 10781
Second edition
2015-08-01
Health Informatics — HL7 Electronic
Health Records-System Functional
Model, Release 2 (EHR FM)
Informatique de santé — Modèle fonctionnel d’un système de dossier
de santé électronique, publication 2 (EHR FM)
Reference number
ISO 10781:2015(E)
©
ISO 2015
ISO 10781:2015(E)
© ISO 2015, Published in Switzerland
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, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2015 – All rights reserved

ISO 10781:2015(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 Overview and definition of the Functional Model (Normative). 3
4.1 Sections of the Function List . 4
4.2 Functional Profiles . 5
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 .10
5.2.1 Functional Profile for Clinical Research based on the EHR-S FM .10
5.2.2 AHRQ Announces Children’s Electronic Health Record Format .10
5.2.3 Linking clinical content descriptions to the EHR-S FM (Reference) .11
6 Conformance Clause .11
6.1 Introduction (Reference) .11
6.2 Scope and Field of Application (Normative) .11
6.3 Concepts (Normative) .12
6.3.1 Functional Profiles .12
6.3.2 Conformance Model .13
6.3.3 Profile Traceability .13
6.4 Normative Language (Normative) .14
6.5 Conformance Criteria (Normative) .14
6.5.1 Criteria in the Functional Profile .14
6.5.2 ‘Dependent SHALL’ Criteria .14
6.5.3 Referencing Other Criteria or Functions .15
6.6 Functional Model Structure and Extensibility (Normative) .15
6.6.1 Hierarchical Structure .15
6.6.2 Naming Convention .17
6.6.3 Priorities .17
6.6.4 Extensibility .17
6.7 Functional Profile Conformance (Normative) .17
6.7.1 Rules for Functional Domain Profiles .17
6.7.2 Rules for Creating New Functions in Functional Profiles .19
6.7.3 Rules for Derived Functional Profiles .21
6.7.4 Conformance Statement .22
6.7.5 Rules for Functional Companion Profiles .22
6.8 Use Cases and Samples (Reference) .23
6.8.1 Functional Profile Use Cases .23
6.8.2 Sample Functional Domain Profile Conformance Clauses .24
6.8.3 Interpreting and Applying a Conditional ‘SHALL’ (Reference) .25
6.8.4 General Concepts .25
ISO 10781:2015(E)
6.8.5 Rationale for ‘Dependent SHALL’ .26
6.8.6 How to Apply the ‘Dependent SHALL’ .26
7 Glossary .28
7.1 Preface (Reference) .28
7.2 Introduction (Normative) .28
7.3 Overview (Reference) .28
7.3.1 Known Issues (Reference) .29
7.4 The Action-Verb Structure (Normative) .29
7.4.1 Secure (System) Category .29
7.4.2 Data Management Category .30
7.4.3 How Action-Verbs are defined .30
7.4.4 Deprecated Verbs .31
7.5 Guidelines for Use (Reference) .31
7.5.1 General Guidance.31
7.5.2 Constructing Rigorous Conformance Criteria .32
7.5.3 Examples of Rewording Conformance Criteria using the Proper Action-Verbs .33
Annex A (normative) Function List .35
Annex B (informative) Glossary of Terms for EHR-S FM .36
Annex C (informative) History of the Action-Verb Hierarchy .60
Annex D (informative) Contributing Organizations .63
Annex E (informative) Background .64
Annex F (informative) Acknowledgements .66
Annex G (informative) Other Offerings and Requests from the EHR Work Group .68
Bibliography .69
iv © ISO 2015 – All rights reserved

ISO 10781:2015(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
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-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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
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 vote.
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 edition cancels and replaces the first edition (ISO/HL7 10781:2009), which has been
technically revised.
ISO 10781:2015(E)
Introduction
Information for readers
EHR System Functional Model Release 2.0 is based on a series of predecessors, starting in 2004 with
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 committed 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 System 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.
Changes from previous Release
The 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
consistently 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 and 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.
Background
What are Electronic 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 calls 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 Functional 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-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/
Comité Européen de Normalization (CEN). This Functional Model leverages these existing EHR-S
definitions and does not attempt to create a redundant definition of an EHR-S.
vi © ISO 2015 – All rights reserved

ISO 10781:2015(E)
Existing EHR System Definitions
The IOM’s 1991 report, The Computer-Based Patient Record: An Essential Technology, and updated
in 1997 (Dick, R.S, Steen, E.B., and 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 includes 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 collection 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 above as well as ISO 13606:
• A system for recording, retrieving and manipulating information in electronic health records.
How were the Functions Identified and Developed?
To achieve healthcare community consensus at the outset, the functions are described at a conceptual
level, providing a robust foundation for a more detailed work. Functions were included if considered
essential in at least one care setting. Written in user-oriented language, the document is intended for a
broad readership.
Functional Granularity is a term used to describe the level of abstraction at which a function is
represented. Functions that are commonly grouped together in practice or by major systems have been
consolidated where appropriate; functions requiring extra or separate language or involving different
workflows have been kept separate where appropriate. For example, decision support is maintained
as a separate section, but mapped to other key sections, to indicate the “smart” function behind an
action. All of the functions could be expanded into more granular elements but a balance between a
usable document and an unwieldy list of functions has been agreed upon. The goal of determining an
appropriate level of functional granularity at this time is to present functions that can be easily selected
and used by readers of this standard, but that are not so abstract that readers would need to create a
large number of additional functions within each function.
Although the determination of functional granularity is a relatively subjective task, systematic
evaluation of each function by diverse groups of industry professionals has resulted in a level of
granularity appropriate for this EHR-S Functional Model. Every attempt has been made to provide
supporting information in the functional descriptions to illustrate the more granular aspects of
functions that may have been consolidated for usability purposes.
Keeping with the intent of this EHR-S Functional Model to be independent with regard to technology
or implementation strategy, no specific technology has been included in the functions, but may be used
in the examples to illustrate the functions. Inclusion of specific technologies in the examples does not
endorse or support the use of those technologies as implementation strategies.
ISO 10781:2015(E)
Drafts of the EHR-S Functional Model and of specific functions have been widely reviewed by
healthcare providers, vendors, and other stakeholders. This proposed standard reflects input from all
these reviewers.
viii © ISO 2015 – All rights reserved

INTERNATIONAL STANDARD ISO 10781:2015(E)
Health Informatics — HL7 Electronic Health Records-
System Functional Model, Release 2 (EHR FM)
1 Scope
The HL7 EHR System Functional Model provides a reference list of functions that may be present in
an Electronic Health Record System (EHR-S). The function list is described from a user perspective
with the intent to enable consistent expression of system functionality. This EHR-S Functional Model,
through the creation of Functional Profiles for care settings and realms, enables a standardized
description and common understanding of functions sought or available in a given setting (e.g. intensive
care, cardiology, office practice in one country or primary care in another country).
The HL7 EHR-S Functional Model defines a standardized model of the functions that may be present in
EHR Systems. From the outset, a clear distinction between the EHR as a singular entity and systems
that operate on the EHR, i.e. EHR Systems, is critical. Section 1.1.3 describes the basis and foundation
for the HL7 definition of an EHR System. Notably, the EHR-S Functional Model does not address whether
the EHR-S is a system-of-systems or a single system providing the functions required by the users.
This International Standard makes no distinction regarding implementation; the EHR-S described in
a Functional Profile may be a single system or a system of systems. Within the normative sections of
the Functional Model, the term “system” is used generically to cover the continuum of implementation
options. This includes “core” healthcare functionality, typically provided by healthcare-specific
applications that manage electronic healthcare information. It also includes associated generic
application-level capabilities that are typically provided by middleware or other infrastructure
components. The latter includes interoperability and integration capabilities such as location discovery
and such areas as cross application workflow. Interoperability is considered both from semantic (clear,
consistent and persistent communication of meaning) and technical (format, syntax and physical
connectivity) viewpoints. Further, the functions make no statement about which technology is used,
or about the content of the electronic health record. The specifics of ‘how’ EHR systems are developed
or implemented is not considered to be within the scope of this model now or in the future. This EHR-S
Functional Model does not address or endorse implementations or technology, nor does it include the
data content of the electronic health record.
Finally, the EHR-S Functional Model supports research needs by ensuring that the data available to
researchers follow the required protocols for privacy, confidentiality, and security. The diversity of
research needs precludes the specific listing of functions that are potentially useful for research.
This Functional Model is not:
— a messaging specification;
— an implementation specification;
— a conformance specification;
— an EHR specification;
— a conformance or conformance testing metric;
— an exercise in creating a definition for an EHR or EHR-S.
The EHR-S Functional Model is not sufficient to provide a longitudinal health record; however, it will
contribute to its development. The information exchange enabled by the EHR-S supports the population
of clinical documents, event summaries, minimum data sets, claims attachments, and in the future will
enable a longitudinal health record.
ISO 10781:2015(E)
Additionally, it is important to note that the EHR-S Function Model does not include a discussion of
clinical processes or the interaction of the healthcare actors. However, ISO 13940 is an international
standard that does outline key principles and processes in the provision of healthcare. Users of the
EHR-S FM can refer to ISO 13940 for clinical processes that EHR systems support.
This EHR-S Functional Model package includes both Reference and Normative sections.
Table 1 — Normative Status Types
Status Description
Reference Content of the EHR-S Functional Model Package that contains information which clar-
ifies concepts or otherwise provides additional information to aid understanding and
comprehension. Reference material is not balloted as part of the standard.
Normative Content that is part of the EHR-S Functional Model which HL7 committee members
and interested industry participants have formally reviewed and balloted following
the HL7 procedures for Balloting Normative Documents. This HL7 developed Func-
tional Model document has been successfully balloted as a normative standard by the
HL7 organization.
Each section within this document is clearly labelled “Normative” if it is normative. For example, in
Clause 7, Conformance Clause, subclauses 7.2 and 7.4 are normative.
In the external Annex A, Function List, the Function ID, Function Name, Function Statement, and
Conformance Criteria components are Normative in this Functional Model.
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 applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO/TR 12773-1:2009, Business requirements for health summary records — Part 1: Requirements
ISO/TS 13606-4:2009, Health informatics — Electronic health record communication — Part 4: Security
ISO/TS 17090-1:2002, Health informatics — Public key infrastructure — Part 1: Framework and overview
ISO 18308:2011, Health informatics — Requirements for an electronic health record architecture
ISO/IEC 2382-8:1998, Information technology — Vocabulary — Part 8: Security
ASTM E1769:1995, Standard guide for properties of electronic health records and record systems
3 Terms and definitions
3.1
access control
means of ensuring that the resources of a data processing system can be accessed only by authorized
entities in authorized ways
3.2
base functional profile
existing domain or companion functional profile from which new functional profiles are created
and/or derived
3.3
conformance
fulfilment of a product, process or service of specified requirements
2 © ISO 2015 – All rights reserved

ISO 10781:2015(E)
3.4
conformance criteria
requirements indicating the behaviour, action and/or capability that constitutes implementation of the
function
3.5
conformance clause
section of a specification that defines the requirements, criteria or conditions to be satisfied in order to
claim conformance
3.6
conformance statement
description of the functions in an EHR system that have been implemented, reflecting the degree to
which an EHR system has met the functional profile’s requirements and which may include optional
functions and information
3.7
derived functional profile
functional domain or companion profile that is created from a base functional profile (i.e. child
functional domain profile to children’s hospital domain profile)
3.8
extension
capability of an EHR-S to incorporate additional functionality beyond what is defined in the
Functional Profile
3.9
functional profile
subset of the Functional Model, in which functions have been designated (sometimes in varying
degrees) for certain EHR systems or healthcare delivery settings or narrow operation requirements
3.10
informative functional profile
registered functional profile that has successfully completed formal public scrutiny via the HL7
consensus process
3.11
inherited criterion
one of a set of conformance criteria listed in a parent function that is inherited by all its children functions
3.12
registered functional profile
functional profile that has successfully completed HL7 EHR Work Group registration process and review
3.13
situational criterion
criterion that is required if the circumstances given are applicable
EXAMPLE IF/Then or Dependent SHALL.
4 Overview and definition of the Functional Model (Normative)
The EHR-S Functional Model is composed of a list of functions, known as the Function List, which is
divided into seven sections: Overarching, Care Provision, Care Provision Support, Population Health
Support, Administrative Support, Record Infrastructure and Trust Infrastructure.
ISO 10781:2015(E)
Figure 1 — Function List Sections
Within the seven Sections of the Functional List the functions are grouped under header functions
which each have one or more sub-functions in a hierarchical structure.
4.1 Sections of the Function List
The seven sections of the function list reflect content of the Interoperability Model, now integrated in
the Functional Model, and input from several profiles if the R.1.1 version of the Functional Model. Below
is a summary description of each of the seven sections:
• Overarching: The Overarching Section contains Conformance Criteria that apply to all EHR Systems
and consequently must be included in all EHR-S FM compliant profiles.
• Care Provision: The Care Provision Section contains those functions and supporting Conformance
Criteria that are required to provide direct care to a specific patient and enable hands-on delivery
of healthcare. The functions are general and are not limited to a specific care setting and may be
applied as part of an Electronic Health Record supporting healthcare offices, clinics, hospitals and
speciality care centres.
• Care Provision Support: The Care Provision Support Section focuses on functions needed to enable
the provision of care. This section is organized generally in alignment with Care Provision Section.
For example, CP.4 (Manage Orders) is supported directly by CPS.4 (Support Orders).
• Population Health Support: The Population Health Support Section focuses on those functions
required of the EHR to support the prevention and control of disease among a group of people (as
opposed to the direct care of a single patient. This section includes functions to support input to
systems that perform medical research, promote public health, and improve the quality of care at a
multi-patient level.
• Administrative Support: The Administrative Support Section focuses on functions required in the
EHR-S to enable the management of the clinical practice and to assist with the administrative and
financial operations. This includes management of resources, workflow and communication with
patients and providers as well as the management of non-clinical administrative information on
patients and providers.
• Record Infrastructure: The Record Infrastructure Chapter consists of functions common to EHR
System record management, particularly those functions foundational to managing record lifecycle
(origination, attestation, amendment, access/use, translation, transmittal/disclosure, receipt, de-
identification, archive…) and record lifespan (persistence, indelibility, continuity, audit, encryption).
RI functions are core and foundational to all other functions of the Model (CP, CPS, POP, AS).
4 © ISO 2015 – All rights reserved

ISO 10781:2015(E)
• Trust Infrastructure: The Trust Infrastructure Chapter consists of functions common to an
EHR System infrastructure, particularly those functions foundational to system operations,
security, efficiency and data integrity assurance, safeguards for privacy and confidentiality, and
interoperability with other systems. TI functions are core and foundational to all other functions of
the Model (CP, CPS, POP, AS and RI).
4.2 Functional Profiles
While the Functional Model should contain all reasonably anticipated EHR-S functions, it is not itself
intended as a list of all functions to be found in a specific EHR-S. Functional Profiles should be used to
constrain the functions to an intended use. This document defines the Functional Model and describes
the general use of profiles and priorities (See 1.4 Anticipated Uses).
In the aggregate, the Functional Model is intended to include the superset of functions from which a
subset can be generated by the user. This subset created by the user illustrates what is needed within
an EHR-S. Only a subset of the superset of functions will apply to any particular EHR-S Profile.
Figure 2 — Profiling from the EHR-S FM
Figure 2 shows that a profile would include all seven sections of the Functional Model, however it may
not be necessary to include all the functions and criteria within each section. A profile may include
additional functions and criteria to meet the requirements of the profile.
The Conformance Clause is a high-level description of what is required of profiles and implementations.
It, in turn, refers to other parts of the standard for details. The Conformance Clause describes concepts
critical to the understanding and implementation of the Functional Model, such as: ‘What is a profile?
What are Conformance Criteria? Or How do you know what is mandatory versus optional? A Conformance
Clause can also provide a communication between the implementers (vendors) and users (buyers) as to
what is required, and gives meaning to the phrases, “conforming profile” and “conforming EHR system”.
Additionally, it serves as the basis for testing and certification activities which may be performed by
organizations external to HL7.
Refer to the Conformance Clause, Clause 7, for additional information related to the rules for selecting
and adding Conformance Criteria in the development of a Functional Profile.
ISO 10781:2015(E)
4.3 EHR-S Function List Components
The EHR-S Function List is a list (superset) of functions organized into discrete sections. Functions
describe the behaviour of a system in user-oriented language so as to be recognizable to the key
stakeholders of an EHR-S.
EHR-S functions can be used to:
• Facilitate describing end user defined benefits such as patient safety, quality outcomes and cost
efficiencies in terms of standard EHR-S functions.
• Promote a common understanding of EHR functions upon which developers, vendors, users and
other interested parties can plan and evaluate EHR-S functions.
• Provide the necessary framework to drive the requirements and applications of next level standards,
such as EHR content, coding, information models, constructs and interoperability for information
portability between sub-systems of an EHR-S and across EHR-S’.
• Establish a standards-based method by which each realm (country) can apply these EHR functions
to care settings, uses, and priorities.
• Inform those concerned with supporting subsequent use of data initially collected for the purpose
of care (also known as “secondary use”) on what functions can be expected in an EHR System.
• Inform those concerned with supporting realm-specific health information infrastructure on what
functions can be expected in an EHR Systems.
Each function in the HL7 EHR-S Functional Model is identified and described using a set of elements or
components as detailed below.
6 © ISO 2015 – All rights reserved

ISO 10781:2015(E)
Table 2 — Function List Example
ID Type Name Statement Description Conformance Criteria
CP.1 H Ma n a ge M a n a ge t h e Patient Clinical History lists
C l i n i ca l patient’s clinical are used to present succinct
History history lists used “snapshots” of critical health
to present sum- information including patient
mary or detailed history; allergy intolerance
information on and adverse reactions; medi-
patient health cations; problems; strengths;
history. immunizations; medical equip-
ment/devices; and patient and
family preferences.
CP.1.4 F Ma n a ge Create and main- A problem list may include, but
P r oblem tain patient- spe- is not limited to chronic con-
List cific problem lists. ditions, diagnoses, or symp-
toms, injury/poisoning (both
intentional and unintentional),
adverse effects of medical
care (e.g. drugs, surgical),
functional limitations, visit
or stay-specific conditions,
diagnoses, or symptoms…
CP.1.4 C 1. The system SHALL provide the
ability to
...