ISO/TR 12773-2:2009
(Main)Business requirements for health summary records — Part 2: Environmental scan
Business requirements for health summary records — Part 2: Environmental scan
ISO/TR 12773-2:2009 reviews a series of initiatives and implementations worldwide that for purposes of this Technical Report are collectively called health summary records (HSRs). It provides an environmental scan and descriptive information on HSR initiatives internationally, including “lessons learned”. The environmental scan was completed by performing web searches and obtaining publicly available documentation on key projects. Project sponsors and/or authorities were contacted as needed to gather additional information and clarify questions and issues arising out of the review
Exigences d'affaire pour les enregistrements de santé sommaires — Partie 2: Balayage environnemental
General Information
Standards Content (Sample)
TECHNICAL ISO/TR
REPORT 12773-2
First edition
2009-06-01
Business requirements for health
summary records —
Part 2:
Environmental scan
Exigences d'affaire pour les enregistrements de santé sommaires —
Partie 2: Balayage environnemental
Reference number
ISO/TR 12773-2:2009(E)
©
ISO 2009
---------------------- Page: 1 ----------------------
ISO/TR 12773-2:2009(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
COPYRIGHT PROTECTED DOCUMENT
© ISO 2009
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2009 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/TR 12773-2:2009(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Terms and definitions. 1
3 Initiatives reviewed. 7
4 Key findings . 19
5 Summary of initiatives. 19
5.1 Overview . 19
5.2 National E-Health Transition Authority (NEHTA) (Australia) – Clinical data specifications
and content specifications . 20
5.3 COMPETE (Computerization of Medical Practices for the Enhancement of Therapeutic
Effectiveness) – Ontario, Canada. 22
5.4 Core dataset — Ontario Clinical Management System (sponsored by OntarioMD), Ontario,
Canada . 23
5.5 Electronic medical summary (e-MS) — British Columbia (BC), Canada. 24
5.6 Medical Summary for Transfer of Patient Data – Physician Office System Program (POSP),
Alberta, CA . 25
5.7 Report on the State of Developing Electronic Patient Summaries in European Union
Member States and Beyond (2007) . 26
5.8 ISO 21549-3:2004 Health informatics — Patient healthcard data — Part 3: Limited clinical
data. 26
5.9 NHS England . 28
5.10 NHS Scotland – Emergency care summary (ECS) . 31
5.11 NHS Wales – Individual health record . 31
5.12 Care record summary – Implementation guide for HL7 CDA Release 2 – Levels 1 and 2
(US Realm). 32
5.13 Continuity of care record E2369 – Specification – ASTM. 33
5.14 Continuity of care document (CCD) – HL7/ASTM. 35
5.15 Medical Summary Integration Profile and Medical Summary Content Specification IHE —
Integrating the Healthcare Enterprise. 35
5.16 VistA — United States Veterans’ Health Administration . 36
6 Sample health summary records — overview of data groups, specifications for structure,
content as applicable . 37
6.1 Australia — National E-Health Transition Authority (NEHTA) . 37
6.2 Canada — Core Dataset — OntarioMD. 37
6.3 Canada — Medical Summary for Transfer of Patient Data (Alberta) . 37
6.4 Canada — Electronic medical summary (British Columbia). 38
6.5 United States — ASTM Continuity of Care Record . 38
6.6 United States — IHE Content Profiles . 39
6.7 United States — HL7 CDA Care Record Summary Implementation Guide Levels 1 and 2
2006 — Required and optional sections of a CRS (US Realm) . 40
6.8 United States — Personal Health Record — Minimum Common Dataset — AHIMA. 41
6.9 ISO 21549-3, Health informatics — Patient healthcard data — Part 3: Limited clinical data. 42
6.10 NHS UK — Scotland – Emergency Care Summary (ECS) . 43
Acronym index . 44
Bibliography . 45
© ISO 2009 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO/TR 12773-2:2009(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.
In exceptional circumstances, when a technical committee has collected data of a different kind from that
which is normally published as an International Standard (“state of the art”, for example), it may decide by a
simple majority vote of its participating members to publish a Technical Report. A Technical Report is entirely
informative in nature and does not have to be reviewed until the data it provides are considered to be no
longer valid or useful.
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/TR 12773-2 was prepared by Technical Committee ISO/TC 215, Health informatics.
ISO/TR 12773 consists of the following parts, under the general title Business requirements for health
summary records:
⎯ Part 1: Requirements
⎯ Part 2: Environmental Scan
iv © ISO 2009 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/TR 12773-2:2009(E)
Introduction
Consumer, clinician, industry and government demands for improved safety, quality, effectiveness and
efficiency in healthcare are driving the need for more “connected” care, which in turn requires improved
communication of clinical information between multiple providers and subjects of care. Internationally, various
“summary” or “snapshot” health records have been developed to meet these communication needs. Many
similarities are evident in these initiatives, but their conceptual foundations have not always been articulated
with a set of business requirements as their starting point.
The purpose of this part of ISO/TR 12773 is to identify the common business requirements these initiatives
are seeking to address as well as the requirements for standards for health summary records (HSRs) that can
guide future HSR development efforts.
Any future ISO initiative to create standards for a generic HSR specification or specifications for one or more
types of HSR will leverage existing initiatives and adopt/adapt relevant standards utilized therein. Such HSR
specifications are unlikely to require new standards, given that much of their content is deemed “common”,
“core”, “essential” or “emergency” in nature and is therefore part of most EHR initiatives world-wide as
evidenced in this part of ISO/TR 12773.
© ISO 2009 – All rights reserved v
---------------------- Page: 5 ----------------------
TECHNICAL REPORT ISO/TR 12773-2:2009(E)
Business requirements for health summary records —
Part 2:
Environmental scan
1 Scope
This part of ISO/TR 12773 reviews a series of initiatives and implementations worldwide that for purposes of
this Technical Report are collectively called health summary records (HSRs). It provides an environmental
scan and descriptive information on HSR initiatives internationally, including “lessons learned”.
The environmental scan was completed by performing web searches and obtaining publicly available
documentation on key projects. Project sponsors and/or authorities were contacted as needed to gather
additional information and clarify questions and issues arising out of the review.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
agent
person, device or software that performs a role in a healthcare activity
2.2
client
patient
individual who is a subject of care
[ISO/TR 20514:2005, definition 2.30]
NOTE The terms “client” and “patient” are synonymous but the usage of one or the other of these terms tends to
differ between different groups of health professionals. Clinicians working in a hospital setting and medical practitioners in
most clinical settings will use the term “patient” whereas allied health professionals may use the term “client”.
2.3
clinical information
information about a person, relevant to his or her health or healthcare
[ISO 13606-1:2008, defintion 3.13]
2.4
clinician
health professional who delivers health services directly to a patient/client
[ISO/TR 20514:2005, definition 2.6]
© ISO 2009 – All rights reserved 1
---------------------- Page: 6 ----------------------
ISO/TR 12773-2:2009(E)
2.5
consumer
individual who may become a subject of care
[ISO/TS 20514:2005, definition 2.9]
2.6
data object
collection of data that has a natural grouping and may be identified as a complete entity
2.7
electronic health record
EHR
〈basic generic form〉 repository of information regarding the health status of a subject of care, in computer
processable form
[ISO/TR 20514:2005, definition 2.11]
2.8
electronic health record composition
EHR composition
set of information committed to one EHR by one agent, as a result of a single clinical encounter or record
documentation
EXAMPLES Progress Note, radiology report, referral letter, clinic visit record, discharge summary, functional health
assessment, diabetes review.
2.9
electronic health record extract
EHR extract
a) unit of communication of the EHR which is itself attestable and which consists of one or more EHR
compositions
[ISO/TR 20514:2005, definition 2.13]
b) part or all of the electronic health record of a subject of care communicated between an EHR provider
system and an EHR recipient
NOTE Adapted from ISO 13606-1:2008.
2.10
electronic health record (EHR) — integrated care (ICEHR)
repository of information regarding the health status of a subject of care in computer processable form, stored
and transmitted securely, and accessible by multiple authorized users and having a standardized or
commonly agreed logical information model that is independent of EHR systems and whose primary purpose
is the support of continuing, efficient and quality integrated healthcare and which contains information that is
retrospective, concurrent and prospective
NOTE 1 Adapted from ISO/TR 20514:2005.
NOTE 2 The definition of the EHR for integrated care should be considered the primary definition of an electronic
health record. The definition of a basic-generic EHR is given only for completeness.
2.11
electronic health record repository
database in which electronic health record information is persisted
2 © ISO 2009 – All rights reserved
---------------------- Page: 7 ----------------------
ISO/TR 12773-2:2009(E)
2.12
electronic health record — shareable
EHR — shareable
electronic health record with a standardized information model, which is independent of electronic health
record systems and accessible by multiple authorized users
NOTE 1 The shareable EHR per se is an artefact between a basic-generic EHR and the integrated care EHR (ICEHR)
which is a specialization of the shareable EHR. The shareable EHR is probably of little use without the additional clinical
characteristics that are necessary for its effective use in an integrated care setting.
NOTE 2 Whilst the ICEHR is the target for interoperability of patient health information and optimal patient care, it
should be noted that the large majority of EHRs in use at present are not even shareable let alone have the additional
characteristics required to comply with the definition of an integrated care EHR. A definition of a basic-generic EHR has
therefore been included to acknowledge this current reality.
2.13
electronic health record system
EHR system
system for recording, retrieving and manipulating information in electronic health records
[ISO 13606-1:2008, definition 3.26]
2.14
health
state of complete physical, mental and social well-being and not merely the absence of disease or infirmity
[WHO: 1948]
2.15
healthcare
activities, services, or supplies related to the health of an individual
[ISO 18308:—, definition 3.28]
2.16
healthcare activity
undertakings (assessments, interventions) that comprise a healthcare service
2.17
healthcare organization
organization involved in the direct or indirect provision of healthcare services to an individual or to a population
[ISO/EN 13606-1:2008]
2.18
healthcare service
service provided with the intention of directly or indirectly improving the health of the person or populations to
whom it is provided
[ISO/EN 13606-1:2008]
2.19
health condition
a) aspect of a person or group’s health that requires some form of intervention
[Canada Health Infoway EHRS Blueprint v1.0: 2003]
NOTE These interventions could be anticipatory or prospective, such as enhancing wellness, wellness
promotion or illness prevention (e.g. immunization).
© ISO 2009 – All rights reserved 3
---------------------- Page: 8 ----------------------
ISO/TR 12773-2:2009(E)
b) symptoms, health problems (not yet diagnosed), diagnoses (known or provisional), e.g. diabetes,
physiological changes that affect the body as a whole or one or more of its parts, e.g. benign positional
vertigo and/or affect the person’s well-being, e.g. psychosis, and/or affect the person’s usual physiological
state, e.g. pregnancy, lactation
[Canada Health Infoway, iEHR Clinical Standards Glossary 2007]
2.20
health information
see clinical information (2.3)
2.21
health problem
see health condition (2.19); see problem (2.34)
2.22
health professional
person who is authorized by a recognised body to directly provide certain healthcare services
NOTE Adapted from ISO/TR 20514:2005 and EN 13940-1:2007.
2.23
health record
repository of information regarding the health of a subject of care
[ISO/TR 20514: 2005, definition 2.25]
2.24
health record extract
attestable unit of communication of all or part of a health record.
2.25
health summary record
health record extract comprising a standardized collection of clinical and contextual information (retrospective,
concurrent, prospective) that provides a snapshot in time of a subject of care’s health information and
healthcare
2.26
HL7 Clinical Document Architecture
CDA
documentation that defines structure and semantics of medical documents for the purpose of exchange
NOTE CDA documents are encoded in Extensible Mark-up Language (XML). They derive their meaning from the
HL7 Reference Information Model (RIM) and use the HL7 Version 3 Data Types, which are part of the HL7 RIM.
[HL7 International- HL7 CDA Release 2.0]
2.27
integrated care electronic health record (EHR) (ICEHR)
see electronic health record (EHR) — for integrated care (ICEHR) (2.10)
2.28
metadata
a) information stored in a data dictionary that describes the content of a document
[ISO/TR 22221:2006; defintion 2.10]
NOTE Metadata can include data structure, constraints, types, formats, authorizations, privileges, relationships,
distinct values, value frequencies, keywords, and users of the database sources loaded in the EHR repository and the
EHR repository itself. Metadata facilitates information management for users, developers and administrators.
4 © ISO 2009 – All rights reserved
---------------------- Page: 9 ----------------------
ISO/TR 12773-2:2009(E)
b) data that define object class and property for the information collected
[ISO 13606-1:2008, definition 3.37]
2.29
organization
unique framework of authority within which a person or persons act, or are designated to act towards some
purpose
[ISO 6523-1:1998, definition 3.1]
2.30
personal health record
PHR
electronic, universally available, lifelong resource of health information needed by individuals to make health
decisions
NOTE Individuals own and manage the information in the PHR, which comes from healthcare providers and the
individual. The PHR is maintained in a secure and private environment, with the individual determining rights of access.
The PHR is separate from and does not replace the legal record of any provider
[AHIMA E-HIM PHR Work Group 2005]
2.31
physician
health professional who has successfully completed the prescribed course of studies in medicine in a
recognised medical school and who has met the qualifications for licensure In the practice of medicine set by
the state or country in which they are practicing
2.32
practice electronic health record (EHR) system
EHR system that a clinician or group of clinicians uses to document the care provided to a subject of care in
their healthcare organization
NOTE In primary and ambulatory care settings, the practice EHR is usually referred to as an electronic medical
record (EMR). In acute care settings such as hospitals, it is commonly referred to as an electronic patient record (EPR). In
community care settings including home care settings, it may be referred to as an electronic client record (ECR) or an
EPR.
2.33
primary care
overall management of a subject of care’s health problems, including direct delivery of care as well as
coordinating care to specialists and other providers in a gatekeeper system, i.e. a system where the primary
care provider acts on behalf of their patients to manage and prioritize access to required healthcare services
NOTE Adapted from Canada Health Infoway iEHR Clinical Standards Glossary 2007.
2.34
problem
entity for which an assessment is made and a plan or intervention is initiated
[NZ EMR:1998]
NOTE The term “issue” is often used rather than “problem” by many allied health professions, especially in the more
social/psychological disciplines. The term “condition” is also sometimes used to describe pregnancy and other non-
disease health states which nevertheless usually involve interaction with a health system.
© ISO 2009 – All rights reserved 5
---------------------- Page: 10 ----------------------
ISO/TR 12773-2:2009(E)
2.35
provider
person or organization involved in or associated with the delivery of healthcare to a subject of care, or caring
for the wellbeing of a subject of care
2.36
records
information created, received, and maintained as evidence and information by an organization or person, in
pursuance of legal obligations or in the transaction of business
[ISO 15489-1:2001, definition 3.15]
2.37
referral
practice of a provider sending a subject of care to receive healthcare services or a clinical opinion from
another provider when the sending provider is not qualified or prepared to offer such services or opinion
NOTE 1 Adapted from Canada Health Infoway iEHR Standards Glossary 2007.
NOTE 2 A referral letter is a clinical document that accompanies the referral request. It contains the reason for the
referral and includes details of the subject’s health condition(s) and other additional health information relevant to the
referral, as well as a date and the authentication of the referring provider.
2.38
secondary use
〈of a healthcare record〉 any legitimate use of a healthcare record other than for the purpose of supporting the
direct delivery of healthcare services to the subject of care
EXAMPLES Medico-legal, quality management, clinical research, epidemiology, population health, health
administration, financial, educational or health service planning purposes.
2.39
security
combination of confidentiality, integrity and availability
2.40
service
number of processes, involving an organization in the provision of specific objectives
[ISO 12967-1:—, definition 3.4.7]
2.41
shareable EHR
see electronic health record — shareable (2.12)
2.42
shared EHR
see electronic health record — shareable (2.12)
2.43
specialist
〈physician〉 whose practice is limited to a particular area of medicine in which the physician is usually certified
by a recognized board or college of physicians
2.44
standard
document, established by consensus and approved by a recognised body that provides, for common and
repeated use, rules, guidelines or characteristics for activities or their results, aimed at achievement of the
optimum degree of order in a given context
[ISO/IEC Guide 2:2004, definition 3.2]
6 © ISO 2009 – All rights reserved
---------------------- Page: 11 ----------------------
ISO/TR 12773-2:2009(E)
2.45
subject of care
one or more persons scheduled to receive, receiving, or having received healthcare
NOTE 1 Adapted from ISO 13606-1: 2008.
NOTE 2 The terms “patient” and “client” are synonymous with subject of care in a health record context and are
commonly used instead of the more formal term “subject of care”.
NOTE 3 The term “consumer” is also often used as a synonym in this context. However, it should be noted that a
consumer may not necessarily be a subject of care since it can be argued that it is possible for a consumer to have a
health record without ever having received a healthcare service.
3 Initiatives reviewed
Table 1 lists the initiatives that were reviewed as part of the environmental scan, along with relevant
information regarding the lead for the initiative, web links and key characteristics. Initiatives are listed in
alphabetical order by country and additional analysis information has been added via a column on the far right
in the table. Because of the diversity and number of initiatives identified, detailed comparisons were not
undertaken beyond summarizing key findings in Clause 4, from which the business requirements in
ISO/TR 12773-1 were largely derived.
Details of well-known/publicized initiatives have been included in Clause 5.
© ISO 2009 – All rights reserved 7
---------------------- Page: 12 ----------------------
ISO/TR 12773-2:2009(E)
8 © ISO 2009 – All rights reserved
Table 1 — HSR Environmental scan — Summary
Country Initiative Lead Link(s) Key Characteristics
Australia National ehealth Data and National E-Health Transition http://www.nehta.gov.au - NEHTA Standards and specifications include detailed
Content Specifications Authority (NEHTA) specifications for high priority clinical data groups and
http://www.nehta.gov.au/index.php?o
the structured content of clinical communications.
ption=com_content&task=view&id=2
35&Itemid=454 The standardized data specifications can be used to
construct various types of care summary records.
National E-Health Data Group Library
Content specifications have been developed for
http://www.nehta.gov.au/index.php?o
Discharge Summary and GP to Specialist/Acute Care
ption=com_content&task=view&id=1
Referral.
39&Itemid=383
Standards Catalogue
Asia - Korea Standard Chief Complaint Set Ho Jun Chin et al; http://kosmi.snubi.org/2003_fall/main. CDA documents are used for discharge summaries
Created from Discharge html — October 22, 2006 — Oral 6 and for creation of a standard chief complaint set in
Department of Internal
Summary, Applicable to EMR: session Korea.
Medicine & Department of
Short Term Experience in
Pediatrics
Seoul National University
Bundang Hospital
Seoul National University
College of Medicine
Seoul, Korea
---------------------- Page: 13 ----------------------
ISO/TR 12773-2:2009(E)
© ISO 2009 – All rights reserved 9
Table 1 (continued)
Country Initiative Lead Link(s) Key Characteristics
Canada – Clinical Profile Canada Health Infoway http://www.infoway- A Clinical Profile is a key component of Infoway’s pan-
Canada inforoute.ca/en/home/home.aspx - Canadian HL7v3 messaging standards for sharing
Health Home clinical information in the context of a shared EHR.
Infoway
http://knowledge.infoway- Profile is generated based on a query to a shared EHR
inforoute.ca/en/ - Knowledgeway repository for all relevant data on a given patient. Data
returned is determined by the query parameters.
http://forums.infoway-
inforoute.ca/webx?14@894.p5spaPo
fd94.48@.eeda7b9 – Pan-Canadian
Standards Forum
or
http://forums.infoway-
inforoute.ca/webx?14@128.CMb6ali
dh2K.29@.eeda7b9 – Standards
Collaborative Working Group 2
Forum
See files on either of above sites:
⎯ Message Definition Worksheet;
Scope & Package Tracking
Framework & Word views of
message models
Canada – Physician Office System Alberta Health & Wellness http://www.health.alberta.ca Point-to-point sharing
Alberta Program Medical Summary for (Alberta Health Ministry) –
http://www.health.alberta.ca/about/HI Scope restricted to permanent transfer of patient
Transfer of Patient Data Alberta Health Information
SCA_standards.html - look under records between physicians or from one EMR vendor
Standards Committee
Physician Office System system to a different one
http://www.health.alberta.ca/about/HI Draft specification released July 2005
SCA_POSP_xferPatData.pdf
Leverages British Columbia and Ontario initiatives (as
listed in this table)
Canada – Electronic Medical Summary British Columbia Ministry of Vancouver Island Health Authority, Point-to-point primary care physician information
(e-MS) Health eMS Project BC sharing
British
Columbia http://www.e-ms.ca/ Component (planned) of a provincial (shared) EHR
Detailed specification based on HL7 CDA; HL7 v3
messages – all artef
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.