ISO/TR 12773-1:2009
(Main)Business requirements for health summary records — Part 1: Requirements
Business requirements for health summary records — Part 1: Requirements
ISO/TR 12773-1:2009 is based on a comprehensive review of a series of initiatives and implementations worldwide that for the purposes of this Technical Report are collectively called health summary records (HSRs). Project sponsors and/or authorities were contacted as needed to gather additional information and clarify questions or issues arising out of the review. ISO/TR 12773-1:2009 defines and describes HSRs in general as well as specific instances of HSRs and their most common use cases. It summarises the business requirements driving HSR development and the content that is common across HSRs, as well as issues associated with them. Finally, it recommends some future ISO/TC 215 activities to support international standardization of HSRs. It is important to note that ISO/TR 12773-1:2009 focuses primarily on requirements that are specific (unique) to HSRs. It does not attempt to articulate, other than at a high level, requirements that are generally applicable to all health records or all electronic health records.
Exigences d'affaire pour les enregistrements de santé sommaires — Partie 1: Exigences
General Information
Standards Content (Sample)
TECHNICAL ISO/TR
REPORT 12773-1
First edition
2009-06-01
Business requirements for health
summary records —
Part 1:
Requirements
Exigences d'affaire pour les enregistrements de santé sommaires —
Partie 1: Exigences
Reference number
©
ISO 2009
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ii © ISO 2009 – All rights reserved
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Terms and definitions. 1
3 Examples of health summary records. 8
4 Nature and definition of health summary records . 10
4.1 General. 10
4.2 Health record extracts. 10
4.3 Standardized health record extracts. 11
4.4 Integrated care EHRs (ICEHRs). 12
4.5 Dynamic creation of a health summary record — List clinical summary/profile. 13
4.6 Defining health summary records. 13
5 Purposes of health summary records .14
6 Common use cases for health summary records . 16
6.1 Overview . 16
6.2 Use case 1: Creating a health summary record . 17
6.3 Use case 2: Querying, viewing, replacing (superseding) the HSR. 17
6.4 Use Case 3: Provider-to-provider referrals .18
6.5 Use case 4: Acute care discharge to home or other ambulatory care environment . 19
6.6 Use case 5: Acute care discharge to a sub-acute care nursing facility (SNF) . 19
6.7 Use case 6: Initiate HSR transfer . 20
6.8 Secondary use cases . 20
7 Business requirements for health summary records . 21
8 Data and information management requirements for health summary records. 22
8.1 General requirements. 22
8.2 Clinical content priorities for health summary records. 22
8.3 Health summary record data development. 24
9 Standardization of health summary records . 25
10 Recommendations. 25
Acronym Index . 27
Bibliography . 28
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 12773-1 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
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 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 ISO/TR 12773-2.
TECHNICAL REPORT ISO/TR 12773-1:2009(E)
Business requirements for health summary records —
Part 1:
Requirements
1 Scope
This part of ISO/TR 12773 is based on a comprehensive review of a series of initiatives and implementations
worldwide that for the purposes of this Technical Report are collectively called health summary records
(HSRs). Project sponsors and/or authorities were contacted as needed to gather additional information and
clarify questions or issues arising out of the review.
This part of ISO/TR 12773 defines and describes HSRs in general as well as specific instances of HSRs and
their most common use cases. It summarises the business requirements driving HSR development and the
content that is common across HSRs, as well as issues associated with them. Finally, it recommends some
future ISO/TC 215 activities to support international standardization of HSRs.
It is important to note that this part of ISO/TR 12773 focuses primarily on requirements that are specific
(unique) to HSRs. It does not attempt to articulate, other than at a high level, requirements that are generally
applicable to all health records or all electronic health records.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
agent
see healthcare agent (2.19)
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 data repository
CDR
data store that holds and manages clinical data collected from service encounters at point of service locations
(e.g. hospitals, clinics)
[ISO/TR 20514:2005, definition 2.5]
NOTE Data from a CDR can be sent to the EHR for that subject of care; in that sense the CDR is recognised as a
source system for a shared EHR or an integrated care EHR.
2.4
clinical data warehouse
CDW
grouping of data accessible by a single data management system, possibly of diverse sources, pertaining to a
health system or sub-system and enabling secondary data analysis for questions relevant to understanding
the functioning of that health system, and hence supporting proper maintenance and improvement of that
health system
[ISO/TR 22221:2006, definition 2.2]
NOTE A CDW tends not to be used in real time; however, depending on the rapidity of transfer of data to the data
warehouse, and data integrity, near real time applications are not excluded.
2.5
clinical information
information about a person, relevant to his or her health or healthcare
[ISO 13606-1:2008, definition 3.13]
2.6
clinician
health professional who delivers health services directly to a patient/client
[ISO/TR 20514:2005, definition 2.6]
2.7
consumer
individual who may become a subject of care
[ISO/TR 20514:2005, definition 2.9]
2.8
data object
collection of data which has a natural grouping and may be identified as a complete entity
2.9
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]
2.10
electronic health record composition
EHR composition
the 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.
2.11
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]
2 © ISO 2009 – All rights reserved
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.
2.12
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 prim
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