This page is part of the FHIR Specification (v1.4.0:
STU
3 Ballot 3). The current version which supercedes this version is
5.0.0
.
For
a
full
list
of
available
versions,
see
the
Directory
of
published
versions
. For a full list of available versions, see the
Directory of published versions 
This implementation guide is a supplement to the base Structured Data Capture (SDC) implementation guide. It defines expectations for Data Element registries, as well as those systems that are responsible for the creation and maintenance of data elements within those registries. This capability is documented as a distinct implementation guide because the expectations for systems creating and maintaining data elements are higher than for those systems that are merely responsible for referencing data elements when creating forms or configuring their systems to support pre-population or auto-population.
The set of expectations described within this implementation guide reflects the consensus view of those stakeholders involved in the Structured Data Capture public consultation group, which included representatives from several large organizations responsible for data element registries, including:
This implementation guide is intended to be conformant with the
ISO/IEC 11179-3 
standard,
though
it
only
defines
(and
requires
support
for)
only
a
subset
of
the
properties
defined
in
that
specification.
This
implementation
guide
was
prepared
as
a
U.S.
Realm
Specification
on
behalf
of
the
Structured
Data
Capture
project
-
an
effort
under
the
U.S.
Office
of
the
National
Coordinator
(ONC)
standard, though it only defines (and requires support for) only a subset of the properties defined in that specification.
This implementation guide was prepared as a U.S. Realm Specification on behalf of the Structured Data Capture project - an effort under the
U.S. Office of the National Coordinator (ONC)
's
Standards
and
Infrastructure
(S
&
I)
Framework
However,
much
of
the
content
is
likely
to
be
useable
in
other
jurisdictions.
The
only
portions
of
this
specification
that
may
be
problematic
for
use
of
this
implementation
guide
in
some
jurisdictions
are
the
bindings
to
terminologies
such
as
SNOMED
CT
and
RxNorm.
The
constraints
and
extensions
used
should
all
have
broad
applicability.
's Standards and Infrastructure (S & I) Framework However, much of the content is likely to be useable in other jurisdictions. The only portions of this specification that may be problematic for use of this implementation guide in some jurisdictions are the bindings to terminologies such as SNOMED CT and RxNorm. The constraints and extensions used should all have broad applicability.
This implementation guide follows the FHIR pattern of being published as a web-based specification. This allows easy navigation between the SDC-specific portion of the implementation guide and the resources, data types, value sets and other specification components leveraged from the FHIR core specification. This approach also allows implementers to easily navigate to the information needed to perform a particular task.
A Table of Contents page is provided that lists all of the pages and artifacts defined as part of this implementation guide. (Do be aware that some pages have multiple tabs.) A table of contents is also available for the full FHIR specification if you really want to read absolutely everything. Tooling may provide support for a PDF or other document-approach representation of this implementation guide in a future release.
Bread-crumb navigation is provided in the gray bar just below the menu at the top of each page, allowing easy navigation back to the main SDC page.
This implementation guide has a number of sections:
This implementation guide is based on the HL7
FHIR
data
types
Using
codes
References
between
resources
How
to
read
resource
&
profile
definitions
Base
resource
RESTful
operations
standard. It uses terminology, notations and design principles that are specific to FHIR. Before reading this implementation guide, it's important to be familiar with some of the basic principles of FHIR as well as general guidance on how to read FHIR specifications. Readers who are unfamiliar with FHIR are encouraged to read (or at least skim) the following prior to reading the rest of this implementation guide.
Feel free to explore other aspects of the FHIR specification that you feel may be relevant or of interest.
DataElement instances do not convey patient-specific information. However, because the mappings associated with data elements can influence the data that might be automatically populated into forms and could also influence the security controls around data associated with the DataElement, security precautions should be taken to ensure that data elements are not created or revised by someone without the proper authority. Security practices for systems complying with this implementation guide are the same as those for the primary SDC implementation guide.
Additional information about the Structured Data Capture project can be found on the
project's wiki
.
.
The following sections describe the artifacts that set expectations for systems wishing to be conformant to the FHIR SDC implementation guide.
FHIR Conformance statements define the expectations for particular system "roles" within an SDC environment. To be considered SDC-conformant, a system must adhere to the requirements defined by at least one of these statements. Some systems might choose to comply with more than one.
Systems supporting the SDC Data Element Registry role SHALL be capable of accepting, persisting and returning all DataElement properties marked as "must support" in the SDC Data Element Exchange profile. Systems supporting the SDC Data Element Curator role SHALL be capable of providing and updating those same properties.
This implementation guide defines profiles on several resources. Implementations are expected to be conformant with these profiles in order to be conformant with this implementation guide.
|
Resource
| SDC Profile | Purpose |
|---|---|---|
|
DataElement
| SDC Data Element Exchange Profile | Used to define data elements for exchange and maintenance within data element registries |
|
ValueSet
| SDC Data Element Exchange Value Set Profile | Used to define permitted values and meanings for data elements |
Additional resources such as
ConceptMap
,
,
Provenance
,
,
AuditEvent
and
others
are
also
likely
to
be
used
in
SDC
solutions,
though
no
SDC-specific
profiles
have
been
created
for
them.
and others are also likely to be used in SDC solutions, though no SDC-specific profiles have been created for them.
ISO 11179 is one of the principle authorities on the notion of "Data Element". For a complete view of the alignment between the SDC FHIR specification and ISO 11179, the FHIR profile on DataElement includes
mappings
to
the
ISO
11179
specification
for
each
of
the
core
elements
and
extensions
of
the
resource.
As
a
summary,
the
FHIR
DataElement
resource
can
express
most
(all,
if
additional
extensions
are
introduced)
of
the
notions
present
in
11179,
however
the
approach
differs
in
a
few
ways:
FHIR
does
not
define
separate
resources
for
the
Data
Element
vs.
the
Data
Element
Concept.
Both
notions
can
be
represented
using
the
same
structure
and
both
conceptual
and
conceptual
domain
and
value
domain
aspects
can
be
represented
within
a
single
instance.
FHIR
uses
to the ISO 11179 specification for each of the core elements and extensions of the resource. As a summary, the FHIR DataElement resource can express most (all, if additional extensions are introduced) of the notions present in 11179, however the approach differs in a few ways:
While this implementation guide and the underlying FHIR are licensed as public domain, this guide mandates the use of terminologies including LOINC, SNOMED CT and RxNorm which have more restrictive licensing requirements. Implementers should make themselves familiar with licensing and any other constraints of terminologies, questionnaires, data elements and other components used as part of their implementation process. In some cases, licensing requirements may limit what systems data captured using this implementation guide may be shared with.
© HL7.org 2011+. FHIR STU3 Candidate (v1.4.0-8139) generated on Thu, Mar 31, 2016 08:10+1100.
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