Release
4B
5
Clinical
Reasoning
This
page
is
part
of
the
FHIR
Specification
(v4.3.0:
R4B
(v5.0.0:
R5
-
STU
).
The
This
is
the
current
published
version
which
supercedes
in
it's
permanent
home
(it
will
always
be
available
at
this
version
is
5.0.0
.
URL).
For
a
full
list
of
available
versions,
see
the
Directory
of
published
versions
.
Page
versions:
R5
R4B
R5
R4B
R4
R3
|
Work
Group
Clinical
Decision
Support
&
Clinical
Quality
Information
|
Standards Status : Informative |
The
Clinical
Reasoning
module
provides
resources
and
operations
to
enable
the
representation,
distribution,
and
evaluation
of
clinical
knowledge
artifacts
such
as
clinical
decision
support
rules,
quality
measures,
public
health
indicators,
order
sets,
and
clinical
protocols.
protocols,
and
evidence
summaries.
In
addition,
the
module
describes
how
expression
languages
can
be
used
throughout
the
specification
to
provide
dynamic
capabilities.
Clinical Reasoning involves the ability to represent and encode clinical knowledge in a very broad sense so that it can be integrated into clinical systems. This encoding may be as simple as controlling whether or not a particular section of an order set appears based on the conditions that a patient has, or it may be as complex as representing the care pathway for a patient with multiple conditions.
The Clinical Reasoning module focuses on enabling two primary use cases:
To enable these use cases, the module defines several components that can each be used independently, or combined to enable more complex functionality. These components are:
and
Clinical
Quality
Language
(CQL)
.
These basic components can then be used to enable a broad variety of clinical decision support and quality measurement use cases, including knowledge sharing, decision support services, and clinical quality assessment and reporting. The topics below provide more detailed discussion on each of these components and uses:
| Topic | Description |
|---|---|
| Overview and Background | If you are interested in the background and development of the FHIR Clinical Reasoning module, this topic covers where it came from and why it exists. See also the general FHIR introductions for clinicians , developers or architects |
| Using Expressions | If you want to see how to add dynamic capabilities to FHIR resources using expressions, start here. |
| Definitional Resources | If you want to see how to describe definitional resources using the ActivityDefinition resource, start here. |
| Representing Knowledge Artifacts | If you want to represent knowledge artifacts such as Event-Condition-Action rules, Order Sets, or Clinical Protocols, start here. |
| Sharing Knowledge Artifacts | If you want to share and distribute knowledge artifacts, start here. |
| Clinical Decision Support Service | If you want to use the Clinical Reasoning module to provide or use Clinical Decision Support services, start here. |
| Quality Reporting | If you want to define or report clinical quality measures, start here. |
| Evidence and Statistics | If you want to share and distribute knowledge artifacts about statistical facts, start here. |
From the perspective of a Knowledge Author, this module describes an approach to representing knowledge artifacts within FHIR.
From the perspective of a Knowledge Content Provider, this module defines search functionality for using a FHIR server as a knowledge artifact repository.
From
the
perspective
of
a
Knowledge
Evaluation
Service
Provider,
this
module
defines
operations
and
profiles
in
support
of
evaluating
quality
measures,
and
defining
and
using
CDS
Hooks
services.
And finally, from the perspective of a Knowledge Evaluation Service Consumer, this module defines the expected available operations and behavior of a knowledge evaluation service.
| Resource | Description |
|---|---|
| ActivityDefinition | A resource to represent definitional resources. |
| ArtifactAssessment | A resource to capture assessments of knowledge artifacts such as ratings, classifiers, reviews, and comments. |
| Citation | Represents the identification, location, and contributor attribution for a knowledge artifact. |
| DataRequirement |
A
|
| Evidence | Represents a single analytic result about a group. |
| EvidenceVariable | Represents the elements that evidence is about, such as the elements of a PICO question. |
| GuidanceResponse | Represents the result from invoking a decision support service. |
| Library | Provides a container for knowledge artifacts that includes logic libraries, model definitions, and asset collections. |
| Measure | Represents a clinical quality measure and provides evaluation through the $evaluate-measure operation. |
| MeasureReport | Represents the response to a specific measure evaluation request returned by the $evaluate-measure operation. |
| PlanDefinition | Represents the description of a plan for accomplishing a particular goal. This resource is used to represent a broad variety of clinical knowledge artifacts including decision support rules, order sets, and protocols. |
|
|
Represents a group of options for a particular subject that can be used to accomplish a particular goal. This resource is often, but not always, the result of applying a PlanDefinition to a particular patient. |
| Extension | Description |
|---|---|
| cdsHooksEndpoint | An extension applied to a PlanDefinition to indicate that it provides the behavior for a CDS Hooks service endpoint. |
| expression | A general purpose extension that supports the use of languages such as FHIRPath and Clinical Quality Language within FHIR. |
| library | A general purpose extension that supports the declaration of dependencies that can be accessed by expression logic. |
| measureInfo | An extension that can be applied to resources to indicate the measure criteria they satisfy. Used in evaluated resource bundles as part of reporting measure results for a patient to identify resources that contributed to the patient's membership in a particular population criteria. |
| qualityOfEvidence | An extension that can be applied to indicate the quality of evidence in support of a particular artifact or recommendation. |
| relativeDateTime | [DEPRECATED] An extension that can be applied to define a date/time value relative to another event. This extension is deprecated, use the relative-date extension instead |
| periodDuration | Allows a period to be specified using a start date and duration rather than specifying an end date. |
| strengthOfRecommendation | An extension that can be applied to indicate the strength of a recommendation. |
| certainty | An extension that can be applied to a knowledge resource to indicate the certainty of some aspect of the resource such as confidence, strength, or quality. |
| contactReference | An extension that can be applied to a ContactDetail to provide a reference to a resource that is the contact. |
| contactAddress | An extension that can be applied to a ContactDetail to indicate the address of a contributor. |
| contributionTime | An extension that can be applied to a ContactDetail to indicate the time when a contributor made their contribution. |
| parameterDefinition | An extension that can be applied to a TriggerDefinition to indicate a parameter that is supplied to the event handler for the trigger. |
| isPrefetchToken | An extension that can be applied to a ParameterDefinition to indicate whether the parameter may be used to parameterize prefetch queries. |
| supportedCqlVersion | An extension that can be applied to a CapabilityStatement to indicate what versions of CQL a server supports processing. |
| Profile | Description |
|---|---|
| Shareable ActivityDefinition | Enforces the minimum information set for the activity definition metadata required by HL7 and other organizations that share and publish activity definitions. |
|
|
Defines a GuidanceResponse that represents the response container for a CDS Hooks response |
| Shareable Library | Enforces the minimum information set for the library metadata required by HL7 and other organizations that share and publish libraries |
| CQL Library | Represents a CQL logic library |
| Shareable Measure | Enforces the minimum information set for the measure metadata required by HL7 and other organizations that share and publish measures |
| Shareable PlanDefinition | Enforces the minimum information set for the plan definition metadata required by HL7 and other organizations that share and publish plan definitions |
| Computable PlanDefinition | Defines a computable PlanDefinition that specifies a single library and requires all expressions referenced from the PlanDefinition to be definitions in that single library |
|
|
Defines a PlanDefinition that implements the behavior for a CDS Hooks service |
|
CDS
Hooks
|
Defines
a
|
| Service | Description |
|---|---|
| Knowledge Repository | Defines minimum service capabilities for a knowledge repository. |
| Measure Processor | Defines minimum service capabilities for a measure processor. |
Because Knowledge Artifacts are typically patient-independent, many of the resources in the clinical reasoning module have no patient security and privacy concerns beyond the normal sensitivity that should be paid in any electronic healthcare system environment. However, the evaluation use case, including decision support guidance request/response, as well as quality measure evaluation have significant patient security and privacy concerns.
For the clinical decision support evaluation use case, as with any patient-specific information, care should be taken to ensure that the request and response are properly secured both at rest and in-motion, and that all access to the patient's information is done via a properly authenticated and authorized mechanism. This is particularly true of decision support artifacts where the logic is ingested as part of the definition of the artifact. In this scenario, the evaluation engine must ensure that data access within the ingested logic is subject to the same authentication and authorization requirements as any other access.
For guidance services that receive patient information, ensure that logging and auditing trails do not inadvertently compromise patient privacy and security by logging potentially sensitive information in an unencrypted way. In addition, guidance and recommendations returned from the service must ensure that content that contains patient information is clearly indicated so that consuming clients can take the appropriate care in integrating and displaying the resulting guidance.
For quality measure evaluation, individual and patient-list reports have the potential to contain large amounts of patient information. As with the decision support guidance responses, care must be taken to ensure the patient information is only accessible to properly authenticated and authorized agents, and that inadvertent breaches are minimized by following appropriate logging and auditing protocols.
In particular, because expression languages, depending on their power and scope, can provide the ability to access large amounts of data, as well as the potential for infinite recursion or looping, care should be taken to ensure that implementations adequately safeguard against Denial-of-Service-style attacks that leverage these capabilities to compromise systems by overloading capacity.
For more general considerations, see the Security and Privacy module , and in particular the Implementer's Safety Checklist .
| Use Case | Description |
|---|---|
| Providing a dynamic value for a resource element | Using expressions to define the value for an element of a FHIR resource. |
| Defining a CQL library | Using the Library resource to incorporate a Clinical Quality Language library for use in FHIR resources. |
| Defining a Model Definition artifact | Using the Library resource to incorporate the definition of an information model for use with expressions in FHIR. |
| Defining an Event Condition Action rule | Using the PlanDefinition resource to represent an event-condition-action rule in FHIR. |
| Defining a Referral Request activity | Using the ActivityDefinition resource to define a referral request activity that can be used as part of a knowledge artifact. |
| Defining a Medication Request activity | Using the ActivityDefinition resource to define a medication request activity that can be used as part of a knowledge artifact. |
| Defining an Order Set | Using the PlanDefinition resource to represent an order set. |
| Defining a Protocol | Using the PlanDefinition resource to represent a protocol. |
|
|
Using the $evaluate operation to request and process guidance from a decision support service. |
| Defining a Measure | Using the Measure resource to represent a clinical quality measure. |
| Evaluating a Measure | Using the $evaluate-measure operation to request calculation of a clinical quality measure. |
| Applying an ActivityDefinition | Using the $apply operation to realize the intent resource defined by an ActivityDefinition. |
| Applying a PlanDefinition | Using the $apply operation to realize a plan definition for a specific context. |
| Representing Quality of Evidence/Strength of Recommendation |
Using
the
qualityOfEvidence
and
strengthOfRecommendation
extensions
to
indicate
ratings
associated
with
evidence
for
a
particular
artifact
or
recommendation.
|
The
resources
defined
for
the
Clinical
Reasoning
module
are
the
result
of
the
combined
efforts
of
multiple
communities
working
on
the
shared
goal
of
harmonized
standards
and
specifications
for
clinical
decision
support
and
support,
quality
measurement
measurement,
public
health
reporting,
evidence
sharing,
and
other
clinical
reasoning
use
case
artifacts.
The
current
state
of
the
module
reflects
changes
incorporated
both
from
previous
ballots
on
the
FHIR-specific
material,
as
well
as
content
derived
from
several
other
balloted
specifications
in
the
CDS
and
CQM
domains.
The
content
at
this
point
is
capable
of
supporting
the
two
primary
use
cases
of
sharing
and
evaluation
in
both
multiple
domains
and
for
a
broad
variety
of
artifacts.
In particular, the use of Clinical Quality Language (CQL) as a foundational mechanism for representing clinical quality logic enables decision support and quality measurement artifacts to share common definitions. For example, a Chlamydia Screening measure and related decision support artifacts focused on improving the measure can share a common library that describes the criteria for detecting when Chlamydia Screening is required in a patient. The decision support rule applies these criteria to determine when and how to impact a workflow, while the quality measure uses these same criteria to determine whether the screening goal has been met for a patient or population. In addition, the resources defined in this module use common patterns for describing the structure of artifacts and their associated metadata, enabling a consistent approach to the sharing and distribution of clinical knowledge artifacts.
Over
the
past
year
several
years
of
trial
use,
the
Clinical
Reasoning
module
has
been
used
in
both
the
quality
measurement
and
decision
support
domains
to
represent,
exchange,
and
evaluate
knowledge
artifacts.
This
usage
has
generated
feedback
resulting
in
the
addition
of
several
new
profiles,
as
well
as
guidance
for
using
the
Clincal
Clinical
Reasoning
module
with
CDS
Hooks
and
for
quality
reporting.
Although
this
feedback
resulted
in
some
substantive
changes,
there
were
comparatively
few,
and
the
goals
of
the
module
for
the
next
year
several
years
are
to
push
towards
higher
maturity
levels
and
continue
to
seek
implementation
feedback.
The
goals
feedback
as
part
of
the
module
over
the
next
year
are
to
provide
a
stable
basis
reaching
normative
status
for
implementation
of
the
sharing
use
case,
as
well
as
unification
with
the
CDS
Hooks
specification
in
support
of
module
resources.
In
particular,
the
evaluation
use
case.
The
Clinical
Quality
Framework
Initiative
will
continue
to
use
these
resources
as
the
basis
for
implementation
projects,
targeting
normative
status
for
at
least
the
Library,
Measure,
ActivityDefinition,
and
PlanDefinition
resources
as
part
of
the
next
FHIR
publication
(R6).
Some of these implementation guides include:
:
This
implementation
guide
provides
universally
applicable
guidance
related
to
the
content
development
lifecycle,
including
authoring,
packaging,
publishing,
distributing,
and
consuming
conformance
resources
and
knowledge
artifacts.
:
This
implementation
guide
provides
an
:
This
implementation
guide
provides
detailed
conformance
requirements
and
guidance
for
:
This
implementation
guide
provides
detailed
guidance
to
support
reporting
quality
measures
specified
by
the
Quality
Measures
IG.
Note
that
the
Canonical
Resource
Management
Infrastructure
implementation
guide
in
particular
includes
general
guidance
for
the
Shareable,
Publishable,
Computable,
and
Executable
content
patterns
used
in
previously
published
versions
of
several
of
the
above
implementation
guides
and
consolidated
as
the
Shareable
and
Publishable
patterns
in
this
specification.
The
profiles
in
the
CRMI
have
the
same
URL
as
the
equivalent
profiles
in
this
specification,
the
intent
being
to
use
the
CRMI
profiles
to
continue
maturing
the
patterns
and
related
profiles,
with
the
ultimate
goal
of
including
the
matured
profiles
in
a
year.
future
version
of
the
FHIR
publication.
Applications
making
use
of
the
Shareable
and
Publishable
patterns
should
use
the
profiles
defined
in
CRMI.
Trial-Use Note:Note to Implementers: We are actively seeking comments on all areas of the module, with particular focus on supporting the following scenarios:
- FHIR-Based Knowledge Artifact Repository
- FHIR-Based Clinical Decision Support Service
- FHIR-Based Quality Measure Evaluation and Reporting
- FHIR-Based Order Set Catalog/Ordering Services
- The use of Measure and MeasureReport for public health indicator reporting
- Enabling population level query
- The use of FHIR Bulk Data as a mechanism to enable population-level quality reporting
- The use of FHIR interactions in general as a mechanism for enabling knowledge artifact repository and distribution functionality.
Feedback is welcome here
The
FHIR
Clinical
Reasoning
module
is
sponsored
by
the
Clinical
Decision
Support
(CDS)
and
Clinical
Quality
Information
(CQI)
HL7
Work
Groups,
with
input
and
coordination
from
the
FHIR
Infrastructure
and
Infrastructure,
Terminology
Infrastructure,
Service
Oriented
Architecture
Architecture,
Patient
Care,
Patient
Administration,
and
Public
Health
HL7
Work
Groups.
The
guidance
in
this
module
was
prepared
as
a
Universal
Realm
Specification
with
support
from
the
Clinical
Quality
Framework
(CQF)
initiative
,
which
was
a
public-private
partnership
sponsored
by
the
Centers
for
Medicare
&
Medicaid
Services
(CMS)
and
the
U.S.
Office
of
the
National
Coordinator
for
Health
Information
Technology
(ONC)
to
identify,
develop,
and
harmonize
standards
for
clinical
decision
support
and
electronic
clinical
quality
measurement.
The
Clinical
Quality
Framework
effort
transitioned
to
HL7's
Clinical
Quality
Information
(CQI)
and
Clinical
Decision
Support
(CDS)
Work
Groups
in
2016.
The Clinical Quality Framework is focused on harmonizing the historically disjointed specifications used by the Clinical Quality Measurement and Clinical Decision Support communities. Specifically, the initiative has focused on the specifications used to represent knowledge artifacts within the two communities. The strategy employed has been to break the conceptual content of knowledge artifacts into three core components, to define common standards for these core components, and to re-use these common standards for both clinical decision support and clinical quality measurement:
The
first
component
has
resulted
in
the
Clinical
Quality
Common
Metadata
Conceptual
Model
,
an
informative
document
harmonizing
metadata
requirements
between
Quality
Measurement
and
Decision
Support
artifacts.
The
second
component
has
resulted
in
the
QUICK
Conceptual
and
Logical
Models,
a
harmonization
of
the
Virtual
Medical
Record
(vMR)
used
in
Decision
Support
and
the
Quality
Data
Model
(QDM)
used
in
Quality
Measurement,
and
with
its
core
requirements
realized
in
FHIR
as
the
Quality
Improvement
Core
(QICore)
profiles
.
Ongoing
work
in
this
area
is
focusing
on
coordination
with
the
Clinical
Information
Modeling
Initiative
(CIMI)
and
a
methodology
for
producing
FHIR
profiles
from
CIMI
models.
Currently,
the
QICore
FHIR
profiles
(which
are
in
turn
derived
from
the
US-Core
profiles)
can
be
used
to
model
clinical
quality
data,
and
to
present
a
consistent
model
for
use
in
authoring
and
evaluating
clinical
quality
artifacts.
Finally,
the
third
component
has
resulted
in
the
Clinical
Quality
Language
specification
,
a
harmonization
of
the
expressive
capabilities
of
the
Clinical
Decision
Support
Knowledge
Artifact
Specification
(CDS
KAS)
(produced
by
the
Health
eDecisions
(HeD)
Standards
and
Interoperability
(S&I)
initiative),
and
the
Health
Quality
Measures
Format
(HQMF)
.
As part of the ongoing CQF initiative pilot efforts, these developing specifications are being used to support knowledge artifact sharing, as well as evaluation of knowledge artifacts as part of decision support request/response and measure evaluation.
This module continues the harmonization of quality domain specifications by defining an approach to using a FHIR server as a component of a knowledge system in both the Knowledge Repository and Knowledge Evaluation Service roles.
The approach and representations within this guide are derived from and intended to be consistent with the following specifications:
This material includes SNOMED Clinical Terms ® (SNOMED CT®), which are used by permission of the International Health Terminology Standards Development Organisation (IHTSDO). All rights reserved. SNOMED CT was originally created by the College of American Pathologists. "SNOMED ®" and "SNOMED CT ®" are registered trademarks of the IHTSDO.
This
material
contains
content
from
Logical
Observation
Identifiers
Names
and
Codes
(LOINC®)
(
http://loinc.org
).
The
LOINC
table,
LOINC
codes,
and
LOINC
panels
and
forms
file
are
copyright
©
1995-2017,
Regenstrief
Institute,
Inc.
and
the
LOINC
Committee
and
available
at
no
cost
under
the
license
at
http://loinc.org/terms-of-use
.
This
material
contains
content
from
the
Unified
Code
for
Units
of
Measure
(UCUM)
(
http://unitsofmeasure.org
).
The
UCUM
specification
is
copyright
©
1999-2017,
Regenstrief
Institute,
Inc.
and
available
at
no
cost
under
the
license
at
http://unitsofmeasure.org/trac/wiki/TermsOfUse
.
This material contains quality measure content developed by the National Committee for Quality Assurance (NCQA). The measure content is copyright (c) 2008-2017 National Committee for Quality Assurance and used in accordance with the NCQA license terms for non-commercial use.
The guidance in this module is the work of a joint project between the HL7 Clinical Quality Information and Clinical Decision Support Work Groups with the co-sponsorship of the FHIR Infrastructure, Implementable Technology Specifications, and Service Oriented Architecture Work Groups.
FHIR
®©
HL7.org
2011+.
FHIR
Release
4B
(v4.3.0)
hl7.fhir.r4b.core#4.3.0
R5
hl7.fhir.core#5.0.0
generated
on
Sat,
May
28,
2022
12:57+1000.
Sun,
Mar
26,
2023
15:26+1100.
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