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Responsible Owner: Work Group Clinical Decision Support & Clinical Quality Information

Ballot Standards Status : Informative

14.0 Clinical Reasoning

14.0.1 Introduction

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, clinical protocols, and protocols. 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.

14.0.1.1 Scope

The Clinical Reasoning module focuses on enabling two primary use cases:

1. Sharing - The ability to represent clinical knowledge artifacts such as decision support rules, order sets, clinical protocols, and quality measures, and to do so in a way that enables those artifacts to be shared across organizations. all organizations involved in care management and delivery.
2. Evaluation - The ability to evaluate clinical knowledge artifacts in the context of a specific patient or population, including the ability to request decision support guidance, impact clinical workflow, and retrospectively assess clinical quality metrics.

Note to implementers: The user-facing external clinical decision support use case supported by the ServiceDefinition/$evaluate operation of the Clinical Reasoning module has significant overlap with the functionality provided by the CDS Hooks specification. As part of FHIR Release 4, it is the intention to unify the CDS Hooks specification with the Clinical Reasoning module, ensuring that implementers have a single consistent mechanism to support this use case that meets the requirements of both the Clinical Quality Framework and CDS Hooks communities. Although the functionality in both specifications is conceptually aligned, this unification will likely result in changes to both specifications. The CQF and CDS Hooks project teams are committed to this unification and will work to ensure that the resulting changes have as little impact as possible on current and ongoing implementation efforts, while meeting the needs of both communities. The project team is planning on a workable implementation tested at the connectathon in May of 2017, with a trial ballot following in September 2017, targeting publication as part of the FHIR Release 4 specification. Specifically, the CDS Hooks/Clinical Reasoning work will impact the ServiceDefinition and GuidanceResponse resources. The ActivityDefinition, PlanDefinition, Library, RequestGroup, Measure, and MeasureReport resources are not expected to be impacted by this work. 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:

• Expression Logic - the representation of logic using languages such as FHIRPath and Clinical Quality Language (CQL). (CQL) .
• Definitional Resources - resources that are not defined on any specific patient, but are used to define the actions to be performed as part of a clinical knowledge artifact such as an order set or decision support rule. These resources can be used directly, or with profiles to provide intended structure for specific types of resources.
• Knowledge Artifacts - representation of clinical knowledge such as decision support rules and rules, clinical quality measures. measures, and evidence summaries.

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.

14.0.1.2 Audience

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 a service for guidance request and response, consistent with the approach taken by the current using Decision Support Service Services specification. .

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.

14.0.2 Index

14.0.2.1 Resources and DataTypes

Resource	Description
ActivityDefinition	A resource to represent definitional resources.
DataRequirement 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 data type datatype that represents a general data requirement for a knowledge asset such as a decision support rule or quality measure.
GuidanceResponse EventDefinition	Represents the definition of an event.
Evidence	Represents a single analytic result about a group.
EvidenceVariable	Represents the response to elements that evidence is about, such as the elements of a specific guidance request returned by PICO question.
GuidanceResponse	Represents the $evaluate operation. 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.
ParameterDefinition	Represents the definition of a parameter to logic.
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.
RequestGroup RequestOrchestration	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.
ServiceDefinition TriggerDefinition	Describes Represents the definition of a specific clinical decision support service triggering event. Used in EventDefinition and supports evaluation using PlanDefinition to define the $evaluate operation. characteristics of an event.

14.0.2.2 Extensions

The following list details extensions that are commonly used as part of clinical reasoning use cases, either representing or evaluating knowledge artifacts. This is not an exhaustive list of extensions, and when a description of an extension here is inconsistent with the currently published description of an extension in the extensions pack, the extensions pack is the source of truth.

Profile

Extension	Description
cqlExpression artifact-author	Allows resources that do not define an author element to provide an author for the artifact.
artifact-citeAs	Allow resources to define how they should be cited.
artifact-contact	Allow resources that do not define a contact element to provide contact details to assist a user in finding and communicating with the publisher of the artifact.
artifact-contactDetailReference	A general reference to a resource that is a more detailed representation of the contact detail.
artifact-copyright	Allows resources that do not define a copyright element to provide copyright information for the artifact.
artifact-copyrightLabel	Allows resources that do not define a copyrightLabel element to provide a copyright label for the artifact.
artifact-date	Allows resources that do not define a date element to provide a date for the artifact.
artifact-description	Allows resources that do not define a description element to provide a description for the artifact.
artifact-editor	Allows resources that do not define an editor element to provide an editor for the artifact.
artifact-effectivePeriod	Allows resources that do not define an effectivePeriod element to provide an effectivePeriod for the artifact.
artifact-endorser	Allows resources that do not define an endorser element to provide an endorser for the artifact.
artifact-experimental	Allows resources that do not define an experimental element to provide an experimental flag for the artifact.
artifact-extended-contact-detail	Contact details (including purpose extension and address) to assist a user in finding and communicating with the publisher.
artifact-identifier	Allows resources that do not define an identifier element to provide identifiers for the artifact.
artifact-isOwned	Used to indicate whether the referenced resource is owned by the referencing resource (i.e., shares the same lifecycle).
artifact-jurisdiction	Allows resources that do not define a jurisdiction element to provide jurisdiction information for the artifact.
artifact-name	Allows resources that do not define a name element to provide a name for the artifact.
artifact-periodDuration	Allows a period to be specified using a start date and duration rather than specifying an end date.
artifact-publisher	Allows resources that do not define a publisher element to provide publisher information for the artifact.
artifact-purpose	Allows resources that do not define a purpose element to provide purpose information for the artifact.
artifact-relatedArtifact	Allows resources that do not define a relatedArtifact element to provide related artifact information for the artifact.
artifact-releaseDescription	Allows artifacts to specify release notes, i.e., a brief description of the contents and updates of a particular artifact release.
artifact-releaseLabel	Allows artifacts to specify a release label, i.e., a human-friendly release label assigned for the version of the artifact.
artifact-reviewer	Allows resources that do not define a reviewer element to provide reviewer information for the artifact.
artifact-status	Allows resources that do not define a status element to provide status information for the artifact. NOTE: This is a modifier extension.
artifact-title	Allows resources that do not define a title element to provide title information for the artifact.
artifact-uriReference	Allows resources to define a reference to a resource that is not canonical, but is being used as a knowledge artifact (e.g., a Substance or Medication resource that is modeling the definition of a substance or medication, rather than a specific instance). The resource referenced must be using the artifact-url and artifact-version extensions to provide a canonical reference for the resource.
artifact-url	Allows resources that do not define a url element to provide a canonical url for the artifact.
artifact-usage	Allows resources that do not define a usage element to provide usage information for the artifact.
artifact-useContext	Allows resources that do not define a useContext element to provide useContext information for the artifact.
artifact-version	Allows resources that do not define a version element to provide version information for the artifact.
artifact-versionAlgorithm	Allows resources that do not define a versionAlgorithm element to provide version algorithm information for the artifact.
artifact-versionPolicy	Allows versioning policy information to be provided for an artifact (e.g., strict, loose, metadata, and package).
codeOptions	This extension supports specifying the use focus of Clinical Quality Language an activity as a set of possible codes when there is no specific code available that captures the candidate activities.
cqf-alternativeExpression	An extension applied to an Expression to indicate an alternative, equivalent expression in a different language.
cqf-artifactComment	Allows comments such as review notes or additional documentation to be added to any artifact.
cqf-cdsHooksEndpoint	An extension applied to a PlanDefinition to indicate that it provides the behavior for a CDS Hooks service endpoint.
cqf-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.
cqf-contactAddress	An extension that can be applied to a ContactDetail to indicate the address of a contributor.
cqf-contactReference	An extension that can be applied to a ContactDetail to provide a reference to a resource that is the contact.
cqf-contributionTime	An extension that can be applied to a ContactDetail to indicate the time when a contributor made their contribution.
cqf-cqlAccessModifier	An extension that can be applied to a ParameterDefinition to indicate whether the declaration it represents is public or private.
cqf-cqlOptions	An extension that can be applied to an artifact to refer to a Parameters resource that provides translation options for a CQL-to-ELM translator.
cqf-cqlType	An extension that can be applied to parameters and parameter definitions to provide the actual FHIRPath or CQL type of the parameter.
cqf-criteriaReference	An extension that can be applied to populations and references to identify a specific measure criteria that is the source for the element on which it appears.
cqf-defaultValue	An extension that can be applied to a ParameterDefinition to indicate the default value for the parameter when none is supplied as part of an evaluation request.
cqf-definitionTerm	An extension that can be applied to any artifact to provide definitions that clarify usage and intent of the artifact.
cqf-directReferenceCode	An extension that can be applied to any artifact to indicate that a specific code is reference by logic within FHIR the artifact.
fhirPathExpression cqf-expansionParameters	An extension that can be applied to a Library or ImplementationGuide resource to indicate what parameters should be used for expansion for artifacts in the library or implementation guide. Also called Manifest Parameters.
cqf-expression	A general purpose extension that supports the use of languages such as FHIRPath and Clinical Quality Language within FHIR FHIR.
library cqf-fhirQueryPattern	An extension that can be applied to a DataRequirement to provide a parameterizable RESTful FHIR API Query that can satisfy the data requirement.
A general purpose cqf-improvementNotationGuidance	An extension that supports can be applied to a Measure and MeasureReport to provide additional guidance for the declaration interpretation of dependencies a measure score.
cqf-initialValue	An extension that can be accessed by applied to any element to define an expression logic that can be evaluated to determine the initial value for the element when it appears in a creation context, such as when filling out a questionnaire or creating a new instance of a resource.
qualityOfEvidence cqf-inputParameters	An extension that can be applied to Attachments any resource to indicate the quality of evidence parameters that were input to the operation that resulted in support the creation of the resource. For example, a particular artifact MeasureReport can use this extension to indicate what parameters were passed to the $evaluate operation that produced the MeasureReport. This extension is also used to capture the input expansion parameters as part of the CRMI $release operation.
cqf-isEmptyList	An extension that is applied to any parameter value to indicate that the value represents an empty list. This is necessary because the FHIR Parameters parameter element does not allow a parameter element to be represented without a value or recommendation. resource present.
strengthOfRecommendation cqf-isEmptyTuple	An extension that is applied to any parameter value to indicate that the value represents an empty tuple. This is necessary because the FHIR Parameters parameter element does not allow a parameter element to be represented without a value or resource present.
cqf-isPrefetchToken	An extension that can be applied to Attachments a ParameterDefinition to indicate whether the strength of a recommendation. parameter may be used to parameterize prefetch queries.
optionCode cqf-isPrimaryCitation	An extension that can be applied to any citation related artifact to indicate that it is considered a primary citation for the artifact.
cqf-isSelective	An extension that can be applied to questionnaire response options a DataRequirement to provide indicate that it is a selective criteria for the artifact, meaning that it is a criteria that has a high selectivity with respect to the given option. artifact (i.e., it has a high likelihood of significantly reducing the number of results that will satisfy the artifact overall). For example, a DataRequirement that indicates Condition of Diabetes, would have a high selectivity for a diabetes recommendation.
sourceValueSet cqf-knowledgeCapability	Allows resources that do not define a knowledgeCapability element to provide knowledge capability information for the artifact.
cqf-knowledgeRepresentationLevel	Allows resources that do not define a knowledgeRepresentationLevel element to provide knowledge representation level information for the artifact.
cqf-library	A general purpose extension that supports the declaration of dependencies that can be accessed by expression logic.
cqf-library	An extension that can be applied to coding elements any library reference to indicate the intended or actual source value set an alias that should be used for that library within expression logic used in the coding. artifact.
measureInfo cqf-logicDefinition	An extension that can be applied to any artifact to allow specific logic definitions used by the artifact to be identified. This extension is not intended to be used to define normatively referenced expression logic, that is done via libraries and expression-valued elements. This extension is only used to facilitate narrative rendering of knowledge artifact logic, and is always generated from other content.
cqf-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.
cqf-messages 14.0.2.3 Profiles	An extension that can be applied to resources to provide any messages that were produced in the evaluation process that produced the resource on which it appears. For example, a MeasureReport may use this extension to provide warnings that were produced during the creation of the MeasureReport.
cqf-modelInfo-isIncluded	An extension that can be applied to conformance resources to indicate whether or not they should be included in the resulting model information.
Description cqf-modelInfo-isRetrievable	An extension that can be applied to conformance resources to indicate whether or not they result in retrievable classes in the resulting model information.
CQIF-Questionnaire cqf-modelInfo-label	Defines extensions An extension that can be applied to conformance resources to indicate an author-friendly label for the base Questionnaire resulting class in the resulting model information.
cqf-modelInfo-primaryCodePath	An extension that allow can be applied to conformance resources to indicate what the primary code path is for the structure on which it appears.
cqf-modelInfoSettings	An extension that can be applied to library or implementation guide resources to provide the model information settings for the conformance resources included in the library or implementation guide.
cqf-parameterDefinition	An extension that can be applied to a TriggerDefinition to indicate a parameter that is supplied to the event handler for the trigger.
cqf-qualityOfEvidence	An extension that can be applied to indicate the quality of evidence in support of a particular artifact or recommendation.
cqf-relatedRequirement	An extension that can be used as on any DataRequirement to define a DocumentationTemplate with behavior specified via logic relationship between data requirements (i.e., to indicate that the data requirement on which it appears is related to another data requirement, and cannot be evaluated without reference to the related data requirement).
cqf-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
cqf-resourceType	An extension that can be used on any canonical reference to indicate the type of the resource that is referenced by the canonical. This is the canonical equivalent of the type element of the Reference type.
cqf-shouldTraceDependency	An extension that can be applied to any structure or element to indicate whether or not the element should be included in a dependency trace.
cqf-strengthOfRecommendation	An extension that can be applied to indicate the strength of a recommendation.
cqf-supportedCqlVersion	An extension that can be applied to a CapabilityStatement to indicate what versions of CQL libraries. a server supports processing.
cqf-testArtifact	An extension that can be applied to a Group or Library to identify the artifact under test.
cqf-valueFilter	An extension that can be applied to any data requirement to define a value-based filter as part of the data requirement. This extension is only used in R4 to provide the capability of the valueFilter element.
data-absent-reason	An extension that is applied to any parameter value to indicate that the parameter it represents does not have a value. This is necessary because the FHIR Parameters parameter element does not allow a parameter element to be represented without a value or resource present.
display	An extension that can be used on any canonical reference to indicate the display for the resource that is referenced by the canonical. This is the canonical equivalent of the display element of the Reference type.
targetConstraint	An extension that can be applied to a definitional resource to define a constraint that should be applied to instances created from the definition. For example, a Measure could use this extension to define a constraint on MeasureReports created from that Measure.

14.0.2.4 14.0.2.3 Services

The following list of services are minimum capability statements defining some basic functionality. More detailed treatment is available in the Canonical Resource Management Infrastructure implementation guide, as well as the Quality Measure implementation guide.

Service	Description
Knowledge Repository	Defines minimum service capabilities for a knowledge repository repository.
Measure Processor	Defines minimum service capabilities for a measure processor processor.

14.0.3 Security and Privacy

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 .

14.0.4 Common use Cases

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.
Defining a Questionnaire with dynamic content Representing Computable Guidelines	Using the Questionnaire resource clinical reasoning module and expression extensions to add dynamic functionality to a FHIR Questionnaire. Defining a Service Module Using the ServiceDefinition resource implementation guides to define a decision support service module. represent computable clinical practice guidelines.
Obtaining guidance from a Decision Support Service	Using the $evaluate operation services such as CDS Hooks 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.

14.0.5 Developmental Roadmap

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 artifacts. measurement, public health reporting, evidence sharing, and other clinical reasoning use cases. 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 decision support, quality measurement, public health, and CQM computable practice guideline 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 knowledge artifacts across this spectrum of use cases 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.

The goals Since the initial trial use publication as part of FHIR STU 3 in 2017, the Clinical Reasoning module over the next year are to provide has been used in a stable basis for implementation broad range of the sharing clinical use case, cases, including quality measurement and decision support, to represent, exchange, and evaluate knowledge artifacts. These use cases have been described in multiple implementation guides built on the Clinical Reasoning Module, and this usage has generated substantial feedback resulting in the addition of new elements, as well as unification with guidance for using the CDS Hooks specification Clinical Reasoning module. Although this feedback has resulted in support some substantive changes, there have been comparatively few, and the goals of the evaluation use case. The Clinical Quality Framework Initiative will use these resources as module for the basis next several years are to sustain this stability for implementation projects, targeting an FMM level the core use cases of 3 or 4 for all module resources within a year. representation and evaluation of clinical knowledge.

STU Note: We are actively seeking comments on all areas Some of the module, with particular focus on supporting the following scenarios: these implementation guides include:

• The Using CQL With FHIR : This implementation guides provides universally applicable guidance for the use of FHIRPath and CQL to provide dynamic functionality throughout Clinical Quality Language with FHIR resources for a variety of use cases.
• FHIR-Based Knowledge Artifact Repository Canonical Resource Management Infrastructure : 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.
• FHIR-Based Clinical Decision Support Service FHIR-Based Quality Measure Evaluation Guidelines : This implementation guide provides an approach and Reporting FHIR-Based Order Set Catalog/Ordering Services The use methodology for the representation and implementation of FHIR operations as computable clinical guidelines using the protocol for defining artifact evaluation requests resources and responses. In particular, capabilities provided by the ability Clinical Reasoning module.
• Using FHIR Clinical Reasoning with CDS Hooks : This implementation guide provides conformance criteria and guidance for using CDS Hooks with FHIR. The IG describes logical models for representing CDS Hooks constructs, mappings from those constructs to bundle multiple requests into a single operation, FHIR resources, as well as how CDS Hooks can be used to surface FHIR Clinical Reasoning services.
• Quality Measures : This implementation guide provides detailed conformance requirements and guidance for the use of a generic FHIR operation for any service module evaluation, versus defining an evaluation specific the Measure and Library resources to a given knowledge artifact. support the specification of quality measures.
• The use of FHIR interactions in general as a mechanism Data Exchange for enabling knowledge artifact repository and distribution functionality. Quality Measures : This implementation guide provides detailed guidance to support reporting quality measures specified by the Quality Measures IG.

Feedback is welcome here . Note that the Canonical Resource Management Infrastructure implementation guide in particular includes the Shareable, Publishable, Computable, and Executable content patterns, profiles, and guidance provided in previously published versions of several of the above implementation guides as well as previous versions of this specification. All of the Shareable, Publishable, Computable, and Executable profiles in the base specification are now defined in and evolving as part of the CRMI implementation guide. Applications making use of these patterns should use the profiles defined in CRMI.

14.0.6 Background

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 is was prepared as a Universal Realm Specification with support from the Clinical Quality Framework (CQF) initiative , which is 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 initiative has is focused on harmonizing the historically disjointed disjoint 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:

• Metadata - Descriptive information about the artifact and its content
• Clinical Information - Information about a patient or population of concern within a given artifact
• Logic - The clinical reasoning involved in an artifact

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.

More broadly, the FHIR Clinical Reasoning module provides a foundation for a Quality Improvement Ecosystem, depicted in the following diagram:

Also referred to as a "Learning Health System", the diagram highlights the ideal iterative flow of data from clinical care, measurement, and reporting, becoming evidence through analytics and synthesis into knowledge in the form of guidelines and protocols, operationalized as decision support, process improvement, and integration with clinical care, ultimately producing data that feeds back into the cycle. This process can be seen at work throughout the healthcare industry, from the microcosm of direct patient-provider interactions to determine and understand the best course of treatment for a patient, through quality improvement initiatives enacted within institutions to drive better patient outcomes and provider experience, up to industry-wide efforts including payer-provider collaboration and quality programs. The FHIR Clinical Reasoning module and the implementation guides based on it, build on the semantic interoperability enabled by FHIR to reduce friction throughout this cycle and across the settings in which it manifests to enable not only exchange of semantically interoperable data, but of knowledge.

14.0.7 Related Specifications

The approach and representations within this guide are derived from and intended to be consistent with the following specifications:

• HL7 Version 3 Standard: Clinical Decision Support Knowledge Artifact Specification, Release 1.3
• HL7 Version 3 Standard: Representation of the Health Quality Measure Format (eMeasure) DSTU, Normative, Release 2.1 1
• HL7 Version 3 Standard: Decision Support Service, Release 2
• HL7 Version 3 Implementation Guide: Decision Support Service, Release 1
• CMS Blueprint

14.0.8 Copyright Information

This material includes SNOMED Clinical Terms ® (SNOMED CT®), which are used by permission of the International Health Terminology Standards Development Organization Organisation (IHTSDO). All rights reserved. SNOMED CT was originally created by the College of American Pathologists. "SNOMED ®" "SNOMED ®" and "SNOMED "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.

14.0.9 Acknowledgements

The resources and guidance provided in this module is are the combined 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.