Clinical Practice Guidelines, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 3.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/cqf-recommendations/ and changes regularly. See the Directory of published versions

Version History

This page details changes made in each version of the Clinical Guidelines implementation guide.

STU 3 Ballot (version 3.0.0-ballot)

The following changes have been applied since the STU2 release (version 2.0.0), organized by their impact on implementations. Within the narrative pages of this guide, new and modified content is highlighted, and the highlighting can be turned on or off using the change display toggle at the top of each page. Changes to profiles, extensions, and other conformance resources are not highlighted in their renderings; refer to the entries below.

Non-compatible Changes

These changes may require existing content or implementations to be updated:

• FHIR-48669: Replaced the cpg-itemImage and cpg-responseImage extensions with the SDC itemMedia and itemAnswerMedia extensions in CPGComputableQuestionnaire, and removed the CPG extensions. Added a dependency on Structured Data Capture 4.0.0, and referenced the SDC $populate and $extract operations from the CPG Interactive Service and CPG Interactive Client capabilities
• FHIR-57512: Removed the unused mergeNestedCarePlans and terminologyEndpoint parameters from PlanDefinition/$apply, and the unused terminologyEndpoint parameter from ActivityDefinition/$apply

Compatible, Substantive Changes

These changes add new capabilities or relax existing requirements, without invalidating existing conformant content:

• FHIR-59768: Established formal conformance statements throughout the guide, listed on the Conformance page, with a new CPG Conformance Category code system. Defined the system Actors (CPG Knowledge Repository, CPG Service, and CPG Client) and the service and client pairs for each level of enablement, with their ActorDefinitions and CapabilityStatements. Relaxed the requirements to use the CRMI profiles for knowledge artifacts, code systems, and value sets from SHALL to SHOULD, because this guide does not take a dependency on CRMI (see Use of CRMI), and clarified that the CQL library requirements apply only to content that uses CQL (see Use of CQL and Libraries)
• FHIR-50165: Added support for interactive clinical decision support, described on the new Interactive Clinical Decision Support page, with the new PlanDefinition/$questionnaire and StructureDefinition/$questionnaire operations
• FHIR-57699: Added coded results for compliance and adherence metrics, with the CPG Metric Result code system and the CPG Compliance Result and CPG Adherence Result value sets, and added the compliance and adherence measure types in the CPG Measure Type value set, bound to CPGComputableMetric. Documented in Metrics, and aligned the Metrics approach and the glossary
• FHIR-50150: Added the cqf-applicabilityBehavior extension to the actions of CPGComputablePlanDefinition, described its effect in PlanDefinition/$apply, and used it in the process patterns and examples. Added a dependency on the FHIR Extensions Pack 5.4.0
• FHIR-48734: Allowed the cqf-messages extension on CPGCarePlan, CPGStrategy, and the recommendation proposal profiles, and described its use in PlanDefinition/$apply and ActivityDefinition/$apply
• FHIR-57515: Added the cpg-applicabilityExpression and cpg-targetExpression extensions, and added them and cqf-library to CPGComputableGraphDefinition
• FHIR-57516: Defined the GraphDefinition/$apply operation, and added it to the CPG Summary Service and CPG Summary Client capabilities
• FHIR-51810: Added the cpg-pertinenceRating and cpg-pertinentTo extensions, added the case feature extensions to the request profiles, and allowed the pertinence extensions on the request, event, case feature, CPGCaseSummary, and CPGCasePlanSummary profiles, as described in Activity Events
• FHIR-49942: Removed content constraints that the infrastructure does not depend on, such as required names, from the domain profiles, including CPGPatient, CPGPractitioner, CPGOrganization, and CPGLocation
• FHIR-52833: Added guidance on developing and maintaining terminology, including guideline-specific code systems and mappings, update cadence, and organizing value sets by code system

Non-substantive Changes

These changes correct or clarify the guide without changing its requirements:

• FHIR-59639: Reorganized and editorially revised the Approach section, including a new Conceptual Knowledge Architecture Index. The Knowledge Engineering Overview, Guideline Development Group, and Knowledge Representation pages were removed, and their content consolidated into the remaining Approach pages
• FHIR-53488: Updated the L1 Checklist to the published version, and referenced the published article
• FHIR-50999: Added the missing reference for Figure 1 on Computable Guideline Artifacts
• FHIR-59638: Updated the learning health system diagram on the home page
• FHIR-51911: Fixed the formatting of the activity profiles table
• FHIR-49790: Corrected the Record Inference activity examples
• FHIR-49033: Fixed a typo in the CHF example O2 saturation case feature goal
• Corrected the FHIR version declared by the CPG Common Patient Registry capability statement and an example library, and updated the build for the latest IG Publisher

STU2 Release (version 2.0.0)

The following changes were applied as a result of comments received during the STU2 ballot:

• FHIR-48658: Removed CarePlan/$apply operation
• FHIR-48634: Added support for ratings in recommendations
• FHIR-48388: Expanded CPGRecommendationDefinition to reference a CPGOrderSet
• FHIR-48019: Clarified pseudo-code for activity multi-step activity flows to use prepare/initiate language, rather than start/end language
• FHIR-46314: Clarified guidance in PlanDefinition/$apply related to the use of option
• FHIR-46097: Allowed cpg-rationale to be used on PlanDefinition.action (recursively)
• FHIR-45999: Clarified behavior of requests within a RequestGroup and the option intent
• FHIR-45460: Provided additional guidance on computability vs interoperability profiles
• FHIR-44984: Reflected doNotPerform and notDone in the ActivityFlow
• FHIR-44983: Defined intent for communicationrequest
• FHIR-44913: Enhanced testing description in the methodology page
• FHIR-44911: Improved definition and explanation of content implementation guides
• FHIR-44240: Removed cpg-indicator value set, should be in a Using CDS Hooks IG
• FHIR-44234: Removed cpg-indicator code system in favor of THO cdshooks-indicator
• FHIR-44160: Reconciled overlaps with the EBMonFHIR IG
• FHIR-44143: Minor grammar and formatting fixes throughout IG
• FHIR-44067: Fixed activity profiles page numbering
• FHIR-43990: Updated opioid examples to latest
• FHIR-43989: Documented state transition from status = draft to status = active
• FHIR-43433: Minor correction typos in 3 Methodology, 3.4.1 Concepts
• FHIR-43361: Added L1 checklist and surface checklists more prominently
• FHIR-43149: Ensured extensions only apply in appropriate contexts
• FHIR-41200: Added stop, hold, and resume activities
• FHIR-40550: Added ActivityDefinition/$apply operation
• FHIR-32962: Added the ability to specify the type of an empty input parameter
• FHIR-32592: Added MustSupport guidance
• FHIR-29679: Added a mergeNestedPlans parameter to PlanDefinition/$apply
• FHIR-27151: Removed rating extensions from context-specific recommendations

STU2 Ballot (version 2.0.0-ballot)

This ballot of the Clinical Guidelines implementation guides incorporates feedback that has been received during the trial-use implementation period. Feedback from production implementations of clinical reasoning capability as well as multiple content development projects covering various aspects of computable guideline content development and implementation has been included.

Major changes include:

• Removed Shareable/Publishable/Executable profiles and referenced the CRMI IG for those capabilities instead (see Profiles)
• Removed the Using CQL and Libraries conformance requirements and referenced the Using CQL with FHIR IG for those capabilities instead (see Libraries)
• Detailed descriptions of activity flow (see Activity Flow)
• Recommend an Immunization activity now uses MedicationRequest
• Added L1 checklist from GIN-NA working group (see L1 Checklist)
• Moved most example IGs to cqframework (see Examples)

The following sections detail the changes that were applied for this ballot.

• FHIR-43074: Add more detailed description of activity flow
• FHIR-42973: Refactor to use CRMI profiles
• FHIR-40964: Unable to file issues against 1.0 version in HL7 JIRA
• FHIR-40486: Add guidance on when available ELM can be used
• FHIR-40298: Change Immunization action
• FHIR-38743: Better definitions for each activity
• FHIR-35796: Add a CPG Packaging Like the Measure Packaging Operation
• FHIR-34350: ImmunizationRecommendation example does not point at meta.profile
• FHIR-32676: Ability to specify supported CQL versions
• FHIR-32672: Add support for specifying CQL options in CQL/ELM libraries and projects
• FHIR-26607: Add description of types of artifacts
• FHIR-25741: Add extensions to identify the packaging and testing tooling for an artifact

In addition, the implementation guide source was completely updated to run on the latest IG publication tooling, which included numerous typographical and technical corrections throughout.

STU1 Publication (version 1.0.0)

• FHIR-30007: Support for images in questionnaire questions and answers
• FHIR-27154: Formalized $cql and Library/$evaluate operations
• FHIR-27151: Removed rating extensions from instance profiles
• FHIR-26885: Formalized conformance requirements for input and output of CQL libraries
• FHIR-26875: Relaxed url requirement in related artifacts
• FHIR-26621: Clarified conformance requirements for Library resolution and naming/namespacing
• FHIR-26612: Defined shareable, computable, publishable, and executable knowledge capabilities and profiles
• FHIR-24236: Added a complete example for Congestive Heart Failure pathway
• FHIR-24227: Updated narratives for examples throughout
• FHIR-24223: Added history of attempts to background section
• FHIR-24221: Formalized activity processing semantics
• FHIR-24217: Formalized triggering behavior
• FHIR-24177: Improved activity catalog
• FHIR-24165: Added Development/methodology documentation and walkthroughs
• FHIR-24163: Added testing and packaging support and documentation
• FHIR-24161: Clarified rating systems conformance requirements
• FHIR-24156: Updated topic binding to preferred for all artifact types
• FHIR-24150: Separated examples vs artifacts and provided index for both
• FHIR-24087: Moved recommendation-specific extensions to recommendation definition
• FHIR-23991: Added a glossary of key terms
• FHIR-23968: Formalized request proposal/plan/order behavior
• FHIR-23964: Formalized eligibility and enrollment behavior
• FHIR-23963: Added case plan summary support
• FHIR-23960: Formalized care plan behavior
• FHIR-23959: Added support for clinical impressions
• FHIR-23958: Added case plan progressing note support
• FHIR-23957: Added case summary support
• FHIR-23956: Formalized metric behavior
• FHIR-23954: Added support for case features
• FHIR-23952: Formalized case behavior
• FHIR-23951: Formalized strategy behavior
• FHIR-23949: Completed examples for all activity types
• FHIR-23948: Reorganized overall guide content and navigation
• FHIR-23945: Changed protocol and workflow to pathway and strategy definitions
• FHIR-23940: Added patient safety discussion to conformance page

In addition, numerous corrections and clarifications were made throughout, as well as substantial expansion of approach and methodology documentation. Refer to the HL7 JIRA for a complete description of changes applied to the 1.0.0 version.

STU1 Ballot (version 0.1.0)

The initial ballot combines experience gained from multiple guideline representation projects, including Opioid Prescribing Support, Chronic Kidney Disease Management, Antenatal Care, HIV/HBV Screening, Prevention, and Treatment, and Immunization Decision Support.