Release 4B Ballot #1

This page is part of the FHIR Specification v4.1.0: R4B Ballot. About the R4B version of FHIR. The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions

FHIR Infrastructure Work GroupMaturity Level: N/AStandards Status: Informative

Welcome to the FHIR R4B ballot. This is a special, limited scope ballot in which most content remains strictly compatible with R4 . However, it advances and revamps a limited set of content to allow advancing the maturity level of this content faster than could be achieved by waiting for the next major release (R5), currently slated for final publication in spring of 2022.

This resulting R4B release will be strictly backward compatible with R4, except as described in the changes listed below:

STU Note: One of the resources with substantive (and breaking changes) made as part of this release falls outside the originally intended scope of R4B - Substance. The FHIR Management Group has chosen to allow the ballot to proceed with these breaking changes in place, however it reserves the right to revert some or all the breaking changes to allow R4B to be safely substitutable for R4 outside the medication regulation and evidence-based medicine communities. Balloters are encouraged to comment on the impact of allowing R4 to be updated with the breaking changes to this resource, as well as the impact of rolling back these breaking changes. Further details can be found below.

  • Breaking changes: Net new resources and/or significant revision to resources in the Evidence-Based Medicine and the Medication Definition spaces
  • Non-breaking enhancements:
  • Formatting & technical corrections
    • A limited set of Technical Corrections addressing formal artifact and computable rule representations used by tools
    • Some enhancements around publication formatting, including the full integration of terminology.hl7.org (THO) as a shared source for HL7 terminology, which moves certain content out of the FHIR specification and into the THO implementation guide
    • Correction of many examples to address issues identified through the improved capabilities of the FHIR validator

All content within this specification falls under one of the following ballot statuses:

  • Normative: Content that is subject to normative ballot rules. Once passed, strict rules are imposed on future change to help ensure inter-version compatibility
  • Trial Use: Content that is undergoing FHIR maturity Model based testing. In a future ballot cycle, once sufficiently mature, it will be balloted as normative
  • Informative: Content that is advisory (e.g. implementers are not required to conform to the content), or navigational content - tables of contents, generated lists, etc.
  • Draft: Content added late in the balloting process that has no formal standing but is published for visibility. It might not be suitable for use in production systems.
  • Deprecated: Content that is in the process of being removed (see deprecation).
  • External: Content that is replicated from external standards (e.g. HL7 v2, DICOM) and is not subject to ballot comment

Note that this ballot is a Standard for Trial Use (STU) ballot. Thus, all changes made to normative artifacts as part of this release, are considered as 'STU' until validated by normative ballot as part of R5.

This ballot will be the first HL7 ballot to trial HL7's new Jira balloting process . As such, ballot comments will need to be submitted in Jira and, in general, balloting spreadsheets will not be used. Some organizational and affiliate balloters may continue to use spreadsheets but will be responsible for importing them into Jira themselves and may have slightly different processes for consolidating ballots to take that into account. The ballot desktop will be used for voter registration but will not be available for vote submission. Voters are encouraged to view the recorded tutorial on Jira balloting in addition to reading through the instructions on submitting Jira feedback and using Jira balloting . A webinar will be held part-way through the ballot cycle to provide an opportunity to ask questions about the process. Questions can also be raised on the Jira/Confluence stream on http://chat.fhir.org.

Because this is a limited-scope ballot, votes can only be submitted on those resources and pages that fall within the scope of the ballot. Specifically:

  • Resources: AdministrableProductDefinition, Citation, ClinicalUseIssue, Evidence, EvidenceReport, EvidenceVariable, Ingredient, ManufacturedItemDefinition, MedicinalProductDefinition, PackagedProductDefinition, RegulatedAuthorization, Substance, SubstanceDefinition
  • Pages: (NA), (many), Ballot Intro, Clinical Reasoning Module, Datatypes, Downloads, Home (index), Medication Definition Module, Table of Contents (toc)

All feedback related to this ballot must be submitted using the FHIR Specification Feedback Jira project and must reference one of the above resources or pages. If commenting on a technical correction or non-substantive change made as part of this release that is relevant to a different artifact or page, simply list the "Ballot Intro" page as one of the relevant pages.

If you have feedback about the FHIR core specification NOT related to the scope of this ballot, feel free to propose changes using Jira in the usual manner - just don't try to vote on them. Note that comments about the FHIR core specification outside the scope of this ballot should ideally be based on the FHIR continuous integration build , rather than on this R4B release snapshot.

Because this is only an STU ballot, only one ballot cycle is anticipated, with final publication of R4B planned for late Q2 or sometime in Q3, 2021.

The detailed list of changes included in this specification is as follows:

The resources in this space were extremely draft when R4 was first published. There has been no uptake of the resources as they were published. The community has provided significant feedback, including connectathon work, and there is a desire by the community to have official 'Standard for Trial Use' releases of these resources. The maturity level for the resources in this space have been increased to '1'. Changes are as follows:

These resources have been significantly refactored based on feedback from the U.S. Federal Drug Administration (FDA), the European Medicines Agency (EMA), Health Canada and others. The community has indicated that the versions of the 'Medication Definition' resources as published in R4 were not implementable as published and have not been implemented - as such a significant refactoring is still 'compatible' with R4. All resources have had adjustments to data elements, data types, definitions, code bindings, etc. The maturity levels of these resources have also been increased. High level changes include:

  • Renamed (and in some cases merged) resources as follows:
  • Added some medication-definition-specific "special" data types now used in the above resources: and updated the Data types page to include references to them
  • Introduced the CodeableReference data type, pre-adopting it from R5 as it is used in some of the Medication Definition resources (and updated the data types page to reference it).
  • Removed SubstanceAmount and SubstanceMoiety special data types (not needed anymore)
  • Removed several Substance-related resources as "not yet ready for use". It is not clear whether or how these concepts will be re-introduced:
    • SubstanceNucleicAcid
    • SubstancePolymer
    • SubstanceProtein
    • SubstanceReferenceInformation
    • SubstanceSourceMaterial
  • Added NutritionProduct as a new resource that will eventually be used several places, but for now is needed in the Medication Definition/Regulation space
  • BREAKING CHANGES TO Substance driven by using Substance as part of the medication definition and regulation process. Specifically:
    • Changed order of appearance of element Substance.instance
    • Changed Substance.code from CodeableConcept to CodeableReference<SubstanceDefinition>
    • Changed Substance.instance from a complex element to a simple boolean
    • Eliminated Substance.instance.identifier and Substance.instance.expiry
    • Moved Substance.instance.quantity to be Substance.quantity
  • Defined the Medication Definition module page to give guidance on how the medication definition resources fit together

The list of allowed targets for Reference or Canonical elements has been extended for the following elements:

The following resources have had their maturity levels increased to level 3+, which involved non-substantive changes including adding missing RIM mappings where appropriate, minor clean-up of definitions and usage notes, corrections to examples, and defining example bindings (and associated code systems and value sets) when needed. Note that additional maturity levels may be adjusted prior to R4B publication where such changes are driven by implementation experience or other factors and do not involve substantive change to resources.

These are minor changes to documentation that do not strictly fall within the banner of "technical corrections" but have no direct impact on implementation:

These technical corrections are not subject to ballot and are listed here for information purposes only. However, if you believe any are erroneous, please submit a comment referencing this page. The technical corrections made here generally align with the FHIR Management Group's policy of only making technical corrections that influence tooling behavior. Wording clarifications, spelling errors, etc. generally are only applied to future versions unless especially likely to create dangerous situations in the previous release.

Resources
AllergyIntoleranceFHIR-23008 - Corrected FHIRPath and Schematron XPath expressions for ait-1 and ait-2 constraints
BundleFHIR-25525 - Correct bdl-8 to allow fullUrl to be missing
CapabilityStatementFHIR-19955 - Correct Schematron XPath on cpb-15 and cpb-16 constraints
ConditionFHIR-23008 - Corrected FHIRPath and Schematron XPath expressions for con-3 constraint
ConsentFHIR-27940 - Corrected invalid example value
FHIR-30793 - Corrected documentation referring to removed 'except' element.
FHIR-31482 - Removed extra closing brackets from ppc-2, ppc-3, ppc-4 and ppc-5 constraint Schematron XPaths
DeviceUseStatementFHIR-26900 - Correct 'patient' search parameter to be only Patients
DomainResourceFHIR-26307 - Correct dom-3 Schematron XPath and FHIRPath expressions
FHIR-26593 - Correct dom-3 to require that referenced contained elements have an id'
LibraryFHIR-29829 - Correct URLs in FHIRHelpers and FHIRModelInfo libraries
ParametersFHIR-21180 - Correct Schematron XPath for inv-1 constraint
PatientFHIR-20462 - Corrected url for motherMaidenName search parameter
QuestionnaireFHIR-25390 - Corrected capitalization in que-7 FHIRPath expression
FHIR-26831 - Corrected FHIRPath expression for que-12 constraint
FHIR-29595 - Corrected context invariant in questionnaire-displaycategory extension
FHIR-31483 - Corrected que-5 constraint Schematron XPath
ResourceFHIR-31387 - Create SearchParameter instance for _list search parameter
RiskAssessmentFHIR-25796 - Corrected FHIRPath expression for ras-2 constraint
StructureDefinitionFHIR-20391 - Corrected Schematron XPath expression for sdf-20 constraint
FHIR-26877 - Removed incorrect sdf-8 escaping in expression
FHIR-28312 - Corrected type for 'profile' parameter in $validate operation to be canonical, not uri
Data Types
DurationFHIR-28415 - Corrected Schematron XPath for drt-1 constraint
ElementFHIR-26565 - Change global-1 to allow empty Parameters instance
ElementDefinitionFHIR-19968 , FHIR-26306 - Correct Schematron XPath for eld-19
TriggerDefinitionFHIR-25088 - Correct trd-3 constraint Schematron XPath
Pages
searchFHIR-28313 - Added the _source search parameter to the summary table