R6 Ballot (2nd Draft)

Publish-box (todo)

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

For background to this version history, see FHIR Version Management Policy.

Major Milestones:

5.0.0 icon Mar 26, 2023 Release 5 (Trial use - see below for discussion)
4.3.0 icon Dec 27, 2018 Release 4B: Staging release of modifications in specific areas
4.0.1 icon Dec 27, 2018 Release 4 (1st Normative Content + Trial Use Developments)
3.0.2 icon Feb 21, 2017 Release 3 (STU - Standard for Trial Use)
1.0.2 icon Oct 24, 2015 DSTU2 (Second Draft Standard for Trial Use)
0.0.82 icon Sept 30, 2014 DSTU1 (First Draft Standard for Trial Use)

About Normative content in this R5 release

This 5th Major release of the FHIR specification is labeled as 'trial-use' because the entire ballot cycle that led to this release was performed under the HL7 STU (Standard for Trial Use). None of the content in this specification is considered "Normative", but the content that was previously normative in Release 4 icon is still labelled as Normative to preserve the status through the publication and implementation of this release. HL7 plans to publish the next release as a normative specification.

A few new artifacts (such as CanonicalResource) are labelled as Normative because they were created by moving existing normative content to a new type.

Version Changes
5.0.0

R5 Milestone. This version has cumulatively made 1000s of changes from the R4+R4B milestones (3969 change requests icon, including 1840 substantive changes icon). Most of the changes are in response to implementation feedback. There is no comprehensive list, but here is a list of the more significant changes:

5.0.0-draft-final R5 Draft: Final QA Version (for internal review by HL7).
5.0.0-snapshot3 R5 Snapshot 3 - Connectathon 32 Base. This stable version for the connectathon and final publication preparation has many changes since the ballot. Some particularly significant changes:
5.0.0-ballot R5 Ballot - Sept/Oct 2022 Ballot. This ballot has 1000s of changes. Some particularly significant changes:
4.6.0 Draft Ballot for R5 - May 2021 Ballot (Apr 14-20 2021). Significant changes:
4.5.0 3rd Milestone for R5 - September 2020 Virtual Connectathon Stable Version (Aug-20 2020). Significant changes:
  • Ongoing development of less mature resources
  • Finish removing content moved to http://terminology.hl7.org
4.4.0 2nd Milestone for R5 - May 2020 Virtual Connectathon Stable Version. Significant changes:
4.3.0

Release R4B: May 28, 2022:

Note that Release 4B was a derivative of Release 4. Release 5 is a direct development from Release 4, with many of the changes found in Release 4B incorporated and further developed.

4.2.0 1st Milestone for R5 - Sydney Connectathon Stable Version. Significant changes:
4.1.0 Current build after 4.1.0 release
4.0.1

Release 4: Dec 27, 2018. First Normative content, with many significant changes

Note that between R3 and R4, nearly 3000 change proposals were applied to the specification, including >1000 substantive changes, of which 339 were labeled 'non-compatible'. As such, providing a comprehensive list of changes between specifications is not appropriate. To help see and understand the differences between the specification releases, implementers can:

To help implementers, the more significant changes are listed here:

3.6.0 Current build after 3.5.0 release
3.5.0

Release R4 Ballot #1: Sept 20, 2018. R4 ballot #2

Major changes from R4 Ballot 1 (3.3.0):

Description Committee + Tasks Pages
All Ballots
Change the canonical URL for all v2 and v3 CodeSystems and ValueSets (and some FHIR ones too), to
http://terminology.hl7.org (from the Unified Terminology Process) Breaking change!
(no task: Vocab committee decision) todo
Normative / Infrastructure
Added reference.type FHIR-I: GF#13543 icon References between Resources ΔB
Clarify definition of is-modifier + impacts on modifier extensions. Note: this lead to breaking changes
on a few extensions (changed from modifierExtension to normal extension)
FHIR-I: GF#16188 icon Conformance Rules ΔB, Extensibility ΔB
Add mode parameter to /metadata FHIR-I: GF#14444 icon RESTful API ΔB
Enhance/extend rules around changes between versions FHIR-I: GF#13089 icon Version Management Policy ΔB
Add fhirVersion parameter to application/fhir mime type FHIR-I: GF#16165 icon RESTful API ΔB
Add the $versions operation FHIR-I: GF#17009 icon Capability Statement Operations ΔB
Allow exponential form for decimals (with corresponding consequences for precision) FHIR-I: GF#16874 icon Datatypes ΔB, XML ΔB
Describe use of exponential form when searching numbers (+ clarifications for precision) FHIR-I: GF#16369 icon Search ΔB
Remove support for operations on historical resources Breaking change! FHIR-I: GF#17258 icon Operations ΔB
Change Money Type to make it simpler Breaking change! FHIR-I: GF#16297 icon Datatypes ΔB
Change ElementDefinition.binding.valueSet to only be of type canonical Breaking change! FHIR-I: GF#16055 icon Element Definition ΔB
Remove restriction on Bundle containing multiple versions of the same resource Breaking change! FHIR-I: GF#17085 icon Bundle ΔB
Rename Binary.content to Binary.data and exclude it from summary (which makes it optional) Breaking change! FHIR-I: GF#16998 icon, GF#16898 icon Binary Resource ΔB
Normative / Conformance + Terminology
Remove ValueSet.$expand profile parameter, and add parameters from ExpansionProfile Breaking change! Vocab: GF#16337 icon & GF#16490 icon ValueSet.$expand ΔB
Remove ValueSet.$expand.limitedExpansion parameter, and document how to use count instead Breaking change! Vocab: GF#16449 icon ValueSet $expand operation ΔB
Move ValueSet.extensible to an extension Vocab: GF#16427 icon ValueSet ΔB
Add CapabilityStatement.implementation.custodian FHIR-I: GF#16342 icon CapabilityStatement ΔB
Add CapabilityStatement.imports FHIR-I: GF#14299 icon CapabilityStatement ΔB
Normative / Observation
Update definition of subject and add note safety page the focus element OO: GF#16136 icon Observation ΔB
Changed cardinality of Observation.interpretation and
Observation.component.interpretation from 0..1 to 0..*
OO: GF#16231 icon Observation ΔB
Changed Observation.context to Observation.encounter with type Reference(Encounter). Breaking change! OO: GF#17661 icon Observation ΔB

This is only the major changes. More comprehensive lists can be found in the ballot introduction (later removed).

Major changes in the other parts of the specification:

3.4.0 Current build after 3.3.0 release
3.3.0

Release R4 Ballot #1: Apr 3, 2018. R4 ballot #1. Major changes from R3:

3.2.0

Release R4 Draft: Dec 21, 2017. R4 draft ballot. Major changes:

3.1.0 R4 development begins
3.0.0

Release 3: Mar 21, 2017. STU3

This is the full FHIR Release 3 (R3). R3 is a complete overhaul of the specification from R2, with over 2400 change proposals process, and applied in R3. Of those changes, 380+ are labeled as a breaking change. Given this level of change, there is no useful way to present a single change list. Users can use the R2/R3 difference comparison, the R2 <-> R3 transforms, or the "Compare to R2" link at the foot of every page to help visualise the differences between R2 and R3.

Many of the changes made in this release (since 1.8.0) are in response to Quality Assurance processes in HL7, with a goal of readying the specification for Normative processes in R4:

Roll up: Of all the many changes (thousands) between R2 and R3, these are the most significant:

1.9.0

FHIR Rolling Build, 2016 Dec onwards

1.8.0

FHIR QA Release, Dec 6, 2016

STU 3 Candidate, and also the basis for several implementation guide ballots and the San Antonio Jan 2017 Connectathon icon

Breaking Changes Summary:

These are only the more significant changes, there were many 100s of changes made in response to ballot comments and ongoing implementation experience. These include breaking changes to may resources. Structural changes are summarized here, and Transforms between DSTU 2 and STU 3 are provided for many resources.

1.6.0

FHIR STU3 ballot, Aug 11, 2016

STU 3 ballot version, and also the basis for the Baltimore Sept 2016 Connectathon icon

Publication Changes:

  • Move the US Realm implementation guides out of the specification (see http://www.fhir.org/guides/registry icon)
  • Rework the home page, and introduce modules as a way to navigate the specification + add significant new implementer advice (e.g. "Getting Started")
  • Change the Navigation menu to focus on indexes to the content in the specification
  • Move FHIRPath expression language to its long term home icon

Technical Changes:

  • RESTful API
    • Change the FHIR mime type to application/fhir+xml|json instead of application/xml|json+fhir (breaking change, for conformance to W3C+IETF rules)
    • Add new uses for the Prefer header (return OperationOutcome, and manage behavior related to unknown / unsupported search parameters
    • Deprecate use of the OPTIONS command to retrieve the CapabilityStatement
    • Add support for conditional references to the transaction interaction
    • Add reverse chaining
  • Formats: No change to XML + JSON formats. Add Turtle Format, and related validation tools
  • For Datatypes and Resources, there is formal difference analysis from DSTU2 (also found throughout the specification), and transforms between DSTU 2 and STU 3 are provided for many resources
1.5.0

FHIR Current Build Update, July 8 2016

Update current version to 1.5 to prevent confusion with implementations still running the May 2016 version.

  • There are many changes in this version from 1.4.0, but no formal list is provided. A formal list will be provided for 1.6 (as a diff to 1.4)
1.4.0

FHIR Connectathon 12 Snapshot, Mar 30 2016

Frozen base for Connectathon 12 & For Comment ballots:

1.2.0

FHIR Connectathon 11 Snapshot, Dec 11 2015

Frozen base for Connectathon 11:

  • Remove GuidanceRequest
  • Add new draft resources: MolecularSequence, ExpansionProfile
  • Modifications to Financial Resource & TestScript resource

Note: this version is temporary, and was removed after Connectathon 11 was complete

1.1.0

GAO Ballot + technical corrections, Dec 2 2015

A ballot publication for the GAO Ballot that also includes:

  • Various technical corrections to the generated snapshots
  • Populate FHIRPath expressions in extensions for all search parameters and invariants
  • Add new draft resources: GuidanceRequest, GuidanceResponse, ModuleMetadata, ModuleDefinition, Library, DecisionSupportServiceModule, DecisionSupportRule, OrderSet, Measure
  • Major restructure of Questionnaire
1.0.2

Technical Correction 1, Oct 24 2015

A series of technical corrections to the specification following extensive review:

  • Corrections to Extension cardinalities in implementation guides
  • Corrections in the conformance resources that support the specifications
  • Correct several erroneous invariants
  • Various typos, broken links, and fixes in examples
  • For a comprehensive list of corrections, see the Task list for FHIR DSTU2 Technical Correction 1 icon
1.0.1

DSTU 2, Sept 23 2015

Changes of significance during the QA process:

  • Remove the Clinical Quality Improvement Framework (CQIF) from this published version
  • made fixes to generated schematrons
  • updated generated conformance resources (StructureDefinitions and SearchParameters) so they were consistent with the specification
  • Many spelling / grammar / broken link fixes
1.0.0

DSTU 2 QA Preview, Aug 31 2015

This version had extensive change as a result of the May 2015 DSTU ballot, ongoing testing, and the open change proposals (1317 tasks). The extent of the changes is best illustrated by the number of the list of changes labeled 'breaking change' icon - 158 changes of 1317 total tasks. Below is a list of the most important changes:

0.5.0

DSTU Ballot, May 2015

This version had extensive change as a result of the January 2015 Draft ballot, ongoing testing, and the open change proposals (over 800 tasks). The list below is a summary of the major changes to resource content. It shows only a limited number of the overall changes.

Enumerations

  • All spaces removed
  • Extensive content changes not noted here

New Datatypes

Changed Datatypes

  • Coding - remove valueSet property
  • Attachment - add creation
  • Identifier - replace label with type
  • Timing - major rework of content
  • ElementDefinition - add label, code, rename 'formal' to definition, rename synonym to alias, add language to mapping, remove conformance and isExtensible and replace with strength

New Resources

Removed Resources

  • CarePlan2 -> collapsed into CarePlan
  • FamilyHistory -> broken up into FamilyMemberHistory
  • InstitutionalClaim, OralHealthClaim, PharmacyClaim, ProfessionalClaim, VisionClaim -> collapsed into Claim
  • Other - use Basic instead
  • PendedRequest,Readjudicate, Reversal, StatusRequest, StatusResponse - use ProcessRequest/Response instead
  • SupportingDocumentation - use DocumentReference instead
  • ProcessRequest, ProcessResponse - use Task instead

Renamed Resources

  • Alert -> Flag: 'alert' made people think it was an action like an alarm
  • SecurityEvent -> AuditEvent: it wasn't just for security purposes
  • ClinicalAssessment -> ClinicalImpression: people got confused with 'assessment' tools like APGAR score
  • Profile -> StructureDefinition: 'Profile' is the process, a package of statements

Changes Inside Resources

  • Parameters - allow parameter.part to contain a resource
  • AllergyIntolerance - rename subject to patient
  • Appointment - remove lastModifiedBy/lastModified, add location
  • AppointmentResponse - remove lastModifiedBy/lastModified, add rename individual to actor
  • AuditEvent - add .event.purposeOfEvent, participant.location, .policy, and .purposeOfUse
  • Bundle - major reorganization
  • CarePlan - pull goal out + other reorganization
  • ClinicalImpression - add status, replace careplan & referral with trigger, rename diagnosis to finding, make plan 0..*,
  • Composition - change .section.content to refer to List only, not any
  • ConceptMap - change identifier to url, add useContext, change telecom to contact,
  • Condition - rename subject to patient, rename status to clinicalStatus, change to bodySite = code or Reference(BodySite), rename .codeableConcept to .code
  • Conformance (now CapabilityStatement) - change identifier to url, add useContext, change telecom to contact, add requirements and copyright, add support for conditional operations,
  • Contract - extensive rewrite
  • Coverage - add bin, subscriberId
  • DataElement (now StructureDefinition) - total rewrite to use ElementDefinition
  • Device - add status, manufactureDate
  • DeviceMetric - rename operationalState to operationalStatus, add measurementMode, rename calibrationInfo to calibration, change color to an enumerations
  • DeviceRequest/DeviceUsage - change to bodySite = code or Reference(BodySite)
  • DiagnosticRequest- change to bodySite = code or Reference(BodySite)
  • DiagnosticReport - add encounter
  • DocumentReference - add format, remove policyManager, make content : Attachment, and remove several related attributes, remove service reference and add context.practiceSetting, sourcePatientInfo, and related
  • Encounter - add incomingReferralRequest, allow reason to repeat, rename diet to dietPreference
  • EpisodeOfCare - rename currentStatus to status, allow referralRequest to repeat,
  • Flag - rename subject to patient, change from note to code
  • Goal - add targetDate, statusDate, author, priority
  • HealthcareService - extensive rewrite
  • ImagingObjectSelection - remove retrieveAETitle, rename retrieveUrl to url, add frames
  • ImagingStudy - add laterality, change url to attachment
  • Immunization - add encounter, rename subject to patient, rename refusedIndicator to wasNotGiven, rename refusalReason to reasonNotGiven
  • ImmunizationRecommendation - rename subject to patient
  • List - add title, status, change ordered to orderedBy, add note
  • Location - remove status
  • Medication - add batch
  • MedicationAdministration - add reasonGiven, note, text. remove timing & maxDosePerPeriod
  • MedicationDispense - collapse to a single dispense, add daysSupply, note and substitution, change quantity to allow range
  • MedicationRequest - add note, change quantity to allow range,
  • MedicationStatement - add informationSource, status, dateAsserted, replace whenGiven with effective[x], remove device, add dosage.text
  • NamingSystem - add date, publisher,
  • NutritionOrder - extensive rewrite
  • Observation - change name to code, allow more types of value[x], change type of dataAbsentReason, change to bodySite = code or Reference(BodySite), allow identifier to repeat, add device,
  • OperationDefinition - change identifier to url, add useContext, change telecom to contact, change name to title, add reuqirements, idempotent,
  • OperationOutcome - change type of .issue.type
  • OrderResponse - rename code to orderStatus
  • Organization - remove location and contact.gender
  • Patient - communication to allow 'preferred'
  • Person - rename other to target
  • Practitioner - change type of birthDate, allow multiple roles per practitioner
  • Procedure - add status and category, change to bodySite = code or Reference(BodySite), allow date to be period too, add location, change followUp to code 0..*, add device tracking
  • ServiceRequest - change to bodySite = code or Reference(BodySite)
  • Provenance - change integritySignature to signature & make it a type, allow reference by Reference as well as URI
  • Questionnaire - add telecom
  • Schedule - move lastModified
  • SearchParameter - change telecom to contact, add status, experimental, date,
  • Slot - move lastModified
  • Specimen - change source to parent, change to bodySite = code or Reference(BodySite)
  • StructureDefinition - complete rewrite
  • Subscription - change type of tag, reanme url to endPoint,
  • ValueSet - change identifier to url, add useContext, change telecom to contact, replace purpose with useContext, add requirements, rename stableDate to lockedDate, change type of expansion.identifier, add expansion parameters
0.4.0

Draft For Comment, January 2015 Ballot

Breaking Changes (full list):

  • Replace atom and taglist with a native Bundle format (3728 icon, 3558 icon, 2889 icon) (and also Binary)
  • JSON: change how extensions are represented (3471 icon)
  • RESTful API: change how version specific upgrades work (3451 icon)
  • DataTypes:
  • Rename Schedule to Timing (3536 icon, 3236 icon)
  • Rename Contact to ContactPoint (3533 icon) and swap order of elements (3108 icon))
  • Address - change zip to postCode (2888 icon)
  • Quantity: Correct schema spelling for "QuantityCompararator" (3531 icon)
  • Change allowable values for the id type to include capital letters, and allow up to 64 chars (3750 icon)
  • Restructure Profile - only one structure, and pull ExtensionDefinition out of Profile (3647, 3498), and pull SearchParameter out (3626 icon)
  • Profile: allow 0..* discriminator (3131 icon), and change the way discriminators work across resource boundaries (3124 icon) + generate multiple types properly (2856 icon)
  • remove _validate interaction, and replace with $validate operation (3686 icon)
  • Patient: separate birth time from birthDate (3731 icon), Change Administrative Gender from a CodableConcept to a Code. Also fixed the values as male|female|other|unknown with mappings to v2 and v3 (3070 icon)
  • DocumentReference: change encoding of Hash to Base64 (3291 icon)
  • Group: rename header to title (3126 icon)
  • Condition: split relatedItem into two (3111 icon)
  • Questionnaire: drop questionnaire.group.question.remarks (3255 icon) and move omitReason from extension to base resource (3260 icon)
  • QuestionnaireResponse: allow multiple answers (3146 icon)
  • ValueSet: replace ValueSet.compose.include.code with ValueSet.compose.include.concept (3258 icon), added new rules about expansion content (3138 icon)
  • Remove DeviceObservationReport and Query
  • Collapse AdverseReaction into AllergyIntolerance
  • Appointment changes - individual field renamed to actor, and added mappings to HL7 V2 icon and HL7 v3 icon
  • FamilyMemberHistory combined with List replaces FamilyHistory (with corresponding updates to related profiles)
  • Flag replaces Alert including improved clarification of how it is used and replacement of "note" with "code"
  • CarePlan significantly refactored including splitting Goal out as a distinct resource, moving elements between activity and detail, introduction of several new elements and supported relationship types

New Resources:

New Implementation Guides (see discussion of status)

  • Argonaut Project
  • Data Access Framework
  • Structured Data Capture & Structured Data Capture - Data Element Exchange
  • US Laboratory Order, Report & Report to Public Health
0.3.0
  • Renamed Namespace to NamingSystem
  • Split QuestionnaireResponse from Questionnaire and significantly revamped the Questionnaire in response to feedback from the Connectathon.
  • Added DataElement (now StructureDefinition) resource (has been previously discussed as ObservationDefinition)
  • Defined Subscription resource for evaluation
  • Add time datatype
  • Define RPC-type operations on the RESTful interface, and add Operation Definition
  • Defined operations on several resources including ConceptMap, Questionnaire and ValueSet
  • Conformance (now CapabilityStatement): Change Conformance.rest.operation to Conformance.rest.interaction and Conformance.rest.resource.operation to Conformance.rest.resource.interaction, and add Conformance.rest.operation to point to Operation Definition
  • Profile: add Profile.url, Profile.structure.snapshot and Profile.structure.differential, and remove query definition (now in OperationDefinition)
  • Add pages for LOINC, RxNorm, and SNOMED CT
  • Significant rework for ConceptMap so it can be used to map between structures as well as value sets
  • Add Contraindication and Risk Assessment and added examples to other resources in support of these
  • Add Referral Request
  • Add supportingInformation to DiagnosticRequest
  • Add fulfills to Encounter
  • Add date and age[x] to FamilyHistory
  • Change cardinality of Location.identifier to 0..*
  • Change cardinality of Practitioner.address to 0..*
  • Add Observation.encounter to 0..*
  • Temporarily added content for the Structured Data Capture implementation guide icon, including profiles on several resources, conformance instances, etc. This content will be moved to an external specification once the necessary tooling is in place to support that form of publication.
0.2.1
  • Minor new optional elements on value set for metadata, new extensions for all the rest of the VSD project metadata, formal profile to express basic minimum metadata for value set
0.2.0
  • Namespace: adjustments based on Grahame's feedback
0.1.0

Note: a useful tool for displaying the differences between pages is the W3C HTML Diff engine icon.