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Transcript of © 2015 HL7 ® International. Licensed under Creative Commons. HL7 & Health Level Seven are...
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FHIR for Specifiers
Michel Rutten
Hilversum, 12 november 2015
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Who am I?
Name: Michel Rutten Company: Furore, Amsterdam Background:
Professional software developer since 1998 Microsoft .NET; Healthcare industries Technical Specialist at Furore since May 2014 Member of the Furore FHIR development team Tool Smith - Lead developer of Forge
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Contents of this tutorial
FHIR 1.0 DSTU 2 Introduction to FHIR Conformance Layer Principal components FHIR Conformance Resources Implementation Guides ValueSet StructureDefinition Registry
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FHIR 1.0 DSTU2Overview of changes
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DSTU 2 Version History
Version Name Publication date
1.0.0 DSTU 2 QA Preview Aug 31 2015
1.0.1 DSTU 2 Sept 23 2015
1.0.2 Technical Correction 1 Oct 24 2015
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Maturity Framework
Level Description
0 Published on current build
1 Produces no warnings during the build processSubstantially complete and ready for implementation
2 Successfully exchanged between 3+ systems at a connectathonResults reported to the FHIR Management Group
3 Meets DSTU Quality Guidelines Subject to a round of formal balloting; 10+ implementer comments drawn from 3+ organizations resulting in 1+ substantive changes.
4 Tested across its scopePublished in a formal publication (e.g. DSTU)Implemented in multiple prototype projects.Sufficiently stable to require implementer consensus for subsequent non-backward compatible changes.
5 Published in two formal publication release cycles at FMM1+ (i.e. DSTU level)Implemented in 5+ independent production systems in >1 country
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RESTful API
Add batch Several clarifications around versioning &
transactional integrity Changed Bundle URL resolution rules
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Search
Changed the way <> etc. works Added _list parameter Changed rules around contained and
included resources
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Data Types
New data types Markdown Annotation
Changed data types Coding Quantity Signature Timing Address ContactPoint
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Data Types
Changes to ElementDefinition Add base
Specifies path & cardinality of base element Make type.profile repeat
Target resource must conform to all profiles Remove constraint.name and replace with
constraint.requirements Remove binding.name Add minValue[x] and maxValue[x]
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Resources
New Account ImplementationGuide TestScript
Removed Supply
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Resources
Renamed resources Contraindication -> DetectedIssue MedicationPrescription -> MedicationOrder QuestionnaireAnswers -> QuestionnaireResponse
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Resources
Changed Almost all resources Too many to list (1317 tasks worth of changes) Add, remove elements Change types, references, definitions & value sets Re-order elements Provide much more documentation and new
examples
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Implementation Guides
Move Argonaut content out http://argonautwiki.hl7.org/index.php?title=Main_Page
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1.0.1
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 comformance resources
(StructureDefinitions and SearchParameters) so they were consistent with the specification
Many spelling / grammar / broken link fixes
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1.0.2
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 116
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PRINCIPAL COMPONENTSFHIR CONFORMANCE LAYER
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Conformance Resources
Terminology
Naming System
Value Set
Concept Map
Content
Structure Definition
Data Element
Operations
Conformance
Operation Definition
Search Parameter
Misc.
Implementation Guide
Test Script
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Conformance
Conformance Resources
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“Profile”
StructureDefinition
SearchParamDefinition
ValueSet
ConceptMap
NamingSystem OperationDefinition
Forge
ExcelImplementation
Guide
TestScript
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Terminology
• Define which terminologies to use in which elements
ValueSet
• Define namespaces with unique symbols
NamingSystem
• Define mappings between terms from different systems
ConceptMap
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Content
• Define data structures• Define restrictions and/or extensions
StructureDefinition
• Define data elements (ISO 11179)
DataElement
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Operations
• Define server capabilities• Define supported API methods
Conformance
• Define additional (custom) operations
OperationDefinition
• Define additional (custom) searches
SearchParameter
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Miscellaneous
• Author and publish an implementation guide
ImplementationGuide
• Define compliance tests against a FHIR server
TestScript
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OVERVIEWFHIR CONFORMANCE RESOURCES
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ImplementationGuide
• Define scope of usage• Describes requirements for an implementation
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ImplementationGuide
Usage: Allow authors to publish an implementation
guide Allow tools to validate conformance Computable!
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StructureDefinition
Defines datastructures• Core resources & datatypes (see validation.zip)• Constraints on resources & datatypes• Extensions
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StructureDefinition
Share/publish to repository / registry Compare Validate resource Use to drive
Code generation Report generation UI generation (e.g. ClinFhir ResourceBuilder)
Computable!
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NamingSystem
Describes “logical” numbering systems in use• What’s the name?• What are equivalent uri/uuid/oids
Represents a "System" used within the Identifier and Coding data types.
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ValueSet
Define codes
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ValueSet
Code System Defines a set of codes with meanings (also
known as enumeration, terminology, classification, and/or ontology)
Value Set Selects a set of codes from those defined by
one or more code systems
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ConceptMap
Define mappingFrom one set of concepts to one or more other concept(s)
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OperationDefinition
• Extend/restrict the API• Defines interactions
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OperationDefinition
Describes additional operations over and above the RESTful interactions defined in the specification What is the name? Input/output parameters What does it do? Works on which resources?
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SearchParameter
Extend/restrict searchesDescribes additional searches to filter resources• What is the name?• Elements filtered• Resource the search works on
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Conformance
A set of capabilities of a FHIR Server
Binds all conformance resources together
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Conformance
Describes how a client or server uses or should use the FHIR API Which wire formats supported? Which resources? Which operations supported? Which profiles supported? Is this a test server? What’s the name of the software?
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For implementer convenience, the specification itself publishes its base definitions using these same resources!
Used in the core spec
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For implementer convenience, the specification itself publishes its base definitions using these same resources!
Used in the core spec
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Define FHIR “Profiling”?
General term: The process of creating an implementation
guide The process of creating a conformance
package The process of creating a conformance
resource
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IMPLEMENTATION GUIDES
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Examples
fhir.hl7.org Implementation > Implementation Guides
Argonaut DAF QICore SDC USLab
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Different Kinds
Strategy•National scope guide•e.g. infrastructure, security
Principles•Overarching principles•e.g. basic components
Subject•Subject with multiple usecases•e.g. medication process
Usecase•Single usecase•e.g. prescription
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Typical Content
Title Table of contents Document information Introduction to the guide Principles & background Functional requirements and high-level use cases Design considerations Package contents (= use case?) Privacy and security guidance Testing and certification Appendix List of all artifacts used in this guide
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ImplementationGuide
New resource type introduced in DSTU2 1.0
Defines: Conformance Packages Documentation Pages Global Profiles Dependencies
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Conformance Package
Defines a set of conceptually related conformance resources
Provides example resources Allows conformance validation of resources
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Documentation Pages
Provides detailed description of the included conformance resources
E.g. HTML, Markdown Binaries: css, js, img, …
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Global Profiles
A set of profiles that all resources covered by this implementation guide must conform to
Note: A resource can conform to the default profile by conforming to any profile derived from it
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Dependencies
Other ImplementationGuide resources this guide depends on
Type Reference (hyperlink) Inclusion (embed)
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Publish!
Test & Verify
Publish
Guide
Author & Store
Implementhttp://simplifier.nethttp://registry.fhir.org
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Forge - Lipid
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VALUE SETS
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Coded types
Codes are defined in code systems
In a Profile, we may want to limit the codes that can possibly be used in coded elements in the Resources
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“Code System”
CodeSystem vs. ValueSet
“Dante’s deadly sins”
PrideEnvyWrathSloth
AvariceGluttony
Lust
“ValueSet”
Takes concepts from…
An enumeration of terms
Definition of terms
Example: SNOMED-CT Example: “Childhood diseases”
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“Special” cases
“All words under B”
“All words in theMerriam-Webster dictionary”
Takes concepts from…
No need to write them all down!
Takes concepts from…
Takes concepts from…
“Words for ‘nerd’”
BookwormGeekGrind
WeenieWonk
Dink (slang)Dork (slang)Swot (slang)
Can take concepts from multipe codingsystems!
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Identification of CodeSystems
If you refer to CodeSystems, you use a URL (instead of OID in v2 and v3): http://snomed.info/sct http://loinc.org http://hl7.org/fhir/sid/icd-10
We have introduced them for v2 and v3: http://hl7.org/fhir/v2/0078 http://hl7.org/fhir/v3/ActClass
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Coded types (again)
The uri of the system
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ValueSets
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ValueSets
This models what we have been discussing so far:
• A ValueSet has metadata (much like Profile: identifier, version, name, etc)
• A ValueSet is built by inclusion of terms from CodeSystems
• A ValueSet can exclude specific codes from other valuesets
• A ValueSet can import codes from other ValueSets
Metadata
Include/Exclude Concepts
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ValueSets
But it can also enumerate (and so indirectly define) all concepts for a new codesystem
• A ValueSet has metadata (much like Profile: identifier, version, name, etc)• A ValueSet is built by defining terms from and for a new CodeSystem• These new concepts have a display label and a definition • …and may be hierarchically organized
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Bindings
When used in a Resource, the modelers include Bindings
Bindings specify which codes can be used
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Profiling bindings
Depending on “core” spec, you can: “required”: not specify a different binding “extensible”: specify a different binding if needed “preferred”: specify a different binding if desired “example”: very likely specify a different binding
Change the bindings as specified in core: Define a new ValueSet
Allow additional codes, Restrict to a subset Specify whether implementers of your profile can
deviate from your valueset.
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This is not too hard…
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ValueSet Editor
Grahame Apolon …
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ValueSet Editor
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ValueSet Editor
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STRUCTUREDEFINITION
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Profiling a resource
“Must use only the Dutch national patient identifier”
“Need to register an administrative race code for a Patient in the US”
“Patient Discharge documents must at least contain section “Discharge Medication” and section “Discharge Diagnosis”
“In our Patient registration system, we use these maritalStatus codes beyond those provided by HL7…”
“Our patient registration system, only supports having one single name per Patient”
+
+
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Profiling a resource
Demand that the identifier uses your national patient identifier
Limit names to just 1 (instead of 0..*)
Limit maritalStatus to another set of codes that extends the one from HL7 international
Add an extension to support “RaceCode”
Note: hardly any mandatory elements in the core spec!
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Uses for profiles
Server & client may publish and check their conformance to a profile
Validating instances, messages
Implement "FHIR spec-like" website from Profiles as part of an Implementation Guide
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In v3 CDA…”text-based”
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Write by hand…? Forge!
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Publish!
http://simplifier.nethttp://registry.fhir.org
Find & maintain
Retrieve & use
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Who publishes?
http://www.hl7.org/Profile/iso-21090
http://www.hl7.nl/Profile/patient-nl
http://www.health4all.nl/h4all-vitals
http://www.fit4all.nl/f4all-vitals
http://www.data4all.nl/d4all-obs
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Fee
dbac
k
Layered profiles
HL7 Norge adapts Patient for Norway
Helse Nord/Vest/… introduces regional differences
Use-case specific constraints
Constrain
Constrain
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(Distributed) validation
DIPS’s server
Norway national validation server
Validate NO
Profile HNIKT, DIPS
Profile NO
Dow
nload &
Validate
StoreProfile
NO
Profile
HNIK
T
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Examples…
Let’s look at DAF Profiles
http://fhir.hl7.org Implementation
Implementation Guides• DAF
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METADATA AND VERSIONS
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What’s in a profile?
Metadata “Lipid Profile” v1.0.0 Drafturn:acme.org:lipid-profile:v1Author: [email protected]
Structure “LipidProfile”Element Definitions …
StructureDefinition for DiagnosticReport
Extension “calculated”
StructureObservation“Triglyceride”
StructureObservation“LDLCholesterol”
DiagnosticReportinstances (via Tag)
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Referring to a profile
ObservationCholesterol
6.3 mmol/LHigh(recommended 4.5)
Metadata “Lipid Profile” v1.0.0 Drafturn:acme.org:lipid-profile:v1Author: [email protected]
Structure “cholesterol”
http://acme.org/
http://acme.org/StructureDefinition/LDLCholesterol
I’m conforming to
http://acme.org/StructureDefinition/LDLCholesterol
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Versioning…
A “version” – author assigned So what if you change something after
publishing? Just a typo? Change of definition? Make something optional that wasn’t? Make something mandatory that was optional? Add an extension?
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“Non-breaking change”?
If old data can still be:
1. Validated against the new profile
2. Correctly interpreted against the new profile This can only be determined by the profile’s
authors (and even depends on the way it is used) A breaking change means you are
producing a new profile The profile’s author-assigned identifier changes A new Profile on the server, with a new REST utl
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Authoring a Profile
Excel
Let’s do this in Forge Click “New Profile” Select base resource, e.g. Observation Edit metadata on tab page “Properties”
Name URL
Save!
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STRUCTURES
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What’s in a profile?
Conformance Package: Lipid Report
Extension“calculated”
StructureObservation“Triglyceride”
StructureObservation“LDLCholesterol”
Structure Diagnostic Report“Lipid Profile”
StructureObservation“HDLCholesterol”
StructureObservation“Cholesterol”
DiagnosticReportinstances (via Tag)
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What’s in a profile?
Metadata “Lipid Profile” v1.0.0 Drafturn:acme.org:lipid-profile:v1Author: [email protected]
Structure “LipidProfile”Element Definitions …
StructureDefinition: DiagnosticReport
Structure DefinitionExtension“calculated”
Structure DefinitionObservation“Triglyceride”
Structure DefinitionObservation“LDLCholesterol”
Resource Reference
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Structure Definitions
Profiles contain “Structure Definitions” Base definition of a core Resource or Datatype A set of constraints on (nested) elements of a
Resource or Datatype An extension definition
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Observation resource
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Let’s start constraining
0..1
= ‘ok’
“if no value…”
1..1
1..1 Subject 0..1? Why not 1..1 in spec?
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Must support?
Authors: SHALL be capable of providing a value for the element and resource
Consumers: SHALL be capable of extracting and doing something useful with the data element.
"Something useful" is context dependent. The Profile SHALL describe what it means for applications to “support” the element
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Lipid
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FORMAL CONSTRAINTS
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Formal constraints
…beyond cardinalities and bindings, there are a lot of other conditions you might want to formulate: “If a Cholesterol value result is not available, use
the comments field” “A patient’s birthdate must be on or before today’s
date” These may concern a single element, or
cover multiple elements.
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Formal constraints
Uses free text (human) + xpath (executable) Constraints should be declared on lowest
element in the hierarchy that is common to all nodes referenced by the constraint.
Identified by (local) ‘Key’, involved elements refer to that id
Specify severity (“error” or “warning”)
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Context of the constraint
• This constraint is on the elements “valueQuantity” and “comments”
• We would have to formulate this constraint on the Observation, this is the context of the constraint
• We assign the constraint a “key” value that’s unique within the Observations’ constraints
• We refer from both “value[x]” and “comments” to this “key”. This means: if my value changes -> revalidate the constraint
“If a Cholesterol value result is not available, use the comments field”
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Example xpath
Keep in mind: the condition is satisfied when the XPath expression evaluates to “true”
“If a Cholesterol value result is not available, use the comments field”
Note: to use both is ok! Otherwise said: not both empty In Xpath: exists(f:valueQuantity) or exists(f:comment) That’s a logical or, so not exclusive!
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More xpath
“Either a valueQuantity or a comment is permitted” not( exists(f:valueQuantity) and exists(f:comment) )
“Can only have normal range if there is a valueQuantity” exists(f:valueQuantity) or not(exists(f:normalRange))
Steal from the spec (e.g. from Profile)
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EXTENSIONS
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Extension Context
An extension has a context type Resource, Datatype, Extension, Mapping
And a context path (Resource) Observation
“The observation was calculated” (Resource) Observation.value
“The observation’s ‘value’ was calculated” (Datatype) Quantity
“This quantity was calculated” (any Quantity used in any resource!)
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Extension Definition
Note: multiplecontexts!
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Extending a name
Key = location of formal definition
Value = value according to definition
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Extensions
Let’s find a representative extension for Practitioner
Add it to the Practitioner (and show it’s both a reference & a definition)
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The “Basic” resource
Now, what if you have the need for a completely “new” resource?
…then add extensions for each element
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FHIR REGISTRYSimplifier
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Collaborate
Manage projects Authorize team members Collaborate on profiles Github integration
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Publish
Publish your conformance resources User-friendly structure rendering Detailed descriptions for elements Download as XML, JSON Related example resources
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Find
Find existing conformance resources Constraints & Extensions (StructureDefinitions) Value Sets Concept Maps Naming Systems Search Parameters Operation Definitions Conformance Packages Implementation Guides
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Resolve
Resolve conformance resources by canonical Url Globally unique identifier SHOULD be the URL at which it is published Example:
http://example.org/fhir/StructureDefinition/MyPatient.xml
Alternative: Resolve from a global registry
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Simplifier.net
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Search
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Constraint
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ValueSet
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User
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Project
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Versioning strategy
FHIR Normative no breaking changes => OK! Published resources will always remain available
and functional
FHIR Draft (current phase) FHIR spec may introduce breaking changes How should registry handle breaking changes?
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Versioning strategy
Registry is based on a specific version of the .NET FHIR API
Uploaded resources are tagged with current API version at time of upload
Registry displays a warning if current system API version differs from saved resource API version => Author should update the resource
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Security
Under development…
https OAuth2 OpenID.Connect
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Base url claims
Under development… Proposal:
User can issue a claim for a specific base url E.g. http://example.org/fhir/
Granted claim provides exclusive permission to publish conformance resources on this base url
Delegation; grant claim permissions to other users Conflicting claim requests => prove domain
ownership
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Forge Integration
Under development…
Configure your simplifier credentials & project(s) in Forge
Publish resources Publish ImplementationGuide packages Integrate simplifier resource rendering
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Q&A
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International HL7 FHIR Developer DaysNovember 18-20, 2015 in Amsterdam
Education 34 tutorials/presentations
pick & choose
Connectathon Meet fellow developers Put FHIR to the test
Networking FHIR experts and authors on hand
http://fhir.furore.com/devdays