1. July DPROV Draft Harmonization Proposals 1.“ProvenanceActRelationshipDocument” value set [Slide 7] 2.ProvenanceActRelationshipEntryRelationship value set [Slide 13] 3.v:ProvenanceActRelationshipExternalReferen ce [Slide 17] 4.REVIEWER ParticipationFunction

2. HEADER - RELATEDDOCUMENT ACTRELATIONSHIP Which x_ActRelationshipDocumentpType codes to use a Gap Fix proposals New Provenance Chaining Rules?

3. The Star and Swoosh, Putting the I in Health IT, the Putting the I in Health IT composite logo, HealthIT.gov, the HealthIT.gov composition logo, HealthITBuzz, and the HealthITBuzz composite logo are service marks or registered service marks of the U.S. Department of Health and Human Services. Office of the National Coordinator for Health Information Technology

4. ParentDocument Relationships The ParentDocument represents the source of a document revision, addenda, or transformation. ParentDocument.text is modeled as an ED data type - allowing for the expression of the MIME type of the parent document. It is not to be used to embed the related document, and thus ParentDocument.text.BIN is precluded from use. Allowable values for the intervening relatedDocument.typeCode are shown in the following table. CodeDefinition APND (append)The current document is an addendum to the ParentDocument. RPLC (replace)The current document is a replacement of the ParentDocument. XFRM (transform)The current document is a transformation of the ParentDocument. Value set for relatedDocument.typeCode (CNE)

5. Allowable Combinations of ParentDocument Relationships A conformant CDA document can have a single relatedDocument with typeCode "APND"; a single relatedDocument with typeCode "RPLC"; a single relatedDocument with typeCode "XFRM"; a combination of two relatedDocuments with typeCodes "XFRM" and "RPLC"; or a combination of two relatedDocuments with typeCodes "XFRM" and "APND". No other combinations are allowed

6. Header relatedDocument Proposed Extension to x_ActRelationshipDocument Propose Value Set Extensions for x_ActRelationshipDocument for richer provenance semantics about a CDA’s relationship to Predecessor Documents COMP [component] - The target act is a component of the source act, with no semantics regarding composition or aggregation implied PART [has part] - The source Act is a composite of the target Acts. The target Acts do not have an existence independent of the source Act. – Usage Note: In UML 1.1, this is a "composition" defined as: "A form of aggregation with strong ownership and coincident lifetime as part of the whole. Parts with non-fixed multiplicity may be created after the composite itself, but once created they live and die with it (i.e., they share lifetimes). Such parts can also be explicitly removed before the death of the composite. Composition may be recursive.” XCRPT [excerpts] The source is an excerpt from the target 6

7. ProvenanceActRelationshipDocument Harmonization Proposal Decision 1 Does the DPROV TT approve submission of: 3 existing codes to be added to existing x_ActRelationshipDocument value set named “ProvenanceActRelationshipDocument” value set – COMP – PART – XCRPT

8. ENTRYRELATIONSHIP Which x_ActRelationshipEntryRelationshipType codes to use a Gap Fix proposals

9. x_ActRelationshipEntryRelationship Current in CDA at Entry Level – GAPS? COMP can be used to indicate non- specific aggregation or composition relationship SAS could indicate succession at in Lifecycle – but would SUCC be better? SUBJ can be used to relate an Entry to a Provenance Act XCRPT can be used to indicate that one Entry is excerpted from another Entry GAP SUCC – Succeed UPDT – Update USE - Uses

10. Other ActRelationships SUCC LEAF CONCEPT: SUCC (succeeds) KC – Seems like best fit for AR from Last ProvenanceEvent to preceding for LifeCycle – would require extension of the x_ActRelationshipEntryRelationship value set – in a new one for DPROV EntryRelationship Description: Definition: A new act that carries forward the intention of the original act, but does not completely replace it. The status of the predecessor act must be 'completed'. The original act is the target act and the successor is the source act.

11. Other ActRelationships Of Interest UPDT LEAF CONCEPT: UPDT (updates (condition)) KC – Could be used for LS/LC would require extension of the x_ActRelationshipEntryRelationship value set – in a new one for DPROV EntryRelationship Description: A condition thread relationship specifically links condition nodes together to form a condition thread. The source is the new condition node and the target links to the most recent node of the existing condition thread.

12. Other ActRelationships Of Interest USE LEAF CONCEPT: USE (uses) KC – Could be the AR from Entry Act to its Provenance Organizer Description: Indicates that the source act makes use of (or will make use of) the information content of the target act. UsageNotes: A usage relationship only makes sense if the target act is authored and occurs independently of the source act. Otherwise a simpler relationship such as COMP would be appropriate.

13. ProvenanceActRelationshipEntryRelationship Harmonization Proposal Decision 2 Does the DPROV TT approve submission of: 3 existing ActRelationship Codes to new ProvenanceActRelationshipEntryRelationship value set? – SUCC – UPDT – USES

14. EXTERNAL REFERENCE Which AR codes to use and Gap Fix proposals

15. x_ActRelationshipExternalReference ActRelationship Type Reasonable Source and Target classesComments ELNK (episode link)[Observation] ELNK [ExternalObservation] Used to show that the source and the target are part of the same episode (for instance, a diagnosis of "pneumonia" can be linked to an external problem list entry of "pneumonia" to show that the current diagnosis is part of the ongoing episode of pneumonia). REFR (refers to)[Act | Observation | Procedure | SubstanceAdministration | Supply] REFR [ExternalAct | ExternalDocument | ExternalObservation | ExternalProcedure] Used to show a general relationship between the source and the target, when the more specific semantics of the relationship isn't known. RPLC (replace)[Act | Encounter | Observation | ObservationMedia | Organizer | Procedure | SubstanceAdministration | Supply] RPLC [ExternalAct | ExternalDocument | ExternalObservation | ExternalProcedure] Used to indicate that the source entry is a replacement for the target external act. SPRT (has support)[Observation] SPRT [ExternalDocument | ExternalObservation] Used to show that the target provides supporting evidence for the source. SUBJ (has subject)[Observation | RegionOfInterest] SUBJ [ExternalObservation] Used to relate a source region of interest to a target image, or to relate an observation to its subject observation. XCRPT (is excerpt of)[Act | Observation] XCRPT [ExternalAct | ExternalDocument | ExternalObservation | ExternalProcedure] Used to show that the source is excerpted from the target (for instance "the hemoglobin is 10.7" is an excerpt of an externally referenced "complete blood count").

16. Proposed ActRelationship Type for new v: ProvenanceActRelationshipExternalReference XCRPT (is excerpt of) [Act | Observation] XCRPT [ExternalAct | ExternalDocument | ExternalObservation | ExternalProcedure] Used to show that the source is excerpted from the target (for instance "the hemoglobin is 10.7" is an excerpt of an externally referenced "complete blood count"). FXCRPT (has full excerpt of) Specializes XCRPT [Act | Observation] XCRPT [ExternalAct | ExternalDocument | ExternalObservation | ExternalProcedure] Used to show that the source is has a full excerpted from the target (“complete blood count” in a Lab report is excerpted from externally referenced “complete blood count”.) PXCRPT (has partial excerpt of) Specializes XCRPT [Act | Observation] XCRPT [ExternalAct | ExternalDocument | ExternalObservation | ExternalProcedure] Used to show that the source is a partial excerpted from the target (for instance "the hemoglobin is 10.7" is an excerpt of an externally referenced "complete blood count").

17. v:ProvenanceActRelationshipExternalReference Harmonization Proposal Decision 3 Does the DPROV TT approve submission of two children specializing XCRPT for addition to new v:ProvenanceActRelationshipExternalReferenc e?

18. RIM Background Reference ActRelationship 4.3.8.5 CDA entries can reference external objects such as external images and prior reports. These external objects are not part of the authenticated document content. They contain sufficient attributes to enable an explicit reference rather than duplicating the entire referenced object. The CDA entry that wraps the external reference can be used to encode the specific portions of the external reference that are addressed in the narrative block. Each object allows for an identifier and a code, and contains the RIM Act.text attribute, which can be used to store the URL and MIME type of the object. External objects always have a fixed moodCode of "EVN". The reference class contains the attribute reference.seperatableInd, which indicates whether or not the source is intended to be interpreted independently of the target. The indicator cannot prevent an individual or application from separating the source and target, but indicates the author's desire and willingness to attest to the content of the source if separated from the target. Typically, where seperatableInd is "false", the exchanged package should include the target of the reference so that the recipient can render it. A description of allowable reference.typeCode values are shown in the following table. As in the table above (CDA entryRelationship Types), the following table is a guideline for reasonable relationships between CDA entries and external objects, and is not a conformance constraint.

19. REVIEWER ParticipationFunction for Verifier ParticipantType Code

20. ParticipationFunction Harmonization Proposal REVIEWER – Business Requirement esMD requested a new ParticipationType REVIEWER Request was declined because ParticipationType is fixed in CDA as a structural code – May be possible to extend CDA ParticipationType value set to include Reviewer as US Realm or for CDA R 2.1 – Propose Harmonization Request to add as ParticipationFunction as interim alternative despite RIM semantic limitations

21. RIM Participation.functionCode ParticipationParticipation.functionCode :: CD (0..1)CD Property conformance: U Concept domain: ParticipationFunctionParticipationFunction Definition: Additional detail about the function that the Participation has in the Act, if such detail is not implied by the Participation.typeCode. Usage Constraint: No HL7 standard specification may be written to depend on the functionCode. When such a constraint is deemed necessary, it is to be defined in the Participation.typeCode. UsageNotes: This code can accommodate a variety of functions greater than that which can be managed in the tightly controlled typeCode. The numbers and kinds of functions applicable depend on the specific kind of act, e.g., each operation may require a different number of assistant surgeons or nurses. Since Participation functions refer to what people do in an Act, they are effectively sub- activities that may all occur in parallel. If more detail needs to be captured about these activities than who does them, component acts should be used instead.

22. ParticipationFunction Harmonization Proposal REVIEWER - Recommendation May add fine detail with ParticipationFunction However, no way to test conformance and receiver can ignore while maintaining Recommendation: Add new REVIEWER ParticipationFunction Usage Note to indicate that REVIEWER is to be used with the ParticipationType = VERIFER

23. ParticipationType VRF (verifier) REVIEWER adds specificity to VRF without connoting attestation SPECIALIZABLE CONCEPT:VRF (verifier) Description: A person who verifies the correctness and appropriateness of the service (plan, order, event, etc.) and hence takes on accountability.

24. Reviewer Proposed Definition Proposed REVIEWER Description: Specifies the exact function an actor is authorized to have as a verifier of an Act. Connotes specialized Verifier per jurisdictional or organizational policy – E.g., The Provider Verifier who takes responsibility for authenticity of a Verified record submitted to a payer Need TT to add more specificity to definition Usage Note: – Used to more fully specify the VERIFER ParticipationType

25. REVIEWER Place in HL7 ParticipationFunction Hierarchy ABSTRACT CONCEPT: _AuthorizedParticipationFunction [abstract term] Description: This code is used to specify the exact function an actor is authorized to have in a service in all necessary detail. Concept Properties: internalId: 22338Concept Relationships: Generalizes (derived): _AuthorizedReceiverParticipationFunction Generalizes (derived): _ConsenterParticipationFunction Generalizes (derived): _OverriderParticipationFunction Generalizes (derived): _AuthorizedProvenanceParticipationFunction – REVIEWER – ASSEMBLER

26. REVIEWER ParticipationFunction Harmonization Proposal Decision Does the DPROV TT approve submission of: REVIEWER ParticipationFunction Constrained to use with VRF [verifier] ParticipationType (not necessary) Defined as: A device that operates on custodian’s algorithms for data extraction for purpose of generating an artifact.

27. ASSEMBLER ParticipationFunction for DEV Participation

28. New ParticipationType/ParticipationFunction? ASSEMBLER [assembly software] Business Need – convey Assembling Software that was used to generate Document or Entry Could propose ASSEMBLER as new ParticipationType code but this would be an extension. Similar to Reviewer issue. TT has previously differentiated ASSEMBLER Device from the Authoring Device because: – It does not create new information – It assembles already created information Recommend proposing as ParticipationFunction to specialize CDA Participation Type SPECIALIZABLE CONCEPT: DEV (device) – Description: Participant used in performing the act without being substantially affected by the act (i.e. durable or inert with respect to that particular service) – Examples: Monitoring equipment, tools, but also access/drainage lines, prostheses, pace maker, etc. Proposed ASSEMBLER Definition: A device that operates on custodian’s algorithms for data extraction of existing information for purpose of generating a new artifact.

29. New ParticipationFunction ASSEMBLER [assembly software] Could make ParticipationFunction to SPECIALIZABLE CONCEPT: DEV (device) Description: Participant used in performing the act without being substantially affected by the act (i.e. durable or inert with respect to that particular service). Examples: monitoring equipment, tools, but also access/drainage lines, prostheses, pace maker, etc.

30. ASSEMBLER [assembly software] Use as Provenance Actor on Entry

31. ASSEMBLER [assembly software] Use as Provenance Actor on Header

32. ASSEMBLER Place in HL7 ParticipationFunction Hierarchy ABSTRACT CONCEPT: _AuthorizedParticipationFunction [abstract term] Description: This code is used to specify the exact function an actor is authorized to have in a service in all necessary detail. Concept Relationships: Generalizes (derived): _AuthorizedReceiverParticipationFunction Generalizes (derived): _ConsenterParticipationFunction Generalizes (derived): _OverriderParticipationFunction _AuthorizedProvenanceParticipationFunction – REVIEWER – ASSEMBLER

33. Assembler ParticipationFunction Harmonization Proposal Decision Does the DPROV TT approve submission of: Assembler ParticipationFunction Constrained to use with Device ParticipationType (not necessary) Defined as A device that operates on custodian’s algorithms for data extraction for purpose of generating an artifact.

34. PROVENANCE EVENT CODES ActCodes for ProvenanceEventActs

35. ProvenanceEventCodes Business Need A ProvenanceEventAct convey an Entry Lifecycle Event [1…*] ProvenanceEvents comprise a ProvenanceOrganizer ProvenanceEvent has ProvenanceEvent Act.code, which conveys the type of Lifecycle event Has effectiveTime [1…1], which conveys temporal relationship among ProvenanceEvents ProvenanceEvents ordered by ActRelationship SAS [starts after start of] with optional Sequence # to explicitly sequence Lifecycle ProvenanceEvents ActRelationshipExternalReference convey limited association with Lifespan ProvenanceEvents of Predecessor ExternalActs – e.g., an Entry Lifecycle Event “update” may reference an External Act that this Entry “replaces” Propose to Harmonization an extended ActRelationshipProvenanceExternalReference value set that includes relevant provenance relationships for future use

36. ProvenanceEvent value set Business Requirements

37. ProvenanceEvent value set Uses ActStatus and DataOperations Only some ActStatus and DataOperations Codes relate to Lifecycle or Lifespan Provenance Others are related only to Workflow

38. ProvenanceEvent value set Description ProvenanceEvent value set described as codes that convey types of Lifecycle or Lifespan event Usage Note: Conveys the change that a system event causes to a resource which entails an additional stage in the resource’s lifespan or lifecycle.

39. Candidate ProvenanceEvents activate Change the status of an object representing an Act to "active", i.e., so it can be performed or is being performed, for the first time DataOperations new An Act that is in the preparatory stages and may not yet be acted uponActStatus create Fundamental operation in an Information System (IS) that results only in the act of bringing an object into existence. DataOperations read Fundamental operation in an Information System (IS) that results only in the flow of information about an object to a subject. DataOperations update Fundamental operation in an Information System (IS) that results only in the revision or alteration of an object. DataOperations append Fundamental operation in an Information System (IS) that results only in the addition of information to an object already in existence. DataOperations annotate Add commentary, explanatory notes, critical notes or similar content to an object. DataOperations delete Fundamental operation in an Information System (IS) that results only in the removal of information. DataOperations cancelled The Act has been abandoned before activation.ActStatus aborted The Act has been terminated prior to the originally intended completion.ActStatus nullified This Act instance was created in error and has been 'removed' and is treated as though it never existed. A record is retained for audit purposes only. ActStatus obsolete This Act instance has been replaced by a new instance.ActStatus

40. ProvenanceEvent value set Harmonization Proposal Does the DPROV TT approve submission of the ProvenanceEvent value set listed in preceding Slide?