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Specializing reason relationship for flavors of indications

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NOTE: Harmonization proposal on public display here for the purpose of commenting and collaborative editing. All your edits are tracked and nothing gets lost. FEEL FREE to improve the proposal and to add any question you want to raise in the discussion. Thanks!

Recommendation for HL7 RIM Change RECOMMENDATION ID:
Submitted by: Gunther Schadow Revision (# and date): 2
Date submitted: 20050212 Committee status: open
Submitted by: Gunther Schadow  
NAME: ActRelationship.typeCode for reason  

Stewards Position

REQUIRED - This table should contain one row for each Steward Committee affected by the recommendation.

TC RECOMMENDATION APPROVAL STATUS AFFECTED ENTITIES OF INTEREST TO TC
(responsibility level: S=Steward; I=Interested)
O&O Unknown I
RCRIM Unknown I
PC Unknown I

Issue

Need to be more specific about the nature of an indication (reason).

Current State

Has reason (RSON) has one specialization already: mitigates (MTGT). No other place to qualify reasons to say how specifically something is a reason.

Recommendation(s)

Add additional ActRelationship subtypes of “has reason” (RSON), thus expanding the hierarchy for types of reasons (indications). Currently HL7 has:

 - RSON - has reason (indication)
 - - MTGT - mitigates - The source act removes or lessens the occurrence or effect of the target act.

and we can propose to add:

 - - TRET - treats - The source act is intended to improve the signs and/or symptoms of a pre-existing disease or condition described by the target act.
 - - PRYL - prophylaxis for - The source act is intended to reduce the risk of developing a disease or condition described by the target act.
 - - DIAG - diagnostic for - The source act is intended to help establish the presence of a disease or condition described by the target act.

Rationale

The change is a logical extension of the finer nuances that are already been made with the difference between has-reason and mitigates, it's necessary to describe indications better.

The change is motivated to complete the U.S. national SPL project with FDA and all of Pharma Industry to provide improved drug labeling in HL7 v3 format. It is implementing a requirement from the Physician’s Labeling Rule that became effective in January 2006.

Workaround Considered

Attaching some arbitrary observation, but that would be an abuse of observations.

For the use case at hand -- indication for treatment -- we could use a has-generalization to a SubstanceAdministration code which would classify the administration act as to its intent to mitigate, cure, diagnose, etc. This seems the wrong place to do it, as we are truly qualifying the reason or rationale of administering a substance.

Recommended Action Items

  • Implement the proposed solution


Resolution