Common Product Model

This page will be used to discuss the content and publication of the Common Product Model.

Ambitions & Scope

The Common Product Model (CPM) will be an overarching domain information model relating to the HL7 v3 modeling of any kind (or instance) of a 'product'. The definition of the term product is intentionally kept loose at this point, but will definitely include:

• Medication, incl. vaccines
• Devices used in medical services
• Anything else a person can be exposed to

The CPM is set up as a joint initiative within HL7 project, 'sponsored' by the O&O work group.

The following stakeholders have been identified:

• Pharmacy (for Medication and possibly for devices)
• Patient Safety (for Individual Case Safety Reports)
• RCRIM (for Structured Product Labeling and Regulated Product Submissions)
• PHER (for vaccines used in Immunization)

Storyboards

This space will list a number of storyboards that relate to the different perspectives on what a product is and how it is used.

These storyboards are divided into groups:

• Pharmacy related storyboards
• ICSR related storyboards
• SPL related storyboards
• Regulated Product Submission Release 2 (RPS R2) Storyboards (not specific to CPM)
• Immunization related storyboards

Current CPM Technical Corrections

Here is a list of issues that require technical corrections to the CPM. Each point is followed by the proposed correction.

R_ProductListed (POCP_RM010100UV)

• There are a number of Marketing Authorization Dates: First Authorization Date, Renewal Date, Variation Date, Withdrawal Date, Expiry Date
  • Provide a recursive COMP relationship from an authorization to itself.

DONE Gunther 16:33, 17 November 2010 (UTC)

• Each Marketing Authorization produces a GTIN
  • Provide a SubjectOf shadow from IdentifiedEntity.

DONE Gunther 16:33, 17 November 2010 (UTC)

• IdentifiedEntity needs an effectiveTime

DONE Gunther 16:33, 17 November 2010 (UTC)

• SubjectOf needs a time to indicate when the relevant product information took effect

QUESTION: such time range would be provided by the connected Act, wouldn't it?

My thought was that the effectiveTime of the document could be different from the time when it was attached to the product. But now that I look at it, I don't think that distinction makes sense.

DONE Jean

• We need to indicate the dose form and the product classification that the marketing authorization pertains to.*
• We need to have the address of the governing agency address.
• How to tie the Marketing Authorization Procedure to the marketing authorization.
• How do we indicate the point where a measurement was made.
• How do we indicate a country or countries where an Ingredient Strength quantity is valid.

R_Substance (POCP_RM080300UV)

• There needs to be a way to link characteristics to each other - either as a grouping of related characteristics or as a parent/child relationship.
• How to indicate the Gene and the specific Gene element that a Substance is derived from?
• We have a status and domain of names.
• Many codes have a status and change date of the code.
• Need to indicate a substance that is related to a characteristic (antigen ID for cells)
• How to indicate what the amount of a moiety is (mole ratio, weight percent) - this may be similar to the "Amount Type" that is present on all amounts.
• We need a "SubjectOf" relationship on the NamedEntity to indicate reference information for the names.
• How to indicate how much of a substance is related to a substance specification's observation?
• Need to provide documentation of a characteristic.
• We have processSteps that have sub-processSteps. SubstanceSpecification does not allow this.