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?

REMOVED: 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.

• 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.