Difference between revisions of "MedicinalProduct FHIR Resource Proposal"

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==FHIR Resource Development Project Insight ID==
 
==FHIR Resource Development Project Insight ID==
  
TBC
+
TBC (PSS has been created and submitted)
  
 
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<!-- Please specify the id of your work group’s PSS for doing FHIR work.  (If submitted but not yet approved, just write “pending”.) The link to the PSS template can be found here: http://gforge.hl7.org/gf/download/docmanfileversion/6832/9398/HL7FHIR_DSTUballotPSS-20120529.doc -->

Revision as of 10:26, 27 September 2017



MedicinalProduct

Owning work group name

BR&R

Committee Approval Date:

13th September 2017

Contributing or Reviewing Work Groups

  • Pharmacy
  • O&O

FHIR Resource Development Project Insight ID

TBC (PSS has been created and submitted)


Scope of coverage

To support the content of the ISO 11615 IDMP Medicinal Product standard and its ISO/TS 20443 Technical Specification, and other domain areas with similar requirements. 11615 covers detailed definition of products, their submissions to regulators, authorization activitues, ingredients, packaging, accompanying devices, clinical particulars etc). Not all of those are expected to be covered in this single resource.

RIM scope

Similar in scope to the product parts of CPM. Entity: Material (EntityClass="MAT")

Resource appropriateness

There is an upcoming requirement to support the standardised exchange of detailed Product data, as covered by the ISO 11615 specification.

This resource does not intend to clash with the existing Medication FHIR resource, but complements with an extra level of detail. It is seen as a sibling rather than a parent or a superclass to be profiled.

It is intended to add an extra level of product specification detail, such as is typically used by regulators, and only indirectly used during normal medication related work flows (e.g. for lookups of unfamiliar products).

Manufacturers submit this data to regulators, when products are registered or altered, or marketing situations change.

Expected implementations

EMA European Drug manufacturers, who have a requirement to submit to EMA (and already do so in a proprietary format. They will be required to move to IDMP, and this is a good opportunity to use a standards based FHIR solution. FDA (currently using SPL, which is not likely to change in the near term, but have expressed an interest in researching what can be done with FHIR).

Content sources

Basis for the resource is the information in ISO 11615 Substances standard. Actual data exists in the EMA XEVMPD data base and XEVPRM XML messages.

Example Scenarios

TODO Substance definitions for the various categories (Chemical, Polymer, Protein etc). Use of "Specified Substance" area of 11238 to add extra information around manufacturing process etc.

Resource Relationships

TODO Reference to Organization, for the manufacturer.

MedicinalProduct and Medication

TODO

MedicinalProduct and Device

TODO

Timelines

Early draft by December 2017 comment-only ballot.

gForge Users

riksmithies (already has commit permission)

When Resource Proposal Is Complete

When you have completed your proposal, please send an email to FMGcontact@HL7.org

FMG Notes