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Difference between revisions of "MedicinalProduct FHIR Resource Proposal"

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This page documents a [[:category:Pending FHIR Resource Proposal|Pending]] [[:category:FHIR Resource Proposal|FHIR Resource Proposal]]
[[Category:FHIR Resource Proposal]]
[[Category:Pending FHIR Resource Proposal]]
<!-- For additional guidance on considerations for resource creation, refer to [[FHIR Resource Considerations]] -->
<!-- Resource names should meet the following characteristics:
* Lower camel case
* U.S. English
* Domain-friendly
* Short
* Clear
* Unique
* Avoid non-universal abbreviations (e.g. URL would be ok)
* Be expressed as a noun
* Be consistent with other similar resources
==Owning work group name==
<!-- The name of the committee that is proposed to have responsibility for developing and maintaining the resources. -->
==Committee Approval Date:==
<i>13th September 2017</i>
==Contributing or Reviewing Work Groups==
<!-- Additional work groups that may have an interest in contributing to, or reviewing  the content of the resource (optional) -->
* Pharmacy
* O&O
==FHIR Resource Development Project Insight ID==
<!-- 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: -->
==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==
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==
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==
Reference to Organization, for the manufacturer.
===MedicinalProduct and Medication===
===MedicinalProduct and Device===
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 []'''
==FMG Notes==

Latest revision as of 09:54, 25 June 2019