Difference between revisions of "SubstanceSpecification FHIR Resource Proposal"
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==Resource Relationships== | ==Resource Relationships== | ||
| − | Reference to Organization, for manufacturer. | + | Reference to Organization, for the manufacturer. |
| − | + | ||
| + | There is expected to be a reference from Substance to SubstanceSpecification, to be able to point to a more detailed definition. | ||
| + | |||
| + | This resource is not expected to replace the existing Substance resource - which is limited in scope to the small number of items needed to support direct clinical/medicinal use. | ||
| + | |||
| + | Instead, it is a collection of definitional information that an instance of a Substance resource (e.g. in a Medication, e.g. in a MedicationDispense) can refer to. | ||
| + | |||
| + | It is not expected that a SubstanceSpecification would ever directly substitute for the use of Substance. | ||
| + | |||
| + | In theory, all the SubstanceSpecification information could be contained in a hugely expanded Substance resource (and then the existing Substance scope could be profiled back out again). But this would create an unmanageably large Substance resource for the very common medicial/clinical use cases. | ||
| + | |||
| + | Since the use of SubstanceSpecification is almost orthogonal to the clinical use cases, it seems appropriate to have the SubstanceSpecification resource available as an "add-on" model. The SubstanceSpecification resource would be used on its own, unrelated to any Substance instance, in the distinct regulartory and drug information use cases. | ||
==Timelines== | ==Timelines== | ||
Revision as of 22:58, 23 September 2017
This page documents a Pending FHIR Resource Proposal
Contents
- 1 SubstanceSpecification
- 1.1 Owning work group name
- 1.2 Committee Approval Date:
- 1.3 Contributing or Reviewing Work Groups
- 1.4 FHIR Resource Development Project Insight ID
- 1.5 Scope of coverage
- 1.6 RIM scope
- 1.7 Resource appropriateness
- 1.8 Expected implementations
- 1.9 Content sources
- 1.10 Example Scenarios
- 1.11 Resource Relationships
- 1.12 Timelines
- 1.13 gForge Users
- 1.14 When Resource Proposal Is Complete
- 1.15 FMG Notes
SubstanceSpecification
Owning work group name
Committee Approval Date:
13th September 2017
Contributing or Reviewing Work Groups
- Pharmacy
- O&O
FHIR Resource Development Project Insight ID
1338
Scope of coverage
To support the content of the revised ISO 11238 IDMP Substance standard and its ISO/TS 19844 Technical Specification, and other domain areas with similar requirements (detailed definition of substances, to molecular level, including manufacturing processes and ingredients).
RIM scope
Similar in scope to the substance parts of CPM. Entity: Material (EntityClass="MAT")
Resource appropriateness
There is an upcoming requirement to support the standardised exchange of detailed definitional Substance data, as covered by the ISO 11238 specification.
This resource does not intend to clash with the existing Substance 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 substance 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 substances).
Manufacturers submit this data to regulators, when substances are created or the parameters change (ingredient manufacturer, process etc).
Regulators exchange this information between each other, to synchronize substance catalogs.
Expected implementations
FDA (already implemented a proprietary message solution for 11238 substances). EMA
Content sources
Basis for the resource is the information in ISO 11238 Substances standard. Actual data exists in the FDA GSRS implementation of 11238.
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.
There is expected to be a reference from Substance to SubstanceSpecification, to be able to point to a more detailed definition.
This resource is not expected to replace the existing Substance resource - which is limited in scope to the small number of items needed to support direct clinical/medicinal use.
Instead, it is a collection of definitional information that an instance of a Substance resource (e.g. in a Medication, e.g. in a MedicationDispense) can refer to.
It is not expected that a SubstanceSpecification would ever directly substitute for the use of Substance.
In theory, all the SubstanceSpecification information could be contained in a hugely expanded Substance resource (and then the existing Substance scope could be profiled back out again). But this would create an unmanageably large Substance resource for the very common medicial/clinical use cases.
Since the use of SubstanceSpecification is almost orthogonal to the clinical use cases, it seems appropriate to have the SubstanceSpecification resource available as an "add-on" model. The SubstanceSpecification resource would be used on its own, unrelated to any Substance instance, in the distinct regulartory and drug information use cases.
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
