SubstanceSpecification FHIR Resource Proposal

SubstanceSpecification

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

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. Initial focus to be on the 'Chemical' type (substance and specified substance parts) of that standard and draft resources will be produced to explore the use of FHIR for this. If successful, future scope may be expanded to other areas, and bring the work forward for formal inclusion in the FHIR draft standard.

RIM scope

Similar in scope to the substance parts of CPM

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 project does not intend to clash with the existing Substance FHIR resource, but could potentially complement it with profiles and/or new resource(s).

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 catalogues.

Expected implementations

FDA (already impmented a proprietary message solution for 11238 substances). EMA

Content sources

Basis for the resource is the information in ISO 11238 Substances

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