Stream: Sweden Drugs on FHIR
Topic: EMA, IDMP och FHIR
Oskar Thunman (May 30 2018 at 11:01):
Data standard for information exchange (new)
In January 2018, the EU Telematics Enterprise Architecture Board (EU TEAB) endorsed using the draft international data standard known as Fast Healthcare Interoperability ResourcesExternal link icon (FHIR, pronounced “fire”) as the basis for the application programming interface (API) for the PMS.
This means that in future FHIR will be the data standard that supports the exchange of information about medicinal products, substances, and related reference data in the European medicines regulatory network.
EMA, the United States Food and Drug AdministrationExternal link icon (FDA) and the European medicines regulatory network will work together with Health Level SevenExternal link icon (HL7) to incorporate the ISO IDMP standards into the FHIR specification.
This allows SPOR to become compatible with HL7 standards while retaining flexibility in defining a new data model for ISO IDMP-based data. It ensures that the European medicines regulatory network aligns with international standards, a key objective of the EU Telematics strategy.
It enables EMA to progress in designing technical solutions and messaging formats for the SPOR programme, to realise technical efficiencies while respecting the content and processing requirements of the ISO IDMP standards.
The European medicines regulatory network is currently discussing the requirements of the operating model for managing medicinal product data, which will determine the API's future use.
Last updated: Apr 12 2022 at 19:14 UTC
