Introduction
SAFEST is based on EMA's IDMP implementation guide, where Chapter 2: Data elements for the electronic submission of information on medicinal products for human use details the relevant data elements.
FHIR - Fast Healthcare Interoperability Resources - is the standard used to exchange the data elements.
The SAFEST implementation guide is based on FHIR Version R4 and is made to be compatible with the upcoming FHIR Version R5. It defines the minimum set of constraints on the FHIR resources used to create the SAFEST profiles. It also defines the FHIR RESTful interactions for each of the SAFEST profiles to access the medical data.
Background
SAFEST API is making available the new master data for medicinal products for the Norwegian healthcare services. It will be incrementally completed over the next few years. The new medicinal product master data is being compiled according to a number of regulatory and clinical requirements and goals, of which the most important are
- Improved patient safety
- Adherence to EU regulation No 520/2012 Chapter IV Article 25 (IDMP), which is incorporated into the Norwegian Medicine Directive (“Legemiddelforskriften”) Chapter 10 §12
- Compatibility with EMA SPOR and UNICOM implementation guides, structure, semantics and content
- Additional support for country-specific clinical, analytical and procurement-related requirements such as “unit dose” and closed-loop medication
- Provisioning of nutrition-related master data
- Support for active-substance-based prescriptions in hospitals (“Virkestoffordinering")
EU regulation 520/2012: https://eur-lex.europa.eu/eli/reg_impl/2012/520/oj
Norwegian Medicine Directive (“Legemiddelforskriften”): <https://lovdata.no/forskrift/2009-12-18-1839/§10-12>
UNICOM: https://unicom-project.eu/
SPOR implementation guides: https://www.ema.europa.eu/en/human-regulatory/research-development/data-medicines-iso-idmp-standards/spor-master-data/substance-product-data-management-services
FHIR Current Build: http://build.fhir.org/