Prototype ISO IDMP Compliant Datafeed to eHealth (Deliverable D4.12)
1.0.0 - STU1 International flag

Prototype ISO IDMP Compliant Datafeed to eHealth (Deliverable D4.12), published by UNICOM. This guide is not an authorized publication; it is the continuous build for version 1.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/unicom-project-eu/d4.12/ and changes regularly. See the Directory of published versions

Artifacts Summary

This page provides a list of the FHIR artifacts defined as part of this implementation guide.

Structures: Logical Models

These define data models that represent the domain covered by this implementation guide in more business-friendly terms than the underlying FHIR resources.

Marketing Authorisation

Marketing authorisation data on package or medicinal product level

Medicinal Product Logical Model

Logical model for a pilot product list's medicinal product

SNOMED Clinical Drug FHIR

SNOMED CT Clinical Drug concept model with FHIR data types

Structures: Resource Profiles

These define constraints on FHIR resources for systems conforming to this implementation guide.

Administrable/Pharmaceutical Product

Administrable Product data

Ingredient

Ingredient data

Manufactured Item

Manufactured Item data

Marketing Authorisation

Marketing Authorisation (Regulated Authorization) data

Medicinal Product

Medicinal Product data

Organization

Marketing Authorisation Holder or its local representative. For unauthorised products, a manufacturer or registration holder.

Packaged Product

Packaged Product data

Structures: Data Type Profiles

These define constraints on FHIR data types for systems conforming to this implementation guide.

AD

Address

ANY

An abstract type

BL

Boolean - true or false

CD

ConceptDescriptor

Class

Class of data elements

DT

Date

ED

Encapsulated data

EN

EntityName

II

InstanceIdentifier

INT

IntegerNumber

PQ

PhysicalQuantity

REAL

RealNumber

RTO

Ratio

ST

CharacterString

TS

TimeStamp

Untyped

No data type defined

Terminology: Value Sets

These define sets of codes used by systems conforming to this implementation guide.

Country (ISO 3166-1-2)

Countries

EMA SPOR ATC

Value set for Anatomical Therapeutic Chemical classification system Human and Veterinary. It combines 2 SPOR/WHO lists

EMA SPOR All Units Combined

Value set for presentation strength denominator unit, combines units of measurement and units of presentation.

EMA SPOR Authorised Dose Form

Value set for authorised dose form. Combines 4 SPOR/EDQM lists: Pharmaceutical dose form, Combined pharmaceutical dose form, Combined term, Combination package.

EMA SPOR Country

Countries. EMA SPOR RMS list.

EMA SPOR Domain

Domain of the medicinal product. EMA SPOR RMS list.

EMA SPOR Language

Languages. EMA SPOR RMS list.

EMA SPOR Legal Status for the Supply

EMA SPOR RMS list

EMA SPOR Marketing Status

Marketing Status

EMA SPOR Material

Package material. EMA SPOR RMS LIST.

EMA SPOR Packaging

Packaging

EMA SPOR Pharmaceutical Dose Form

Pharmaceutical dose form. Does not include combination dose forms.

EMA SPOR Record Status

Value set for record status.

EMA SPOR Regulatory Entitlement Status

Regulatory Entitlement Status

EMA SPOR Routes and Methods of Administration

Routes and methods of medication administration. EMA SPOR RMS list, based on EDQM.

EMA SPOR SMS Substances

Value set for substances, PPL subset from SMS.

EMA SPOR Shelf Life Type

Shelf Life Type

EMA SPOR Unit of Measurement

Units of measurement. EMA SPOR RMS list based on UCUM.

EMA SPOR Unit of Presentation

Units of presentation. EMA SPOR RMS list based on EDQM.

Language (FHIR)

All languages

WHO ATC

World Health Organization Anatomical Therapeutic Chemical (ATC) classification system. Note: The currently implemented code system and the value set expansion contain only a set of example ATC codes, not the complete code system content.

Terminology: Code Systems

These define new code systems used by systems conforming to this implementation guide.

ATC Human EMA

ATC classification recoded with EMA SPOR RMS codes. Flat list, WHO ATC codes provided in description field for easier use.

Combination Package EMA

Dose forms for combination packages. Based on EDQM. Re-coded with RMS codes. Only used for authorised dose form.

Combined Pharmaceutical Dose Form EMA

Combined Pharmaceutical Dose Form. Based on EDQM. Re-coded with RMS codes. Used only for authorised dose form.

Combined Term EMA

Combined Term. Based on EDQM. Re-coded with RMS codes. Only used for authorised dose form.

Country EMA

Country codes by EMA. Based on ISO 3166-1-2, recoded with RMS codes.

Domain EMA

Domain of the medicinal product (human, veterinary, both)

Language EMA

Language codes by EMA. Based on BCP-47, recoded with RMS codes.

Legal Status for the Supply EMA

Legal status of supply. EMA SPOR RMS list.

Marketing Status EMA

Marketing status of the product in given country. EMA SPOR RMS codes.

Material EMA

Package material. EMA SPOR RMS list. Hierarchical.

Packaging EMA SPOR

Package types, including closures and administration devices. Based on EDQM, recoded with EMA SPOR RMS codes.

Pharmaceutical Dose Form EMA

Pharmaceutical dose form. Based on EDQM, re-coded with RMS codes.

Record Status EMA SPOR

Record Entitlement Status EMA SPOR

Regulatory Entitlement Status EMA SPOR

Regulatory Entitlement Status EMA SPOR

Routes and Methods of Administration EMA

Routes and methods of medication administration. Based on EDQM, re-coded with RMS codes.

Substances EMA SPOR SMS

UNICOM PPL substances from EMA SPOR SMS

Unit of Measurement EMA

Unit of Measurement. Based on UCUM. Re-coded with RMS codes.

Unit of Presentation EMA

Unit of presentation list from EMA SPOR. List id 200000000014. Content based on EDQM, re-coded with RMS codes.

Example: Example Instances

These are example instances that show what data produced and consumed by systems conforming with this implementation guide might look like.

AT-Curocef-1500-Powder

Curocef 1500mg Powder for solution for injection/infusion. Austria.

Amlor-harde-caps-10-mg-13-BEL

Amlor. Amlodipine 10mg. Hard capsules. Belgium.

Brufen-tabl-verl-afgifte-Retard-800-mg-53-BEL

Brufen. Ibuprofen 800mg. Prolonged release tablets. Belgium.

Cholemed-20mg-BE-MPD

Cholemed. Simvastatin 20mg. Film coated tablets. Multiple names. Belgium.

EE-Betaklav500-125-Tablet

Betaklav. Amoxicillin 500mg, clavulanic acid 125mg. Tablets. Estonia.

PT-Augmentin-500-125-FilmCoatedTablets

Augmentin. Amoxicillin 500mg, clavulanic acid 125mg. Film coated tablets. Portugal.

PT-Brufen-200-FilmCoatedTablet

Brufen. Ibuprofen 200mg. Film coated tablets. Portugal.

Pedea-inf-oploss-i-v-amp-10-mg-2-ml-48-BEL

Pedea. Ibuprofen 10mg/2ml. Solution for infusion. Belgium.