Prototype ISO IDMP Compliant Datafeed to eHealth (Deliverable D4.12)
1.0.0 - STU1
Prototype ISO IDMP Compliant Datafeed to eHealth (Deliverable D4.12)
1.0.0 - STU1
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
Contents:
This page provides a list of the FHIR artifacts defined as part of this implementation guide.
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 |
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 |
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 |
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. |
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. |
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. |