UnicomIG
0.1.0 - ci-build

UnicomIG, published by UNICOM. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/unicom-ig/ and changes regularly. See the Directory of published versions

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Official URL: http://unicom-project.eu/fhir/ImplementationGuide/hl7.eu.fhir.unicom Version: 0.1.0
Draft as of 2024-10-11 Computable Name: UnicomIG

Introduction

This is FHIR Implementation Guide for UNICOM project, created to assist work with pilot product list product data in FHIR.

Specification

The specification herewith documented is a demo working specification, and may not be used for any implementation purposes. No liability can be inferred from the use or misuse of this specification, or its consequences.

UNICOM FHIR Implementation Guide is a proof of concept within the UNICOM project.

The purpose of the UNICOM Implementation Guide:

  • describe how ISO IDMP is used in the regulatory domain;
  • provide FHIR specifications compatible with EMA ISO IDMP Implementation Guide;
  • explain challenges and possible issues in the current EMA specification;
  • provide guidance how to make regulatory data useful and usable in the clinical domain.

UNICOM Implementation Guide contains the following:

  • Logical models for regulatory product (subset of ISO IDMP) and eHealth product;
  • FHIR profiles for regulatory product;
  • ConceptMaps between EMA SPOR and MyHealth@EU terminologies;
  • Custom search parameters and operations to enhance searchability of the products;
  • Example data on a UNICOM visualisation template;
  • Dedicated pages for guidance, references, and highlighted implementation considerations.

UNICOM aims to work in alignment with other ongoing projects that focus on medication data:

Authors and contributors

UNICOM Implementation Guide is a work result across different work packages. Only a few people have been actively writing the implementation guide, while many people have contributed with their knowledge. Most of the work observable in the implementation guide is a result of lengthy discussions, which have happened in different work packages, mostly in WP4 (national competent authorities) and WP9 (medical product dictionaries).

Coordination and FHIR content creation:

  • José Costa Teixeira (IHE, WP1,5,6)
  • João Almeida (HL7 Europe, WP5)
  • Giorgio Cangioli (HL7 Europe, WP1,5,6,7,8)

Creation of relevant ISO IDMP subset and content guidance:

  • Rutt Lindström (EE, WP4)
  • Triin Mäesalu (EE, WP4)
  • Ursula Tschorn (DE, WP9)
  • Julie James (UK, WP9)
  • Johan Aulin (SE, WP4)

Creation of example data:

  • Isebelle Skog (SE)
  • Penny Lindström Carmanius (SE)
  • Bersabel Sirak (SE)
  • Alva Jonsson (SE)
  • Triin Hirvlaan (EE, WP4)

Excessive testing and improvements:

  • DataWizard (WP6)
  • GNOMON (WP6)