EU projects
Subgroup of Semantics
The Subgroup on Semantics contributes to the eHealth Network, a voluntary platform of national authorities responsible for health data exchange. The Subgroup on Semantics advises the eHealth Network on the strategic development of code systems in Europe and prepares proposals for semantic interoperability and standardization in Europe to advance cross-border health data exchange. The BfArM contributes viewpoints from Germany and coordinates them at the European level (see SGB V § 219d para. 6).
European Commission- Digital health and care (eHealth)
eHDSI-Collaboration
eHDSI stands for eHealth Digital Service Infrastructure and supports the cross-border exchange of health data in Europe, especially for the patient summary and the electronic prescription. DIMDI was involved in the precursor project epSOS (European Patient Smart Open Services) as an expert for semantic interoperability. Citizens in Europe should be able to access their health data at any time when they are traveling in Europe. eHDSI is building the infrastructure so that personal health data can be exchanged securely and interoperable between EU countries. Together with the other European countries and in coordination with the organizations involved in Germany, the BfArM is defining the semantic building blocks for cross-border data exchange and is supporting the fact that data can be provided and exchanged in an encoded form and thus language-independently (see SGB V § 219d para. 6).
eHDSI - Master Value Sets Catalogue (MVC)
X-eHealth
The X-eHealth project supports the advancement of cross-border health data exchange infrastructure in Europe. Within the framework of the project, a common path for the exchange of data in the area of laboratories, for medical images, for hospital discharge reports and for the documentation of rare diseases in the EU is being explored and prepared for possible implementation in the eHealth Digital Service Infrastructure (eHDSI). In order to accompany these developments at an early stage and also to introduce the developments into processes in Germany, BfArM is contributing its semantic expertise.
X-eHealth - Exchanging Electronic Health Records in a common framework
Xt-EHR
The Xt-EHR Joint Action supports the European Commission's commitment to a ‘Europe fit for the digital age’ and the objectives of the EU4Health programme to strengthen healthcare systems in the member states. In Xt-EHR, more than 50 partner organisations from 26 European countries are working together to describe the requirements, technical specifications and implementation guidelines that will improve the interoperability and electronic exchange of healthcare data between EU Member States. The Joint Action paves the way for the Regulation implementing the European Health Data Space (EHDS) regarding the collection and exchange of health data for primary use in the electronic health record in Europe. Xt-EHR describes, for example, framework conditions for the harmonisation and exchange of data for the so-called priority categories (EHDS Regulation, Article 5), the electronic patient summaries, prescriptions, laboratory results and medical images as well as hospital discharge reports. In the Joint Action gematik GmbH and BfArM are responsible for work package 2 ‘Dissemination’ and coordinate the participation of stakeholders and the receipt of requirements for the specifications to be developed for Germany.
Further information: Xt-EHR - Extended EHR@EU Data Space for Primary Use
RD-Action
The European project Rare Disease Action (RD-Action) aimed at creating a consistent European way of meeting challenges in the field of rare disease.
Further information:RD-Action - Rare Disease Action
RD-Action - Rare Disease Action on the BfArM-Website
RD-CODE
The EU project RD-CODE (Rare Disease Code) aimed to implement ORPHAcodes for coding rare diseases in the national coding systems of four European countries. The BfArM was involved in the process support in an advisory capacity as part of work package 5.
Further information:RD-CODE - Rare Disease Code
RD-CODE - Rare Disease Code on the BfArM-Website
OD4RD
The OD4RD (Orphanet Data for Rare Diseases) project, funded by the European Union, started on the first January 2022. A pilot phase of 15 month was held from January 2022 to March 2023 (OD4RD1) and then the project has been renewed until the end of 2025 (OD4RD2). The project builds on Orphanet’s specific expertise, and on its organisation as a long-lasting, well-established network. In terms of content, the project aims to promote the generation of standardised, interoperable data on rare diseases (RD) by maintaining and further developing the Orphanet nomenclature and implementing it in expert centres (hospitals specialising in rare diseases). This contributes to the standardisation of data collection in the various application areas of participating European countries (registers, electronic data files, etc.).
As in the preliminary project OD4RD1, BfArM has taken the lead for work package 4 (‘Consolidate and Expand national Orphanet nomenclature hubs’) and is supported by Karolinska University Hospital, Sweden. In this work package, the expansion of national Orphanet contact points will be promoted, which will act as contact points for the support of ORPHAcode implementation. Other tasks of the Orphanet contact points include to provide training on ORPHAcode use and to raise awareness of its benefits among policy makers and practitioners working in the healthcare system for people with RD.
Further information:OD4RD - Orphanet Data for Rare Diseases
Flyer Orphanet National Hub Germany
JARDIN
The EU project JARDIN (Joint Action on Rare Diseases Integration) is a Joint Action co-financed by the EU4Health funding programme. Its goal is to integrate the European Reference Networks (ERNs) for rare and highly complex diseases, which have been established EU-wide since 2017, into the national health systems of EU member states more effectively. JARDIN brings together a consortium of 60 partner organisations from 29 countries to work towards making the specialised care competencies available in the ERNs more accessible to people with rare and highly complex diseases. Representatives of national health authorities, experts in rare diseases and patient organisations work closely together to develop recommendations and implementation pilots for patient pathways, national reference networks and data management for rare diseases, as well as to exchange experience and best practices.
Germany is participating in JARDIN with a multidisciplinary consortium. In addition to the Federal Ministry of Health as the consortium leader, this includes the secretariat of the National Action Alliance for People with Rare Diseases, the Federal Institute for Drugs and Medical Devices (BfArM), the Alliance of Chronic Rare Diseases (ACHSE e.V.), and the Centres for Rare Diseases at the University Hospitals Frankfurt/Main, Heidelberg, Tübingen and Würzburg.
Germany has a unique opportunity to actively contribute to the development of cross-border healthcare, share its expertise in rare diseases and promote the establishment of interoperable processes and standards.
Further information: JARDIN - Joint Action on Rare Diseases Integration