BfArM - Federal Institute for Drugs and Medical Devices

Navigation and service

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).

eHealth DSI Operations

eHDSI - Master Value Sets Catalogue (MVC)

epSOS-Projekt

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

RD-Code

The European Union started a new project in January 2019 named RD-Code (Rare disease code) with participation of DIMDI and now BfArM as legal successor.

Read more

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.

Read more

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