19/04/2023 - Event: HDL at DMEA - Connecting Digital Health


DMEA is one of Europe's most important events for digital health and takes place on April 25 to 27, 2023. The Health Data Lab (HDL) will be represented with a BfArM booth. We look forward to seeing you at booth B106 in hall 5.2.

08/04/2022 - Grant application for "European Health Data Space" pilot project approved

Following the submission of the grant application in January 2022 (see article of 30 March 2022), the EU Commission announced the approval of the EHDS2 pilot project on 15 July. The Health Data Lab is involved as a project partner, supporting the goal to build and test a first version of the European Health Data Space (EHDS) in the field of secondary use of health data.

The pilot project aims to explore a concrete basis for the future EHDS. The consortium, led by the French Health Data Hub, consists of 16 partners from 10 different European countries.

The consortium has the mission to establish a health data infrastructure by interconnecting the platforms of the participating countries. The implementation will then be tested based on specific application cases, so-called "use cases," from medical research. Furthermore, the transferability of the developed infrastructure to the European Union will be evaluated.

In autumn 2022, the EHDS2 pilot project will start and run for two years.

To the international press release of the Health Data Hub (PDF 1.258 kB).

03/30/2022 - HDL participates in grant application to the EU commission for pilot version of the „European Health Data Space“

The Health Data Lab (HDL) of the BfArM is part of a large consortium of 16 European partners (national platforms, European research infrastructures and EU agencies), coordinated by the French Health Data Hub, which aims to build and test a first pilot version of the future „European Health Data Space“ (EHDS). Thus, a joint grant application in the context of the EU commission‘s EU4Health Programme was submitted on 25 January 2022.

In case of a positive decision, the participating data platforms are to be connected within the framework of the pilot project in order to enable researchers to query the metadata catalogues of all the nodes, to request selected data via a single common form and to analyse data across national nodes. For this purpose, secure IT infrastructures will be built and concepts for the legal framework will be developed. Networking with the ongoing TEHDAS Joint Action ("Towards a European Health Data Space"), in which many of the partners are also involved, will also play an important role in this context. In the course of the pilot project, the established infrastructure will be tested with the help of „use cases“ on various medical-scientific topics (e.g. COVID-19, rare diseases, genomics in cancer).

The application is currently being reviewed by the EU Commission and a decision is expected in summer 2022. If the consortium is selected, the pilot project could start in September 2022. 

To the international press release of the Health Data Hub

01/27/2021 - Press release

The Health Data Lab (HDL), located at the Federal Institute for Drugs and Medical Devices (BfArM), provides authorised institutions with pseudonymised billing data of statutory health insurance patients for research purposes and to improve medical care. In the course of a fundamental restructuring of the "Forschungsdatenzentrum Gesundheit", data access to the HDL data will also be redesigned. To support this, the working group of authorised users provided for in Section 303d (2) SGB V will be established in spring 2022 and convened under the coordination of the TMF. The aim of the working group of authorised users is to develop recommendations for the design of the research data center and to participate in an advisory capacity in the design, further development and evaluation of data access (...).

To the press release of the BfArM from 01/27/2021