European and national implementation in sync.

The European Health Data Space (EHDS) offers great potential for patients, service providers, researchers and companies in the European Union (EU). While the European regulation is still pending, national implementation in Germany is already running in parallel. An overview:

European implementation

The regulation to establish the EHDS at EU level required a great deal of patience. Following lengthy negotiations, the Council, Parliament and Commission agreed on a unified regulation text in the trialogue in April. However, the subsequent legal and linguistic revision as part of the amendment procedure under Article 241 of the European Parliament's Rules of Procedure dragged on into the autumn. The revised text is now available in all languages.

The revised text of the EHDS regulation was officially adopted during the last parliamentary week of the European Parliament. According to the rules of procedure of the Parliament (Article 251, paragraph 4), no request was made to vote on the corrigendum. Therefore, the corrected text is automatically considered approved. The Council now has three months to approve the regulation. After its publication in the Official Journal of the EU, the regulation will enter into force 20 days later.

National implementation

The long wait for the European regulation does not prevent national implementation in Germany. On the contrary, preparations are already in full swing. The national framework for the EHDS is established by focussing on the use of primary and secondary data.

Primary data use under DigiG – EHR for all

The Digital Act (DigiG) will introduce the electronic health record (EHR) for all statutory health insurance policyholders in Germany starting 2025. This is set up automatically unless the insured person objects to its use as part of an opt-out procedure. The aim of the DigiG is to simplify everyday treatment for doctors and patients, promote the exchange and use of health data and provide targeted support for medical care. Important health information can be stored in the EHR, including an electronic medication plan, a patient summary file, hospital discharge letters, laboratory results and the patient's emergency data. The emergency data will also be stored on the health card to allow access outside of the EHR. The electronic prescription will also become an integral part of the EHR.

Secondary data use under GDNG – development of the research data centre

The Act on the Improved Use of Healthcare Data (GDNG), which came into force on 26 March 2024, aims to intensify and simplify healthcare research in Germany. The aim is to make healthcare data more usable for public welfare purposes. To this end, a decentralised healthcare data infrastructure is being established in Germany, which will be supported by a central data access and coordination centre, the Forschungsdatenzentrum Gesundheit (FDZ Gesundheit). While the data remain decentralised at their original storage locations, they are made available for research applications in a secure processing environment.

The FDZ Gesundheit at the Federal Institute for Drugs and Medical Devices (BfArM), which has been in existence since 2020, will be further developed under the GDNG. A key innovation is that the authorisation to apply will be linked to a specific purpose in future. The decisive factor is whether the research purpose is in the public interest, regardless of the applicant. This means that industry will be able to use healthcare data for research in Germany for the first time. The National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) plays an important role. They are responsible for collating, checking and forwarding the data supplied by the health insurance funds to the FDZ Gesundheit and the Robert Koch Institut (RKI), which acts as a trust centre.

A further step is the draft regulation submitted by the German Federal Ministry of Health on 11 November entitled "1st Regulation for the Further Specification of Procedures under the Act to Improve the Use of Health Data". A new master ordinance, the "Forschungsdatenzentrum Gesundheit-Verordnung" (FDZGesV), is intended to specify the procedures of the FDZ Gesundheit, in particular the data transparency and consent for use procedures. The regulation is intended to regulate the transmission and use of routine data from statutory health insurance for the first time and expand the dataset by care data in order to create a broader data basis for research. The ordinance also contains fee regulations for the provision of datasets by the FDZ Gesundheit in a secure processing environment.