The Federal Ministry of Health has presented a draft bill for a new law for data and digital innovation in healthcare. The so-called GeDIG Act is intended to significantly advance the digitization of care and nursing care, further develop the electronic patient record (ePA) and implement the requirements of the European EHDS Regulation on time. The aim is to provide more user-friendly, interoperable and data-driven healthcare.

Among other things, the draft provides for the introduction of electronic referrals in the outpatient sector from September 2029. Insured persons are to receive digital access to a nationwide initial assessment and appointment booking via the ePA app. Pharmacists’ access rights to the ePA will be expanded to improve drug therapy safety. In addition, digital vaccination documentation is to be introduced as a preliminary stage of a fully digitized vaccination process.

In the area of the secondary use of health data, real-world laboratories are made possible by health insurance companies, in which innovative data use can be tested. The Health Research Data Centre at the Federal Institute for Drugs and Medical Devices is being expanded, including the possibility of identifying service providers in certain cases. The telematics infrastructure is to become more stable and efficient, and the Gesellschaft für Telematik (gematik) will receive significantly expanded control and operating competencies.

The law also serves to implement the EU regulation on the European Health Data Space (EHDS). These include the establishment of a national contact point for digital health as well as regulations on cross-border data transfer from 2029.Interoperability and accessibility of the systems are to be strengthened in order to enable processes without media discontinuity and to relieve service providers of bureaucracy.

The federal government will incur one-off budget expenditures of around 22 million euros as well as annual additional expenditure of up to 10 million euros. The statutory health insurance must expect about 2.2 million euros in additional expenditure annually. At the same time, considerable relief for service providers of up to 440 million euros per year is planned through efficiency gains.

The law is intended to consistently continue the digitalisation of healthcare and care and to better exploit the potential of data for care, research and innovation.

Editor: X-Press Journalistenbüro GbR

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