Digital Law came into force in Germany

On March 26, 2025, the Law to accelerate the digitalization of the healthcare system (Digital Law, DigiG) came into force.

Some of the key changes expected to be introduced are described below:

• Further development of the electronic patient record (ePA);
• Further development of the e-prescription;
• Expansion of Digital Health Applications (DiGAs):
  • The scope of DiGAs will be broadened to include digital medical devices classified as risk class IIb, allowing their use in more complex treatment settings such as telemonitoring;
  • Pricing models will be increasingly tied to outcome-based criteria;
  • All DiGAs listed in the Health Apps Directory will be subject to mandatory success measurement, with continuous reporting of results to the Federal Institute for Drugs and Medical Devices (BfArM) and publication within the Directory.
• Digital advancement of structured treatment programs (Disease Management Programs, DMPs);
• Improvement of interoperability;
• Enhancement of cybersecurity;
• Stabilization and further development of the Innovation Fund:
  • The sustainability of the Innovation Fund will be formally regulated;
  • Funding frameworks will be expanded, enabling broader support for healthcare innovations;
  • Knowledge generation processes will be accelerated, and the Innovation Committee’s remit will be extended;
  • Ongoing evaluations will continue to monitor and assess the Fund’s impact as a driver of innovation in the healthcare system.

The full details in German can be found here and here.

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