The adoption and integration of digital health technologies (DHTs), including digital therapeutics (DTx), remote patient monitoring (RPM) platforms, and artificial intelligence (AI)-driven diagnostics, across European healthcare systems present a fragmented landscape. While market access for traditional medical devices in the European Union relies on unified regulatory standards under the European Medical Devices Regulation (MDR), the pathways governing Health Technology Asse

The German Digital Health Act (DiGA), a foundational element of Germany's broader digital healthcare transformation, represents a pioneering legislative initiative to integrate digital health applications into mainstream medical care. Initiated by the Digital Healthcare Act (DVG) in 2019 and further bolstered by the Digital Act (DigiG) in 2024, this framework enables "apps on prescription" to be reimbursed by statutory health insurers, covering approximately 90% of the German