Germany’s Digital Healthcare Act and Real-World Evidence

Germany’s 2019 Act to Improve Healthcare Provision through Digitization and Innovation has accelerated the implementation of digital health applications (DiGa). This legislation lets DiGA be prescribed to patients and reimbursed by German Statutory Health Insurance (SHI) after passing an assessment of the Federal Office for Drugs and Medical Devices (BfArM). Manufacturers apply for provisional listing with real-world evidence (RWE) suggesting a benefit. If approved, they have one year to demonstrate a medical benefit or improve patient-relevant healthcare structures. Otherwise, the DiGA is unlisted. However, many applicants are’t well-informed of study requirements.

According to Röhrkaste et al., “…considering all applications received to date, about half (n=49 applications) were withdrawn by the manufacturers. Reasons for withdrawals are not publicly available but may include incompleteness of the application or failure to meet study requirements, highlighting the importance of understanding the process and planning accordingly.”

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(Source: AmerisourceBergen Xcenda, November 1^st, 2021)