Germany’s pioneering 'apps on prescription' model offers the most structured entry point into the European digital health and medtech market. With access to 73 million insured lives, the potential for scale is unmatched, but the barrier to entry is high. This guide breaks down the essential steps for securing DiGA reimbursement in Germany, from navigating the BfArM Fast-Track and building the right clinical evidence, to preparing for the major regulatory shifts arriving in 2026.