The Regional Social Court of Schleswig-Holstein recently addressed interim legal protection in the context of including DiGA in the DiGA directory. The case arose from an application for provisional reinstatement of a DiGA that the BfArM had not permanently included in the directory after a trial phase.
The key finding of the ruling: while lower evidence requirements than for medicinal products may apply to DiGA, proof of the “positive healthcare effect” must be more than statistical. The effect must be noticeable for insured persons and relevant to their care. A purely statistical improvement that is barely perceptible in everyday life is not sufficient.
The decision makes clear: inclusion in the directory cannot take place if the effect is not relevant in everyday clinical practice.
The full text of the ruling is available here: L 10 KR 21/25 B ER | Schleswig-Holstein Regional Social Court, 10th Senate | January 20, 2026 | Ruling