{"id":27692,"date":"2026-03-26T12:30:48","date_gmt":"2026-03-26T12:30:48","guid":{"rendered":"https:\/\/quickbirdmedical.com\/?post_type=news&p=27692"},"modified":"2026-09-03T07:31:50","modified_gmt":"2026-09-03T07:31:50","slug":"ruling-clinical-relevance-diga-inclusion","status":"publish","type":"news","link":"https:\/\/quickbirdmedical.com\/en\/news\/ruling-clinical-relevance-diga-inclusion\/","title":{"rendered":"Court Ruling: Clinical Relevance Determines DiGA Inclusion"},"content":{"rendered":"

The Regional Social Court of Schleswig-Holstein<\/strong> recently addressed interim legal protection in the context of including DiGA in the DiGA directory<\/strong>. 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.<\/p>\n

The key finding of the ruling: while lower evidence requirements than for medicinal products<\/strong> may apply to DiGA, proof of the “positive healthcare effect” must be more than statistical<\/strong>. The effect<\/strong> must be noticeable<\/strong> for insured persons and relevant<\/strong> to their care<\/strong>. A purely statistical improvement that is barely perceptible in everyday life is not sufficient.<\/p>\n

The decision makes clear: inclusion in the directory cannot take place if the effect is not relevant in everyday clinical practice.<\/p>\n

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<\/a><\/p>\n","protected":false},"featured_media":0,"template":"","categories":[],"tags":[],"display":[54],"class_list":["post-27692","news","type-news","status-publish","hentry","display-display-on-news-page"],"acf":[],"yoast_head":"\nCourt Ruling: Clinical Relevance Determines DiGA Inclusion<\/title>\n<meta name=\"description\" content=\"A German court clarifies that DiGA must show clinically relevant, noticeable benefits\u2014not merely statistically significant effects.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/quickbirdmedical.com\/en\/news\/ruling-clinical-relevance-diga-inclusion\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta 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