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Incorporating DiGA into standard medical care must be based on evidence-based success factors; however, a comprehensive overview of the evidence required of scientific studies for their approval is lacking.<\/jats:p>\n <\/jats:sec><jats:sec>\n <jats:title>Objective<\/jats:title>\n <jats:p>The study aims to, (1) identify specific requirements defined by\u00a0the Federal Institute for Drugs and Medical Devices (German: Bundesinstitut f\u00fcr Arzneimittel- und Medizinprodukte; BfArM) to design adequate studies, proving a positive healthcare effect, and (2) to assess the evidence given for applications permanently listed in the DiGA directory.<\/jats:p>\n <\/jats:sec><jats:sec>\n <jats:title>Methods<\/jats:title>\n <jats:p>A multi-step approach was used: (1) identification of the evidence requirements for applications permanently listed in the DiGA directory, (2) identification of the evidence available supporting them.<\/jats:p>\n <\/jats:sec><jats:sec>\n <jats:title>Results<\/jats:title>\n <jats:p>All DiGA permanently listed in the DiGA directory (13 applications) are included in the formal analysis. Most DiGA addressed mental health (<jats:italic>n<\/jats:italic>\u2009=\u20097), and can be prescribed for one or two indications (<jats:italic>n<\/jats:italic>\u2009=\u200910). All permanently listed DiGA have demonstrated their positive healthcare effect through a medical benefit, and most of them provide evidence for one defined primary endpoint. All DiGA manufacturers conducted a randomized controlled trial.<\/jats:p>\n <\/jats:sec><jats:sec>\n <jats:title>Discussion<\/jats:title>\n <jats:p>It is striking that\u2014 although patient-relevant structural and procedural improvements show high potential for improving care, especially in terms of processes \u2014 all DiGA have provided a positive care effect via a medical benefit. Although BfArM accepts study designs with a lower level of evidence for the proof of a positive healthcare effect, all manufacturers conducted a study with a high level of evidence.<\/jats:p>\n <\/jats:sec><jats:sec>\n <jats:title>Conclusion<\/jats:title>\n <jats:p>The results of this analysis indicate that permanently listed DiGA meet higher standards than required by the guideline.<\/jats:p>\n <\/jats:sec>","DOI":"10.1186\/s12913-023-09287-w","type":"journal-article","created":{"date-parts":[[2023,4,17]],"date-time":"2023-04-17T07:02:53Z","timestamp":1681714973000},"update-policy":"http:\/\/dx.doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Evidence requirements of permanently listed digital health applications (DiGA) and their implementation in the German DiGA directory: an analysis"],"prefix":"10.1186","volume":"23","author":[{"given":"Melanie","family":"M\u00e4der","sequence":"first","affiliation":[]},{"given":"Patrick","family":"Timpel","sequence":"additional","affiliation":[]},{"given":"Tonio","family":"Sch\u00f6nfelder","sequence":"additional","affiliation":[]},{"given":"Carsta","family":"Militzer-Horstmann","sequence":"additional","affiliation":[]},{"given":"Sandy","family":"Scheibe","sequence":"additional","affiliation":[]},{"given":"Ria","family":"Heinrich","sequence":"additional","affiliation":[]},{"given":"Dennis","family":"H\u00e4ckl","sequence":"additional","affiliation":[]}],"member":"297","published-online":{"date-parts":[[2023,4,17]]},"reference":[{"issue":"1","key":"9287_CR1","doi-asserted-by":"publisher","first-page":"31","DOI":"10.1038\/s41746-022-00573-1","volume":"5","author":"A Ess\u00e9n","year":"2022","unstructured":"Ess\u00e9n A, Stern AD, Haase CB, et al. 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