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{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2023,9,4]],"date-time":"2023-09-04T23:31:58Z","timestamp":1693870318818},"reference-count":65,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2023,4,17]],"date-time":"2023-04-17T00:00:00Z","timestamp":1681689600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2023,4,17]],"date-time":"2023-04-17T00:00:00Z","timestamp":1681689600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100008678","name":"Universit\u00e4t Leipzig","doi-asserted-by":"crossref"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Health Serv Res"],"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n <jats:title>Background<\/jats:title>\n <jats:p>With its digital health application (DiGA)-system, Germany is considered one of Europe's pioneers in the field of evidence-based digital health. 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 D
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