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Evidence requirements of permanently listed digital health applications (DiGA) and their implementation in the German DiGA directory: an analysis
BACKGROUND: 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 ev...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BioMed Central
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10108444/ https://www.ncbi.nlm.nih.gov/pubmed/37069592 http://dx.doi.org/10.1186/s12913-023-09287-w |
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author | Mäder, Melanie Timpel, Patrick Schönfelder, Tonio Militzer-Horstmann, Carsta Scheibe, Sandy Heinrich, Ria Häckl, Dennis |
author_facet | Mäder, Melanie Timpel, Patrick Schönfelder, Tonio Militzer-Horstmann, Carsta Scheibe, Sandy Heinrich, Ria Häckl, Dennis |
author_sort | Mäder, Melanie |
collection | PubMed |
description | BACKGROUND: 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. OBJECTIVE: The study aims to, (1) identify specific requirements defined by the Federal Institute for Drugs and Medical Devices (German: Bundesinstitut für 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. METHODS: 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. RESULTS: All DiGA permanently listed in the DiGA directory (13 applications) are included in the formal analysis. Most DiGA addressed mental health (n = 7), and can be prescribed for one or two indications (n = 10). 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. DISCUSSION: It is striking that— although patient-relevant structural and procedural improvements show high potential for improving care, especially in terms of processes — 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. CONCLUSION: The results of this analysis indicate that permanently listed DiGA meet higher standards than required by the guideline. |
format | Online Article Text |
id | pubmed-10108444 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-101084442023-04-18 Evidence requirements of permanently listed digital health applications (DiGA) and their implementation in the German DiGA directory: an analysis Mäder, Melanie Timpel, Patrick Schönfelder, Tonio Militzer-Horstmann, Carsta Scheibe, Sandy Heinrich, Ria Häckl, Dennis BMC Health Serv Res Research BACKGROUND: 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. OBJECTIVE: The study aims to, (1) identify specific requirements defined by the Federal Institute for Drugs and Medical Devices (German: Bundesinstitut für 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. METHODS: 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. RESULTS: All DiGA permanently listed in the DiGA directory (13 applications) are included in the formal analysis. Most DiGA addressed mental health (n = 7), and can be prescribed for one or two indications (n = 10). 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. DISCUSSION: It is striking that— although patient-relevant structural and procedural improvements show high potential for improving care, especially in terms of processes — 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. CONCLUSION: The results of this analysis indicate that permanently listed DiGA meet higher standards than required by the guideline. BioMed Central 2023-04-17 /pmc/articles/PMC10108444/ /pubmed/37069592 http://dx.doi.org/10.1186/s12913-023-09287-w Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/ Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Research Mäder, Melanie Timpel, Patrick Schönfelder, Tonio Militzer-Horstmann, Carsta Scheibe, Sandy Heinrich, Ria Häckl, Dennis Evidence requirements of permanently listed digital health applications (DiGA) and their implementation in the German DiGA directory: an analysis |
title | Evidence requirements of permanently listed digital health applications (DiGA) and their implementation in the German DiGA directory: an analysis |
title_full | Evidence requirements of permanently listed digital health applications (DiGA) and their implementation in the German DiGA directory: an analysis |
title_fullStr | Evidence requirements of permanently listed digital health applications (DiGA) and their implementation in the German DiGA directory: an analysis |
title_full_unstemmed | Evidence requirements of permanently listed digital health applications (DiGA) and their implementation in the German DiGA directory: an analysis |
title_short | Evidence requirements of permanently listed digital health applications (DiGA) and their implementation in the German DiGA directory: an analysis |
title_sort | evidence requirements of permanently listed digital health applications (diga) and their implementation in the german diga directory: an analysis |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10108444/ https://www.ncbi.nlm.nih.gov/pubmed/37069592 http://dx.doi.org/10.1186/s12913-023-09287-w |
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