Artikel
Manufacturers’ experiences with digital health apps (DiGAs) and the fast-track procedure of the Federal Institute for Drugs and Medical Devices (BfArM)
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Autoren
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Clara Coellen
- BQS Institut für Qualität und Patientensicherheit GmbH, Hamburg, Deutschland
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Roland Polacsek-Ernst
- MBA Gesundheitsmanagement und Digital Health der E-Learning-Group in Kooperation mit dem Executive Education Center (EEC) der FH des BFI Wien, Wien, Österreich
| Veröffentlicht: | 2. Oktober 2023 |
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Gliederung
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Objectives: In order to expand the digital health services in Germany, digital health apps (DiGAs) and the fast-track procedure for independent, clear and scientific evaluation of these were introduced in 2019. In this work it was examined to what extent this procedure supports the rapid introduction of safe DiGAs, based on the experiences of the manufacturers. The aim was to identify the challenges manufacturers are experiencing with the fast-track process and to suggest areas for improvement.
Methods: As a preliminary study, an online survey of the 35 manufacturers of DiGAs was carried out in a first step. Based on the results of the survey, a semi-structured interview guide was developed. The interviews were conducted with representatives of the manufacturer associations, transcribed and analyzed with a qualitative content analysis.
Results: The results show that the biggest challenge for manufacturers was the evidence-based evaluation. Due to constant changes in the very high requirements, there was a lack of commitment and transparency. Manufacturers also struggled to prove that they had the necessary human resources with the appropriate expertise. A comparison of startups and larger companies showed that startups had less experience in complying with regulations, but more know-how about digitization and IT. For startups, the funding process was more challenging, but their fast, flexible and agile way of working was an advantage. Advice from BfArM was described as helpful and necessary. External advice was also recommended in some cases, but it was also very expensive.
Conclusion: The impact of takeovers of start-ups by larger companies on the competition of DiGAs should be examined. Further studies should include other stakeholders and their influence. In addition, the revision of the DiGA guidelines, more transparency, clarity as well as more liability for DiGA consultations were mentioned. More flexibility and a sense of proportion were called for in the review of applications, as well as longer deadlines overall for the introduction and testing of the DiGA.
