Guide for DiGA Marketing and Sales
With all regulatory parameters fulfilled and entry into the central DiGA directory, are all hurdles cleared and successful market entry guaranteed? Unfortunately, not quite. Contrary to some wishful thinking, entry into the central DiGA directory itself does not mean...
All insights: DiGA development & approval in 2026
Since the DiGA concept was launched, we have learned a great deal about the development of digital health applications. We share as much of this knowledge as possible with (prospective) DiGA manufacturers through our specialist articles. This means that not everyone...
Switzerland: Reimbursement for digital health applications (DiGA & dGA)
In 2020, Germany became the first country to establish DiGA in regular healthcare. This means that digital health applications (DiGA) can be approved in a structured, transparent process. Once approved, DiGA can then be prescribed by doctors in a similar way to...
Is your app a DiGA? Definition criteria of digital health applications
So-called DiGA (digital health applications) can be reimbursed by statutory health insurance companies. This became possible for the first time when the Digital Supply Act (DVG) came into force on December 19, 2019. However, not every health app or medical software...
BSI TR-03161 for DiGA: Data Security Certification
Since January 1, 2025, manufacturers of digital health applications (DiGA) must prove compliance with data security requirements by means of an official certificate. The basis for certification is BSI TR-03161, which was first published in 2020. The BfArM checks...
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