Disillusioned by DiGA?
by David Schmoldt
One of the first medical device apps in Germany
Back in 2015, we were thrilled when we were invited to present our smart medication eDiary (an app for the rare chronic disease hemophilia) as the very first use case in front of 200 experts at the “1st BfArM Dialogue Congress on Medical Apps”. This put us directly in the public spotlight at an early stage, when many questions around apps as medical devices had not yet been settled at all. The gray area and the uncertainty in interpreting laws and regulations were enormous. We were all the more relieved afterwards that, at the very least, we had not done anything obviously wrong.
The draft legislation for DiGAs arrives
Another highlight came in 2019 with the DVG draft legislation on DiGAs. The fact that topics we had raised were included in the draft strongly reinforced our approach, even though some passages were rightly removed from the law again. For example, DiGAs would have been far too restricted if apps from the public app stores had not been permitted.
DiGAs seemed to change everything. There was not just a spirit of optimism — there was outright euphoria among medical app developers. Finally, a viable path seemed to exist for successfully implementing the many great projects for the benefit of patients and physicians. At the time, we were frequently asked whether we would become the very first DiGA.
Euphoria was followed by disillusionment
However, our years of experience with digitalization in healthcare made us hesitate and watch the DiGA topic from the sidelines for the time being. And unfortunately, we would be proven right… The euphoria turned into disillusionment. The regulatory hurdles have reached a scale that a small or medium-sized company can hardly manage without a financially strong partner. At the same time, there are attempts to push manufacturer reimbursement down to a level at which, even with a successful listing, it becomes very difficult to justify the high investments.
But don’t get me wrong — I still fundamentally believe in DiGAs. Our European neighbors (France and Belgium, for example) are showing how good the underlying idea is. But with DiGAs, too, we will probably lose out once again, and “our German” idea will only be implemented really pragmatically — and thus successfully — abroad.
An outlook
We have now decided to take new, different paths. Good ideas and great solutions can sometimes only be implemented and expanded with great partners. We are very much looking forward to the tasks and challenges ahead!
On this topic, today in E-HEALTH-COM by Philipp Grätzel von Grätz, opens in a new tab (editor-in-chief): “Desillusioniert durch DiGA” (in German).