Germany is at a crossroads. While the country has long been seen as an economic and technological powerhouse, its resistance to change is becoming a major roadblock for innovation. The recent Wall Street Journal article by Bertrand Benoit sheds light on a deeply ingrained issue:
"The problem with consensus societies is that sometimes the consensus is wrong, and when it is, there is no corrective mechanism." – Wolfgang Münchau, author of Kaput - The End of the German Miracle
This statement rings particularly true in the context of Germany’s approach to digital health and AI-driven solutions—and it directly reflects LINDERA’s experience with the DiPA (Digitale Pflegeanwendungen) approval process.
LINDERA has spent years developing a scientifically validated, AI-powered mobility analysis to reduce fall risks for millions of older adults. Falls lead to 500,000 hospitalizations every year in Germany and are one of the most pressing public health challenges. Yet, despite clear legal provisions supporting digital care solutions, our application for DiPA approval was rejected—not due to a lack of efficacy, but because the system is built to resist change rather than enable progress.
The rejection reflects a broader issue: Germany’s regulatory bodies prioritize risk avoidance over action. The BfArM (Federal Institute for Drugs and Medical Devices) dismissed LINDERA’s proven solution with reasoning that contradicts both the law and the fundamental principles of preventive care.
This aligns with Benoit’s analysis:
"At crucial moments, there is simply no one willing to take responsibility for doing it."
In our case, no one in the regulatory framework is willing to acknowledge that the DiPA system is fundamentally failing. It was designed to foster digital solutions in care, yet not a single application has been approved. Instead of adapting to innovation, the process upholds an outdated, bureaucratic model that prioritizes status quo thinking over patient outcomes.
This is not just about LINDERA. The rejection of digital care solutions like ours is a symptom of a larger issue—Germany’s reluctance to embrace AI and digital transformation in healthcare.
The consequences are clear:
Yet, this challenge also presents an opportunity. If Germany is to remain a leader in healthcare innovation, policymakers and regulators must rethink their approach.
For Germany to transition from reaction to action, three things must happen:
Germany’s healthcare future depends on how willing we are to challenge outdated structures. The rejection of the LINDERA DiPA application isn’t just our challenge—it’s a sign that the system is fundamentally broken for all digital health pioneers.
If Germany is serious about gaining again a leading role in healthcare and AI, it must move beyond the comfort of the status quo and start creating an environment where technology, prevention, and patient care take priority over bureaucracy.
Now is the time for change.
Join the conversation on Linkedin: What do you think Germany needs to do to foster real healthcare innovation?