Dear readers of PM-Online,

It’s a pleasure to have you peruse my Digital Health Notes once again, where I delve into current developments in the expansive field of digital health.

Speaking of perspectives: when two individuals look at the same object—one sees “black,” the other “white”—it often warrants a second glance. This was my experience while reading the two recent DiGA reports: one from the GKV-Spitzenverband, the other from the SVDGV (German Association for Digital Health). Both examine the same market, both rely on the same data foundation—yet they seem to present entirely different pictures.

Two Truths, Many Numbers – A System in Motion

Fact is: the DiGA landscape has evolved remarkably in a short time. From 24 DiGAs at the end of 2021 to 68 by the end of 2024, with 59 actively listed. That’s nearly a 200% growth over three years—in a healthcare system typically characterized more by persistence than agility.

Over one million prescriptions have been issued, with approximately 81% activated by patients, according to the GKV report—a sign that DiGAs are not only prescribed but also utilized. In the last reporting period alone, about 420,000 activations occurred—a 100% increase compared to the previous year.

Financially, the sector is also gaining momentum: the annual market volume now stands at approximately €110 million, a 72% increase over the previous year. Since the introduction of the DiGA system, total expenditures by statutory health insurance have reached about €234 million—a significant volume for a care sector that has existed for only four years.

Content-wise, clear focal points emerge: the majority of applications address mental health conditions, followed by metabolic and musculoskeletal disorders. Notably, a single DiGA (Oviva Direkt) accounts for nearly 28% of all code activations—a strong indicator of the potential for targeted applications in major indication areas.

User demographics also paint a clear picture: the average age is 47, with the highest usage among those aged 55 to 60. Women comprise 73% of users—men, younger, and older individuals are currently underrepresented.

Approximately 20% of prescriptions are repeat prescriptions—suggesting that many DiGAs are not yet used long-term or repeatedly. Whether this is due to efficacy, user-friendliness, or structural barriers remains unclear—but it indicates that integration into standard care is still ongoing.

The GKV’s Perspective: Expensive, Weakly Substantiated, Not Yet Integrated

The GKV-Spitzenverband’s report reads more critically. The tone: many DiGAs are costly—but deliver little. Only 18% of applications demonstrated a positive healthcare effect upon inclusion in the directory. The vast majority—56 applications—were initially included on a trial basis.

And the success? According to the GKV, mixed. As of the reporting date, 21 DiGAs were still under evaluation. Of the remaining 35, nine were fully removed, and seven partially removed by the BfArM due to insufficient evidence of benefit. This means: only about half of trial DiGAs fully deliver on their promises.

Economic concerns also arise: manufacturer prices averaged €580 in 2024, with the highest exceeding €2,000. Negotiated prices, however, average €226 per quarter. The GKV-Spitzenverband refers to this difference as “startup financing without return.” This totals around €96 million—€41 million in the first year, where the manufacturer sets the price freely and the GKV covers it fully, and another €55 million in the second year, as many DiGAs remain in trial longer. While there is a general obligation to repay—insolvencies, as already filed by seven DiGA manufacturers, negate this guarantee. Thus, the GKV provides significant liquidity over two years—with high economic risk and no repayment assurance.

The report also highlights deficits in evidence: many studies are methodologically weak, using retrospective designs, lacking control groups and blinded evaluations, and often relying on self-reports from users—subjective assessments of symptoms, mood, or behavior. Objective measures are frequently absent, significantly limiting the validity. Particularly critical are DiGAs that were removed without demonstrating benefit: nearly €4 million was spent in the first year alone—without repayment obligation and without proven healthcare effect. From the GKV’s perspective, this contradicts the principle of evidence-based medicine—and unnecessarily burdens the solidarity system.

The SVDGV’s Perspective: Young, Growing, Learning

The SVDGV report offers a contrasting viewpoint. Where the GKV-Spitzenverband sees risks, the SVDGV sees a system in development—with learning curves but also clear progress. The high number of trial inclusions is interpreted as a feature of a learning system. Over two-thirds of trial DiGAs have achieved permanent listing—now with study designs comparable to those required for drug approval. This demonstrates: the process works—when innovation is given space.

The SVDGV also positively notes the increasing establishment of DiGAs as a “third care sector” alongside inpatient and outpatient care. Nearly one in five DiGAs is re-prescribed—a sign of therapeutic trust and sustainable benefit.

Significant regulatory advancements, such as the integration of DiGAs into electronic patient records (ePA), a mandatory success verification (AbEM) from 2026, and the inclusion of risk class IIb products, indicate: DiGAs are no longer mere novelties but integral parts of the healthcare system. However, the association also calls for: less bureaucracy, more digital processes—and especially an end to the “analog activation code,” which still unnecessarily complicates access.

My Conclusion – Somewhere Between App Store Romanticism and Evidence Obligation

DiGAs are neither the sole future of medicine nor its downfall. They represent an attempt to digitize care—especially considering that we must treat more patients with fewer professionals. This is their structural value: not as a replacement for human interaction, but as a means to alleviate processes, ease access, and allocate resources more effectively.

What currently concerns me: the overly simplistic categorization into “works” or “doesn’t work.” It’s not that straightforward.

What we need instead is a nuanced perspective:

• Yes, stronger evidence is necessary.
• Yes, not every app belongs in the directory.
• But also: Yes, innovation requires space—and time to demonstrate impact.

 

And me? I remain curious.

I’ve tried several DiGAs—out of genuine interest. Not out of sheer tech enthusiasm, but from an earnest desire to understand how care can be different. Better, more accessible, more digital—where it fits.

What I hope for? That we judge innovation not by how flawlessly it starts, but by its willingness to learn. DiGAs are no substitute for doctors, no miracle cure. But they are a step—perhaps not perfect, but necessary.

And when my smartwatch vibrates again soon, I won’t just think of my step counter. I’ll remember that movement sometimes starts in the mind. Not everything is black or white. But it’s often in between where things get interesting.

Yours,
Torsten Christann