Reimbursement is often seen as the end goal in digital health. In reality, it is rarely the same as revenue – and for many companies in Europe, that distinction has proven existential. 

Across the region, digital therapeutics (DTx) companies have learned this the hard way: regulatory approval and access to public funding rarely translate into real adoption or scalable businesses. Fragmented systems, slow implementation, and reliance on healthcare professionals have made even well-validated solutions difficult to commercialise. 

Germany’s DiGA system has often been considered the exception. With a structured reimbursement pathway and national coverage, it offered something close to a blueprint for scaling digital health in Europe. And yet, even in DiGA, only a handful of companies have managed to convert access into meaningful revenue. 

Now, that system is changing. 

Recent reforms (often referred to as “DiGA 2.0”) mark a shift from accessibility to accountability. While this raises the bar for companies, it also signals the emergence of a more mature and potentially more valuable market. 

A SYSTEM EVOLVING TOWARD OUTCOMES

At the core of DiGA 2.0 is a move toward continuous real-world evidence. Instead of relying primarily on initial clinical studies, companies must now demonstrate value on an ongoing basis. Outcomes will increasingly influence pricing and reimbursement levels. 

This aligns DiGA more closely with how healthcare systems operate: value is not defined by approval, but by measurable impact. 

For companies, this creates a clearer – but also more demanding – path to differentiation. In a performance-based system, strong products can stand out. Over time, this could strengthen trust among payers and providers and unlock more sustainable reimbursement models. 

THE OVIVA BENCHMARK, AND THE QUESTION AHEAD

The current market dynamics illustrate both the promise and the concentration of success. 

According to the latest German statutory insurer association (GKV-SV) annual DiGA report, the DiGA market reached 695,000 activations and €171 million in spending in 2025, growing 63% year-on-year. But one company dominates: Oviva accounts for 44% of activations and 40% of total spending. 

Oviva’s success proves that DiGA can work commercially. But it also raises a critical question: can others replicate it? 

DiGA 2.0 cuts both ways. 

On one hand, outcome-based reimbursement should reward more high-performing solutions. On the other hand, the increased requirements for continuous evidence, data infrastructure, and operational excellence may reinforce concentration. The capabilities needed to succeed – like clinical validation, data collection, and patient engagement – are capital-intensive and difficult to build. 

In that sense, DiGA 2.0 may make it harder to build the next Oviva, but easier for those who succeed in defending their position. 

DATA AND EVIDENCE AS COMPETITIVE MOATS 

One of the most important implications of the reform is the role of data. Continuous reporting requirements force companies to invest in real-world evidence infrastructure from day one. 

While this increases complexity, it also creates opportunity. Companies that successfully collect and leverage longitudinal data can: 

• Improve product performance faster 

• Strengthen payer negotiations 

• Build defensible, proprietary datasets 

For investors, this marks a shift toward higher-quality assets. Companies are no longer valued solely on potential, but on demonstrated outcomes and real-world performance. 

FROM COMPLIANCE TO CORE ARCHITECTURE 

One of the most important implications of DiGA 2.0 is how deeply regulation now shapes the product itself. 

The new framework introduces binding standards for data collection and evaluation. Standardised questionnaires and statistical methods are no longer optional. This limits flexibility but creates comparability across solutions targeting the same indication. 

Interoperability is also moving from ambition to obligation. Integration with Germany’s electronic patient record (ePA) is becoming mandatory, requiring companies to comply with defined semantic and syntactic standards and ensure structured, exportable data. 

The implication is clear: building a DiGA is no longer just about clinical validation and user experience. It requires health system-grade infrastructure. 

For companies, this fundamentally changes how products must be designed. Data pipelines, interoperability, security, and compliance can no longer be retrofitted – they must be built into the product from day one. 

For investors, this raises an important question: not just whether a product works, but whether the company has the technical and regulatory capabilities to operate in an increasingly complex environment. 

A HIGHER BAR AND FAMILIAR CHALLENGES

At the same time, many of the structural challenges highlighted in the original reimbursement discussion remain and, in some cases, intensify. 

DiGA 2.0 does not remove the role of healthcare professionals as gatekeepers. Prescription behaviour, awareness, and incentives still determine adoption. As seen with both Sleepio in the UK and Oviva in Germany, access alone is not enough, distribution remains the bottleneck. 

What changes is the level of commitment required. Companies must now: 

• Build for long-term evidence generation, not just market entry 

• Ensure sustained patient engagement 

• Navigate performance-linked revenue models 

This increases both capital requirements and execution risk, particularly for early-stage companies. 

FROM 'GETTING IN' TO STAYING IN

The key shift is conceptual. 

DiGA is no longer primarily an entry strategy; it is an operating model. Success is not defined by getting listed, but by continuously proving value in a real-world setting. 

This may reduce the number of companies entering the market. But it also has the potential to create a more robust ecosystem, where digital health solutions are trusted, integrated, and sustainably funded. 

THE BOTTOM LINE FOR FOUNDERS AND INVESTORS

The lesson from the first wave of DTx in Europe still holds: reimbursement alone does not create a business. 

DiGA 2.0 does not change that; it reinforces it. 

What it does change is the nature of the opportunity. The winners in this next phase will not be those who can navigate regulation fastest, but those who can combine clinical impact, patient engagement, real-world data, and the infrastructure required to continuously generate and validate it. 

For those companies, the prize is significant: not just access to reimbursement, but a path to building durable, defensible healthcare businesses in Europe. Something the first wave of DTx largely failed to achieve.