Europe’s digital health innovators face a maze of reimbursement barriers. David Chadima explores how to turn breakthroughs into patient impact.
Imagine creating a piece of technology that could help a diabetic manage their insulin, allow a stroke patient to do their physiotherapy from home, or predict a life-threatening fall in an elderly person. Now, imagine that brilliant, validated technology left sitting on a shelf, unable to reach a single one of them. This is the frustrating reality for hundreds of Europe’s most promising digital health innovators. Despite the impressive digital health technologies developed across the EU, many fail to reach the public at scale.
A major obstacle for these innovators is reimbursement – the complex and fragmented process of getting new technologies paid for and adopted by national healthcare systems across Europe. This often prevents their solutions from securing market access. The complex and varied national rules act as a major roadblock, making it exceedingly difficult for technologies to be adopted, regardless of their potential to transform patient care.
The maze of national reimbursement systems
For digital health startups, there is no such thing as a single “EU market.” Obtaining a CE mark for their device is just the first step on a long and expensive journey. After that, the path splits into dozens of different national routes, each with its own set of rules, demands, and gatekeepers. Germany’s DiGA framework has specific requirements for local clinical studies, while France and Belgium have distinct systems for temporary reimbursement. The Nordic countries are developing the NordDEC standard, and Spain is working on its Digi-HTA framework, inspired by the UK and Germany.
Navigating this maze can be a daunting task for innovators, who must proceed market by market, duplicating efforts and losing precious resources. This complexity often leads to delays, with each country requiring an extensive process that can take over a year to complete. For many startups, this fragmentation ultimately leads to failure, and patients are left without access to life-changing innovations.
Building a harmonised pathway
The solution is being explored within the Digital Health for All (DigiH4A) project. DigiH4A is an EU-funded initiative of €4.2 million that unites 11 partners from seven countries representing the triple helix in healthcare. The goal of DigiH4A isn’t to create a single highway overnight but to learn from the cross-country experiences already in place. By identifying the best practices from each national model, a harmonised framework can be developed. This will enable evidence generated for one market to be recognised in others, turning what are currently isolated and inefficient pathways into a connected network.
Proving your worth across borders
One of the significant hurdles innovators face is proving the value of their solution to different authorities across Europe. Many startups fail to support their efficacy claims with the robust, peer-reviewed evidence that payers require. The problem isn’t that the technology doesn’t work, it’s that the evidence demands vary from one country to the next. Payers require proof of positive care effects or socio-economic value, often necessitating resource-intensive quantitative studies. For a startup, funding these trials for each market is an impossible task.
To address this, the DigiH4A project is developing a cost-benefit analysis method that will provide innovators with the evidence needed to demonstrate their solution’s value. Developed by academics and research groups from multiple EU countries, with input from reimbursement experts, this tool will provide proof of how much money a solution can save for health authorities or the quality improvements it brings to patients. It creates a robust value proposition that resonates across Europe, making it easier for innovators to navigate the reimbursement process.
From fragmentation to collaboration
The journey through the reimbursement maze remains challenging, but there is a turning tide in favour of collaboration. In January 2025, the EU’s Health Technology Assessment Regulation (HTAR) came into effect, establishing a permanent framework for joint work among Member States on health technologies. This, combined with the European Health Data Space (EHDS), signals a strong commitment from the EU to build the very bridges that DigiH4A is pioneering at the ground level.
Bax’s role in connecting policy to progress
At Bax, we play a key role in turning policy into progress. As part of the DigiH4A project, we are working with experts and stakeholders across the EU to create a clear path forward. We see the complex maze of digital health reimbursement as creating a critical ‘innovation gap’ in EU healthcare, separating powerful new technologies from the citizens they were designed to help. Our work focuses on:
- Developing harmonised assessment frameworks based on the best national examples.
- Providing innovators with tools and methodologies to demonstrate the value of their solutions.
- Building a collaborative network of health authorities to ensure these frameworks lead to real-world reimbursement.
Through these efforts, we are helping to create a more streamlined and efficient pathway for digital health innovations, enabling them to reach the patients who need them most.
Work with us to drive better healthcare
In the Healthcare Innovation team, we believe that healthcare systems are among society’s most valuable assets, and we work to secure their sustainability for future generations. We do so by focusing on three main workstreams:
Tackling bottlenecks: Recognising the limitations of current frameworks, we bring stakeholders together to accelerate the adoption of innovative treatments and technologies, ensuring equitable access to quality care.
Facilitating the adoption of innovative solutions: Leveraging our sector’s expertise and extensive networks, we offer strategic insights into healthcare markets, competing technologies, and emerging trends.
Empowering patients & citizens: Through our experience in Patient and Public Involvement (PPI) and healthcare innovation, we empower patients and citizens to actively participate in the management of their health.
Want to collaborate or learn more? Get in touch.
