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Healthcare

FDI Insight: A Magnet for International Digital Health Players

Germany is establishing itself as one of Europe's leading hubs for digital healthcare innovation. The German Act to Accelerate the Digitalization of the Healthcare System (also known as the Digital Act or DigiG) is creating the conditions for a thriving ecosystem for digital health applications. Julia Pietsch, an expert at Germany Trade & Invest (GTAI), outlines the key developments and explains why there has never been a better time to invest.

Ms Pietsch, what is the goal of the Digital Act and why does it matter for international companies?

The Digital Act is steadily advancing the digitalization of the German healthcare system – spanning telemedicine, digital health applications (DiGAs), and artificial intelligence (AI). By establishing reliable national standards and accelerating processes such as approval and reimbursement procedures, it creates a transparent, scalable market environment that international companies can plan around with confidence.

Which digital applications are driving the transformation?
The electronic health record is one important element. From 2025, it was made available automatically to all patients covered by statutory health insurance. In addition, DiGAs are continuing to gain importance: about 60 applications are already listed, covering a wide range of indications – from mental health conditions and metabolic disorders to musculoskeletal complaints. The use of AI, particularly in radiology and diagnostics, has also been advancing rapidly and will become even more central in the years ahead – whether in digital monitoring and remote care for patients with chronic conditions, or in automated clinical documentation.

“Germany is in the midst of a profound modernization – and more open to digital innovation than ever before.”

Julia Pietsch, GTAI Expert

Why is now the right time to enter the market?
These reforms have opened Germany to digital innovation to a degree not seen before. Of particular note is the fast-track process operated by the Federal Institute for Drugs and Medical Devices (BfArM): a world first, it enables rapid approvals for DiGAs, while maintaining rigorous quality standards. Access to European funding programs and a large pool of highly qualified professionals adds further appeal, as does an outstanding scientific environment: internationally recognized institutions such as the Charité in Berlin, the Helmholtz centers, the Fraunhofer Society, and specialist AI bodies like the German Research Center for Artificial Intelligence (DFKI) are all active here. Many of these institutions collaborate with international start-ups on pilot projects or are establishing dedicated innovation centers. HealthLab NRW is a great example: here German hospitals are developing new digital care models alongside international partners such as Viduet Health from the Netherlands. Established global players – among them Doctolib, Epic, Cerner, and Philips – have already built a strong presence in the German market.

How does the Health Data Use Act complement these developments?
Through the BfArM's Health Data Lab, the act opens up access to anonymized data from 74 million people covered by statutory health insurance – a data pool without parallel in Europe. Early project submissions, including those from the National Association of Statutory Health Insurance Funds, illustrate the considerable international value this holds for research and product development.

Why is the German market attractive, despite its famously strict regulations?

Reliable legal frameworks and transparent standards are a clear locational advantage, not a deterrent. Germany is also widely regarded as a reference market: products that satisfy the high data protection and quality requirements here tend, almost by definition, to meet the criteria applied in other EU countries as well.

What are the broader factors that make the German healthcare market compelling?

With annual healthcare spending of around EUR 538 billion – roughly 12 per cent of GDP – Germany ranks among the largest healthcare markets in the world. The system encompasses approximately 1,800 hospitals, more than 16,000 pharmacies, and a well-developed outpatient care network. Some 7.7m people are employed in the healthcare sector. And with one of the most aging populations on earth – second only to Japan – Germany faces a sustained and growing demand for digital solutions addressing chronic disease management and home care. That is a structural issue that’s not going away.

Which regions are of particular interest to investors in digital health?
Berlin is home to Charité – Europe’s largest university hospital, surrounded by a dense network of leading research institutions such as the Berlin Institute of Health and the Hasso Plattner Institute. This environment fosters close collaboration with innovation programs and accelerators, including the BIH Digital Health Accelerator, the Pfizer Healthcare Hub, and Future4Care, creating a strong ecosystem for advancing medical and digital health technologies. The ecosystem is further enriched by home-grown start-ups such as Nia Health and Noah Labs, alongside international providers like Doctolib and Oracle Health.

Other regions are also generating significant momentum. In the west, the renowned Smart Hospital at Essen University Hospital and initiatives such as the Health Scale Up Challenge (an internationally oriented innovation program) are shaping the digital transformation of care. In the south, Freiburg and Heidelberg rank among the leading centers for data-driven medical research: the University Hospital in Freiburg is working on AI-assisted image analysis, while the German Cancer Research Center in Heidelberg is developing novel approaches to personalized oncology. And in the region around Nuremberg and Erlangen, one of Europe's densest medtech landscapes has taken root – a highly networked environment built around Germany’s Medical Valley.

How can foreign start-ups, research institutes, and innovative companies navigate this diversity and find the right points of entry?
GTAI supports companies at every stage – from first contact through to the concrete implementation of a business case. We begin by explaining how the German healthcare system actually works in practice. Then we advise on regulatory approval processes, analyze market potential, and identify suitable partners. A central part of what we do is connecting companies with hospitals, research centers, innovation clusters, and business networks. We also provide practical support for company formation, site selection, and market analysis. In short, if you’re serious about entering the German market, we will provide you with everything you need to succeed.

 

Want to join one of the world’s most dynamic digital health markets?

Julia Pietsch

GTAI’s Digital Health Expert

julia.pietsch@gtai.de