EHDS & DiGA: How Europe Is Rewiring Digital Health

How is Europe changing the rules of the digital health game?

While the U.S. has relied heavily on market-driven innovation, Europe is taking a more structural approach. Two major developments stand out:

• The European Health Data Space (EHDS) – a new EU-wide framework to govern access to and use of electronic health data for care and secondary use.
• Germany’s DiGA model – “apps on prescription,” where certain digital health apps can be prescribed and reimbursed like drugs.

Together, they signal a bet: if Europe can standardize access to data and create clear reimbursement pathways, it can unlock a new generation of digital health products.

What is the European Health Data Space (EHDS) in practice?

EHDS is an EU regulation aiming to:

• Give citizens better access to and control over their electronic health data across member states.
• Set rules and infrastructure for secure sharing of health data for care delivery (primary use).
• Enable secondary use of data (for research, innovation, public health, policymaking) under strict safeguards.

It’s not just a legal framework; it comes with technical mandates for interoperability, data formats, logging, and governance across the EU.

For digital health companies, this means:

• A more harmonized market for interoperable solutions.
• New opportunities to build products that rely on cross-border data.
• Increased compliance obligations around how data is accessed and reused.

How does DiGA work, and why does it matter?

Germany’s DiGA program allows certain digital health apps and web applications to be prescribed by physicians and reimbursed by statutory health insurance. To qualify, a DiGA must:

• Demonstrate positive care effects (medical benefit or patient-relevant structural improvements).
• Meet stringent standards for data protection, security, and quality.
• Undergo evaluation by the German Federal Institute for Drugs and Medical Devices (BfArM).

While the program has faced challenges (price renegotiations, evidence demands), it has led to hundreds of thousands of prescriptions for digital therapies and tools, providing a rare example of structured reimbursement for apps.

For digital health teams, DiGA shows that:

• Evidence and regulatory rigor can unlock stable reimbursement, not just pilot funding.
• “App as a prescription” is more than a buzzword when backed by policy.

What opportunities do EHDS and DiGA create for digital health companies?

1. Data-driven products with a clearer legal basis
   EHDS provides a framework for secondary data use across borders, which could turbocharge research, AI training, and population health tools—if you design with compliance in mind.
2. Reimbursed digital therapeutics and management tools
   DiGA-type models show that digital products can earn “real” health system money, not just B2C subscriptions, when backed by evidence.
3. Cross-border scale
   With EHDS harmonizing certain aspects of data exchange, pan-European products become more realistic—though local adaptations will still be needed.

What challenges should teams expect?

• Complex compliance – EHDS adds another layer on top of GDPR, national health laws, and sectoral regulations.
• Evidence expectations – DiGA-type models demand robust clinical and real-world evidence, not just engagement metrics.
• Operational overhead – approvals, audits, and ongoing reporting require mature processes.

In other words, Europe’s model rewards teams that are both design-led and regulatory-savvy.

How should product and design teams respond?

If you’re eyeing Europe:

• Start by mapping which of your use cases intersect with EHDS-defined data categories and flows.
• Design consent, access, and transparency flows that reflect European expectations, not just minimum legal text.
• For DiGA-like reimbursement, bake outcome measurement into your product from day one—so you can generate evidence without re-architecting later.

Europe’s health data gamble is that structure will unlock innovation. For digital health teams, the question is whether you’re ready to design for that structure instead of working around it.

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