- Mohammad
- 15 May, 2025
- 8 min read
Building Healthtech in the EU: Technical and Compliance Deep Dive
Embark on your healthtech startup journey in EU with this comprehensive guide by the EU of Digital Economy.
The European Union, with its 27 countries and nearly 450 million people, is not just a massive market — it’s the second-largest medical devices market in the world. For healthtech founders, CTOs, and product teams eager to build or expand in this region, knowing both the technical infrastructure and compliance landscape inside out is key to success. In this deep dive, we’ll explore the technical stacks, integration standards, and regulatory frameworks that you absolutely need to navigate the European healthtech scene confidently.
At Beitroot, we help health tech companies navigate the EU’s complex regulatory and technical landscape with custom software solutions built for compliance and scale
Why the EU Healthtech Market is So Unique
Europe’s health tech market isn’t just about scale; it’s about complexity. The combination of multiple countries, languages, and regulatory frameworks makes it a tough nut to crack. But with challenge comes opportunity—if you get it right, you’re tapping into one of the richest healthcare ecosystems worldwide.
Technical Aspects of EU Health Tech Solutions
Cloud Infrastructure Options for Healthcare
When it comes to hosting health data in the EU, cloud infrastructure isn’t just about storage — it’s about trust, security, and compliance.
AWS – A Global Giant with Local Focus
AWS is a powerhouse, offering 240+ services across 36 regions worldwide. But what really stands out for European health tech? Their upcoming European Sovereign Cloud launching in Germany by end of 2025. This specialized cloud promises operational autonomy and strict data residency, crucial for GDPR compliance and local regulations.
Microsoft Azure Health Data Services
Azure offers purpose-built tech for handling protected health information (PHI) in the cloud. Their services come with built-in compliance guarantees tailored for European rules, making them a solid choice for enterprises wanting a seamless, secure health data platform.
Our team at Beitroot has deep experience deploying HIPAA- and GDPR-compliant architectures on AWS, Azure, and OVHcloud for health tech startups and enterprises.
Google Cloud Healthcare API
Google Cloud’s Healthcare API stands out with strong support for common healthcare data formats and standardized data exchange. It’s designed to enable smooth communication between healthcare applications — a must-have in today’s interconnected systems.
European Providers – OVHcloud
For those wary of global giants, OVHcloud delivers cloud hosting with a European digital sovereignty edge. Their healthcare data hosting meets stringent security standards while emphasizing control over strategic data — perfect for companies prioritizing European values in data sovereignty.
Interoperability Standards and Integration
Why Interoperability Matters
Imagine trying to speak to someone who doesn’t understand your language. That’s what happens when healthcare systems can’t share data seamlessly. Interoperability is the translator that enables smooth communication between systems.
Fast Healthcare Interoperability Resources (FHIR)
FHIR is the shining star of EU health tech interoperability. Both Azure and Google’s healthcare APIs are built on FHIR, which helps connect diverse healthcare systems effortlessly. Plus, it plays a critical role in the emerging European Health Data Space (EHDS) initiative.
HL7 V3 API in the UK NHS
The UK’s NHS uses HL7 V3 APIs, fully aligned with FHIR standards and approved by NHS Digital. This API-driven integration means systems can securely share patient data and health records, ensuring continuity of care.
DICOM for Medical Imaging
Medical imaging data needs its own language — and that’s where DICOM comes in. Both Azure and Google Cloud support DICOM standards, enabling easy storage, sharing, and analysis of medical images.
Data Architecture and Storage Strategies
Handling Health Data with Care
In the EU, health data is sacred and heavily regulated. So building your data architecture requires a strategy that respects privacy and compliance.
AWS Compliance Frameworks
AWS doesn’t just store data — it offers comprehensive frameworks supporting HIPAA, HITRUST, GDPR, and local certifications like France’s HDS and Germany’s DiGAV. Their reference architecture encourages decentralized data governance, keeping data secure but accessible where needed.
Azure’s Unified Healthcare Data Cloud
Azure Health Data Services helps unify clinical, imaging, device, and unstructured data into one compliant cloud platform. It’s like having a single, secure library for all your health data, simplifying compliance and boosting analytics.
Hybrid Architectures with OVHcloud
Many European healthcare organizations prefer hybrid models. OVHcloud highlights that combining on-premises and cloud infrastructure reduces costs while ensuring compliance — the best of both worlds.
Security Implementation Best Practices
Why Security is Non-Negotiable
In healthcare, a security breach isn’t just a technical failure — it’s a direct risk to patient safety and privacy.
AWS Security and Compliance
AWS leads with certifications across Europe and supports initiatives like GAIA-X and CISPE. They offer encryption, identity management, access controls, and audit logging tailored for healthcare.
Azure’s PHI Boundaries and Data De-Identification
Azure lets you maintain strict PHI boundaries and offers tools to de-identify data for research and analytics, balancing security with usability.
Common Security Measures
- Encryption for data at rest and in transit
- Strong identity and access controls
- Detailed audit logs
- Regional healthcare compliance certifications
AI and Machine Learning Applications
AI – The Future of European Health Tech
AI and machine learning are transforming diagnosis, research, and patient care across Europe.
Azure’s AI-Ready Data Platform
Azure prepares standardized data for advanced AI, enabling creation of new diagnostic algorithms and integration with tools like Power BI and Synapse Analytics for visualization.
Google Cloud’s AI and De-Identification
Google Cloud lets users de-identify data to unlock large-scale analytics and AI applications safely, critical for clinical decision support and research.
Navigating AI Compliance
But deploying AI isn’t just about tech — it demands transparency, validation, and compliance with evolving EU rules on algorithmic fairness and explainability.
Compliance and Regulatory Framework
GDPR and Health Data Protection
GDPR treats health data as especially sensitive. Health tech companies must:
- Have clear legal bases for data processing
- Implement enhanced security measures
- Respect patient rights around data access and control
- Conduct data protection impact assessments
The European Health Data Space (EHDS)
EHDS is set to revolutionize health data sharing across the EU, enabling citizens to control their electronic health data better and facilitating research and innovation.
AWS’s reference architectures for EHDS emphasize decentralized data ownership and federated governance—setting the stage for future-ready health tech systems.
Medical Device Regulation (MDR and IVDR)
MDR and IVDR overhaul the classification and regulation of medical devices in the EU. If your software serves diagnostic or therapeutic roles, it likely qualifies as a medical device requiring CE marking and compliance documentation.
Data Sovereignty and Residency
Data sovereignty is becoming a dealbreaker. AWS’s Sovereign Cloud and OVHcloud’s European-focused hosting underline the importance of local data residency, reflecting varying national rules within the EU.
Implementation Strategies and Best Practices
Picking the Right Technical Stack
- Support healthcare standards like FHIR, HL7, and DICOM
- Ensure regional data residency and compliance
- Check for scalability across multiple EU countries
- Prioritize integration with local healthcare systems
Preparing for Regulation
- Confirm if your solution qualifies as a medical device
- Implement GDPR-compliant workflows for health data
- Design for EHDS compatibility and interoperability
- Obtain relevant certifications and prepare thorough documentation
Wrapping It Up: Your Roadmap to EU Health Tech Success
Building health tech solutions in the EU is a journey through a complex but rewarding landscape. Choosing the right cloud infrastructure—whether AWS, Azure, Google Cloud, or European providers like OVHcloud—forms the foundation of your success. Embracing interoperability standards like FHIR will unlock seamless integration with healthcare systems. Compliance with GDPR, MDR, and new frameworks like EHDS isn’t optional; it’s your ticket to trust and market access.
As data sovereignty demands grow and AI reshapes healthcare, your architecture and compliance programs must be flexible and forward-looking. With the right technology partners and a deep understanding of EU rules, you can deliver innovative, secure health tech that transforms care across Europe.
If you’re looking to launch or scale a compliant health tech solution in the EU, let’s talk — our team specializes in building secure, scalable platforms from day one.
