The Healthcare Poland Foundation has become a key integrator within the European health innovation ecosystem, bridging the worlds of medicine, academia, technology, and industry. In an environment shaped by strict regulations, complex healthcare structures, and accelerating digitalisation, Healthcare Poland provides a safe, compliant and operationally mature pathway for deploying new technologies – from AI and medical data systems to MedTech devices and autonomous solutions.
Our mission is to connect sectors that historically operated in parallel: hospitals, universities, deeptech startups, technology companies, and public institutions. Through this integration, Poland gains a unique space where research, pilots, validation and certification of breakthrough technologies can take place in a structured and legally secure environment.
Next-Generation R&D Infrastructure: The Healthcare Poland CM-KLARA LivingLab
A central component of our work is the Healthcare Poland CM-KLARA LivingLab Hospital – the first clinical infrastructure in Poland designed to test and validate:
- high-risk artificial intelligence (AI Act),
- medical data systems and interoperability (EHDS, FHIR),
- medical devices in class IIa/IIb (MDR),
- robotics, automation and medical IoT,
- autonomous systems, including medical U-Space and drone-based transport.
The LivingLab allows companies and research institutions to validate technologies across TRL 3–7, bridging the gap between laboratory research and real-world clinical implementation.
Regulatory Sandbox for AI & MedTech – A Safe Space for Innovation
Healthcare Poland operates one of Poland’s first regulatory sandboxes dedicated to AI, medical data and MedTech solutions, offering comprehensive support to innovators in:
- compliance with the EU AI Act (High-Risk Systems),
- EHDS implementation and medical data interoperability,
- Data Act requirements and the protection of sensitive information,
- MDR documentation and conformity validation,
- cybersecurity audits aligned with NIS2,
- evaluation of clinical, operational and organisational risks.
This sandbox environment allows innovators to test and deploy new solutions without regulatory or operational exposure, accelerating safe market entry.
Ecosystem Integration: Connecting Science, Industry and DeepTech
Healthcare Poland acts as a systemic integrator, connecting:
- universities and research institutes,
- deeptech startups in AI, robotics, neurotechnology, bioengineering,
- hospitals and clinical environments,
- industrial and technological enterprises,
- public agencies, regulators and European institutions.
Through this integrative model, we support technologies along the full development pathway – from TRL 2 research to TRL 9 deployment – covering concept development, prototyping, validation, certification and market scaling.
Healthcare Poland Centre for Quality, Audit and Certification
Our Quality and Certification Centre provides the market with comprehensive regulatory and technical support:
- clinical and operational audits,
- technical documentation and conformity assessments,
- validation of AI algorithms and expert decision systems,
- MDR, ISO and cybersecurity readiness,
- regulatory and operational risk mapping.
We provide a trusted framework enabling organisations to enter the healthcare market with confidence and compliance.
European and Global Reach
Healthcare Poland holds a unique institutional mandate through:
- its leadership role in the Global Healthcare Travel Council (Brussels),
- integration with the Polish Hospital Federation (over 300 hospitals),
- cooperation with ministries, regulators and EU-level bodies,
- participation in shaping cross-border health technology standards.
This global positioning allows Polish innovations to scale internationally and supports European partners in testing their solutions directly within the Polish healthcare ecosystem.
Supporting the Market – From Concept to Deployment
Healthcare Poland offers a full pathway for the development and deployment of health technologies:
- Needs assessment and challenge definition – mapping clinical and organisational requirements.
- Building interdisciplinary project teams – connecting science, industry and healthcare partners.
- Pilot projects and validation – testing solutions in real clinical environments.
- Regulatory guidance and compliance – preparing solutions for EU conformity.
- Certification and market access – MDR, AI Act, EHDS and cybersecurity alignment.
- Scaling and internationalisation – entering the EU and global markets with validated solutions.
Healthcare Poland – Building the Future of Health Technologies
Our objective is to support innovation that is safe, compliant and meaningful for the healthcare system. We work with organisations of all sizes – from startups to global enterprises – to accelerate technologies that have the potential to transform medicine.
Healthcare Poland remains open to collaboration with partners from Poland, Europe and around the world, offering an ecosystem that removes barriers, accelerates development, and ensures the safe deployment of technologies shaping the future of healthcare.
