The Healthcare Poland Foundation Innovation Center (CI HCPL) manages the Open HCPL HIS and AI Regulatory Sandbox projects and takes medical, digital and AI solutions from idea to implementation: through independent qualification, validation in a real clinical environment, regulatory compliance, funding and scale-up across a hospital network.
Why an Innovation Center
Healthcare innovation rarely fails because of the technology. It fails at the interfaces — between the lab and the ward, between prototype and certification, between pilot and contract. Start-ups lack access to hospitals, hospitals lack tools to assess the risk of a new solution, investors lack independent information on its maturity, and regulators need evidence before a solution can be widely used.
The Innovation Center brings order to these interfaces. It combines resources that already operate within the HCPL ecosystem into one process: a clinical validation environment, an AI regulatory sandbox, innovation qualification, investor events and a portfolio of grant-funded projects.
Flagship projects managed by the Center
The Innovation Center manages two projects of systemic importance. They are interlinked: AI modules of Open HCPL HIS are validated in the Regulatory Sandbox, and the sandbox uses the open system as its reference environment.
Open HCPL HIS — open health information system
A Polish distribution of OpenEMR 8.0 — the world’s most widely deployed open-source electronic health record (over 100 countries, more than 20 years of development) — adapted for hospitals, long-term care facilities (ZOL/ZPO) and senior and long-term care.
- Open core, no licence fees — GNU GPLv3, auditable code, no dependence on a single vendor (vendor unlock).
- Interoperable from day one — native FHIR R4 API, SMART on FHIR, data export in open formats.
- Polish e-health — adapters for P1 (e-Prescription, e-Referral, Medical Events, EDM), the National Health Fund (eligibility checks, reporting), ZUS e-sick-leave and Central e-Registration, built as separate, replaceable components on top of the open API.
- Security and data sovereignty — architecture aligned with NIS2 requirements; AI models run on national infrastructure or on hospital premises, with no medical data sent to external commercial AI services.
- AI modules — including a documentation assistant (AI Scribe), Smart Barthel, medication reconciliation and a Quality Dashboard; higher-risk modules are validated in the Regulatory Sandbox.
- Entry model — Community (self-deployment), Managed (hosting and maintenance), Enterprise (AI modules, premium integrations, higher SLA). Commercial value lies only in services, never in licences.
Status: localisation and integration architecture designed, P1 adapter at proof-of-concept stage, pilots in preparation. P1 and National Health Fund integrations are not yet in production.
AI Regulatory Sandbox
A controlled environment in which AI and MedTech solutions are tested for compliance with the AI Act, MDR/IVDR and GDPR before wide clinical use. Run in cooperation with GRAI at the Polish Ministry of Digital Affairs and linked to Living Lab Healthcare for testing in a real hospital setting.
Scope of services — available as a whole or in part, for a selected stage or segment:
- solution qualification — MedTechID, TRL level, preliminary AI Act and MDR classification;
- test plan under regulatory supervision;
- operational testing in an isolated environment and in the Living Lab;
- risk assessment, data protection impact assessment (DPIA), compliance documentation;
- evidence report and pathway to certification or deployment;
- formats: Triage Sprint (2–3 weeks), 90-day validation sprint, ongoing governance support.
Participation modes: development (HCPL projects, including Open HCPL HIS modules) · scientific research · regulatory (within the national AI sandbox framework) · commercial (Sandbox-as-a-Service).
Status: the operational sandbox is running; the Sandbox-as-a-Service offer is ready and fully customised to each project.
Mission
The innovation pathway
MedTechID · TRL→Validation plan→Living Lab testing→Report and evidence→Deployment and scale-up
At qualification we determine technology readiness (TRL), regulatory scope (including MDR/IVDR, the AI Act, GDPR and NIS2) and the mode of further work: development, scientific research, regulatory or commercial. Validation produces documented evidence — a case study, an operational assessment and a compliance pathway — that supports certification, production deployment and investor discussions.
Pillars of the Center
operating
operating
operating
available · custom made
operating
Who it is for
- MedTech, AI and e-health start-ups and manufacturers — qualification, access to a clinical environment, a regulatory pathway and visibility to investors.
- Hospitals and healthcare providers — safe pilots of new solutions, independent risk assessment and access to curated innovation.
- Investors — partnership with the Foundation, access to verified companies and independent assessment of their maturity (Vetted Investor status after KYC verification).
- Universities and research institutions — joint consortia, technology transfer and validation of research results in clinical practice.
- Public administration and regulators — validation evidence supporting regulatory decisions and system-wide deployment.
Our principles
- Independent assessment. The methodology is transparent, and validation outcomes do not depend on who pays — the innovator, an investor or a sponsor. Competition juries and qualification remain independent of financial partnerships.
- Two-way vetting. We vet not only companies for investors but also investors before they enter the ecosystem — protecting innovators and the integrity of the process.
- Confidentiality and consent. A company’s profile is shared with an investor only with its knowledge and consent, under a non-disclosure agreement.
- No promised outcomes. We validate quality, safety and compliance — we do not guarantee investment returns or market success.
- Just Culture. Fairness, proportionality and transparency as the standard for relations between all participants.
Ecosystem and infrastructure
custom made
in development
See also: MedTech Innovation Day (MedTechID) · StartUp Innovation Day (SUID) · Coordinated Care Center
Team
The Center’s work is led by the HCPL Innovation Department, headed by Dr. habil. eng. Piotr Senkus, Director of the Department. Strategic direction is provided by Michał P. Dybowski, co-founder and President of the Board of the Healthcare Poland Foundation.
Submit a solution for MedTechID qualification or validation in the AI Regulatory Sandbox, ask about deploying Open HCPL HIS in your facility, propose a hospital pilot, or join as a partner, research institution or investor. We work with partners in Poland and abroad, in English and Polish.
✉ innowacje@healthcarepoland.pl · tel./WhatsApp +48 787 000 827
