The Legal and Compliance Department ensures that the activities of the Healthcare Poland Foundation and its projects comply with the law and with the Foundation’s principles of ethics and governance. It supports departments in digital and medical regulation, including Regulation (EU) 2024/1689 (AI Act), Regulation (EU) 2025/327 on the European Health Data Space (EHDS), Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR) and the GDPR.
Leadership and team
- Ewelina Bogiel — Director of the Legal and Compliance Department; Proxy of the Management Board
- Robert Kroplewski — Adviser on AI regulation and digital law
- cooperating teams: Centre for Quality, Audit and Certification, Clinical Research Department
Competencies
- organisational compliance, internal policies and Foundation governance
- protection of personal data and health data
- artificial intelligence regulation and digital law
- medical device and clinical trial regulation
- partnership agreements, NDAs, letters of intent and consortium agreements
Tasks
- reviewing and drafting Foundation agreements
- compliance assessment of projects and services before launch
- legal support for EU and research projects run under the Management Board (incl. HeliX – EHDS, REHEAL)
- legal support for the operational AI sandbox and the Living Lab
- compliance training for Foundation teams and partners
Process scope
- Agreements — drafting, negotiation, approval, contract register
- Compliance assessment — legal risk qualification of a project or service
- Data protection — legal bases, processing agreements, impact assessments (DPIA)
- AI and MedTech regulation — classification of solutions and obligation mapping
- Monitoring — obligations register, periodic reviews, reporting of irregularities
Procedures
- Submission of a matter by a department or partner.
- Risk qualification and appointment of a responsible lawyer.
- Legal analysis and preparation of an opinion or draft document.
- Agreement with the requester and approval by the Foundation’s Management Board.
- Registration, monitoring of implementation and transfer of conclusions to the Foundation’s self-learning loop.
Links within the Foundation system
The Department works with all Foundation departments, in particular the Innovation Department (AI, sandbox), the Clinical Research Department and the Centre for Quality, Audit and Certification.
Contact
Write to: ewelina.bogiel@healthcarepoland.pl · global@healthcarepoland.pl
All departments: Medical Care and HCPL Academy · Clinical Research · Quality, Audit and Certification · Innovation · Cross-Border Medicine · Security and Civil Defence · Health System · Operational Excellence · Legal and Compliance
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