Compliance built for healthcare.
Protect patient data, meet clinical standards, and stay audit-ready — without slowing down care delivery.
Patient Data GDPR
Full GDPR compliance for electronic health records and patient systems
Healthcare Data Privacy
Data protection policies tailored to healthcare environments
MDR Documentation
Medical Device Regulation compliance documentation automated
Clinical Data Privacy
Anonymization and pseudonymization workflows for research data
Access Controls
Role-based access policies for sensitive medical information
Audit Preparation
Audit-ready documentation packages for healthcare regulators
Industry Challenges
Compliance challenges in healthcare
Patient consent management
GDPR Art. 9 imposes strict rules on health data processing. Managing patient consent across EHR systems, research databases, and third-party integrations is error-prone and labor-intensive.
Cross-system health data flows
Patient data flows between hospitals, labs, pharmacies, insurers, and research institutions — each with different access controls and processing purposes.
Clinical trial data protection
Research involving patient data requires pseudonymization, DPIAs, and specific consent mechanisms that differ from standard clinical operations.
Why Marsstein
Compliance that doesn't slow down patient care.
Healthcare compliance shouldn't mean more paperwork for clinicians. Marsstein understands the unique data flows in healthcare — from patient intake to lab results to insurance claims. The AI agent generates MDR documentation, DPIA assessments for health data processing, and GDPR-compliant consent workflows, all while maintaining the audit trail regulators expect. Less time on compliance, more time on care.
Key Regulations
Regulations that matter for healthcare
The regulatory framework for protecting patient data and medical devices.
GDPR Art. 9
Special category data rules — health data requires explicit consent or specific legal basis
MDR
Medical Device Regulation — technical documentation and post-market surveillance requirements
ISO 27001
Information security management system standard — increasingly required for health IT providers
Frequently asked questions
How does GDPR apply to patient health records?+
Health data is classified as 'special category data' under GDPR Art. 9, requiring explicit consent or a specific legal basis for processing. This applies to electronic health records, lab results, prescriptions, and any data that reveals a patient's health status. Marsstein automates consent tracking and generates the required processing records.
Do clinics and hospitals need a DPO?+
Yes. Healthcare providers typically process health data at scale, which triggers the mandatory DPO requirement under GDPR Art. 37. Marsstein supports your DPO with automated documentation, gap analysis, and real-time compliance monitoring.
What is a DPIA and when do we need one?+
A Data Protection Impact Assessment (DPIA) is required under GDPR Art. 35 when processing is likely to result in high risk to individuals. In healthcare, this includes large-scale processing of health records, new health IT systems, and clinical research databases. Marsstein generates DPIAs tailored to healthcare scenarios.
How does MDR compliance relate to GDPR?+
Medical devices that process personal data must comply with both MDR and GDPR. MDR requires technical documentation and post-market surveillance, while GDPR governs how patient data is collected, stored, and shared. Marsstein maps controls across both frameworks to avoid duplicate documentation efforts.