GDPR health data, AI Act medical AI, DORA health IT, NIS2 hospital security — comprehensive EU healthcare compliance from one platform.
Healthcare organisations in the EU operate under strict regulatory requirements for patient data protection, medical device safety, and health IT security. The GDPR classifies health data as a special category requiring enhanced protections. The AI Act regulates medical AI and diagnostic systems as high-risk. DORA applies to health insurance and healthcare IT systems. NIS2 covers hospitals and digital health infrastructure as essential entities.
Hospitals, clinics, health insurance companies, digital health platforms, telemedicine providers, medical device manufacturers, health data processors, and healthtech startups operating in the EU.
Healthcare Compliance face a unique set of regulatory obligations across multiple EU frameworks. Understanding these challenges is the first step to effective compliance.
Access GDPR provisions on special category data, including health data processing conditions, patient rights, and breach notification requirements specific to healthcare.
Query AI Act articles relevant to medical AI systems — classification criteria, conformity assessment procedures, and clinical validation requirements.
Understand NIS2 and DORA obligations for healthcare IT infrastructure, including incident reporting timelines and resilience testing requirements.
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Yes. Article 9 of the GDPR classifies health data as a "special category" of personal data. Processing is prohibited unless a specific condition applies — typically explicit consent, necessity for healthcare purposes, or public health reasons. Additional safeguards include data protection impact assessments and heightened security requirements.
AI systems intended to be used for medical purposes — including diagnosis, treatment planning, patient triage, and clinical decision support — are generally classified as high-risk under the AI Act. This requires conformity assessment, clinical validation, data governance, and post-market monitoring.
Healthcare providers are listed among the essential entities under NIS2. Hospitals and healthcare facilities above the size threshold (50+ employees or €10M+ turnover) must implement cybersecurity risk management measures and report significant incidents within 24 hours.
All EU healthcare regulations, structured and ready for your compliance workflows.