EU compliance for healthcare & life sciences

GDPR, NIS2, and cybersecurity for hospitals, pharma, medical devices, and research

Our expertise

Healthcare and life sciences sectors face strict data protection and cybersecurity regulations. We help hospitals, pharmaceutical companies, medical device manufacturers, and research organizations with GDPR, NIS2, incident response, and AML compliance.

Our services for healthcare

GDPR for medical data

Protection of sensitive health data, DPIA for EHR systems, clinical databases, and research. Consent management, access rights, and retention policies.

Patient data protection

Secure management of patient databases, anonymization for research, pseudonymization, access controls, and processing records.

NIS2 for healthcare infrastructure

Cybersecurity of hospital IT systems, incident response, ransomware protection, backup strategies, and business continuity.

Healthcare incident response

72-hour GDPR breach reporting, DPA coordination, patient communications, and post-incident analysis.

DPA agreements with suppliers

Data processing agreements with cloud providers, lab systems, billing partners, ensuring appropriate safeguards.

Healthcare staff training

Training programs for medical and administrative staff on patient data protection, cybersecurity, and AML procedures.

Sectors we support

Hospitals and healthcare facilities
Pharmaceutical companies
Medical device manufacturers
Clinical research organizations (CRO)
Laboratories and diagnostic centers
Private clinics and polyclinics
Pharmacies and distribution
Healthtech and telemedicine

EU regulations for healthcare

Key regulations:

GDPR

Patient personal data protection

Scope: EHR systems, clinical databases, patient portals

NIS2 Directive

Healthcare infrastructure cybersecurity

Scope: Hospitals, healthcare providers as essential entities

AML Directives

Anti-money laundering

Scope: Pharmaceutical transactions, private healthcare

ePrivacy Directive

Communications privacy

Scope: Telemedicine, patient communications

Healthcare compliance challenges

Sensitive health data

GDPR measures for special categories of data, encryption, access controls, and detailed processing records.

Legacy IT systems

Phased migration, compensating controls for old systems, network segmentation, and enhanced monitoring.

Ransomware attacks

NIS2 incident response plans, backup strategies, network segmentation, endpoint protection, and 24/7 monitoring.

Data sharing for research

Anonymization, pseudonymization, data use agreements, consent management, and ethical approval processes.

Case study: large hospital

Challenge

A 500+ bed hospital needed comprehensive GDPR compliance for EHR systems, clinical databases, and administrative systems while preparing for NIS2.

Solution

Detailed assessments of all systems, data governance implementation, policy and procedure development, training of 800+ staff, incident response plan, and NIS2 gap analysis.

Results

GDPR compliance achieved in 10 months
Centralized access management implemented
NIS2 readiness plan delivered
800+ medical and admin staff trained

Need EU compliance for your healthcare organization?

Typical outcomes: GDPR roadmap, NIS2 priorities, incident response readiness.

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Vision Compliance - EU Compliance Advisory | GDPR, NIS2, AI Act | Zagreb, Croatia