Healthcare & Life Sciences

Patient data protection. Automated.

Healthcare organizations handle the most sensitive data in the EU - patient records, genetic information, and clinical trial data. NIS2 classifies hospitals as essential entities, GDPR Article 9 imposes strict rules on special category health data, and connected medical devices expand the attack surface daily. Matproof automates compliance across these overlapping obligations so your teams focus on patient care, not audit preparation.

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Key Compliance Challenges in Healthcare

01
NIS2 essential entity obligations

Hospitals, laboratories, and healthcare providers are classified as essential entities under NIS2. This means stricter supervisory requirements, mandatory risk management measures, and direct reporting obligations to national authorities - with senior management held personally accountable for compliance failures.

02
GDPR Article 9 special category data

Health data is classified as special category data under GDPR Art. 9, requiring explicit consent or specific legal bases for processing. Data Protection Impact Assessments are mandatory for large-scale health data processing, and breach notification carries heightened urgency when patient records are exposed.

03
Connected medical device security

IoT-enabled medical devices, remote patient monitoring, and hospital information systems create complex attack surfaces. Each connected device must be inventoried, risk-assessed, and monitored - while maintaining patient safety and regulatory compliance for medical device software.

04
Cross-border patient data transfers

EU health data exchange under EHDS, cross-border clinical trials, and telemedicine services require compliant data transfer mechanisms. Standard contractual clauses, adequacy decisions, and supplementary measures must be documented and maintained for every data flow.

Frameworks That Apply to Healthcare

Healthcare organizations must navigate a complex regulatory landscape spanning cybersecurity, data protection, and sector-specific requirements.

NIS2
NIS2

Hospitals and healthcare providers are essential entities. NIS2 mandates risk management measures, incident reporting within 24 hours, and supply chain security for medical technology providers.

GDPR
GDPR

The foundation for patient data protection. Art. 9 special category rules, mandatory DPIAs, 72-hour breach notification, and strict requirements for health data processing and research.

ISO
ISO 27001

The international standard for information security management. ISO 27001 provides the structured ISMS framework that healthcare organizations need to demonstrate security maturity to partners and regulators.

How Matproof Helps Healthcare Organizations

Purpose-built compliance automation for the unique demands of healthcare data protection.

Automated DPIA workflows

Generate and maintain Data Protection Impact Assessments for large-scale health data processing. Matproof maps data flows, identifies risks, and documents mitigation measures - keeping DPIAs current as processing activities evolve.

Medical device vendor risk management

Build and maintain a complete register of connected medical device vendors. Track security certifications, software update compliance, and contractual obligations for every device in your clinical environment.

Incident reporting to health authorities

When a cybersecurity incident affects patient data or clinical operations, generate NIS2-compliant notifications to national CSIRTs and GDPR breach reports to data protection authorities from a single incident record. Meet the 24-hour NIS2 and 72-hour GDPR deadlines consistently.

EU data residency and transfer compliance

Map and document all patient data flows across borders. Matproof tracks transfer mechanisms, monitors adequacy decisions, and alerts when cross-border data transfer arrangements need updating.

Healthcare Compliance in Numbers

1.3M+

healthcare workers in the EU

58%

of hospitals targeted by cyberattacks

EUR 10M

maximum NIS2 fine for essential entities

72h

GDPR breach notification deadline

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Protect patient data. Automate compliance.

Book a 30-minute demo. We'll show you how Matproof maps NIS2, GDPR, and ISO 27001 requirements to your healthcare operations.

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