Healthcare Compliance

Your hospital already uses AI. Your compliance should keep up.

Built for hospitals and clinics under NIS2, GDPR, and the EU AI Act

Hospitals are critical infrastructure under NIS2, process the most sensitive data categories under GDPR, and deploy high-risk AI in diagnostics and triage. Three regulations, one daily operation.

Metrica.uno automates daily compliance so your team focuses on patient care, not spreadsheets.

NIS2 Critical healthcare infrastructure
GDPR Patient data and special categories
EU AI Act High-risk AI in diagnostics and triage
ENS National Security Framework (Spain)

Business impact

NIS2 compliance without disrupting care

Assess and document NIS2 compliance while the hospital keeps running. No months-long projects, no full-time consultants.

Full control over clinical AI

Every AI system — triage, diagnostics, bed management — is inventoried, risk-classified, and monitored per the EU AI Act.

Inspection-ready evidence

When a data protection authority, ENS, or NIS2 auditor arrives, all evidence is traceable: policies, training, incidents, vendors.

How it works in practice

01

We connect hospital systems (HIS, LIS, PACS) and map vendors and clinical data flows.

02

We assess NIS2, GDPR, and EU AI Act compliance with healthcare-adapted questionnaires.

03

We identify gaps, generate policies, and activate automated remediation workflows.

04

Compliance runs itself: training, incidents, vendors, evidence, and surveillance — every day.

Key capabilities

Click each module to see what it covers and how it applies in the hospital environment.

Patient Data Protection

Manage ROPA, legal bases, and data subject rights for clinical and administrative data under GDPR.

Clinical AI Governance

Inventory, classify, and monitor AI systems used in diagnostics, triage, and hospital management.

NIS2 Self-Assessment

65-question NIS2 self-assessment adapted for critical healthcare infrastructure.

Healthcare Incident Management

Cybersecurity incidents with NIS2 deadlines, GDPR breaches, and CRA vulnerability reporting.

Healthcare Vendor Compliance

Assess and monitor HIS, lab, imaging, and cloud service vendors under NIS2 and GDPR.

AI Literacy & Training

AI literacy courses for clinical and administrative staff per EU AI Act Article 4.

Hospital GRC Automation

Policies, approvals, evidence, and compliance folders that manage themselves.

Patient Data Protection

Manage ROPA, legal bases, and data subject rights for clinical and administrative data under GDPR.

Automated inventory of processing activities: HIS, LIS, PACS, telemedicine, patient apps.

Legal basis control by data type: explicit consent for genetics, vital interest for emergencies.

Data subject request tracking (access, rectification, erasure) with deadlines and response evidence.

Pre-configured DPIAs for clinical AI projects and health data spaces.

Clinical AI Governance

Inventory, classify, and monitor AI systems used in diagnostics, triage, and hospital management.

AI system registry: imaging diagnostics models, triage algorithms, readmission prediction, bed management.

Automatic EU AI Act risk classification: diagnostics and triage systems are high-risk by default.

Continuous drift and bias monitoring by demographic group, pathology, and facility.

Conformity documentation for CE marking and post-market surveillance of AI-powered medical devices.

NIS2 Self-Assessment

65-question NIS2 self-assessment adapted for critical healthcare infrastructure.

65-question questionnaire covering all 10 NIS2 domains: governance, risk management, continuity, supply chain.

Automatic scoring with gap identification and prioritization by clinical impact.

Remediation plan with hospital-specific controls: medical OT network isolation, HIS backup.

NIS2 vendor assessment template (47 questions) for HIS integrators, cloud providers, and outsourced services.

Healthcare Incident Management

Cybersecurity incidents with NIS2 deadlines, GDPR breaches, and CRA vulnerability reporting.

Automatic classification: patient data breach (72h DPA), NIS2 incident (24h early warning + 72h notification), CRA vulnerability.

Multi-regulator notification workflows: DPA, sectoral healthcare CSIRT, NIS2 authority, ENISA.

Root cause analysis and corrective actions (CAPA) with automated follow-up.

Incident dashboard by facility, department, and vendor with response time metrics.

Healthcare Vendor Compliance

Assess and monitor HIS, lab, imaging, and cloud service vendors under NIS2 and GDPR.

Vendor self-assessment portal with NIS2 (47 questions) and GDPR (data processor) templates.

Tracking of DPA contracts, ISO 27001 certifications, SOC 2 audits, and ENS compliance.

Alerts for certification expiry, contractual changes, and compliance degradation.

Supply chain risk assessment per NIS2 Art. 21(2)(d): critical hospital infrastructure vendors.

AI Literacy & Training

AI literacy courses for clinical and administrative staff per EU AI Act Article 4.

Mandatory EU AI Act training in effect since August 2025: modules adapted to clinical roles.

Role-specific courses: AI-assisted radiology, algorithmic triage, pharmacogenomics, predictive bed management.

Completion tracking by department, facility, and role with expiry alerts.

Exams with downloadable certificates and audit-ready evidence trail.

Hospital GRC Automation

Policies, approvals, evidence, and compliance folders that manage themselves.

Pre-configured GRC folders for hospitals: GDPR + NIS2 + EU AI Act + ENS with evidence structure.

Approval and acknowledgment workflows for security policies, data protection protocols, and AI usage guidelines.

Automated evidence collection: training logs, vendor certificates, committee minutes.

AI-assisted policy generation: clinical AI usage policy, data breach protocol, business continuity plan.

Operational advantage

Zero impact on clinical operations

Set up in hours, not months. The hospital keeps running while compliance gets underway.

Multi-framework in one platform

NIS2 + GDPR + EU AI Act + ENS in one place. No spreadsheets, no rotating consultants.

Continuous, not one-time compliance

Approvals, incidents, training, vendors, and evidence are managed automatically every day.

The platform in numbers for healthcare

65

NIS2 Questions

70

GDPR Questions

47

NIS2 Vendor Assessment Questions

142+

Platform features

Your Compliance OS for Healthcare

NIS2, GDPR, EU AI Act, and ENS in one platform. Set up in hours, continuous compliance from day one.

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