Healthcare

Regulations for the Healthcare Sector

Healthcare is particularly heavily regulated due to the processing of sensitive patient data and its role as critical infrastructure.

Why Is Healthcare Especially Affected?

  • Critical infrastructure: Hospitals and healthcare facilities are classified as essential entities under NIS2
  • Sensitive data: Health data is a special category of personal data under the GDPR, subject to enhanced protection
  • High-risk AI: Medical AI systems (diagnostics, treatment planning) fall under the highest risk category of the AI Act
  • Sustainability: Large healthcare groups and pharmaceutical companies are subject to the CSRD

Key Challenges

  • Electronic health records and telemedicine increase data protection and cybersecurity requirements
  • AI-assisted diagnostics (imaging, laboratory findings) must meet strict AI Act requirements
  • Medical devices with AI components are additionally subject to the MDR
  • Research data and biobanks require dedicated data protection concepts
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Relevant Regulations

AI Act The EU AI Act regulates the use of AI systems in the EU. Learn about the risk categories and what your company needs to consider. CSRD The CSRD requires companies to provide comprehensive sustainability reporting. Find out whether your company is affected. CRA The Cyber Resilience Act mandates cybersecurity across the product lifecycle. Find out what requirements apply to your organisation. Data Act The Data Act governs fair access to data from connected products. Find out what rights and obligations apply to your organisation. EHDS The EHDS creates a European framework for accessing and using health data. Find out what it means for the healthcare sector. eIDAS 2.0 eIDAS 2.0 establishes the framework for the EU Digital Identity Wallet. Find out how it impacts regulated industries. GDPR The GDPR governs the handling of personal data in the EU. Learn about your company's obligations and what you need to comply with. NIS2 The NIS2 Directive tightens cybersecurity requirements for companies in the EU. Find out if your organisation is affected and what steps to take.