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ISO 27001 SME Assessment for Healthcare | ComplyDev

ISO 27001. Information Security Management System (ISMS) Competent Authority: Accredited certification bodies (Accredia in Italy). Deadline: Ongoing compliance

Last updated: 13/03/2026

Key Points

  • 93 security controls (Annex A)
  • Risk assessment and risk treatment
  • Statement of Applicability (SoA)
  • Annual internal audits
  • Certification issued by accredited bodies
  • Triennial renewal with annual surveillance

What is ISO 27001 and how does it apply to Healthcare?

ISO 27001. Information Security Management System (ISMS) Competent Authority: Accredited certification bodies (Accredia in Italy). Legal Basis: ISO/IEC 27001:2022 - International standard. Deadline: Ongoing compliance

Who in the Healthcare sector must comply with ISO 27001?

ISO 27001. Hospitals, clinics, laboratories and healthcare providers 50-5000 employees. For Medium enterprises (50–249 employees) in the Healthcare sector, ISO 27001 compliance requires specific attention to: Key Requirements: 93 security controls (Annex A); Risk assessment and risk treatment; Statement of Applicability (SoA).

Penalties for non-compliance with ISO 27001

Penalties: N/A (voluntary standard). Important: The ISO 27001 compliance deadline is approaching. Do not wait to start your assessment.

How to start your ISO 27001 compliance journey

Check your ISO 27001 compliance for free. ComplyDev's AI-powered assessment analyses your Healthcare company against 111+ EU regulations in 20 minutes — no registration, no credit card. Key Requirements: 93 security controls (Annex A); Risk assessment and risk treatment; Statement of Applicability (SoA).

Sector Advice

  • Check your ISO 27001 compliance for free. ComplyDev's AI-powered assessment analyses your Healthcare company against 111+ EU regulations in 20 minutes — no registration, no credit card.
  • For Medium enterprises (50–249 employees) in the Healthcare sector, ISO 27001 compliance requires specific attention to:
  • SME Assessment: Accredited certification bodies (Accredia in Italy). Deadline: Ongoing compliance.

Frequently Asked Questions

ISO 27001 Key Requirements
93 security controls (Annex A); Risk assessment and risk treatment; Statement of Applicability (SoA); Annual internal audits; Certification issued by accredited bodies; Triennial renewal with annual surveillance
ISO 27001 Penalties
N/A (voluntary standard)
ISO 27001 - Healthcare
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