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ISO 27001 certification for healthcare and health technology

Certification for organizations handling health data, aligned with HIPAA, ISO 27799, and hospital procurement requirements.

Why organizations in this sector certify

  • Hospital and health system procurement requiring independent security certification
  • HIPAA business associate obligations and customer audits
  • Demonstrating governance over sensitive personal data to patients, partners, and regulators

Why health organizations certify

Health data is among the most sensitive information an organization can hold, and the consequences of a breach reach patients as well as the balance sheet. Hospitals, health systems, and insurers increasingly require independent certification from technology suppliers, and regulators expect to see a governed security program rather than a list of tools.

What the audit focuses on

For health technology companies, the audit examines how protected health information flows through the platform and who can see it. For providers, it examines the clinical and administrative environments where records are created and used. In both cases we look closely at:

  • Data classification. Whether health information is identified, labeled, and handled according to its sensitivity throughout its lifecycle.
  • Minimum necessary access. Role design, break-glass procedures, and monitoring of access to records.
  • De-identification. Data masking in non-production environments and analytics.
  • Retention and deletion. Evidence that information is deleted when no longer required, including in backups and with suppliers.
  • Integrations and devices. Security of interfaces with electronic health record systems, connected devices, and third-party services.
  • Breach response. Incident procedures that include regulatory and contractual notification timelines, with evidence of testing.

Aligning with HIPAA and ISO 27799

We expect the ISMS to identify HIPAA, state law, and contractual business associate obligations as requirements, and to show how the controls in the Statement of Applicability address them. ISO 27799, the health informatics guidance for ISO 27002, is a useful reference for control selection and we are familiar with it.

Scope and timing

Health technology scopes usually cover the platform, engineering, support, and corporate functions. Provider scopes may cover selected facilities or the whole organization. Where facilities are included, audit time increases to allow for site visits, and we plan them to minimize disruption to clinical work.

Questions

Questions from healthcare and health technology clients

Does ISO 27001 certification mean we are HIPAA compliant?
No. HIPAA is a legal obligation; ISO 27001 is a management system standard. An ISMS that identifies HIPAA as a requirement and implements controls to meet it provides strong evidence of a compliance program, and many customers accept it as such, but the certificate does not itself certify HIPAA compliance.
Can we add ISO 27701 for privacy?
Yes, and many health technology companies do. ISO/IEC 27701 extends the ISMS with privacy governance requirements that map well to patient data obligations. We can audit both together in one program; see integrated audits.
How do you audit clinical environments?
Sites where patient data is accessed or stored, such as clinics or hospitals in scope, are visited on site at least once in the cycle. The auditor observes physical access, clean desk practice, and workstation security. For technology companies serving healthcare, the audit is mostly remote.

Other industries

More sectors we audit

Ready to scope your audit?

Tell us about your organization, your ISMS scope, and your target date. We reply with a fixed-fee quote and available audit dates within two business days.

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