ISO 27001 · Healthcare & Health Tech
ISO 27001 for Healthcare & Health Tech
Global health-tech companies increasingly need ISO 27001 alongside HIPAA and SOC 2.
Why this matters
European hospital systems demand ISO 27001; US HIPAA is not portable.
ISO 27701 (privacy extension) supports GDPR alignment.
Layering ISO on HIPAA + SOC 2 covers 90% of global enterprise health procurement.
Typical timeline
8–12 months.
Typical cost
$45k–$95k.
What bites hardest in Healthcare & Health Tech
Frequently asked
Does ISO 27001 cover HIPAA?
It covers the security safeguards but not the HIPAA-specific artifacts like BAAs or breach notification workflows. You need both for US healthcare buyers.
Should I add ISO 27701?
Yes if you're selling into Europe. It's the privacy extension of ISO 27001 and maps to GDPR obligations.
SOC 2 or ISO 27001 — which first?
US-heavy customers → SOC 2 first. International or European customers → ISO 27001. Selling to both? Do them in parallel — 80% of the work overlaps.
How often do I recertify?
Certification lasts three years with annual surveillance audits. Recertification audit at year three.
Is HIPAA enough for enterprise health-system deals?
Rarely. Most hospital systems demand HIPAA + SOC 2 Type 2 + a security questionnaire. Some ask for HITRUST.
Do I need BAAs with every vendor?
Every vendor that touches PHI on your behalf — yes. Missing BAAs are the top HIPAA violation category in OCR enforcement actions.
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Framework
ISO/IEC 27001
The international standard for information security management.
Industry
Healthcare & Health Tech
HIPAA is the floor. Enterprise health-system buyers want more.