ISO 27001 for healthcare and healthtech
ISO/IEC 27001:2022 is the international standard for an information security management system (ISMS), certified by an accredited body. For healthtech, it complements HIPAA: HIPAA is a US legal obligation, while ISO 27001 is an internationally recognized certification buyers can point to.
Why it matters for healthcare and healthtech
Large health systems and non-US buyers often want a certification, not just a HIPAA attestation of your own making. A healthtech company that already runs HIPAA safeguards can formalize the same practices into an ISMS that carries weight beyond the United States.
What to focus on
ISO 27001 requires a managed system: scope, risk assessment and treatment, objectives, internal audits, and management review. Your HIPAA risk analysis and safeguards feed directly into that system rather than sitting beside it.
The 2022 revision organizes Annex A into 93 controls across four themes: Organizational, People, Physical, and Technological. You select the applicable controls and document them in a Statement of Applicability.
The HIPAA administrative, physical, and technical safeguards (access controls, audit controls, encryption where appropriate, workforce training) map closely to Annex A. On one crosswalked control library, that work counts toward ISO 27001 too.
Do it once, not twice
Keel is built on one crosswalked control library, so a control you implement for ISO/IEC 27001 counts toward every other framework it satisfies. Add a second framework later and it mostly reuses this work. See the crosswalk explorer for the exact overlap.
Start free Check your readinessCommon questions
Do healthtech companies need ISO 27001 if they already do HIPAA?
Not always, but international sales and large enterprise buyers frequently ask for it, because HIPAA has no certification and ISO 27001 does. The controls overlap, so on Keel the HIPAA work carries into ISO 27001.
Is ISO 27001 a substitute for HIPAA?
No. If you handle protected health information you still have HIPAA obligations regardless of any certification. ISO 27001 sits alongside HIPAA and gives buyers an independent, accredited signal of your security posture.
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