ISO 27001 Compliance for Healthcare Startups
Tailored for Healthcare and your role.
Head of Compliance Strategy • CPA, CISA, ISO 27001 Lead Auditor
Strategic Priorities for Healthcare Leaders
Raphael N
Head of Compliance Strategy
Raphael leads go-to-market compliance strategy for high-growth SaaS and AI teams. With over a decade of experience across Big Four firms and fintech startups, he specializes in translating complex SOC 2 requirements into automated, engineering-friendly workflows.
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Audit readiness checklist
- •Define scope and evidence owners for ISO 27001 Compliance
- •Map controls to your Healthcare workflows
- •Confirm evidence cadence and review approvals
- •Document exceptions and compensating controls
- •Validate auditor expectations before kickoff
Evidence to prepare
- •ISMS policy and scope
- •Risk register updates
- •Statement of Applicability
- •Internal audit records
Frequently Asked Questions
Does ISO 27001 satisfy HIPAA requirements?
ISO 27001 provides a strong foundation but doesn't fully satisfy HIPAA. You'll need additional controls for PHI-specific requirements, breach notification, and Business Associate Agreements.
What healthcare-specific controls should be added?
Extend your ISMS with medical device security, clinical system availability requirements, patient consent management, and healthcare-specific incident response procedures.
How does ISO 27701 relate to healthcare privacy?
ISO 27701 extends ISO 27001 with privacy controls. While designed for GDPR, its privacy information management system (PIMS) framework can support HIPAA Privacy Rule compliance efforts.
About RiscLens
Our mission is to provide transparency and clarity to early-stage technology companies navigating the complexities of SOC 2 (System and Organization Controls 2) compliance.
Who we serve
Built specifically for early-stage and growing technology companies—SaaS, fintech, and healthcare tech—preparing for their first SOC 2 audit or responding to enterprise customer requirements.
What we provide
Clarity before commitment. We help teams understand realistic cost ranges, timeline expectations, and common gaps before they engage auditors or expensive compliance vendors.
Our Boundaries
We do not provide legal advice, audit services, or certifications. Our assessments support internal planning—they are not a substitute for professional compliance guidance.
SOC 2 (System and Organization Controls 2) is a voluntary compliance standard for service organizations, developed by the AICPA, which specifies how organizations should manage customer data based on the Trust Services Criteria: security, availability, processing integrity, confidentiality, and privacy.
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