HIPAA Compliance for AI/ML Startups
Tailored for AI/ML and your role.
Head of Compliance Strategy • CPA, CISA, ISO 27001 Lead Auditor
Strategic Priorities for AI/ML 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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All RiscLens content is researched, written, and reviewed by compliance professionals with real-world audit experience. We maintain strict editorial independence and never accept payment for coverage or rankings.
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Audit readiness checklist
- •Define scope and evidence owners for HIPAA Compliance
- •Map controls to your AI/ML workflows
- •Confirm evidence cadence and review approvals
- •Document exceptions and compensating controls
- •Validate auditor expectations before kickoff
Evidence to prepare
- •Policy ownership records
- •Control testing results
- •Risk assessments
- •Monitoring evidence
Frequently Asked Questions
Can we use PHI for AI model training?
Yes, with proper safeguards. Options include de-identification per Safe Harbor/Expert Determination, obtaining authorization, or using the research exception with IRB approval.
What security controls are needed for healthcare AI?
Controls include encrypted model training environments, access restrictions to PHI datasets, audit logging of data access, secure model serving, and protection against model inversion attacks.
How do we handle AI-generated insights from PHI?
AI outputs derived from PHI may still be PHI if individually identifiable. Apply minimum necessary principle, document data flows, and ensure downstream uses comply with HIPAA.
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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