ISMS Copilot for healthcare compliance
HIPAA Security and Privacy Rule mapping, ISO 27018 for cloud-hosted health data, and SOC 2 cross-walks — documentation only, never PHI.
The healthcare compliance stack, and the PHI boundary
Healthcare compliance is not one framework. A US covered entity carries the HIPAA Security Rule (administrative, physical, technical safeguards under 45 CFR §164.308–§164.312), the Privacy Rule, and the Breach Notification Rule's 60-day clock. The moment patient data sits in a cloud, ISO 27018 layers PII-processor controls onto an ISO 27001 ISMS, and most digital health teams selling B2B also face SOC 2. ISMS Copilot does not sign a Business Associate Agreement (BAA), so it cannot lawfully process Protected Health Information under 45 CFR §164.502. Never paste actual PHI or ePHI — names, dates, MRNs, diagnoses, provider-patient conversations — into chats. Drafting an SOP about how your team handles PHI is fine; entering the PHI itself is not. If your use case requires processing PHI through an AI assistant, you need a BAA-signed vendor instead.
Full HIPAA stance and limitations →What ISMS Copilot does for HIPAA-covered teams
- Draft the HIPAA policy pack — Information Access Management, Workforce Security, Audit Controls, Contingency Planning, Breach Notification
- Map your environment to the HIPAA Security Rule administrative, physical, and technical safeguards (45 CFR §164.308–§164.312)
- Draft the Risk Analysis methodology and remediation plan template (45 CFR §164.308(a)(1)(ii)(A))
- Map ISO 27018 cloud PII-processor Annex A controls onto an ISO 27001 Statement of Applicability for hosted health data
- Cross-walk HIPAA Security Rule to SOC 2 Security and Confidentiality TSC — most controls overlap
- Prepare workforce HIPAA training material, sanction policies, and a subprocessor BAA template
Built for healthcare compliance leads
HIPAA Security Rule control library — administrative, physical, technical safeguards
Privacy Rule templates (Notice of Privacy Practices, minimum necessary, authorizations)
Breach Notification Rule workflow (60-day clock, HHS reporting, individual notification)
ISO 27018:2025 PII-processor control guidance mapped to the 11 ISO/IEC 29100 privacy principles
SOC 2 + HIPAA combined control matrix for digital health startups going for both
State-law layering — California CMIA, NY SHIELD, Texas HB 300 considerations
Are you a NIS 2 essential entity? (free first-pass checker)
Healthcare is one of the Annex I sectors under NIS 2, so most hospitals and many digital-health platforms fall into the essential-entity tier — but the test still depends on entity type, size, and national transposition. The free NIS 2 Applicability Checker walks the Article 2/3 essential-versus-important test as a structured first pass (with national-transposition data) — a starting point alongside the HIPAA/ISO 27018 stack above, not a final legal determination.
Open the free NIS 2 Applicability Checker →Frequently Asked Questions
Will ISMS Copilot sign a BAA?
No. We do not sign Business Associate Agreements. The AI infrastructure underneath ISMS Copilot does not have a BAA chain we can pass through to you. Treat ISMS Copilot as a documentation and training tool — not a PHI processor. Never paste PHI or ePHI into chats.
Where does ISO 27018 fit for a healthcare cloud product?
ISO 27018 is not separately certifiable — its Annex A controls are incorporated into an ISO 27001 Statement of Applicability and scoped to public-cloud PII processing. If you host patient data, ISMS Copilot helps you draft those SoA entries and map them to the ISO/IEC 29100 privacy principles. See /frameworks/iso-27018.
We need both SOC 2 and HIPAA — does that work?
Yes, and it is a common pattern for digital health SaaS. The HIPAA Security Rule technical safeguards overlap heavily with the SOC 2 Security TSC, so ISMS Copilot generates a combined control matrix and you write each control once. See /frameworks/soc-2 and /frameworks/hipaa.
Ready to streamline your compliance work?
Built for speed, accuracy, and audit-ready output.