Your EDC vendor has a BAA. Does your cloud host? Your central lab? The LLM tool your team uses to draft narratives? Every system that touches PHI is a potential breach point — and under HITECH, the burden is on you to prove it wasn't compromised.
Meanwhile the rules keep multiplying: HIPAA Security Rule audit controls, 21 CFR Part 11 signatures, GDPR consent and erasure rights, and now AI models that can memorize PHI they were never supposed to retain.
Who this is for
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Regulatory affairs and compliance leaders building or auditing a HIPAA program that actually covers eClinical vendors, not just clinical sites.
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Clinical operations and IT security teams responsible for access control, encryption, and audit logging across EDC, CTMS, and eTMF platforms.
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Sponsors and CROs managing Business Associate Agreements across a growing chain of vendors, sub-contractors, and cloud infrastructure providers.
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Data privacy and DPO-adjacent roles navigating the gap between HIPAA and GDPR in multinational trials — especially where AI tools now sit in the data flow.
What's inside
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Plain-language definitions of PHI, PII, and de-identified data — and where each shows up in your EDC, CTMS, and ePRO systems
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A full breakdown of HIPAA Privacy Rule, Security Rule, and Breach Notification Rule obligations, mapped to real eClinical workflows
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How 21 CFR Part 11 and ALCOA+ intersect with HIPAA audit controls (and where they diverge)
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A Business Associate Agreement checklist for eClinical vendors, cloud hosts, and sub-contractors
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A side-by-side HIPAA vs. GDPR comparison for cross-border trial data
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A dedicated look at AI and LLM tools in clinical workflows — and the new PHI exposure risks they introduce
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A 5-level compliance maturity model plus a 12-month implementation roadmap
Why it matters now
A single breach incident in an eClinical environment rarely touches one system. It can span the clinical site, the CRO, the EDC vendor, and the cloud host simultaneously — each with its own notification obligations and its own BAA. Add AI-powered tools now processing PHI in prompts and logs, and the compliance surface area is larger than most HIPAA programs were built for.
This isn't a one-time audit problem. It's an architecture problem — and it needs a framework, not a checklist.
See exactly where HIPAA, 21 CFR Part 11, and GDPR obligations overlap in your eClinical stack — and what a compliant, audit-ready architecture looks like end to end.
Cloudbyz Unified eClinical — pre-executed HIPAA BAA, 21 CFR Part 11-ready audit trails, built-in role-based access control
