Clinical Trials - When Data Must Come Back

Most anonymization is irreversible - once data is redacted, it is gone forever. But legal discovery, audit requirements, and clinical research demand the ability to re-identify data under controlled conditions.

100%
HIPAA permits pseudonymization
AES-256
Encryption standard
100%
User key control
Full
Audit capability

The Reversibility Requirement

GDPR distinguishes between anonymization (irreversible) and pseudonymization (reversible). Many use cases require pseudonymization: legal discovery, audit requirements, clinical trials, and research validation.

  • Legal discovery blocked - Irreversibly anonymized data cannot be produced when ordered
  • Audit gaps - Cannot demonstrate what was protected without reversibility
  • Research limitations - Cannot validate findings or report adverse events
  • LLM workflow breaks - AI responses with placeholders cannot be restored

Clinical Trial Adverse Event Reporting

Pharmaceutical companies must de-identify data for analysis, re-identify for adverse events (FDA requirement), and audit on demand. Without reversibility, FDA adverse event reporting becomes impossible.

Legal Discovery Requirements

Companies under litigation need to preserve original documents, create working copies for review, and produce specific documents when ordered. Irreversible anonymization means discovery obligations cannot be fulfilled.

Audit Trail Requirements

Regulators may ask to see exactly what PII was in a document and how it was protected. With irreversible anonymization, this cannot be demonstrated. Evidence-based compliance requires reversibility.

AES-256-GCM Reversible Encryption

cloak.business offers five anonymization methods including reversible encryption:

Replace

Substitute with fake data

Redact

Remove entirely

Mask

Partial obscuring

Hash

One-way transformation

Encrypt

AES-256-GCM, reversible

Technical Specifications

Algorithm
AES-256-GCM
Key derivation
Argon2id
Nonce
Random 12-byte per encryption
Authentication
GCM tag integrity check
Key storage
Client-side only (zero-knowledge)

Reversibility Enables Compliance

ScenarioWithout ReversibilityWith cloak.business
Legal discoveryBlockedSupported
Adverse event reportingImpossibleCompliant
Audit demonstrationTrust-basedEvidence-based
LLM workflow restorationBrokenFunctional

Key Takeaways

  • Irreversible anonymization blocks legal discovery - Courts may order original documents
  • HIPAA explicitly permits pseudonymization - Re-identification key is allowed
  • Clinical trials require re-identification capability - Adverse event reporting is mandatory
  • Audit compliance requires demonstration - Show what was protected
  • Reversible encryption is a unique differentiator - Most tools do not offer it

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