Medical and Clinical Document Redaction with AI Redaction Software
Clinical research sites and healthcare organizations redact source documents, trial records, patient files, and recorded sessions before sharing with sponsors, monitors, regulators, and third parties. VIDIZMO Redactor detects PHI across documents, scanned records, video, and audio so teams can prepare files in minutes, not days.
Manual Redaction Consumes Hours That Should Go to Patient Care
Every monitor visit, SAE package, and regulatory submission requires source documents with participant identifiers removed. Each package can run into hundreds or thousands of pages. Research sites do this repeatedly, manually, pulling staff away from study coordination and patient care to redact page by page.
HIPAA Safe Harbor
De-identifying PHI under Safe Harbor requires removing all 18 specified identifiers, including names, MRNs, DOBs, SSNs, insurance IDs, and geographic data.
21 CFR Part 11
Redactor supports Part 11 with tamper-proof audit trails, role-based access, and chain of custody. Electronic signatures and system validation belong to your deployment.
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ICH-GCP E6(R2)
Source documents shared off-site for monitoring, regulatory submissions, or central review must have PHI removed while clinical data stays verifiable.
HITECH Act
HITECH extends HIPAA to business associates and raises breach penalties. Every site sharing electronic PHI with sponsors or CROs is covered.
Sponsor monitoring and SDV
Source documents must have participant PHI removed before sponsor monitors review them during routine site visits. Clinical data must remain visible for verification.
SAE documentation
Serious adverse event reports generate large document bundles with participant identifiers, medical histories, and investigator assessments. Redacted before submission to sponsors, IRBs, and regulators.
Unblinding event records
Documentation includes treatment assignments, randomization codes, and participant identifiers. Identity removed while clinical and safety data preserved for the unblinding report.
Regulatory submissions
Study reports and submission packages sent to FDA or EMA must have participant PHI removed within regulatory timelines.
Research data sharing
De-identified datasets shared with research partners, IRBs, or public health registries. Safe Harbor compliance verified through audit documentation.
Billing and insurance records
Patient billing records shared with insurers or auditors must have PHI removed beyond what the transaction requires.
HIPAA Safe Harbor identifier coverage
40+ PII detection types plus custom patterns cover Safe Harbor requirements across documents, scanned files, and recordings.
Configurable protocol field highlighting
Configure patterns to highlight IP name, SAE type, and relationship to IP while redacting participant identifiers.
OCR for scanned and legacy records
Handwritten notes, faxed referrals, printed lab results, and image-based PDFs read with OCR and redacted.
Video and audio PHI redaction
Telehealth recordings, clinical session videos, and patient call audio processed alongside documents. Spoken PHI transcribed and redacted.
Batch processing
Upload entire source document packages or trial libraries. Configure rules once, process thousands of pages in minutes.
Sponsor-ready audit trail
Every redaction logged with identifier type, reviewer, timestamp, and confidence score. Exportable for monitor review and compliance verification.
EHR / EMR
CTMS
eTMF
DMS
Need Redaction Handled for You?
VIDIZMO also offers managed redaction services for organizations that need documents, recordings, and clinical files redacted without building an internal workflow. Dedicated redaction specialists process your files and return redacted output with full audit documentation.
