If you're reading this page, you've likely received an OCR breach notification involving unauthorized access to Protected Health Information in test, development, backup, or training systems.
You need three things fast:
1. Technical remediation (eliminate the root cause)
2. Expert validation (third-party certification)
3. Compliance documentation (satisfy OCR requirements)
We deliver all three in 21-30 days.
When OCR investigates "Unauthorized Access/Disclosure" breaches, they typically discover one of these scenarios:
The common thread: organizations didn't realize they had production data where it shouldn't be—until OCR discovered it during an investigation.
OCR's corrective action plan requirements focus on three mandates:
How did production PHI end up in these systems?
What process failures allowed this to occur?
What have you done to eliminate the current exposure?
How did you secure or remove the PHI?
How will you ensure this NEVER happens again?
What systematic controls have you implemented?
Most organizations can handle #1 and #2 internally with their IT and compliance teams.
#3 is where we provide the systematic, documented solution OCR expects to see.
We provide the systematic fix OCR expects to see in preventive measures:
Replace all production PHI in test, development, backup, and training systems with fully synthetic data that maintains clinical validity and referential integrity but contains zero real patient information.
HIPAA §164.514(b)(1) Expert Determination letter certifying your synthetic data meets federal de-identification standards. This is the third-party validation OCR wants to see.
Pre-written sections for your corrective action plan explaining the technical solution, methodology, ongoing compliance measures, and preventive controls.
Test Data Management Policy and procedures you can adopt immediately to demonstrate ongoing compliance.
Audit trails, methodology documentation, validation reports, and technical evidence that prove you've eliminated the root cause.
Kickoff call, review OCR notification, assess your test data environment, define scope and deliverables
Create synthetic datasets, validate referential integrity, test data quality, generate required volumes
Complete HIPAA §164.514(b) Expert Determination, draft corrective action plan language, finalize all OCR materials
Assist with loading synthetic data, validate system functionality, train staff, support OCR submission
For urgent OCR deadlines, we can compress delivery to 10-14 days with expedited fees. Contact us immediately if your deadline is critical.
Annual Maximum: $1.5 million per violation category
Typical OCR Settlement Range: $500,000 - $3,000,000
Investment: $75,000 - $200,000
Timeline: 21-30 days
Includes: Complete technical solution + expert validation + full documentation package
Risk: Minimal (proven technology, phased payment, guarantee)
The ROI Decision: Avoid $500K-$3M OCR settlement + prevent future violations + deploy in 21-30 days
A: They can create data with made-up names and addresses, but that won't satisfy OCR's requirements.
OCR wants to see: (1) Statistically valid synthetic data, (2) Expert Determination under §164.514(b)(1) from an independent third-party, (3) Documented methodology that withstands regulatory audit, (4) Proof that production PHI was never accessed, (5) Systematic controls preventing future violations.
Your IT team can generate data. We provide the complete compliance package that closes OCR investigations.
A: We provide Expert Determination under HIPAA §164.514(b)(1)—one of two de-identification methods explicitly recognized in federal regulations.
OCR must accept approaches that meet §164.514(b) standards when properly documented and validated. We ensure yours does. Our documentation format matches OCR expectations.
A: No. While sooner is always better, we can work with organizations at various stages:
Call us to discuss your specific timeline and situation.
If you're facing an OCR investigation involving unauthorized PHI access:
STEP 1: Schedule a confidential consultation (15-30 minutes)
STEP 2: Receive a custom proposal (24-48 hours)
STEP 3: Begin implementation immediately (2-5 business days)
STEP 4: Submit your corrective action plan with confidence
Timeline critical? Call 703 431 6181 immediately
If your OCR deadline is within 30 days, we can begin expedited delivery within 48 hours of engagement.