SynthABA Synthetic Data Attestation
ATTESTATION OF SYNTHETIC DATA ORIGIN AND PHI ABSENCE
SynthABA, a product of FPI Enterprises, Inc., hereby attests and certifies the following regarding the Dataset identified below:
1. Synthetic Origin
The Dataset is 100% synthetically generated using AI models and clinical templates. No real patient records, electronic health records, claims data, or other individually identifiable health information was used as input to the generation process. Every record in the Dataset was created programmatically from parameterized templates with randomized patient contexts.
2. Zero PHI
The Dataset contains zero Protected Health Information as defined by 45 CFR Section 160.103. Every record has been scanned by an automated, version-stamped PHI verification pipeline (verifier phi-content-1.0.0: 6 validity-aware rules, plus a 9-pattern quality-gate pre-screen) under a zero-tolerance policy; the verifier version and verdict are sealed in each document's provenance passport. If any record flags a potential PHI match, the entire batch is blocked: nothing is sealed, nothing is shipped, and an alert is raised. A released Dataset therefore contains only records from batches that passed with zero findings.
3. Template-Based Generation
Records are generated from parameterized clinical templates using randomized patient contexts, including age bands (not specific ages), diagnosis codes (not patient names), generic service settings, and synthetic provider identifiers. The generation methodology does not derive from, reference, or reverse-engineer any real patient's health information.
4. Automated Compliance Pipeline
Every batch passes a 4-step automated compliance pipeline prior to release:
| Step | Gate | Description |
|------|------|-------------|
| 1 | Ingest | Raw synthetic records are ingested and formatted |
| 2 | PHI Scan | Automated version-stamped scan (validity-aware rules + quality-gate pre-screen), zero-tolerance |
| 3 | Synthetic Validation | Statistical validation confirms synthetic origin and clinical plausibility |
| 4 | Release | Provenance passports sealed per document; batch MANIFEST.passport.json issued with SHA-256 integrity hash |
Every delivered dataset includes one provenance passport per document, a MANIFEST.passport.json binding all passports (its SHA-256 is recorded below), and a standalone verify_passport.py script so the recipient can independently verify the integrity of every document, passport, and the manifest with stock Python 3 -- no vendor tooling required. The manifest is the batch-level integrity artifact: it carries the batch ID, record count, generation timestamp, and per-document hashes. The dataset's ATTESTATION.json file carries the exact values for the Dataset Details table below.
5. Clinical Review
Automated PHI content verification runs on every batch; results are sealed in each document's provenance passport. Clinical templates and reference materials are reviewed by Board Certified Behavior Analysts. The scope of human validation for any given document is declared in its passport (human_validation.scope) -- never implied.
This attestation is made in good faith and to the best of our knowledge as of the date signed below.
Dataset Details
| Field | Value | |-------|-------| | Dataset Version | _________________________________ | | Batch ID | _________________________________ | | Record Count | _________________________________ | | Document Types | _________________________________ | | Generation Date | _________________________________ | | Manifest SHA-256 (MANIFEST.passport.json) | _________________________________ | | Passport Count | _________________________________ |
Attesting Officer
| Field | | |-------|---| | Name | _________________________________ | | Title | _________________________________ | | Organization | FPI Enterprises, Inc. (SynthABA) | | Signature | _________________________________ | | Date | _________________________________ |
This attestation covers only the specific Dataset identified above. A separate attestation is issued for each Dataset version and batch.