Industries · Healthcare

FHIR R4 bundles, trial cohorts, EHR fixtures. Zero real PHI.

Deterministic HL7 FHIR R4 patient bundles with 100% referential integrity by construction. LOINC, RxNorm, and the full US ICD-10-CM catalogue shipped under free licences. Safe Harbor de-identification is a property of the generator input, not a post-hoc scrub — built for health-tech, providers, trial operators, and medical-device validators.

HIPAA Safe Harbor by design Zero BAA required FHIR R4 conformant 21 CFR Part 11 ready
app.radmah.ai / generateproduct view
FHIR R4 BUNDLE541 resources across 8 typesObservation 295 · Encounter 61 · Condition 50 · …
✓ validator passedDownload bundle JSON
Condition20 rowsAllergyIntolerance6 rowsEncounter20 rowsImmunization20 rows
Conditionpreview · 20 rows · 5 columns
Evidence CSVFinal → 5
clinicalStatusicd10_codeicd10_displayid
activeI50.9Heart failure, unspecifiedCP000000-000
activeN39.0Urinary tract infection, site not specifiedCP000000-001
activeD64.9Anemia, unspecifiedCP000001-000
activeH52.4PresbyopiaCP000001-001
activeE55.9Vitamin D deficiency, unspecifiedCP000002-000
activeZ00.00General adult medical exam without abnormal findingsCP000002-001
activeG47.00Insomnia, unspecifiedCP000005-000
activeF41.1Generalized anxiety disorderCP000005-001
activeN39.0Urinary tract infection, site not specifiedCP000005-002
activeR07.9Chest pain, unspecifiedCP000005-003
activeE78.5Hyperlipidemia, unspecifiedCP000005-004

Showing all 20 preview rows

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◆ Where teams use it

Four workflows clinical + research teams buy first.

Clinical-trial digital twin

Simulate a trial's primary-endpoint population before enrolment to right-size the protocol. Deterministic seeds mean the same statistical cohort replays byte-identical in the FDA submission package as in the internal simulation.

EHR integration + conformance fixtures

Drive millions of FHIR R4 bundles against your EHR's ingest, search, and query paths. Every bundle is R4-validator-clean by construction; failures are unambiguously server-side, so regression tests diff cleanly.

ML training sets for care-delivery models

Train readmission-risk, sepsis-onset, and medication-adherence models on millions of synthetic patient timelines without a single IRB submission or BAA. Collaborators at other institutions re-run the same seed and see the same bundles byte-for-byte.

Drug-safety signal testing

Stress-test pharmacovigilance pipelines on millions of synthetic medication-administration + adverse-event records with tunable co-occurrence rates. The sealed contract + seed lets you share the test cohort with a regulator who can reproduce it exactly.

◆ Compliance posture

Privacy office, ethics board, regulator.

HIPAA Safe Harbor by design

Every Patient resource is seeded from a PRF, never derived from real patient records. Names, MRNs, birthDates, addresses — all synthetic. HIPAA §164.514 Safe Harbor is a property of the generator input, not a post-hoc scrub. The bundle is a Limited Data Set on arrival.

Zero BAA required

No real PHI ever enters the generator, so its output is not Protected Health Information. A Business Associate Agreement is not required to ship synthetic data between partners. You still get a DPA for the SaaS control-plane metadata on request.

21 CFR Part 11 + GxP ready

The sealed evidence bundle carries the determinism proof + signed evidence record + timestamp chain required for Part 11 §11.10(c) record integrity. Validation packages (IQ / OQ / PQ) are available to Enterprise customers under NDA; the deterministic-reproducibility property is the core of the OQ test plan.

GDPR Art 4(1) outside-scope

Synthetic data that cannot be re-identified to a natural person falls outside GDPR's definition of personal data. DPIAs are simplified; cross-border transfers stop being a blocker. There is no re-identification attack surface because there is no person to re-identify.

Ship your EHR fixture today. No IRB, no BAA.

Free tier: 25 runs a month. Enterprise: a Hybrid SDK deployment that keeps any real reference data inside your enclave, plus a dedicated healthcare solutions engineer and a 21 CFR Part 11 validation pack under NDA.