The thesis
Healthcare data is the most sensitive corpus most regulated industries handle, and the most regulated. The current state — HIPAA business associate agreements, data-use agreements, anonymization-and-pray, multi-year FDA audit cycles, claims-adjudication disputes — exists because verifiable computation on this data has been impossible. zkDB removes the impossibility.
Where we engage
Clinical trial endpoint verification
Multi-site Phase III trials commit per-site, per-patient event ledgers. The central adjudication committee computes the trial endpoint (MACE, OS, PFS, composite safety) as a verifiable query. The headline number ships to the FDA with a proof that the result derives from the committed cohort under the locked Statistical Analysis Plan — no selective reporting, no per-site cherry-picking, full statistical integrity, full per-patient confidentiality.
Relevant frameworks: FDA 21 CFR Part 11 · ICH E6(R3) GCP · EMA EudraCT · HIPAA · GDPR Article 9.
Decentralized clinical trials
Patient-device streams (wearables, CGMs, home spirometers) commit to a per-patient event log at the edge. Adjudication is verifiable; per-patient data never aggregates into a central honeypot. Particularly relevant for trials with patient-recruitment friction in EU member states under GDPR.
Insurance claims adjudication
Prove a claim was approved or denied per the literal text of the policy, on the committed claim record, under the agreed adjudication function. Drastically reduces dispute volume — and where disputes remain, the verifier (regulator, ombudsman, court-appointed master) checks the math in milliseconds.
Value-based care contracts
For risk-bearing providers and payers: prove that outcomes-based incentives were correctly computed on the committed patient cohort, without exposing per-patient outcomes or attribution logic. The contract becomes mathematically auditable.
Research dataset reuse
Researchers publish a statistic; a proof accompanies it that the statistic is the exact computation of the committed dataset. Ends the reproducibility crisis at the statistical level. Pairs naturally with the open-science movement and major-funder open-data mandates.
How an engagement is shaped
- Clinical / regulatory framing — your medical or biostatistics leadership frames the verifiable claim; our team confirms the cryptographic shape.
- Trial-or-claim circuit design — the statistical analysis plan or adjudication function is translated into a verifiable circuit. We work in parallel with your CRO, biostatistics group, or claims operations.
- Pilot on a synthetic or completed cohort — end-to-end commitment, proof generation, regulator-side verification.
- Production engagement under your trial-management or claims-operations governance.
Engagements are strictly confidential. We work under HIPAA-grade BAAs and the relevant EU-MDR / EU-IVDR data-processor agreements where applicable.
What we typically deliver
- Verifiable-trial protocol addendum (drafted to fit your existing SAP / SOP)
- Circuit specifications for the trial's primary, secondary, and safety endpoints
- Reference prover and verifier libraries with integration into Veeva Vault, Medidata Rave, OpenClinica, or in-house EDC
- Regulator-side verifier package
- Commitment ceremony governance and key-custody design
Request a briefing
Reserved for senior medical, biostatistics, regulatory affairs, and engineering principals at pharma, CROs, payers, and integrated provider systems. Request a briefing →
