Every AI-assisted decision is now part of the record the FDA will read.
Tokto records every prompt, every model output, and every vendor AI interaction that touches a molecule, a trial, a submission, or a patient, ready for the FDA, the EMA, OCR, the AG, the IRB, opposing counsel, and the reinsurer.
A federal investigation opens into whether AI in your EMR drove unnecessary utilization. DOJ subpoenas land. The legal team has a SIEM, a data lake, and a vendor risk file. None ties a model decision to a clinician, a patient, an episode, and the labeling in force that day.
What you get with Tokto
- Every model decision tied to a molecule, a trial, a patient, a clinician, a submission, and the labeling in force.
- A complete record for the FDA, the EMA, OCR, the DOJ, the AG, and opposing counsel on the same evidence.
- Policy applied at the prompt: no PHI without authorization, no compound IP into a non-controlled model, no labeled claim past the boundary.
- Defensibility under Part 11, HIPAA, GxP, FCA, and EU AI Act (high-risk) at the same time.
How it works
Tokto governs the AI surface of the company. Research co-pilots, regulatory drafting assistants, CRO-shared scoring models, ambient clinical-listening tools — all become records at the moment they fire. The record carries the molecule, the trial, the patient, the clinician, the submission, and the consent captured. The GC controls one trail, not seven dashboards.
When a DOJ subpoena hits an EMR AI utilization theory, when OCR opens a HIPAA enforcement after a breach, when the IRB asks for the AI history of a protocol, the record is the same record. The GC answers in days, not quarters.
What goes wrong without it
- DOJ subpoenas your EMR AI usage. The legal team produces dashboards from four vendors that do not reconcile.
- An AI-assisted regulatory submission relies on a model output the team cannot reproduce. The FDA opens an integrity review.
- An adverse event surfaced first by an AI tool was never captured as part of the safety record. Class action plaintiffs find it before pharmacovigilance does.
- A CRO co-pilot used in a trial leaks unpublished results. The reinsurer asks for an AI-governance audit at the next placement.
On January 6, 2025, HHS OCR proposed the first major HIPAA Security Rule update in 20 years, removing the distinction between required and addressable safeguards and tightening risk management and resilience expectations. In May 2025 the Serviceaide breach exposed PHI for 483,126 Catholic Health patients through an unsecured database. Industry research finds 83% of pharma organizations operate without basic technical controls preventing molecular structures, trial data, and PHI from leaking into public AI tools.
See how Tokto makes enterprise AI visible, governed, and accountable for Legal & Compliance in Life Sciences.
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