Regulated beachhead
Cut the administrative burden. Keep humans accountable for safety.
Governed by overlapping frameworks, MDR, IVDR, FDA 21 CFR Part 11, GDPR Art.9, that demand precision and audit depth. Agents run in shadow and supervised modes, with quarantined processing of patient data and fail-closed evidence, so administrators move faster while clinicians own the patient-safety calls.
The gap we close
Clinical and regulatory teams drown in documentation while the frameworks governing them tolerate zero shortcuts on precision or auditability. Patient-safety and submission decisions cannot be delegated to a probabilistic system, but the paperwork around them can be, if and only if the sensitive data stays contained and every step is provable.
What an agent does here
Concrete, document-heavy processes, governed, auditable, and honest about where a human must stay in the loop.
4 mapped processes, each with a defined autonomy boundary.
Clinical documentation assembly
The agent structures clinical notes and records into the required formats, with patient data handled by a quarantined component that never gains the privilege to act, and PII routed to on-prem models by sensitivity label. Clinicians review and own the content; the agent removes the transcription and formatting load.
Prior-authorization processing
It reads the request, the clinical evidence and the payer criteria, checks completeness, and prepares the authorization pack, flagging gaps for a human rather than guessing. A high-volume, rule-bound process compressed, with a full evidence trail written before each step commits.
Pharmacovigilance triage
Adverse-event reports are read, coded and prioritized, with signal candidates escalated to a safety scientist with the source evidence attached. The agent triages at volume; the regulatory safety determination stays with a qualified human, autonomy bounded by liability, by design.
Regulatory submission support
The agent conferences the source documents against the submission checklist for MDR/IVDR or FDA dossiers, assembles the pack, and surfaces every inconsistency with its provenance, turning a fragile manual assembly into an auditable, repeatable one.
Precision and audit depth are the whole point in banking too, which is why the governance transfers: shadow-mode baselines, quarantined patient-data handling, hash-chained evidence, and alignment to MDR, IVDR, FDA 21 CFR Part 11 and GDPR Art.9.
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