Industries · Healthcare & life sciences
Autonomous care, agentic claims - with a leash the FDA can understand.
We're building Hootleash to govern the autonomous agents now appearing inside claims, pre-authorization, pharmacovigilance, and clinical decision support - without putting clinicians in the loop for every routine decision, and without exposing your PHI surface.
Where we're focused
Autonomous workflows we want to govern first in healthcare & life sciences.
The first release of Hootleash is being engineered around a deliberately narrow set of high-risk autonomous workflows - chosen with our design partners.
Agentic claims & prior auth
Default-deny on out-of-policy reroutes, age cohorts, and high-cost drugs. Reputational and patient-impact scoring designed in.
Clinical decision support
Govern AI suggestions to clinicians under FDA SaMD with continuous outcome monitoring and bias drift alarms.
Pharmacovigilance
Autonomous adverse-event triage with traceability for ICH E2B and FDA FAERS submissions.
Revenue cycle automation
Coding, billing, and denials management with HIPAA-grade audit trails and dollarized exception thresholds.
PHI governance
Inline de-identification, purpose-of-use checks, and time-bounded access - at the agent layer, not the warehouse.
Trial protocol assistants
Constrain LLM authors to IRB-approved templates with citation provenance and audit-grade redlines.
Regulations & frameworks
Built against the standards your auditors live in.
HIPAA
Privacy, Security & Breach Notification
Inline PHI minimisation; documented incident response.
HITRUST CSF v11
Common Security Framework
Designed against 19 HITRUST domains.
FDA SaMD
Software as a Medical Device
Predetermined Change Control Plan support and post-market surveillance evidence.
EU AI Act
High-risk healthcare AI
Article 9–17 obligations from 2 Aug 2026.
NIST AI RMF
Healthcare profile
Bias, fairness, and clinical safety metrics, continuously.
21 CFR Part 11
Electronic records & signatures
WORM event log designed to meet evidentiary standard.
Design partner program
Want to shape how Hootleash works in healthcare & life sciences?
We're working with a small cohort of design partners through 2026 - risk, security, and AI leaders willing to trade input for influence over the first release. If that's you, get in touch.
- Co-design how PHI minimisation and purpose-of-use checks ship at the agent layer
- Access to our regulatory team for FDA SaMD and EU AI Act questions
- Draft evidence templates for HIPAA and HITRUST CSF
- A say in how the v1 risk taxonomy handles clinical-safety severity
Ready when you are
Put your healthcare & life sciences autonomous workflows on a leash, before everyone else does.
We're building Hootleash in private design partnership with a small number of regulated enterprises. If you run autonomous AI in production, get in touch.
Pre-launch · design partner program open · early access 2026