A complete regulatory operating system for AI systems — from raw data to governance, liability, and insurance.
Real-time regulatory data across every major jurisdiction. Structured, classified, and ready for machine consumption by every layer above.
RegWatch monitors FDA, CMS, HIPAA, all 50 state medical boards, EU MDR, and GDPR health provisions in real time — delivering a structured feed of every regulatory change relevant to CareFlow's appointment booking, prescription management, and post-operative care agents.
Change timeseries and structured regulatory context. The raw feed — what changed, when, where, and what it means.
Jurisdiction-aware memory and RL environments. Regulations expressed as constraints for training and runtime context.
Evals, test scenarios, scoring models, and compliance forecasts. Feeds release gates and liability estimation.
Explainability layer, evidence collection, and structured decision logs. Why the agent decided what it did — feeds L5 Audit directly.
A new CMS telehealth billing rule triggers an alert. CareFlow's billing agent gets an updated constraint within hours.
The appointment agent tracks California CMIA and Texas HB 300 simultaneously — two different consent regimes, automatically resolved.
The prescription agent scores 0.78 compliance risk against the EU. Forecasting flags MDR certification as a blocker for the Q3 launch.
Every prescription decision is logged with the regulatory context active at decision time — ready for FDA complaint response.
Reg context injection, MCP server, jurisdiction memory for live agents.
RegOps gate, geo-specific deploy checks, pre-release compliance pass/fail.
Contract monitoring, document compliance, data governance agents.
Continuous re-evaluation when underlying models change post-deployment.
Automated stop conditions, kill switches, confidence threshold triggers.
Agent-to-agent and human-agent provenance, signed payloads, injection prevention.
Guardrail enforcement, shadow AI detection, trust boundary management.
Live monitoring of agent behavior against regulatory expectations.
Future opportunities, competitive risk analysis, scenario-led roadmap decisions.
Regulatory trust positioning, market entry signals, jurisdiction readiness.
Anticipate regulatory risk, contract updates, governance sign-off trail.
Continuous monitoring, structured reporting, cross-jurisdiction coverage.
Prescription agent auto-pauses if confidence drops below threshold or jurisdiction mismatch is detected.
All agent-to-EHR messages are signed — injection attacks cannot alter prescriptions.
When the LLM vendor updates the model, CareFlow's test suite re-runs automatically.
Live dashboard shows which agents are operating within regulatory bounds.
CMS reimbursement expansion identified as opportunity for a new billing module.
Cleared to promote HIPAA-certified status in three new states after automated compliance checks.
Updated consent language automatically generates contract redlines.
Continuous monitoring across all states with automated reporting.
Sets and enforces guardrail policies. Updates propagate automatically to all deployment environments.
Jurisdiction-specific rule enforcement. Ensures agents behave correctly where regulations differ.
Oversees the full arc — conceptualization, approval, deployment, and ongoing operations.
Prepares evidence packages and decision logs for external auditors. Bridges L3 to L5.
Failure mode registry, regulatory notification SLAs (DORA 72h, HIPAA breach), fallback behavior definitions, and post-incident reporting templates.
Maps each agent action class to a responsible party — developer, deployer, operator, or user — using EU AI Act provider/deployer definitions. Machine-readable for insurers.
When the post-op care agent fails mid-session, the recovery protocol notifies the patient, logs the incident, and files a HIPAA breach report within the 60-day window — automatically.
A prescription error is traced: the LLM vendor owns the model failure, CareFlow owns the deployment decision, and the prescribing physician owns the final sign-off. Machine-readable for insurers.
External verification of agent behavior against regulatory expectations using observability and decision log data from L2.
Compliance estimation across jurisdictions. Feeds from audit findings, legal sign-offs, and the liability ownership map in L4.
Regulatory exposure quantified for underwriting. Receives from the liability chain or directly from governance via the evidence package.
External continuity verification. Validates that recovery protocols meet regulatory SLAs and that fallback behavior is certified compliant.
External auditor verifies the appointment agent accessed no records outside permitted scope. Zero violations across 2.3M interactions.
EU MDR certification confirmed for the post-op agent. Q3 EU launch unblocked. Liability: €0.2M vs €4.8M unmitigated.
Prescription agent underwritten at 0.4% annual premium — 60% below market rate for unaudited AI systems.
CareFlow's recovery SLA certified at 4-hour RTO — satisfying HIPAA continuity requirements and state medical board standards.
1000+ regulators monitored continuously — consultation papers, draft rules, and enforcement signals delivered before they become obligations.
