Healthcare

AI agent governance for healthcare and life sciences

AI agents handling PHI, clinical decisions, and EHR integrations need governance that matches the stakes. Roval gives you HIPAA compliance tracking, PHI detection in every prompt, and audit trails for every agent interaction.

Request detail: triage-assistant
Prompt content
Summarize recent notes for patient Sarah Chen, MRN 00847123. Diagnosis: Type 2 diabetes.
phi-protection Blocked
patient-name Sarah Chen
mrn 00847123
diagnosis Type 2 diabetes
The problem

Healthcare AI moves fast. Compliance can't afford to move slow.

AI agents in healthcare don't just process data. They influence clinical decisions, handle PHI, and interact with systems where errors have patient safety consequences.

"HIPAA requires audit trails for every system that touches PHI. Most organizations can't tell you which of their AI agents have access to patient data, let alone log every interaction."

"Clinical AI agents that call external LLM APIs send patient context (diagnoses, medications, lab results) in their prompts. Without interception, PHI leaves your network with every API call."

"FDA 21 CFR Part 11 requires electronic records to be tamper-proof and attributable. AI agent logs stored in application databases don't meet this bar."

Regulatory frameworks for healthcare

Pre-mapped requirements for every framework you need.

Pre-mapped requirements for healthcare AI governance. Activate and track evidence per requirement.

US
HIPAA hipaa

PHI access controls, audit trail requirements, breach notification, and minimum necessary standard for AI agents.

Active
16 requirements Healthcare
US
FDA 21 CFR Part 11 fda-21cfr11

Electronic records and signatures: tamper-proof audit trails, user attribution, and system validation for clinical AI.

Active
12 requirements Clinical systems
Industry
SOC 2 Type II soc2-type-ii

Trust service criteria for healthcare SaaS, required by hospital systems and health plans.

Active
18 requirements Annual audit
EU
GDPR gdpr

Patient data processing, consent management, and right to explanation for AI systems in EU healthcare.

14 requirements Data protection
Industry
ISO 42001 iso-42001

AI management system standard: governance and risk management for clinical AI deployments.

31 requirements AIMS certification
US
NIST AI RMF nist-ai-rmf

Risk management framework for clinical AI: trustworthiness dimensions mapped to patient safety.

22 requirements Risk management
Pre-built policies for healthcare

Enforce PHI protection and clinical safety from day one.

Enforce PHI protection, clinical safety, and audit compliance from day one.

PHI detection and blocking

Scans every prompt for patient identifiers (names, MRNs, SSNs, dates of birth, diagnosis codes). Blocks PHI from reaching external model APIs.

Active
12 blocked · 14 sensitive · 4 read-only
Clinical decision audit trail

Enforces logging for every agent interaction that could influence clinical decisions. Tamper-proof timestamps and user attribution.

Active
8 blocked · 10 sensitive · 6 read-only
EHR integration controls

Restricts which agents can read from and write to EHR systems. Enforces minimum necessary access and role-based permissions.

14 blocked · 8 sensitive · 12 read-only
Prescription and medication safety

Guards against agents making dosage calculations or drug interaction checks without human oversight confirmation.

10 blocked · 6 sensitive · 4 read-only
Research data governance

Enforces de-identification rules for AI agents processing research datasets. IRB protocol compliance tracking.

7 blocked · 9 sensitive · 8 read-only
Breach notification readiness

Monitors for PHI exposure events and generates breach assessment documentation within the 60-day HIPAA notification window.

5 blocked · 8 sensitive · 3 read-only
How it works

Built for the specific demands of clinical AI.

PHI detection in every prompt

Every prompt scanned for 18 PHI pattern types before it leaves your network. Emails, phone numbers, MRNs, diagnosis codes, medication names, flagged and blocked in real time.

Request detail: triage-assistant
Prompt content
Summarize recent notes for patient Sarah Chen , MRN 00847123 . Diagnosis: Type 2 diabetes, Stage 2 CKD . Review last 30 days of labs.
phi-protection Violated
patient-name Sarah Chen
mrn 00847123
diagnosis-code Type 2 diabetes, Stage 2 CKD

Agent inventory with clinical context

Know which agents handle PHI, which departments own them, and what data they can access. When a clinician leaves, their agents surface immediately.

Clinical agent inventory
Agent Department Data access Risk
ehr-summarizer Clinical ops PHI Critical
triage-assistant Emergency PHI Critical
lab-interpreter Pathology De-identified High
discharge-planner Care coord. None Low

Continuous HIPAA compliance

Track compliance posture in real time across HIPAA, FDA, and SOC 2. Drift detection every 15 minutes. Certification auto-expiry with escalating alerts.

Compliance posture
HIPAA
92%
FDA 21 CFR
88%
SOC 2
100%
PHI access policy expired for triage-assistant

Start governing your healthcare AI agents

Request early access. HIPAA compliance tracking and PHI detection from day one.

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