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HIPAA Compliance

This guide outlines how the PaiTIENT Secure Model Service helps you meet HIPAA compliance requirements when deploying and using AI models in healthcare contexts.

HIPAA Overview

The Health Insurance Portability and Accountability Act (HIPAA) establishes standards for protecting sensitive patient health information. The PaiTIENT Secure Model Service is designed to help covered entities and business associates maintain HIPAA compliance when leveraging AI models.

Key HIPAA Requirements

The PaiTIENT platform addresses key HIPAA requirements:

Privacy Rule

The HIPAA Privacy Rule establishes standards for the protection of Protected Health Information (PHI).

RequirementPaiTIENT Implementation
Minimum Necessary UseData minimization techniques in prompts and responses
De-identificationAutomatic PHI detection and redaction capabilities
Use LimitationRole-based access controls for model deployments
Patient RightsAudit trails for tracking PHI access and usage

Security Rule

The HIPAA Security Rule establishes safeguards for electronic PHI (ePHI).

RequirementPaiTIENT Implementation
Administrative SafeguardsRole-based access control, security policies
Physical SafeguardsSecure data center with physical access controls
Technical SafeguardsEncryption, access controls, authentication
Organizational SafeguardsBusiness Associate Agreements, documentation

Breach Notification Rule

RequirementPaiTIENT Implementation
Breach DetectionReal-time monitoring and alerting
Notification ProceduresIncident response protocols
Risk AssessmentTools for evaluating potential breach impact

HIPAA-Compliant Deployment

Core Security Features

The PaiTIENT platform includes these HIPAA-specific security features:

  1. Hybrid Encryption: AES-256-GCM with post-quantum key encapsulation
  2. Network Isolation: Client-specific VPCs and private endpoints
  3. Access Controls: Role-based access with fine-grained permissions
  4. Audit Logging: Comprehensive logging of all operations
  5. PHI Detection: Automatic detection and protection of PHI
  6. Business Associate Agreement: PaiTIENT offers a HIPAA BAA

Enabling HIPAA Mode

Enable HIPAA compliance mode to activate all required security controls:

python
# Python example
from paitient_secure_model import Client
from paitient_secure_model.security import SecuritySettings, ComplianceSettings

client = Client(
    security_settings=SecuritySettings(
        compliance=ComplianceSettings(
            hipaa=True,  # Enable HIPAA mode
            audit_logging=True,
            log_retention_days=365,  # 1 year retention
            phi_detection=True
        )
    )
)

# Create a HIPAA-compliant deployment
deployment = client.create_deployment(
    model_name="ZimaBlueAI/HuatuoGPT-o1-8B",
    deployment_name="hipaa-clinical-assistant",
    compute_type="gpu",
    instance_type="g4dn.xlarge",
    security_settings=SecuritySettings(
        network_isolation=True,
        private_endpoints=True,
        encryption_level="maximum"
    ),
    vpc_config={
        "subnet_ids": ["subnet-abc123", "subnet-def456"],
        "security_group_ids": ["sg-123456"]
    },
    tags={
        "compliance": "hipaa",
        "data-sensitivity": "phi"
    }
)
javascript
// Node.js example
const { PaiTIENTClient } = require('paitient-secure-model');
const { SecuritySettings, ComplianceSettings } = require('paitient-secure-model/security');

const client = new PaiTIENTClient({
  securitySettings: new SecuritySettings({
    compliance: new ComplianceSettings({
      hipaa: true,  // Enable HIPAA mode
      auditLogging: true,
      logRetentionDays: 365,  // 1 year retention
      phiDetection: true
    })
  })
});

// Create a HIPAA-compliant deployment
async function createHipaaDeployment() {
  try {
    const deployment = await client.createDeployment({
      modelName: "ZimaBlueAI/HuatuoGPT-o1-8B",
      deploymentName: "hipaa-clinical-assistant",
      computeType: "gpu",
      instanceType: "g4dn.xlarge",
      securitySettings: new SecuritySettings({
        networkIsolation: true,
        privateEndpoints: true,
        encryptionLevel: "maximum"
      }),
      vpcConfig: {
        subnetIds: ["subnet-abc123", "subnet-def456"],
        securityGroupIds: ["sg-123456"]
      },
      tags: {
        compliance: "hipaa",
        "data-sensitivity": "phi"
      }
    });
    
    console.log(`HIPAA-compliant deployment created: ${deployment.id}`);
  } catch (error) {
    console.error('Deployment failed:', error);
  }
}

PHI Protection Features

PHI Detection and Redaction

The platform can automatically detect and redact PHI in prompts and responses:

python
# Python example
response = client.generate_text(
    deployment_id="dep_12345abcde",
    prompt="Patient John Smith (DOB: 01/15/1965) has been diagnosed with type 2 diabetes.",
    security_settings=SecuritySettings(
        phi_detection=True,
        phi_redaction=True
    )
)

# The prompt is processed as:
# "Patient [REDACTED NAME] (DOB: [REDACTED DATE]) has been diagnosed with type 2 diabetes."

PHI Handling Modes

The platform supports different PHI handling modes:

  1. Detect Only: Identifies PHI but doesn't modify content
  2. Redact: Replaces PHI with placeholders like [REDACTED]
  3. Reject: Rejects requests containing PHI
  4. De-identify: Replaces PHI with synthetic data
python
# Python example with de-identification
response = client.generate_text(
    deployment_id="dep_12345abcde",
    prompt="Patient John Smith (DOB: 01/15/1965) has been diagnosed with type 2 diabetes.",
    security_settings=SecuritySettings(
        phi_handling="de-identify"
    )
)

# The prompt is processed as:
# "Patient Jane Doe (DOB: 02/22/1970) has been diagnosed with type 2 diabetes."

Audit and Compliance Reporting

Comprehensive Audit Logs

HIPAA compliance requires detailed audit logs:

python
# Python example for retrieving audit logs
audit_logs = client.get_audit_logs(
    start_time="2023-11-01T00:00:00Z",
    end_time="2023-11-30T23:59:59Z",
    filter={
        "deployment_id": "dep_12345abcde",
        "event_type": ["model.inference", "phi.detection"]
    }
)

for log in audit_logs:
    print(f"Event: {log.event_type}, Time: {log.timestamp}, User: {log.user_id}")

Compliance Reports

Generate compliance reports for auditing purposes:

python
# Python example for generating compliance reports
report = client.generate_compliance_report(
    report_type="hipaa",
    time_period="last_30_days",
    include_sections=[
        "phi_access",
        "security_events",
        "authentication_events",
        "user_activity"
    ],
    output_format="pdf"
)

print(f"Report generated: {report.url}")

Business Associate Agreement

PaiTIENT offers a Business Associate Agreement (BAA) for covered entities and business associates. Contact your account representative to establish a BAA.

Technical Safeguards for HIPAA

Access Controls

Implement proper access controls:

python
# Python example for role-based access control
from paitient_secure_model import Client
from paitient_secure_model.security import SecuritySettings, AccessControlSettings

client = Client(
    security_settings=SecuritySettings(
        access_control=AccessControlSettings(
            require_mfa=True,
            session_timeout_minutes=15,
            concurrent_sessions_limit=1,
            ip_restrictions=["10.0.0.0/8"]
        )
    )
)

# Create a role with restricted permissions
client.create_role(
    name="clinical-viewer",
    permissions=[
        "model:read",
        "deployment:read",
        "text:generate"
    ],
    resource_pattern="deployment/hipaa-*"
)

# Assign the role to a user
client.assign_role(
    user_id="user_12345",
    role_name="clinical-viewer"
)

Transmission Security

Ensure secure data transmission:

python
# Python example for secure transmission settings
client = Client(
    security_settings=SecuritySettings(
        transmission_security={
            "enforce_tls_1_2_plus": True,
            "secure_ciphers_only": True,
            "hsts_enabled": True
        }
    )
)

Emergency Access

Configure emergency access procedures:

python
# Python example for emergency access configuration
client = Client(
    security_settings=SecuritySettings(
        emergency_access={
            "enabled": True,
            "authorized_roles": ["security-admin", "compliance-officer"],
            "require_multi_approval": True,
            "access_duration_hours": 4
        }
    )
)

HIPAA Compliance Checklist

Before using the PaiTIENT platform with PHI, ensure you've addressed these key areas:

  • [ ] BAA: Business Associate Agreement in place
  • [ ] HIPAA Mode: HIPAA compliance mode enabled
  • [ ] Network Security: Private endpoints, VPC configuration
  • [ ] Access Controls: Role-based access with least privilege
  • [ ] Encryption: Data encrypted at rest and in transit
  • [ ] Audit Logging: Comprehensive logging configured
  • [ ] PHI Protection: PHI detection and handling configured
  • [ ] Incident Response: Breach notification procedures in place
  • [ ] Training: Staff trained on HIPAA requirements
  • [ ] Documentation: Policies and procedures documented

Next Steps

Released under the MIT License.