hipaa-compliance（健康保险流通与责任法案 (HIPAA) 合规性）

HIPAA Compliance

Implement HIPAA Security Rule, Privacy Rule, and Breach Notification Rule requirements for systems that create, receive, maintain, or transmit electronic Protected Health Information (ePHI).

When to Use

• Building or operating systems that handle electronic Protected Health Information
• Configuring cloud infrastructure for HIPAA-eligible workloads
• Establishing Business Associate Agreements with vendors
• Implementing technical safeguards for PHI protection
• Preparing for HIPAA compliance audits or OCR investigations

HIPAA Rules and Safeguards

security_rule:
  administrative_safeguards:
    164.308_a_1: "Security Management Process"
    actions:
      - Conduct risk analysis (required)
      - Implement risk management program (required)
      - Apply sanction policy for violations (required)
      - Review information system activity (required)

    164.308_a_3: "Workforce Security"
    actions:
      - Authorization/supervision procedures (addressable)
      - Workforce clearance procedure (addressable)
      - Termination procedures (addressable)

    164.308_a_4: "Information Access Management"
    actions:
      - Access authorization policies (addressable)
      - Access establishment and modification (addressable)
      - Isolate healthcare clearinghouse functions (required)

    164.308_a_5: "Security Awareness and Training"
    actions:
      - Security reminders (addressable)
      - Protection from malicious software (addressable)
      - Log-in monitoring (addressable)
      - Password management (addressable)

    164.308_a_6: "Security Incident Procedures"
    actions:
      - Response and reporting procedures (required)

    164.308_a_7: "Contingency Plan"
    actions:
      - Data backup plan (required)
      - Disaster recovery plan (required)
      - Emergency mode operation plan (required)
      - Testing and revision procedures (addressable)
      - Applications and data criticality analysis (addressable)

    164.308_a_8: "Evaluation"
    actions:
      - Periodic technical and nontechnical evaluation (required)

  physical_safeguards:
    164.310_a: "Facility Access Controls"
    164.310_b: "Workstation Use"
    164.310_c: "Workstation Security"
    164.310_d: "Device and Media Controls"

  technical_safeguards:
    164.312_a: "Access Control"
    actions:
      - Unique user identification (required)
      - Emergency access procedure (required)
      - Automatic logoff (addressable)
      - Encryption and decryption (addressable)

    164.312_b: "Audit Controls"
    actions:
      - Implement hardware/software/procedural mechanisms to record and examine access (required)

    164.312_c: "Integrity"
    actions:
      - Mechanism to authenticate ePHI (addressable)

    164.312_d: "Person or Entity Authentication"
    actions:
      - Verify identity of person/entity seeking access (required)

    164.312_e: "Transmission Security"
    actions:
      - Integrity controls (addressable)
      - Encryption (addressable)

privacy_rule:
  minimum_necessary: "Limit PHI use, disclosure, and requests to minimum necessary"
  individual_rights: "Access, amendment, accounting of disclosures, restrictions"
  notice_of_practices: "Provide notice of privacy practices to individuals"

breach_notification_rule:
  individual_notification: "Within 60 days of discovery"
  hhs_notification: "Annual for <500 records; within 60 days for 500+"
  media_notification: "Required when 500+ individuals in a state/jurisdiction"

Technical Safeguards Implementation Checklist

encryption_requirements:
  at_rest:
    standard: AES-256
    aws_services:
      - [ ] RDS encryption enabled (KMS managed key)
      - [ ] S3 bucket default encryption (SSE-KMS)
      - [ ] EBS volume encryption enabled
      - [ ] DynamoDB table encryption (KMS)
      - [ ] ElastiCache encryption at rest enabled
      - [ ] Redshift cluster encryption enabled
      - [ ] EFS encryption enabled
    azure_services:
      - [ ] Azure SQL TDE enabled (customer-managed key)
      - [ ] Storage Account encryption (CMK)
      - [ ] Managed Disk encryption (SSE with CMK)
      - [ ] Cosmos DB encryption at rest
    gcp_services:
      - [ ] Cloud SQL encryption (CMEK)
      - [ ] Cloud Storage encryption (CMEK)
      - [ ] BigQuery encryption (CMEK)
      - [ ] Persistent Disk encryption (CMEK)

  in_transit:
    standard: TLS 1.2 or higher
    checks:
      - [ ] TLS 1.2+ enforced on all load balancers
      - [ ] HTTP-to-HTTPS redirect enabled
      - [ ] Internal service-to-service mTLS configured
      - [ ] Database connections use SSL/TLS
      - [ ] API gateways enforce TLS minimum version
      - [ ] Email encryption for PHI (S/MIME or TLS)
      - [ ] VPN or private connectivity for admin access

  key_management:
    - [ ] Customer-managed KMS keys for PHI data stores
    - [ ] Key rotation enabled (annual minimum)
    - [ ] Key access restricted to authorized roles only
    - [ ] Key usage audited via CloudTrail / audit logs
    - [ ] Key deletion protection enabled

access_control:
  unique_user_identification:
    - [ ] Individual user accounts (no shared credentials)
    - [ ] MFA enforced for all users accessing PHI systems
    - [ ] Service accounts with unique identities and audited usage
    - [ ] Federated identity with SSO (SAML/OIDC)

  role_based_access:
    - [ ] Least privilege roles defined per job function
    - [ ] PHI access restricted to need-to-know
    - [ ] Separate roles for data access vs. administration
    - [ ] Privileged access requires just-in-time approval

  session_management:
    - [ ] Automatic session timeout (15 minutes idle for workstations)
    - [ ] Re-authentication for sensitive operations
    - [ ] Concurrent session limits
    - [ ] Session tokens secured (HttpOnly, Secure, SameSite)

  emergency_access:
    - [ ] Break-glass procedure documented and tested
    - [ ] Emergency access credentials stored securely
    - [ ] All emergency access usage audited and reviewed
    - [ ] Emergency access automatically expires

audit_controls:
  logging_requirements:
    - [ ] All PHI access logged (read, write, delete)
    - [ ] User authentication events logged
    - [ ] Administrative actions logged
    - [ ] Failed access attempts logged
    - [ ] Log integrity protection (hash chaining or WORM storage)
    - [ ] Logs retained for minimum 6 years
    - [ ] Regular log review process documented

  monitoring:
    - [ ] Real-time alerting on unauthorized PHI access attempts
    - [ ] Anomaly detection for unusual data access patterns
    - [ ] Privileged action monitoring
    - [ ] Data export/download alerting

AWS HIPAA-Eligible Architecture

# Verify you are using only HIPAA-eligible AWS services
# Reference: https://aws.amazon.com/compliance/hipaa-eligible-services-reference/

# Create a dedicated VPC for PHI workloads
aws ec2 create-vpc --cidr-block 10.100.0.0/16 \
  --tag-specifications 'ResourceType=vpc,Tags=[{Key=Name,Value=phi-vpc},{Key=Compliance,Value=HIPAA}]'

# Enable VPC flow logs for network auditing
aws ec2 create-flow-log \
  --resource-type VPC \
  --resource-ids vpc-XXXXXXXX \
  --traffic-type ALL \
  --log-destination-type cloud-watch-logs \
  --log-group-name /vpc/phi-flow-logs \
  --deliver-logs-permission-arn arn:aws:iam::123456789012:role/VPCFlowLogsRole

# Create encrypted RDS instance for PHI
aws rds create-db-instance \
  --db-instance-identifier phi-database \
  --db-instance-class db.r6g.large \
  --engine postgres \
  --master-username admin \
  --master-user-password "USE_SECRETS_MANAGER" \
  --storage-encrypted \
  --kms-key-id arn:aws:kms:us-east-1:123456789012:alias/phi-rds-key \
  --vpc-security-group-ids sg-XXXXXXXX \
  --db-subnet-group-name phi-subnet-group \
  --backup-retention-period 35 \
  --multi-az \
  --deletion-protection \
  --enable-cloudwatch-logs-exports '["postgresql","upgrade"]' \
  --tags Key=Compliance,Value=HIPAA Key=DataClassification,Value=PHI

# Create S3 bucket with HIPAA controls
aws s3api create-bucket --bucket phi-data-bucket --region us-east-1

aws s3api put-bucket-encryption --bucket phi-data-bucket \
  --server-side-encryption-configuration '{
    "Rules": [{"ApplyServerSideEncryptionByDefault": {"SSEAlgorithm": "aws:kms", "KMSMasterKeyID": "alias/phi-s3-key"}, "BucketKeyEnabled": true}]
  }'

aws s3api put-public-access-block --bucket phi-data-bucket \
  --public-access-block-configuration BlockPublicAcls=true,IgnorePublicAcls=true,BlockPublicPolicy=true,RestrictPublicBuckets=true

aws s3api put-bucket-versioning --bucket phi-data-bucket \
  --versioning-configuration Status=Enabled

aws s3api put-bucket-logging --bucket phi-data-bucket \
  --bucket-logging-status '{"LoggingEnabled": {"TargetBucket": "phi-access-logs", "TargetPrefix": "phi-data-bucket/"}}'

# Enable CloudTrail data events for PHI buckets
aws cloudtrail put-event-selectors --trail-name hipaa-audit-trail \
  --advanced-event-selectors '[{
    "Name": "PHI-S3-DataEvents",
    "FieldSelectors": [
      {"Field": "eventCategory", "Equals": ["Data"]},
      {"Field": "resources.type", "Equals": ["AWS::S3::Object"]},
      {"Field": "resources.ARN", "StartsWith": ["arn:aws:s3:::phi-data-bucket/"]}
    ]
  }]'

Business Associate Agreement Tracking

baa_tracking:
  required_when:
    - Vendor creates, receives, maintains, or transmits PHI on your behalf
    - Subcontractor of a business associate handles PHI
    - Cloud service provider stores or processes PHI

  not_required_for:
    - Conduit exception (postal service, ISP carrying encrypted data)
    - Treatment providers sharing PHI for treatment purposes
    - Plan sponsor receiving summary health information

  baa_registry:
    format:
      vendor_name: ""
      baa_execution_date: ""
      baa_expiration_date: ""
      phi_types_shared: []
      services_provided: ""
      subcontractors_identified: []
      breach_notification_sla: "hours"
      last_risk_assessment: ""
      next_review_date: ""
      status: "active | pending | expired"

  cloud_provider_baas:
    aws:
      - Sign AWS BAA via AWS Artifact in the console
      - Applies to all HIPAA-eligible services in the account
      - Must restrict PHI to eligible services only
    azure:
      - Microsoft BAA is part of Online Services Terms
      - Automatically applies when using qualifying services
    gcp:
      - Sign Google Cloud BAA via Google Workspace Admin or Cloud console
      - Covers HIPAA-eligible GCP services

  review_schedule:
    - [ ] Annual review of all active BAAs
    - [ ] Verify vendor compliance certifications are current
    - [ ] Confirm subcontractor BAAs are in place
    - [ ] Update BAA registry with any vendor changes
    - [ ] Assess vendor security posture annually

Risk Analysis Automation

#!/usr/bin/env bash
# hipaa-risk-scan.sh - Technical risk analysis checks for HIPAA

echo "=== HIPAA Technical Safeguard Checks ==="

echo "--- Encryption at Rest ---"
# Check for unencrypted RDS instances
UNENCRYPTED_RDS=$(aws rds describe-db-instances \
  --query 'DBInstances[?StorageEncrypted==`false`].DBInstanceIdentifier' --output text)
[ -z "$UNENCRYPTED_RDS" ] && echo "PASS: All RDS instances encrypted" || \
  echo "FAIL: Unencrypted RDS: $UNENCRYPTED_RDS"

# Check for unencrypted S3 buckets
for bucket in $(aws s3api list-buckets --query 'Buckets[*].Name' --output text); do
  enc=$(aws s3api get-bucket-encryption --bucket "$bucket" 2>/dev/null)
  [ -z "$enc" ] && echo "FAIL: S3 bucket $bucket has no default encryption"
done

# Check for unencrypted EBS volumes
UNENCRYPTED_EBS=$(aws ec2 describe-volumes \
  --query 'Volumes[?Encrypted==`false`].VolumeId' --output text)
[ -z "$UNENCRYPTED_EBS" ] && echo "PASS: All EBS volumes encrypted" || \
  echo "FAIL: Unencrypted EBS: $UNENCRYPTED_EBS"

echo "--- Access Control ---"
# Check for users without MFA
aws iam generate-credential-report > /dev/null 2>&1 && sleep 5
aws iam get-credential-report --output text --query Content | base64 -d | \
  awk -F, '$4=="true" && $8=="false" {print "FAIL: User without MFA: "$1}'

# Check for unused access keys (90+ days)
THRESHOLD=$(date -d '90 days ago' +%Y-%m-%dT%H:%M:%S 2>/dev/null || date -v-90d +%Y-%m-%dT%H:%M:%S)
aws iam get-credential-report --output text --query Content | base64 -d | \
  awk -F, -v t="$THRESHOLD" 'NR>1 && $11!="N/A" && $11<t {print "WARN: Stale access key for "$1}'

echo "--- Audit Controls ---"
# Verify CloudTrail is logging
CT_STATUS=$(aws cloudtrail get-trail-status --name hipaa-audit-trail --query 'IsLogging' --output text)
[ "$CT_STATUS" = "True" ] && echo "PASS: CloudTrail active" || echo "FAIL: CloudTrail not logging"

# Verify VPC flow logs
for vpc in $(aws ec2 describe-vpcs --query 'Vpcs[*].VpcId' --output text); do
  fl=$(aws ec2 describe-flow-logs --filter "Name=resource-id,Values=$vpc" --query 'FlowLogs[0].FlowLogId' --output text)
  [ "$fl" = "None" ] && echo "FAIL: No flow logs for VPC $vpc"
done

echo "--- Transmission Security ---"
# Check for ALBs without HTTPS listener
for alb in $(aws elbv2 describe-load-balancers --query 'LoadBalancers[*].LoadBalancerArn' --output text); do
  HTTPS=$(aws elbv2 describe-listeners --load-balancer-arn "$alb" \
    --query 'Listeners[?Protocol==`HTTPS`].ListenerArn' --output text)
  [ -z "$HTTPS" ] && echo "FAIL: ALB without HTTPS: $alb"
done

echo "=== Scan complete ==="

HIPAA Compliance Checklist

hipaa_compliance_checklist:
  administrative:
    - [ ] Risk analysis conducted and documented
    - [ ] Risk management plan implemented
    - [ ] Security officer designated
    - [ ] Privacy officer designated
    - [ ] Workforce security awareness training completed
    - [ ] Sanction policy documented and communicated
    - [ ] Contingency plan (backup, DR, emergency mode) documented
    - [ ] Business associate agreements signed for all applicable vendors
    - [ ] Periodic evaluation/audit scheduled

  technical:
    - [ ] Unique user identification enforced
    - [ ] MFA enabled for all PHI system access
    - [ ] Automatic logoff configured (15-minute timeout)
    - [ ] Encryption at rest (AES-256) for all PHI stores
    - [ ] Encryption in transit (TLS 1.2+) for all PHI transmission
    - [ ] Audit logging enabled for all PHI access
    - [ ] Log retention configured for 6+ years
    - [ ] Integrity controls on PHI (checksums, signatures)
    - [ ] Emergency access (break-glass) procedure tested

  physical:
    - [ ] Facility access controls documented
    - [ ] Workstation use policy in place
    - [ ] Device and media disposal procedures documented
    - [ ] Media re-use procedures documented

  breach_response:
    - [ ] Breach notification procedure documented
    - [ ] Breach risk assessment methodology defined
    - [ ] Individual notification template prepared
    - [ ] HHS notification process understood
    - [ ] Breach log maintained
    - [ ] Annual breach assessment reviewed

  operational:
    - [ ] PHI data inventory maintained
    - [ ] Minimum necessary access enforced
    - [ ] Access reviews conducted quarterly
    - [ ] Vendor risk assessments current
    - [ ] Incident response plan tested annually
    - [ ] Policies reviewed and updated annually

Best Practices

• Conduct a thorough risk analysis annually and after significant system changes
• Use only HIPAA-eligible cloud services and sign BAAs before deploying PHI workloads
• Encrypt all PHI at rest and in transit with no exceptions
• Implement the minimum necessary standard: grant access only to the PHI needed for each role
• Maintain audit logs of all PHI access for a minimum of 6 years
• Train all workforce members on HIPAA policies at onboarding and annually
• Test contingency plans (backup restore, DR failover, emergency access) at least annually
• Track all Business Associate Agreements in a central registry with review dates
• Document every addressable specification decision (implement, alternative, or not applicable with rationale)
• Prepare breach notification templates and procedures before an incident occurs