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Audit trail generation for regulatory review

Purpose

 1.1. Ensure comprehensive and tamper-proof records of all compliance-related system activities for Allergy & Immunology practices.
 1.2. Support meeting HIPAA, HITECH, and local regulatory requirements by creating immutable audit logs covering patient interactions, data access, EHR edits, billing, and disclosure.
 1.3. Enable traceability for inspections, legal audits, and internal reviews, spanning clinical and administrative workflows.
 1.4. Facilitate root-cause analysis and corrective action tracking during compliance breaches or suspicious activities.

Trigger Conditions

 2.1. Modification, viewing, creation, or deletion of any protected health information (PHI) within EHR.
 2.2. Authorization or permission changes for user roles related to PHI access.
 2.3. Execution of medical billing or insurance claim submissions.
 2.4. Clinical documentation updates or new allergy test records.
 2.5. User login attempts, failed access, and suspicious account activities.
 2.6. Data export/import, file sharing, or external data sync actions.
 2.7. Scheduled periodic compliance checks (e.g., nightly, weekly).

Platform Variants

 3.1. Google Cloud Audit Logs
  • Function: Enable Audit Logs for Cloud Healthcare API
  • Sample: Configure all write/read/delete operations to trigger log entries.
 3.2. Amazon CloudTrail
  • Function: Enable event history for AWS HealthLake resources
  • Sample: Log API calls for resources storing allergy-related PHI.
 3.3. Microsoft Azure Monitor
  • Function: Configure Diagnostic Settings for Azure API for FHIR
  • Sample: Log create/update/delete for FHIR data types (AllergyIntolerance, Patient).
 3.4. Datadog
  • Feature: Ingest EHR app logs via Pipelines
  • Sample: Configure auto-tagging on "Allergy" field edits.
 3.5. Splunk
  • Feature: HTTP Event Collector for healthcare system events
  • Sample: Store custom logs for PHI access, indexed by user and timestamp.
 3.6. Elastic Stack
  • Feature: Filebeat with custom EHR app log path
  • Sample: Forward allergy record changes into Elasticsearch for audit search.
 3.7. Okta
  • Feature: System Log API
  • Sample: Capture user sign-in and admin privilege escalations.
 3.8. Auth0
  • Feature: Logs Stream
  • Sample: Forward authentication/authorization events to SIEM.
 3.9. Salesforce Health Cloud
  • Function: Field Audit Trail
  • Sample: Enable history tracking for "Allergy Information" custom objects.
 3.10. ServiceNow
  • Feature: Audit History Module
  • Sample: Activate for all compliance-related tables (e.g., allergy workflow tasks).
 3.11. Jira Service Management
  • Feature: Issue History Log
  • Sample: Log compliance ticket edits key to allergy claims.
 3.12. Freshservice
  • Feature: Audit Log API
  • Sample: Log every allergy record access/change by helpdesk agents.
 3.13. DocuSign
  • Feature: Envelope Audit Events
  • Sample: Log signing of patient consent/allergy disclosure forms.
 3.14. Box
  • API: Events endpoint
  • Sample: Monitor document downloads or shares containing allergy records.
 3.15. Dropbox Business
  • API: Team Events
  • Sample: Log viewing/sharing of regulated content.
 3.16. Slack
  • API: Audit Logs API
  • Sample: Track messages/channels where PHI might be posted.
 3.17. PagerDuty
  • Feature: Audit Trail
  • Sample: Log incident creation tied to compliance alerts.
 3.18. Epic EHR
  • Setting: Audit Logs for Chart Access
  • Sample: Capture all allergy chart modifications or opens.
 3.19. Cerner EHR
  • Setting: PowerChart Audit Reports
  • Sample: Log edits on allergy list modules.
 3.20. InterSystems HealthShare
  • Feature: Security Audit Log
  • Sample: Log access to allergy-related HL7 messages.
 3.21. SAP SuccessFactors
  • Feature: Compliance Logging
  • Sample: Track HR compliance workflows connected to allergy clinic staff.

Benefits

 4.1. Strengthens compliance posture and accelerates response to audits.
 4.2. Detects suspicious activity and improper PHI access in real time.
 4.3. Centralizes diverse audit logs for unified search and regulatory response.
 4.4. Minimizes human error in documentation, ensuring full traceability.
 4.5. Reduces legal and financial risk due to precise, verifiable audit histories.

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