Information Security and Risk Assessment Checklist for Business Associates and PHI

This checklist helps you build Protected Health Information Security that meets HIPAA expectations while staying practical for day-to-day operations. It focuses on Business Associate Compliance, a defensible HIPAA Risk Assessment process, and the controls that keep PHI confidential, accurate, and available.

Identification of PHI

Map where PHI lives and moves

• Catalog PHI data elements (names, MRNs, diagnoses, billing details) and classify sensitivity.
• List systems and locations: EHR portals, billing platforms, email, collaboration tools, mobile devices, imaging, logs, and paper files.
• Trace data flows: intake forms, APIs, SFTP, secure messaging, and integrations with downstream vendors.
• Include backups, archives, disaster-recovery replicas, and test environments that contain copied PHI.
• Identify non-obvious sources such as screenshots, spreadsheets, ticketing systems, and voicemail/fax services.

Apply “minimum necessary” at the source

• Limit collection to required fields; mask or tokenize when full identifiers are not needed.
• Label and segregate PHI repositories to simplify Data Access Controls and monitoring.
• Record owners and custodians for each dataset to clarify accountability.

Designated Officers Appointment

Assign accountable leadership

• Designate a Security Official to oversee safeguards, risk management, and Security Incident Response.
• Designate a Privacy Officer to manage HIPAA Privacy Policies, notices, and complaint handling.
• Define written charters, authority to enforce controls, and decision rights for exceptions.
• Name alternates and establish an escalation path for incidents and regulatory inquiries.
• Create a governance forum that includes IT, legal, compliance, operations, and vendor management.

Conducting Risk Assessments

Run a repeatable HIPAA Risk Assessment

• Inventory assets that store or process PHI and map applicable threats (ransomware, insider misuse, misdelivery, lost devices, service outages).
• Identify vulnerabilities (unencrypted endpoints, misconfigurations, weak MFA, unpatched systems, third‑party gaps).
• Evaluate likelihood and impact to confidentiality, integrity, and availability; rate inherent and residual risk.
• Document selected controls, accepted risks with rationale, and remediation owners and timelines.

Cadence and validation

• Perform enterprise-wide assessments at least annually and whenever technology, processes, or vendors change materially.
• Feed results into a living risk register; track closure and verify effectiveness after remediation.
• Exercise Security Incident Response with tabletop scenarios and post-incident reviews to improve readiness.

Policy and Procedure Management

Author, approve, and maintain policies

• Publish HIPAA Privacy Policies and security standards covering access, encryption, device use, vendor risk, incident response, and breach notification.
• Maintain version control, effective dates, approvals, and cross-references to regulatory requirements.
• Translate policies into step-by-step procedures and playbooks that staff can execute.
• Review at least annually, or sooner after incidents, audits, or major system changes.

Employee HIPAA Training

Build role-based competence

• Deliver onboarding and annual refreshers tailored to job duties (clinical, billing, engineering, support).
• Cover PHI handling, minimum necessary, secure messaging, phishing awareness, and reporting obligations.
• Track completion, assess comprehension, and retrain when policies update or gaps appear.
• Reinforce culture with just-in-time tips in tools and periodic phishing or breach simulations.

Business Associate Agreements

Set clear expectations with vendors

• Define permitted and required uses/disclosures of PHI and prohibit unauthorized secondary use.
• Require appropriate administrative, physical, and technical safeguards aligned to HIPAA.
• Mandate prompt breach/security incident reporting with cooperation on investigation and notification.
• Flow down obligations to subcontractors and ensure right-to-audit where PHI is handled.
• Specify termination assistance, PHI return or secure destruction, and data retention limits.
• Evaluate vendors for Business Associate Compliance before contracting and at renewal.

Disaster Recovery Planning

Design for resilience

• Set recovery time objectives (RTO) and recovery point objectives (RPO) for PHI systems.
• Implement encrypted, tested backups; offsite or cross-region replication; and documented failover steps.
• Define emergency mode operations for critical workflows when primary systems are down.

Disaster Recovery Testing

• Conduct regular restoration drills, failover exercises, and tabletop tests; capture lessons and action items.
• Validate that backups are complete, recent, and recoverable; monitor backup success and integrity.
• Coordinate with key vendors to confirm their disaster recovery capabilities and SLAs.

Access Control Implementation

Enforce strong Data Access Controls

• Use least privilege and role-based access; require unique IDs and multi-factor authentication.
• Segment networks and applications to isolate PHI; enable “break-glass” with enhanced logging and review.
• Automate joiner-mover-leaver processes; review access rights at defined intervals.
• Secure endpoints and mobile devices with encryption, MDM, screen locks, and remote wipe.
• Set session timeouts, restrict shared accounts, and limit administrative privileges.

Audit and Monitoring Processes

Detect and respond quickly

• Log access to ePHI, administrative actions, and data exports; retain logs for forensic needs.
• Correlate events in a monitoring platform; alert on abnormal queries, mass downloads, or unusual hours.
• Run periodic audits of user activity in PHI systems and investigate anomalies.
• Integrate monitoring with Security Incident Response workflows and breach assessment criteria.
• Perform vulnerability scanning and, when appropriate, penetration testing to validate defenses.

Documentation and Record-Keeping

Prove what you practice

• Maintain the risk register, assessment reports, remediation evidence, and management approvals.
• Store policies, procedures, training materials, attendance records, and attestation forms.
• Keep BAAs, vendor due diligence, audit results, data maps, and system inventories current.
• Retain incident reports, investigation notes, notifications, and post-incident reviews.
• Archive Disaster Recovery Testing artifacts, backup logs, and restoration results.

Summary

By mapping PHI, assigning accountable officers, running a disciplined HIPAA Risk Assessment, and enforcing policies, training, access controls, monitoring, and recovery, you create a robust, auditable program. This approach advances Business Associate Compliance and sustains Protected Health Information Security across daily operations.

FAQs

What are the key steps in identifying PHI within an organization?

Start with a data map of all intake points, systems, and vendors that touch PHI. List data elements, owners, and flows, including backups and test copies. Classify sensitivity, label repositories, and apply minimum necessary so only required PHI is collected and shared.

How often should risk assessments be conducted for PHI security?

Conduct a comprehensive assessment at least annually and whenever material changes occur—such as new systems, mergers, major configurations, or vendor onboarding. Update the risk register continuously and verify that remediation lowered residual risk.

What are the essential elements of business associate agreements?

BAAs should define permitted uses/disclosures, require appropriate safeguards, mandate timely breach reporting and cooperation, flow down duties to subcontractors, provide audit/assurance rights, and specify termination, PHI return or destruction, and retention limits.

How can organizations ensure compliance with HIPAA training requirements?

Deliver role-based onboarding and annual refreshers, track completion and comprehension, retrain after policy or system changes, and reinforce behavior with simulations and reminders. Keep records of content, attendance, and results to demonstrate compliance.