Reasonable Safeguards Checklist: Reduce Risk of Accidental PHI Exposure

This checklist helps you put practical, reasonable safeguards in place to reduce accidental exposure of protected health information (PHI) and electronic protected health information across everyday workflows. It aligns administrative safeguards, technical safeguards, and physical safeguards so your HIPAA compliance policies work in real life, not just on paper.

Conduct Thorough Risk Analysis

Map where PHI and electronic protected health information are created, received, maintained, and transmitted. Trace data flows across your EHR, email, patient portals, cloud apps, mobile devices, printers, and third parties to reveal exposure points such as misdirected messages, misconfigurations, or unattended screens.

• Identify threats and vulnerabilities: human error, social engineering, lost devices, improper disposal, overbroad access, and insecure file sharing.
• Assess likelihood and impact to prioritize risks that could cause unauthorized disclosure, alteration, or loss of availability.
• Produce actionable risk assessment documentation that lists each risk, owner, due date, selected controls, and acceptance criteria.
• Revisit the analysis whenever systems, workflows, vendors, or regulations change, and after any security incident.

Validate assumptions with frontline staff. Short “walking audits” often uncover simple fixes—like relocating printers or enabling automatic logoff—that cut risk quickly.

Implement Risk Management Strategies

Translate your findings into a time-bound plan that blends administrative, technical, and physical safeguards. Tackle high-risk items first, then work down the list while tracking progress visibly.

• Administrative safeguards: formal HIPAA compliance policies, procedures for access requests, incident response, vendor due diligence and BAAs, and targeted role-based training.
• Technical safeguards: strong authentication and MFA, least-privilege access, encryption in transit and at rest, device management, email protection, DLP, automatic logoff, and audited “break-glass” workflows.
• Physical safeguards: badge-controlled areas, privacy screens, locked storage, clean-desk practices, secure printing and shredding, and visitor controls.

Stand up security incident tracking to record events, root causes, and corrective actions. Trend the data monthly to verify that controls are reducing near-misses and misdirected disclosures.

Enforce Sanction Policies

Your sanction policy should define prohibited behaviors, match consequences to severity and intent, and require fair, consistent application. Staff must attest to policy receipt during onboarding and after major updates.

• Use progressive discipline: coaching and retraining for minor errors; written warnings, suspension, or termination for reckless or repeated violations.
• Document every event in security incident tracking and the HR record, including evidence, decisions, and remediation steps.
• Incorporate privacy-by-design feedback so systemic issues are fixed, not just individual behavior.

Consistent enforcement reinforces culture and deters shortcuts that expose PHI.

Review Information System Activity Regularly

Establish routine, risk-based reviews of audit logs to detect inappropriate access, data exfiltration, or configuration drift. Monitor your EHR, IAM, email, VPN, cloud storage, and endpoint protection tools.

• Automate alerts for unusual access patterns, bulk record views, after-hours spikes, failed logins, and use of emergency “break-glass.”
• Correlate signals in a central dashboard; investigate and document outcomes in security incident tracking.
• Retain logs for a defined period, synchronize system time, and periodically test alert fidelity with tabletop exercises.
• Use sampling and focused audits to verify that the minimum necessary standard is being met in daily operations.

Assign Security Official

Designate a Security Official with authority and resources to run your program. This role oversees risk analysis, control implementation, policy lifecycle, incident response, training, and vendor management.

• Form a cross-functional security and privacy committee to review metrics, approve exceptions, and unblock remediation work.
• Publish an annual security plan with KPIs (e.g., training completion, time-to-close incidents, percent of high risks mitigated) and report results to leadership.
• Name an alternate to ensure continuity during absences and emergencies.

Ensure Workforce Security

Protect PHI by controlling who gets access, when they get it, and how quickly it’s removed. Build these controls into everyday HR and IT processes.

• Pre-hire screening appropriate to role; role-based onboarding with least-privilege access and MFA from day one.
• Role changes trigger prompt access reviews; terminations trigger immediate revocation and device return.
• Ongoing training that emphasizes real scenarios—faxing to wrong numbers, misaddressed email, or shared credentials—and how to prevent them.
• Device hygiene: encryption, screen locks, automatic logoff, and protections for remote or hybrid work.

Apply Minimum Necessary Policies

Operationalize the minimum necessary standard so staff access only the PHI needed to perform their duties, except where treatment or specific legal requirements justify broader access.

• Define role-based access profiles; restrict sensitive data elements by default and require justification for exceptions.
• Use limited data sets or de-identified data for analytics and training when full PHI is not required.
• Enforce technical controls that curb over-sharing: DLP rules, print controls, secure messaging, and time-limited links.
• Require justification for “break-glass” access and review those events in your audit program.
• Standardize disclosure workflows to third parties and verify identity before releasing information.

In summary, you reduce accidental PHI exposure by pairing solid risk assessment documentation with concrete controls, continuous monitoring, enforced sanction policies, and day-to-day practices that keep administrative safeguards, technical safeguards, and physical safeguards working together.

FAQs

What are reasonable safeguards to protect PHI?

Reasonable safeguards combine policies, technology, and facility practices that measurably lower the chance of accidental disclosure. Examples include role-based access and MFA for electronic protected health information, privacy screens and secure printing, staff training with confirmed understanding, encryption for data in transit and at rest, automatic logoff on shared workstations, standardized disclosure procedures, and security incident tracking that feeds continuous improvement.

How often should risk assessments be conducted?

Perform a comprehensive risk analysis at least annually and whenever you introduce new systems, change critical workflows, onboard a major vendor, experience a significant incident, or undergo mergers and reorganizations. Update your risk assessment documentation after each review, capture residual risk decisions, and verify that mitigation plans are on track.

What actions are taken for non-compliance with PHI policies?

Actions follow your sanction policy and the facts of the case. Typical steps include coaching and retraining for inadvertent, low-impact errors; written warnings for policy breaches; suspension or termination for reckless, repeated, or intentional violations. Every case is documented, tied to HIPAA compliance policies, and logged in security incident tracking with corrective actions to prevent recurrence.

How is information system activity monitored?

Audit logs from the EHR, identity systems, email, network, and cloud services feed dashboards or a SIEM. You set alerts for anomalies such as mass record access, unusual export activity, failed logins, and emergency overrides. Analysts review alerts, perform root cause analysis, document outcomes, and tune rules. Periodic sampling validates that minimum necessary policies are working and that technical safeguards and physical safeguards are functioning as intended.