45 CFR §164.308 Explained: The Full HIPAA Administrative Safeguards List

45 CFR §164.308 is the Administrative Safeguards section of the HIPAA Security Rule. It requires you to put policies, procedures, and workforce measures in place to protect electronic protected health information (ePHI) from threats and misuse.

Each standard includes implementation specifications marked “required” or “addressable.” Addressable does not mean optional—you must implement the control as stated, implement an equivalent alternative, or document why it is not reasonable and appropriate based on your Risk Analysis.

Security Management Process

What this covers

Establish a risk-based security program that identifies, evaluates, and reduces risks to ePHI. This is the foundation of 45 CFR §164.308 and informs the rest of your safeguards.

Implementation specifications (required)

• Risk Analysis: Identify where ePHI resides, threats, vulnerabilities, likelihood, and impact.
• Risk Management: Apply controls to reduce risks to reasonable and appropriate levels.
• Sanction Policy: Define consequences for workforce noncompliance.
• Information System Activity Review: Regularly review audit logs, access reports, and security event data.

How to put it into practice

• Inventory assets and data flows containing ePHI, then perform a formal Risk Analysis at least annually and upon major changes.
• Document a risk register with owners, treatment plans, and deadlines; revisit residual risk after remediation.
• Implement log collection, alerting, and periodic reviews; define escalation for suspicious activity.
• Publish a sanction matrix and enforce it consistently.

Evidence auditors expect

• Current Risk Analysis report and Risk Management plan.
• Policies for sanctions and system activity review.
• Sampled audit reviews, tickets, and remediation artifacts.

Common pitfalls

• Treating Risk Analysis as a one-time project.
• Failing to document rationale for chosen controls or exceptions.
• Collecting logs without reviewing or acting on them.

Assigned Security Responsibility

What this covers

Designate a single security official responsible for developing and implementing policies and procedures required by the Security Rule.

How to put it into practice

• Issue a formal appointment letter describing authority and accountability.
• Establish governance (e.g., security steering group) and reporting to executive leadership.
• Define backup designee and cross-coverage for absences.

Evidence auditors expect

• Organizational chart, job description, and appointment documentation.
• Meeting minutes showing oversight of security initiatives.

Workforce Security

What this covers

Ensure only appropriate members of your workforce have access to ePHI, and remove access promptly when it is no longer needed.

Implementation specifications (addressable)

• Authorization and/or Supervision.
• Workforce Clearance Procedures.
• Termination Procedures.

How to put it into practice

• Define role profiles and Access Authorization workflows with supervisor and data owner approvals.
• Apply Workforce Clearance Procedures proportional to role sensitivity (e.g., background checks for privileged roles).
• Automate offboarding to disable accounts, recover devices, and revoke tokens the moment employment ends.

Evidence auditors expect

• Access request forms or tickets, approval records, and periodic access attestation results.
• Termination checklists and timestamps showing timely deprovisioning.

Common pitfalls

• Granting broad access by default instead of least privilege.
• Incomplete revocation of access across all systems.

Information Access Management

What this covers

Establish and maintain role-based access to ePHI consistent with the minimum necessary standard.

Implementation specifications

• Isolating Healthcare Clearinghouse Function (required, if applicable).
• Access Authorization (addressable).
• Access Establishment and Modification (addressable).

How to put it into practice

• Use an identity and access management process to grant, modify, and revoke access based on roles and documented Access Authorization.
• Segment environments and isolate clearinghouse operations from other functions.
• Run periodic access reviews for critical applications and data repositories.

Evidence auditors expect

• Access control policy, role matrices, and change logs for access establishment and modification.
• Results of quarterly or semiannual access attestations.

Security Awareness and Training

What this covers

Provide ongoing education so your workforce can recognize and prevent security threats.

Implementation specifications (addressable)

• Security Reminders.
• Protection from Malicious Software.
• Log-in Monitoring.
• Password Management.

How to put it into practice

• Deliver onboarding and annual training, with periodic security reminders and targeted refreshers.
• Run phishing simulations and teach reporting; emphasize strong passwords and multi-factor authentication.
• Enable anti-malware, EDR, and alerting; monitor for repeated failed logins and anomalous access.

Evidence auditors expect

• Training curriculum, attendance records, and completion rates.
• Phishing metrics, reminder calendars, and password policy artifacts.

Security Incident Procedures

What this covers

Prepare for, detect, document, and respond to security incidents affecting ePHI. Security Incident Response must be timely and coordinated.

Implementation specification (required)

• Response and Reporting.

How to put it into practice

• Define “security incident,” reporting channels, and 24/7 escalation paths.
• Create playbooks for common scenarios (phishing, ransomware, lost device) and rehearse them.
• Document actions, containment, eradication, recovery, and post-incident lessons learned.

Evidence auditors expect

• Incident response policy, runbooks, and incident tickets with timelines and outcomes.
• Communications templates and after-action reports.

Contingency Plan

What this covers

Ensure you can continue critical operations and protect ePHI during and after disruptions. Prioritize Data Backup and Disaster Recovery Planning aligned to business impact.

Implementation specifications

• Data Backup Plan (required).
• Disaster Recovery Plan (required).
• Emergency Mode Operation Plan (required).
• Testing and Revision Procedures (addressable).
• Applications and Data Criticality Analysis (addressable).

How to put it into practice

• Set RTO/RPO targets; implement immutable and offsite backups; test restores routinely.
• Document Disaster Recovery Planning with step-by-step failover and return-to-service procedures.
• Define how you will operate in emergency mode, including alternate communications and manual workarounds.
• Conduct tabletop and technical exercises; update plans after each test or major change.

Evidence auditors expect

• Backup policies, recent restore test results, and retention schedules.
• Contingency plans, exercise reports, and criticality analysis outputs.

Evaluation

What this covers

Perform periodic technical and nontechnical evaluations to confirm your safeguards meet the Security Rule and remain effective as your environment changes.

How to put it into practice

• Schedule regular evaluations (commonly annual) and additional reviews after significant operational or technology changes.
• Assess policies, technical controls, and evidence; track remediation to closure.

Evidence auditors expect

• Evaluation plan, reports, findings, and remediation trackers.
• Change logs demonstrating trigger-based evaluations.

Business Associate Contracts and Other Arrangements

What this covers

Obtain satisfactory assurances from vendors and partners that handle ePHI. Business Associate Agreements must require appropriate safeguards and breach reporting.

How to put it into practice

• Inventory Business Associates; execute standardized Business Associate Agreements with required terms.
• Perform due diligence and, when appropriate, ongoing oversight of vendors’ security programs.
• Flow down privacy and security obligations to subcontractors that touch ePHI.

Evidence auditors expect

• Executed agreements, vendor inventories, and risk assessments.
• Contract clauses for incident reporting, minimum necessary, and termination rights.

Conclusion

45 CFR §164.308 ties your security program together: start with Risk Analysis, apply role-based access and training, prepare for Security Incident Response and continuity, evaluate regularly, and bind vendors with strong Business Associate Agreements. When you document decisions and test controls, you demonstrate reasonable and appropriate protection of ePHI.

FAQs.

What are the main requirements of 45 CFR §164.308?

The rule lists nine Administrative Safeguards: Security Management Process, Assigned Security Responsibility, Workforce Security, Information Access Management, Security Awareness and Training, Security Incident Procedures, Contingency Plan, Evaluation, and Business Associate Contracts and Other Arrangements. Together they require Risk Analysis, risk treatment, Access Authorization controls, training, Security Incident Response, continuity planning, ongoing evaluations, and Business Associate Agreements.

How does HIPAA define workforce security?

Workforce security requires policies and procedures to ensure appropriate workforce access to ePHI and to prevent unauthorized access. It covers authorization/supervision, Workforce Clearance Procedures, and termination steps so people have only the minimum access they need—and lose it as soon as they no longer need it.

What procedures are required for security incident response?

HIPAA requires response and reporting procedures. You must detect and escalate incidents, contain and mitigate impact, document actions and outcomes, and report as your policies, contracts, and applicable law dictate. Maintaining playbooks, roles, communication templates, and post-incident reviews is essential.

How often should security evaluations be conducted under HIPAA?

The regulation requires periodic evaluations and additional evaluations when environmental or operational changes affect security. Many organizations perform formal evaluations at least annually, then run targeted reviews after significant system changes, migrations, or new threats are identified.