164.316(b)(2) Policies and Procedures

Time Limit

Medium Risk Moderate Implementation Medium Cost

Retain the documentation required by paragraph (b)(1) of this section for 6 years from the date of its creation or the date when it last was in effect, whichever is later.

Implementation Guidance

Implement comprehensive retention procedures including retention schedules, storage requirements, and disposal procedures.

Required Documentation

Retention schedules, storage procedures, disposal procedures, record management procedures.

Best Practices

Comprehensive retention schedules, effective storage procedures, proper disposal procedures, systematic record management.

Common Violations

Inadequate retention schedules, poor storage procedures, insufficient disposal procedures, lack of record management.

Testing Procedures

Review retention schedules, test storage procedures, verify disposal procedures, assess record management.

Audit Considerations

Retention schedule compliance, storage procedure effectiveness, disposal procedure implementation, record management processes.

NIST Cybersecurity Framework Alignment

This HIPAA control aligns with the following NIST Cybersecurity Framework functions and controls:

Identify (ID)

ID.AM-1: Physical devices and systems within the organization are inventoried
ID.AM-2: Software platforms and applications within the organization are inventoried
ID.AM-3: Organizational communication and data flows are mapped

Protect (PR)

PR.AC-1: Identities and credentials are issued, managed, verified, revoked, and audited
PR.AC-3: Remote access is managed
PR.DS-1: Data-at-rest is protected
PR.DS-2: Data-in-transit is protected

Detect (DE)

DE.AE-1: A baseline of network operations and expected data flows is established
DE.CM-1: The network is monitored to detect potential cybersecurity events
DE.CM-3: Personnel activity is monitored to detect potential cybersecurity events

Respond (RS)

RS.CO-1: Personnel know their roles and order of operations when a response is needed
RS.CO-2: Incidents are reported consistent with established criteria
RS.AN-1: Notifications from detection systems are investigated

Recover (RC)

RC.RP-1: Recovery plan is executed during or after a cybersecurity incident
RC.IM-1: Recovery plans incorporate lessons learned
RC.CO-1: Public relations are managed

Note: This mapping provides a general alignment between HIPAA controls and NIST Framework functions. Specific implementation may vary based on your organization's risk profile and compliance requirements.

Implementation Templates & Checklists

Download our expert-developed templates and checklists to implement this control effectively:

Implementation Checklist

Step-by-step checklist to ensure complete implementation of this control

Download Checklist

Policy Template

Ready-to-customize policy template for this specific control

Download Template

Risk Assessment Form

Comprehensive risk assessment form for this control

Download Form

Training Materials

Staff training materials and awareness resources

Download Materials

Expert Implementation Recommendations

Based on our experience with 500+ healthcare organizations, here are our expert recommendations for implementing this control:

High Priority

Start with Risk Assessment

Conduct a comprehensive risk assessment to identify specific vulnerabilities and threats related to this control. This will help prioritize implementation efforts and allocate resources effectively.

Identify all systems and data covered by this control
Assess current security measures and gaps
Evaluate potential impact of security incidents
Document findings and remediation priorities

Medium Priority

Develop Comprehensive Policies

Create detailed policies and procedures that address all aspects of this control. Ensure policies are specific, actionable, and aligned with your organization's risk profile.

Define roles and responsibilities clearly
Establish approval workflows and escalation procedures
Include specific technical requirements and standards
Regular review and update schedules

Low Priority

Implement Monitoring and Testing

Establish ongoing monitoring and testing procedures to ensure the control remains effective over time. Regular testing helps identify new vulnerabilities and compliance gaps.

Automated monitoring where possible
Regular manual testing and validation
Incident response procedures
Continuous improvement processes

Recommended Implementation Timeline

Week 1-2: Assessment & Planning

Conduct risk assessment and develop implementation plan

Week 3-4: Policy Development

Create and review policies and procedures

Week 5-8: Implementation

Deploy technical controls and train staff

Week 9-10: Testing & Validation

Test controls and validate compliance

Related Controls

164.316(a) - Policies and Procedures, 164.316(b)(1) - Documentation

Control ID: 164.316(b)(2)

Category: Policies and Procedures

Subcategory: Documentation

Risk Level: Medium

Difficulty: Moderate

Cost: Medium

Timeframe: 1-3 months

Last Updated: Dec 6, 2025