Documentation
164.316(b)(1)
Policies and Procedures
High Risk
Moderate
Maintain the policies and procedures implemented to comply with this subpart in written (which may be electronic) form.
Implementation Guidance
Maintain comprehensive documentation of all policies and procedures including version control, access controls, and retention requirements.
NIST References
NIST SP 800-66 Rev. 2: Section 3.5.2
Best Practices
Comprehensive documentation, effective version control, proper access controls, appropriate retention policies.
Testing Procedures
Review documentation completeness, test version control, verify access controls, assess retention policies.
Frequently Asked Questions
Q: What documentation is required? A: All policies and procedures must be maintained in written or electronic form with proper controls.
Control Information
Control ID:
164.316(b)(1)
164.316(b)(1)
Category:
Policies and Procedures
Policies and Procedures
Subcategory:
Documentation
Documentation
Risk Level:
High
High
Implementation Difficulty:
Moderate
Moderate
Estimated Cost:
Medium
Medium
Implementation Timeframe:
2-4 months
2-4 months
Views:
3
3
Last Updated:
Oct 1, 2025
Oct 1, 2025
Related Controls
Additional Resources
NIST SP 800-66 Rev. 2: Documentation Guidance, HHS Documentation Guidance, Documentation Management Best Practices