45 CFR 164.316 — HIPAA Security Rule: Policies and procedures and documentation requirements

What this rule requires your agency to do

• 1A covered entity or business associate must maintain a written (which may be electronic) record of any action, activity, or assessment that the subpart requires to be documented (§ 164.316(b)(1)(ii)).(45 CFR 164.316 — HIPAA Security Rule: Policies and procedures and documentation requirements)
• 2A covered entity or business associate must make documentation available to those persons responsible for implementing the procedures to which it pertains (§ 164.316(b)(2)(ii)).(45 CFR 164.316 — HIPAA Security Rule: Policies and procedures and documentation requirements)
• 3A covered entity or business associate must retain required documentation for 6 years from the date of its creation or the date when it last was in effect, whichever is later (§ 164.316(b)(2)(i)).(45 CFR 164.316 — HIPAA Security Rule: Policies and procedures and documentation requirements)
• 4A covered entity or business associate may change its policies and procedures at any time, provided the changes are documented and implemented in accordance with the subpart (§ 164.316(a)).(45 CFR 164.316 — HIPAA Security Rule: Policies and procedures and documentation requirements)
• 5A covered entity or business associate must implement reasonable and appropriate policies and procedures to comply with the standards, implementation specifications, and other requirements of the Security Rule subpart, taking into account the § 164.306(b)(2) factors (§ 164.316(a)).(45 CFR 164.316 — HIPAA Security Rule: Policies and procedures and documentation requirements)
• 6A covered entity or business associate must maintain its Security Rule policies and procedures in written (which may be electronic) form (§ 164.316(b)(1)(i)).(45 CFR 164.316 — HIPAA Security Rule: Policies and procedures and documentation requirements)
• 7A covered entity or business associate must review documentation periodically and update it as needed in response to environmental or operational changes affecting the security of the electronic PHI (§ 164.316(b)(2)(iii)).(45 CFR 164.316 — HIPAA Security Rule: Policies and procedures and documentation requirements)