[Code of Federal Regulations]
[Title 45, Volume 1]
[Revised as of January 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 45CFR164.316]

[Page 742-743]
 
                        TITLE 45--PUBLIC WELFARE
 
                           AND HUMAN SERVICES
 
PART 164_SECURITY AND PRIVACY--Table of Contents
 
Subpart C_Security Standards for the Protection of Electronic Protected 
                           Health Information
 
Sec. 164.316  Policies and procedures and documentation requirements.

    A covered entity must, in accordance with Sec. 164.306:
    (a) Standard: Policies and procedures. Implement reasonable and 
appropriate policies and procedures to comply with the standards, 
implementation specifications, or other requirements of this subpart, 
taking into account those factors specified in Sec. 164.306(b)(2)(i), 
(ii), (iii), and (iv). This standard is not to be construed to permit or 
excuse an action that violates any other standard, implementation 
specification, or other requirements of this subpart. A covered entity 
may change its policies and procedures at any time, provided that the 
changes are documented and are implemented in accordance with this 
subpart.
    (b)(1) Standard: Documentation. (i) Maintain the policies and 
procedures implemented to comply with this subpart in written (which may 
be electronic) form; and
    (ii) If an action, activity or assessment is required by this 
subpart to be documented, maintain a written (which may be electronic) 
record of the action, activity, or assessment.
    (2) Implementation specifications:
    (i) Time limit (Required). 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.
    (ii) Availability (Required). Make documentation available to those 
persons responsible for implementing the procedures to which the 
documentation pertains.

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    (iii) Updates (Required). Review documentation periodically, and 
update as needed, in response to environmental or operational changes 
affecting the security of the electronic protected health information.