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    HIPAA Regulations: Security Standards for the Protection of Electronic PHI: Policies and Procedures and Documentation Requirements - § 164.316

    As Contained in the HHS HIPAA Security Rules

     

    HHS Regulations as Amended January 2013
    Security Standards for the Protection of Electronic PHI: Policies and Procedures and Documentation Requirements - § 164.316

     

    A covered entity or business associate must, in accordance with §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 §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 or business associate 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.

    (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.

     

    HHS Description
    Security Standards for the Protection of Electronic PHI: Policies and Procedures and Documentation Requirements

     

    We proposed requiring documented policies and procedures for the routine and nonroutine receipt, manipulation, storage, dissemination, transmission, and/or disposal of health information. We proposed that the documentation be reviewed and updated periodically.

    We have emphasized throughout this final rule the scalability allowed by the security standards. This final rule requires covered entities to implement policies and procedures that are reasonably designed, taking into account the size and type of activities of the covered entity that relate to electronic protected health information, and requires that the policies and procedures must be documented in written form, which may be in electronic form. This final rule also provides that a covered entity may change its policies and procedures at any time, provided that it documents and implements the changes in accordance with the applicable requirements. Covered entities must also document designations, for example, of affiliation between covered entities (see § 164.105(b)), and other actions, as required by other provisions of the subpart.

     

    HHS Response to Comments Received
    Security Standards for the Protection of Electronic PHI: Policies and Procedures and Documentation Requirements

     

    Comment: One commenter wanted development of written policies regarding such things as confidentiality and privacy rights for access to medical records, and approval of research by a review board when appropriate.

     

    Response: These issues are covered in the Privacy Rule (65 FR 82462) (see, in particular, § 164.512(i), § 164.524, and § 164.530(i)).

    Comment: One commenter asked if standards will override agreements that require others to maintain hardcopy documentation (for example, signature on file) and no longer require submitters to maintain hardcopy documentation.

    Response: The security standards will require a minimum level of documentation of security practices. Any agreements between trading partners for the exchange of electronic protected health information that impose additional documentation requirements will not be overridden by this final rule.

    Comment: One commenter stated that there should be a requirement to document only applications deemed necessary by an applications and data criticality assessment.

    Response: Electronic protected health information must be afforded security protection under this rule regardless of what application it resides in. The measures taken to protect that information must be documented.

    Comment: One commenter asked how detailed the documentation must be. Another commenter asked what "kept current" meant.

    Response: Documentation must be detailed enough to communicate the security measures taken and to facilitate periodic evaluations pursuant to § 164.308(a)(8). While the term "current" is not in the final rule, this concept has been adopted in the requirement that documentation must be updated as needed to reflect security measures currently in effect.

    Comment: We received one comment concerning review and updating of implementing documentation suggesting that "periodically" be changed to "at least annually."

    Response: We believe that the requirement should remain as written, in order to allow individual entities to establish review and update cycles as deemed necessary. The need for review and update will vary dependent upon a given entity's size, configuration, environment, operational changes, and the security measures implemented.