Section § 164.316(b)(1)Documentation

What it says

(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.

HIPAA, the United States rules protecting health information, § 164.316(b)(1)

What is in the packs for this

From HIPAA Security Rule Readiness. Each one helps with this requirement.

• XLSExcel

  Security Rule Safeguard Register

  Its Framework References cite this section. Lists the 22 Security Rule standards and their 41 implementation specifications in plain words, required or addressable, with an owner and the evidence to keep.
• DOCWord

  Security Risk Analysis Method

  Its Framework References cite this section. Sets out a repeatable method for the security risk analysis: the inventory of electronic patient information, threats, vulnerabilities, ratings and the signed record.
• XLSExcel

  HIPAA Documentation & Evidence Checklist

  Its Framework References cite this section. Lists the documents and records to keep ready, the paragraph of the Rule behind each, and how long each must be kept.
• XLSExcel

  HIPAA Gap & Remediation Tracker

  Its Framework References cite this section. Tracks the gaps found against the readiness items, with priority, owner, deadline and status.
• XLSExcel

  HIPAA Security Rule Readiness Self-Assessment

  Its Framework References cite this section. Rates readiness against the Security Rule items and returns the blocking gaps, in counts and with no score.