EvidenceSheet
HIPAA Security Rule · Policies and Procedures

164.316(b)(1) Documentation (Standard)

Maintain the policies and procedures and a written or electronic record of any required action, activity, or assessment. NIST recommends document management platform with controlled retention.

Source: HIPAA Security Rule, 164.316(b)(1). The statement above is our statement of the clause, read from the published text and cited so you can check it against the official text, not the instrument verbatim. Open HIPAA Security Rule in the compliance library.

Applies to covered entities and business associates. An addressable specification can be met by a documented, reasonable alternative.

4
artefacts
1
held by a system
2
at each review
moderate
to go live
Document repository
where the evidence lives
teal = a system already holds it · olive = produced at each review. To go live: easy when half or more of the artefacts are already held by a system, moderate from a quarter to a half, hard below a quarter.

These are the artefacts auditors commonly ask for on this requirement, our guidance rather than text from the standard. Your assessor decides what is sufficient in your context, and asks for samples across the period when a report covers one.

system holds itEvidence a system already holds

  • Document management platform export · Document repository

periodic reviewEvidence produced at each review

  • Evidence repository index · Source control / CI pipeline
  • Access controls on records · Document repository

governing documentDocuments that govern the control

  • Records retention schedule · Policy repository / GRC workspace

First move

Start with the 1 of 4 artefacts that already live in a system (Document repository); keep the periodic reviews but log each one as a dated record with a named reviewer.

Common gaps auditors find

Do this for your whole sheet

Paste the rows you run your controls from and get this mapping for every control at once, with the periodic-review ones flagged and a first move per row. No account for the first run.

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164.316(a) Policies and Procedures (Standard) · 164.316(b)(2)(i) Time Limit (Documentation Retention)