EvidenceSheet
HIPAA Security Rule · Administrative

164.306 Security Standards: General Rules

Covered entities and business associates must ensure the confidentiality, integrity, and availability of all electronic protected health information (ePHI) they create, receive, maintain, or transmit; protect against reasonably anticipated threats; protect against reasonably anticipated impermissible uses or disclosures; and ensure workforce compliance. Entities may use flexibility of approach considering size, complexity, capabilities, technical infrastructure, costs, and probability and criticality of risks to ePHI.

Source: HIPAA Security Rule, 164.306. 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.

8
artefacts
1
held by a system
1
at each review
hard
to go live
Policy repository / GRC workspace
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

  • Workforce compliance attestation records · Vendor register / contract repository

periodic reviewEvidence produced at each review

  • Annual security program review minutes with executive sign-off · Policy repository / GRC workspace

governing documentDocuments that govern the control

  • Information security program charter signed by executive leadership · Policy repository / GRC workspace
  • Documented determination of covered entity vs. business associate status · Policy repository / GRC workspace
  • EPHI inventory and data flow diagrams identifying creation, receipt, maintenance, transmission · Policy repository / GRC workspace
  • Documented rationale for flexibility of approach decisions citing size, complexity, capabilities, costs, risk · Policy repository / GRC workspace
  • Statement of applicability mapping security measures to CIA triad · Policy repository / GRC workspace
  • Risk acceptance register for residual risks · Policy repository / GRC workspace

First move

Mostly documents and reviews. Pull the 1 system-held artefact from your Vendor register / contract repository on a schedule; put the documents under version control with an owner and review date, and log each review 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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164.308(a)(1)(i) Security Management Process (Standard)