164.312(d) Person or Entity Authentication (Standard)
Implement procedures to verify that a person or entity seeking access to ePHI is the one claimed. NIST recommends multi-factor authentication and authenticator assurance levels per SP 800-63B.
Source: HIPAA Security Rule, 164.312(d). 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.
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
- MFA deployment report · Identity provider / directory
periodic reviewEvidence produced at each review
none for this control
governing documentDocuments that govern the control
- Authentication standard aligned to NIST SP 800-63B · Policy repository / GRC workspace
- Service account authentication design · Policy repository / GRC workspace
- Federation and SSO design · Policy repository / GRC workspace
First move
Common gaps auditors find
- No MFA on ePHI access
- Weak factor combinations
- Service-to-service authentication uses static secrets
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.
Build my evidence sheet164.312(c)(2) Mechanism to Authenticate ePHI (Addressable) · 164.312(e)(1) Transmission Security (Standard)