HIPAA Technical Safeguards (45 CFR 164.312)
Five standards covering access control, audit controls, integrity, person or entity authentication, and transmission security for ePHI.
Primary source
45 CFR 164.312 — eCFR →https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-C/part-164/subpart-C/section-164.312
Verified May 23, 2026 · This is the authoritative regulator URL. The summary below is a research aid; the linked source controls.
45 CFR 164.312 sets five technical safeguard standards.
Access Control (a)(1): unique user identification (R), emergency access procedure (R), automatic logoff (A), encryption and decryption (A).
Audit Controls (b): hardware, software, and procedural mechanisms that record and examine activity in systems containing ePHI. Required.
Integrity (c)(1): policies to protect ePHI from improper alteration or destruction. Spec: authentication of ePHI (A).
Person or Entity Authentication (d): verify the identity of any person or entity accessing ePHI. Required.
Transmission Security (e)(1): protect against unauthorized access to ePHI during transmission. Specs: integrity controls (A), encryption (A).
The standards are technology-neutral but the encryption addressable specification, in particular, is the implicit baseline for any system carrying ePHI over the internet — TLS 1.2+ in transit, AES-256 at rest. A risk analysis that concludes encryption is not reasonable and appropriate for ePHI traversing the public internet is difficult to defend.
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Related across the archive
- RegulationHIPAA Security Access Control (45 CFR 164.312(a))Technical policies and procedures for systems containing ePHI to allow access only to those granted access rights, with required specifications for unique user identification and emergency access.
- RegulationHIPAA Audit Controls Standard (45 CFR 164.312(b))Required technical safeguard: implement hardware, software, and procedural mechanisms that record and examine activity in information systems containing ePHI.
- RegulationHIPAA Security Rule: General Rules (45 CFR 164.306)Required objectives — confidentiality, integrity, and availability of ePHI — plus the flexibility provisions that govern how covered entities select and implement specific safeguards.
- RegulationHIPAA Person or Entity Authentication (45 CFR 164.312(d))Required standard to verify that a person or entity seeking access to ePHI is the one claimed. The Security Rule is technology-neutral on the mechanism; risk analysis drives whether MFA is reasonable.
- ComplianceHIPAA Encryption Policy Template (45 CFR § 164.312(a)(2)(iv) + (e)(2)(ii))2026 HIPAA encryption policy template — 45 CFR § 164.312(a)(2)(iv) at-rest, § 164.312(e)(2)(ii) in-transit, NIST SP 800-111 algorithms, key management.
- SRACMS Promoting Interoperability and the Security Risk Analysis AttestationHow the CMS Promoting Interoperability program (formerly Meaningful Use) requires a HIPAA Security Risk Analysis for each EHR reporting period, what the attestation actually claims, and how CMS audits it after the fact.
- GlossaryAccess ControlsTechnical policies and procedures that allow only authorized persons or software programs to access ePHI.
- BillingBusiness Associate Agreement Checklist for Small PracticesA working checklist for small practices to identify which vendors need a Business Associate Agreement, what clauses the BAA must contain, and how to track them.
Last reviewed May 23, 2026 · Citation verified May 23, 2026
Research aid, not legal advice. This summary is an administrative research aid prepared by D3rx. It does not certify compliance, provide legal advice, replace counsel, or guarantee an audit outcome. For authoritative regulatory text follow the primary source link at the top of this page. The practice remains responsible for reviewing, adopting, and maintaining its compliance program.