Technical safeguards

The five technical safeguard standards in 45 CFR 164.312 and their implementation specifications: access control, audit controls, integrity, person or entity authentication and transmission security, including encryption.

164.312(a)(1) Access control

The technical standard that systems holding ePHI allow access only to people or software granted rights under information access management. Parent of two required specifications (unique user ID, emergency access) and two addressable ones (automatic logoff, encryption).

164.312(a)(2)(iii) Automatic logoff

Addressable electronic procedures that end a session after a set period of inactivity. The rule leaves the timeout to the entity's risk analysis.

164.312(a)(2)(iv) Encryption and decryption

Addressable mechanism to encrypt and decrypt ePHI, generally read as protection for stored data (transmission encryption is in 164.312(e)). Covers when not encrypting can be justified and the 2025 proposal to make it mandatory.

164.312(b) Audit controls

The standard requiring hardware, software or procedural mechanisms that record and examine activity in systems containing or using ePHI. The logging foundation that information system activity review depends on.

164.312(c)(1) Integrity

The standard requiring policies and procedures that protect ePHI from improper alteration or destruction, for stored data. Parent of one addressable specification: a mechanism to authenticate ePHI.

164.312(d) Person or entity authentication

The standard requiring procedures to verify that anyone or anything seeking access to ePHI is who it claims to be. The current text does not mandate multi-factor authentication; the 2025 proposal would.

164.312(e)(1) Transmission security

The standard for guarding ePHI against unauthorized access while it travels over an electronic communications network. Parent of two addressable specifications: integrity controls and encryption.

164.312(e)(2)(ii) Encryption

Addressable mechanism to encrypt ePHI in transit whenever deemed appropriate, such as TLS for web, email and API traffic, and the 2025 proposal to require it.

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