45 CFR Part 164, Subpart C — Administrative, Physical, and Technical safeguards for ePHI. Required vs. Addressable specifications, Breach Notification timelines, and OCR risk analysis requirements.
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Required (R) — must implement exactly as stated
Addressable (A) — implement a reasonable equivalent OR document why not applicable
Addressable ≠ optional. If an implementation specification is addressable, a covered entity must still implement it if reasonable and appropriate — or document its reasoning and implement an equivalent measure. Source: 45 CFR § 164.306(d).
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Administrative Safeguards § 164.308
Security Management Process§ 164.308(a)(1)
Required
Risk analysis — identify threats and vulnerabilities to ePHI
Risk management — implement security measures to reduce risk
Sanction policy — apply appropriate sanctions for policy violations
Information system activity review — audit logs, access reports
Assigned Security Responsibility§ 164.308(a)(2)
Required
Designate a security official responsible for HIPAA Security Rule compliance
Periodic technical and non-technical evaluation of compliance with Security Rule
Business Associate Contracts§ 164.308(b)(1)
Required
BAA must require BA to implement reasonable and appropriate safeguards for ePHI
BA must report security incidents to covered entity
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Physical Safeguards § 164.310
Facility Access Controls§ 164.310(a)(1)
Addressable
Contingency operations (facility access during emergency)
Facility security plan
Access control and validation procedures
Maintenance records
Workstation Use§ 164.310(b)
Required
Policies specifying proper functions performed on workstations and their physical environment
Workstation Security§ 164.310(c)
Required
Physical safeguards for workstations accessing ePHI — restrict access to authorized users only
Device and Media Controls§ 164.310(d)(1)
Required
Disposal — final disposition of ePHI before reuse or disposal of media
Media reuse — removal of ePHI before media is reused
Addressable
Accountability — records of movements of hardware and media
Data backup and storage before movement of equipment
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Technical Safeguards § 164.312
Access Control§ 164.312(a)(1)
Required
Unique user identification — assign unique name/number to each user
Emergency access procedure — obtain ePHI during emergencies
Addressable
Automatic logoff
Encryption and decryption of ePHI
Audit Controls§ 164.312(b)
Required
Hardware, software, and/or procedural mechanisms to record and examine activity in information systems containing ePHI
Integrity§ 164.312(c)(1)
Addressable
Electronic mechanism to corroborate that ePHI has not been altered or destroyed in an unauthorized manner
Person or Entity Authentication§ 164.312(d)
Required
Verify that a person or entity seeking access to ePHI is the one claimed
Transmission Security§ 164.312(e)(1)
Addressable
Integrity controls — guard against unauthorized modification of ePHI in transit
Encryption of ePHI in transit
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Breach Notification Rule §§ 164.400–414
A "breach" is the unauthorized acquisition, access, use, or disclosure of PHI that compromises its security or privacy, unless a specific exception applies. An impermissible use or disclosure is presumed a breach unless the covered entity demonstrates low probability that PHI was compromised under a four-factor risk assessment.
60 days
→ Affected Individuals
Written notification. First-class mail. Substitute notice if contact info is outdated. § 164.404
60 days
→ HHS Secretary
Breaches of 500+: notify simultaneously. Breaches under 500: log and report annually. § 164.408
60 days
→ Media (500+ in state)
Prominent media outlet notification for breaches affecting 500+ in a state or jurisdiction. § 164.406
ASAP + 60 days
Business Associate → CE
BA notifies Covered Entity "without unreasonable delay" and within 60 days of discovery. § 164.410
The Security Risk Assessment (SRA) is the first document OCR investigators and enforcement agents request. It must be accurate, thorough, and documented. The following eight elements are drawn from OCR's published guidance on risk analysis.
Scope — Identify all ePHI your organization creates, receives, maintains, or transmits. Include all systems, applications, and media.
Data collection — Document where ePHI is stored, accessed, and transmitted. Interviews + technical review.