HIPAA Security Rule requirements
HIPAA Security Rule (§164.308-316) mandates flexible safeguards for ePHI protection, categorized as administrative, physical, and technical, with required and addressable specifications.
Proposed 2026 updates eliminate the addressable distinction, mandating controls like encryption and MFA amid rising cyber threats. Programs must demonstrate ongoing effectiveness through risk-based implementation, tying into your compliance program and BAA frameworks.
Administrative safeguards
These focus on processes and people:
Physical safeguards
Protect facilities and devices:
Implementation notes
Conduct enterprise risk analysis scoping all ePHI assets, including cloud/SaaS; and remediate with a prioritized roadmap. Integrate into compliance program (OIG seven elements), BAAs, and OCR response plans from prior discussions. Sprinto automates audits, mappings, and evidence for 2026 prescriptive shifts. Retain docs 6 years; leverage NIST 800-66/HITRUST for safe harbor.
| Specification | Requirements | 2026 Updates |
| Security Management (§164.308(a)(1)) | Risk analysis, management, sanction policy, info systems activity review | Annual penetration tests, biannual scans; objective third-party assessments. |
| Assigned Security Responsibility (§164.308(a)(2)) | Designate officer | Documented governance with C-suite reporting. |
| Workforce Security (§164.308(a)(3)) | Authorization, clearance, supervision | Unique credentials; revoke on termination. |
| Security Awareness Training (§164.308(a)(5)) | Phishing, password management, incident reporting | Annual mandatory; basic/enhanced cybersecurity hygiene. |
| Contingency Plans (§164.308(a)(7)) | Data backup, disaster recovery, emergency access | Centralized incident response; 24-hour BA reporting. |
- Facility Access Controls (§164.308(a)(8)): Contingency operations, facility security plans, access records.
- Workstation Use/Security (§164.308(a)(6-7)): Secure locations, auto-logoff (5-15 min), screen privacy.
- Device/Portable Media (§164.308(a)(12)): Disposal, media re-use, data movement policies.
| Specification | Requirements | 2026 Focus |
| Access Control (§164.308(a)(4)) | Unique user IDs, emergency access, auto-logoff | Mandatory MFA for PHI systems/remote access. |
| Audit Controls (§164.308(a)(1)(ii)(D)) | Hardware/software logs for ePHI activity | Centralized logging/monitoring; regular reviews. |
| Integrity (§164.308(a)(1)(ii)(C)) | Mechanism to authenticate ePHI | Detection of unauthorized changes. |
| Person/Entity Authentication (§164.308(a)(4)(ii)(B)) | Verify identities before access | Strengthened via MFA/encryption. |
| Transmission Security (§164.308(a)(4)(ii)(C)) | Integrity controls, encryption | Mandatory for ePHI at rest/transit (AES-256). |
SOC Frameworks Overview
SOC 2 Basics
SOC 2 Compliance Process
SOC 2 Compliance Process
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