HIPAA Security Risk Analysis Standard (45 CFR 164.308(a)(1)(ii)(A))
Required implementation specification: conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of ePHI.
Primary source
45 CFR 164.308(a)(1)(ii)(A) — eCFR →https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-C/part-164/subpart-C/section-164.308#p-164.308(a)(1)(ii)(A)
Verified May 23, 2026 · This is the authoritative regulator URL. The summary below is a research aid; the linked source controls.
Additional sources
45 CFR 164.308(a)(1)(ii)(A)(1)(ii)(A)) requires a covered entity to conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of ePHI held by the entity. This is a required specification, not addressable.
OCR's 2010 Guidance on Risk Analysis defines nine essential elements: scope (all ePHI), data collection (where ePHI is created, received, maintained, transmitted), identification of threats, identification of vulnerabilities, assessment of current security measures, likelihood of threat occurrence, impact of threat occurrence, level of risk, and documentation.
A risk analysis is not a one-time event. It must be updated when the entity adopts a new technology, experiences a significant operational change, or as part of a periodic review. The Risk Management standard at 164.308(a)(1)(ii)(B) then requires the entity to implement security measures sufficient to reduce risks to a reasonable and appropriate level.
Risk analysis findings are the single most common deficiency in OCR enforcement actions. Settlements regularly cite missing, stale, or scope-limited analyses as primary or contributing failures.
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Related across the archive
- RegulationHIPAA Administrative Safeguards (45 CFR 164.308)Nine standards covering security management, workforce security, training, contingency planning, incident procedures, evaluation, and business associate contracts.
- 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.
- RegulationNIST SP 800-66 Revision 2: HIPAA Security Rule Cybersecurity Resource GuideNIST's 2024 update to the implementation guide for the HIPAA Security Rule, mapping the rule's standards to NIST Cybersecurity Framework subcategories and current cybersecurity practices.
- 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.
- ComplianceHIPAA Contingency Plan Template — 45 CFR § 164.308(a)(7)2026 HIPAA contingency plan template — 45 CFR § 164.308(a)(7) data backup, DRP, emergency mode, testing, and applications/data criticality analysis.
- SRAChange Healthcare Ransomware: What Small Practices Took AwayThe February 2024 Change Healthcare cyberattack, what HHS and UnitedHealth Group disclosed, and the small-practice lessons about clearinghouse concentration risk, contingency planning, and the Security Rule's information system activity review.
- GlossarySecurity Risk AnalysisThe accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of ePHI required by the HIPAA Security Rule.
- 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.