HIPAA 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.
Primary source
45 CFR 164.306 — eCFR →https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-C/part-164/subpart-C/section-164.306
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 164.306 sets the Security Rule's four general requirements: ensure the confidentiality, integrity, and availability of all ePHI the entity creates, receives, maintains, or transmits; protect against reasonably anticipated threats and impermissible uses; and ensure workforce compliance.
The rule is technology-neutral. Implementation specifications are labeled "required" (must implement as written) or "addressable" (must implement, implement an equivalent alternative, or document why neither is reasonable and appropriate). Addressable does not mean optional.
The flexibility provisions at 164.306(b)(2) direct entities to consider their size and complexity, technical infrastructure, cost of security measures, and probability and criticality of risks. A solo practice and a hospital system implement to different scales but against the same standards.
A covered entity's specific safeguards flow from the risk analysis at 164.308(a)(1)(ii)(A)(1)(ii)(A)). Without a documented risk analysis tied to current threats, addressable decisions cannot defensibly be made.
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D3rx assembles the documentation linked to this regulation, walks the practical decisions in plain English, and stores the artifacts against the .gov sources cited above. It is an administrative research aid, not a substitute for counsel.
Related regulations
D3rx is a healthcare-billing and compliance research aid maintained by D3rx Inc. Articles are drafted by an LLM (Anthropic Claude) against primary HHS, OCR, CMS, eCFR, NIST, and state-regulator publications, and reviewed for restraint and source fidelity by the D3rx team.
Reviewer status: a named credentialed reviewer (CHC, CHPC, or healthcare attorney) is being engaged. Until that engagement is finalized, this page does not claim credentialed review.
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 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.
- RegulationHIPAA Technical Safeguards (45 CFR 164.312)Five standards covering access control, audit controls, integrity, person or entity authentication, and transmission security for ePHI.
- 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.
- 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.