How often to update your HIPAA risk analysis (and why annual is the floor)
OCR treats risk analyses older than 12 months as presumptively stale. Here's when to update, what triggers immediate review, and how to document the cycle.
By CoreFolio
7-minute read
In every Office for Civil Rights (OCR) settlement citing a risk analysis failure, the investigator notes the date. A risk analysis from 2019 is not current in 2026. A risk analysis completed before your last electronic health record (EHR) migration does not reflect your present environment. The requirement at 45 CFR § 164.308(a)(1)(ii)(A) is for an assessment of risks you currently face — not risks you once faced.
The regulation says "periodic." OCR's enforcement says "annual minimum." The proposed 2026 Security Rule would write "annual" into the text. But even annual review is a floor, not a ceiling. Significant changes to your practice require immediate reassessment, not waiting for the calendar.
This article explains the timing requirements, what triggers out-of-cycle updates, and how to document your review cycle.
What the rule says
Current Security Rule (2005, amended 2013)
45 CFR § 164.308(a)(1)(ii)(A) requires covered entities to:
"Conduct an accurate and thorough assessment of the potential risks and vulnerabilities..."
The rule does not specify a frequency. However, the same section requires technical and physical safeguards that are maintained and updated as necessary. The preamble to the 2003 Security Rule states that risk analysis is "an ongoing process" that should be revisited when the environment changes.
The 2013 Omnibus Rule added a requirement for "periodic review" of security measures and updates in response to changing conditions.
OCR enforcement interpretation
OCR's resolution agreements reveal the practical standard. When investigators find a risk analysis, they check:
- Date: When was this completed?
- Currency: Does it reflect current systems, vendors, and workflows?
- Review cycle: Is there a documented process for keeping it current?
Analyses older than 12 months are treated as presumptively stale. Practices have been cited specifically for documentation that was "not current" — a separate finding from "not accurate" or "not thorough."
The Risk Analysis Initiative settlements (2024–2025) emphasize currency. Several practices had analyses from prior years but were cited because they had not been updated to reflect current environments.
Proposed 2026 Security Rule
The Notice of Proposed Rulemaking (NPRM) (90 Fed. Reg. 898, January 2025) would add explicit language:
"Conduct an accurate and thorough assessment... at least once every 12 months and whenever there is a significant change to the security environment..."
This codifies OCR's enforcement position. Annual becomes the explicit floor rather than the implied minimum.
The annual cycle
For most small practices without major changes, an annual review is appropriate. The annual cycle should include:
Month 1: Schedule and prepare
- Calendar the analysis review
- Gather any documentation of changes since last analysis
- Verify system inventory is current
Month 2: Conduct review
- Validate prior findings (what has changed, what is still accurate)
- Assess new threats or vulnerabilities
- Update risk ratings based on current conditions
- Review and revise Risk Management Plan
Month 3: Document and approve
- Date the updated analysis
- Obtain Security Officer attestation
- Distribute to relevant personnel
- Archive prior version
Documentation best practice: Keep version history. An investigator should be able to see that you conducted analyses in 2024, 2025, and 2026 — not just that you have a 2026 analysis.
Trigger events requiring immediate update
Annual review is the minimum. Certain events require out-of-cycle updates:
Technology changes
- New EHR or practice management system: The core system change affects the entire threat model
- New email or cloud platform: Changes transmission security and access controls
- New telehealth platform: Introduces new endpoints and vendor relationships
- New backup or disaster recovery solution: Changes data availability risks
- Significant network changes: New locations, VPN implementation, WiFi restructuring
Organizational changes
- New location or office: Expands physical security considerations
- Major workforce change: New roles, significant hiring or departures
- Merger or acquisition: Combines environments with different risk profiles
- Service line expansion: New procedures may mean new ePHI types or systems
Security events
- Breach or security incident: May reveal threats or vulnerabilities not previously assessed
- Audit or investigation finding: Requires validation that analysis addressed the area
- Ransomware or malware event: Demonstrates threat likelihood was higher than rated
Vendor changes
- New business associate: Requires business associate agreement (BAA) review and risk assessment
- Vendor security incident: Third-party breach may affect your risk rating
- Vendor service changes: New capabilities or discontinued features
Regulatory changes
- New OCR guidance: May change expectations for methodology or scope
- Proposed 2026 rule finalization: Will require gap analysis and potential control updates
- State law changes: California, Texas, or other state-specific requirements
Update vs. redo: determining the scope
Not every change requires starting from scratch. Determine whether to update or redo:
When to update (incremental)
- Minor vendor changes (version updates, not platform changes)
- Staff additions or departures in existing roles
- Confirmed accuracy of most prior findings
- New threat intelligence that affects ratings but not scope
Process: Review each section of prior analysis. Mark sections "validated – no change" or "revised – see below." Update affected sections only. Document what triggered the update.
When to redo (full analysis)
- Core system change (new EHR, email platform migration)
- New location or significant expansion
- Prior analysis found significantly inaccurate
- Major security incident revealing systemic gaps
- No analysis in 24+ months (too much change to track incrementally)
Process: Start from current environment inventory. Do not assume prior findings remain valid. Fresh assessment of threats, vulnerabilities, and risks.
Documenting the review cycle
OCR expects to see process, not just product. Your documentation should include:
The analysis itself
- Completion date
- Review due date (typically 12 months)
- Trigger events that would accelerate review
- Scope boundaries
Supporting records
- System inventory (current as of analysis date)
- Vendor list with BAA status
- Changes log (what changed since prior analysis)
- Methodology documentation
Version history
- Prior analysis dates and versions
- Summary of changes between versions
- Archive location
Example notation:
Risk Analysis v2026.1 — Completed May 15, 2026 Previous: v2025.2 — Completed November 10, 2025 Changes: Updated for new telehealth platform (Doxy.me added); revised likelihood ratings for ransomware based on industry threat intelligence; all other sections validated current.
Common timing mistakes
Mistake 1: The one-and-done analysis Completing a risk analysis in 2018 and considering the requirement satisfied. OCR settlements specifically cite outdated analyses.
Mistake 2: Undocumented updates Making changes to systems or vendors without updating the analysis. The practice knows the environment changed; the documentation does not.
Mistake 3: Calendar-only triggers Waiting for the annual review when a major change (new EHR, breach, new location) has already occurred. Trigger events require immediate response.
Mistake 4: No version history Keeping only the current analysis with no record of prior analyses or what changed. Version history demonstrates ongoing compliance.
Mistake 5: Update without revision Dating a new version without actually reviewing or changing content. OCR investigators read analyses; they can tell when findings are stale despite a recent date.
The practical workflow
For a small practice, maintaining current risk analysis is manageable with a simple system:
Calendar reminder: Annual review scheduled 11 months from last analysis (allowing time for completion before the 12-month mark)
Change log: Maintain a running list of system, vendor, and staff changes as they occur. Reference this during updates.
Trigger event protocol: When a major change occurs, calendar a risk analysis review for 30 days post-implementation.
Documentation template: Use a structured format that clearly shows what was validated unchanged and what was revised.
CoreFolio approach: The CoreFolio HIPAA assessment stores your prior answers and flags sections that may need review based on your change log. Re-assessment takes 20–30 minutes for annual updates, producing a new dated analysis with version history.
What "current" means to OCR
Current does not mean perfect. It means:
- Dated within the past 12 months (or since last significant change)
- Reflecting the systems, vendors, and workflows you actually use
- Incorporating current threat intelligence
- Connected to a current Risk Management Plan
An imperfect analysis from this month is more defensible than a perfect analysis from three years ago. The requirement is ongoing, not historical.