Creating a Risk Assessment
Start a new assessment
Click New Assessment. Choose the assessment type:
- Security Risk Assessment (SRA) — required for HIPAA, aligned with HHS guidance
- General Risk Assessment — suitable for SOC 2, NIST CSF, ISO 27001, and other frameworks
Define the scope
Specify which systems, data types, and business processes are in scope. For HIPAA SRAs, this includes all systems that create, receive, maintain, or transmit electronic protected health information (ePHI).
Identify threats and vulnerabilities
Work through the assessment questionnaire to identify threats (what could go wrong) and vulnerabilities (weaknesses that could be exploited). Regentra provides a curated threat catalog to guide this process.
For HIPAA-covered entities and business associates, the Security Risk Assessment is not optional. The HHS Office for Civil Rights (OCR) cites failure to conduct an SRA as one of the most common HIPAA violations.
Risk Scoring Methodology
Regentra uses a 3×3 likelihood × impact lookup calibrated against the HHS/ONC SRA Tool v3.6.1Risk_Logic matrix. A customer running both Regentra and the SRA Tool workbook sees consistent scores.
The matrix
| Low impact | Moderate impact | High impact | |
|---|---|---|---|
| Low likelihood | Low | Low | High |
| Moderate likelihood | Low | Moderate | Critical |
| High likelihood | Moderate | High | Critical |
- Moderate × High = Critical (high-impact events deserve immediate attention even at moderate likelihood)
- High × High = Critical
- Low × High = High (a low-probability but catastrophic event is still a high-priority finding)
Regentra also accepts a fourth “Critical likelihood” tier (for findings the operator wants to flag as effectively-certain). Any cell in the Critical likelihood row is at minimum the same level as the corresponding High likelihood row, never lower.
Alignment with the HHS/ONC SRA Tool
For HIPAA-covered entities, Regentra is structured to map 1:1 against the HHS/ONC SRA Tool v3.6.1 workbook. The alignment touches every layer of the risk-assessment surface:- All 60 SRA Tool §refs are covered by Regentra’s HIPAA 2026 framework requirements. The 5 sub-clauses the SRA Tool checks but the prior version of Regentra hadn’t surfaced (§164.316(b)(2)(i/ii/iii) for documentation hygiene, §164.314(a)(2)(i)(A) and §164.314(a)(2)(iii) for BA contract clauses) are now present.
- Canonical 40-entry threat catalog. When you create a Finding, the Threat Library picker has two tabs: a generic NIST/OCR-derived catalog and the HHS SRA Tool catalog. Threats picked from the SRA tab carry a stable code (e.g.,
SRA-S4-T1) and surface in audit-package exports as “X of Y findings came from the SRA Tool catalog.” - Per-§ref question reference. On each control card, a collapsible “HHS SRA Tool questions for §164.xxx” panel shows the SRA Tool’s questions probing that §ref, with HHS’s multiple-choice answers and per-answer compliant/risk-indicated markers. Read-only reference for customers running both tools in parallel.
- Risk-matrix calibration (the table above) matches the SRA Tool’s
Risk_Logicexactly on the LOW/MEDIUM/HIGH subset.
Risk Register
The risk register is your living inventory of identified risks. Every risk from every assessment feeds into the register, creating a centralized view of your organization’s risk posture. Each risk entry includes:- Description — what the risk is
- Threat source — the actor or event that could cause harm
- Vulnerability — the weakness being exploited
- Likelihood and impact scores — with the calculated risk level
- Treatment plan — how you plan to address the risk
- Owner — the person responsible for treatment
- Status — Open, In Remediation, Mitigated, Accepted, or Closed
Treatment Plans
For each risk, you must document a treatment approach:- Mitigate
- Accept
- Transfer
- Avoid
Implement controls to reduce the likelihood or impact. This is the most common approach. Link the risk to specific controls in Regentra to track mitigation progress.
Annual Review Requirements
Most compliance frameworks require risk assessments to be reviewed and updated on a regular cadence:- HIPAA — annual SRA review is a best practice and OCR expectation
- SOC 2 — risk assessments must be current for each audit period
- NIST CSF — recommends ongoing risk assessment as part of the Identify function
- ISO 27001 — requires risk assessment updates when significant changes occur or at planned intervals