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 likelihood x impact matrix to calculate risk scores:| Factor | Scale | Description |
|---|---|---|
| Likelihood | 1 (Rare) to 5 (Almost Certain) | How probable is it that this threat will exploit this vulnerability? |
| Impact | 1 (Negligible) to 5 (Severe) | What is the potential damage to the organization if the risk materializes? |
| Risk Score | 1 to 25 | Likelihood multiplied by Impact |
- Low (1-6) — acceptable risk, monitor periodically
- Medium (7-12) — requires a documented treatment plan
- High (13-19) — prioritize remediation, escalate to leadership
- Critical (20-25) — immediate action required
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 Treatment, Accepted, Mitigated, 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