Required under 45 CFR §164.308(a)(1)(ii)(A) — Document threats, vulnerabilities, and risk levels for all systems containing ePHI.
Identify all systems, applications, and locations where ePHI is created, received, maintained, or transmitted.
| System / Application | ePHI Types Stored | Location (Cloud / On-Prem) | Users with Access | Vendor (if applicable) |
|---|---|---|---|---|
For each system identified above, document potential threats to ePHI. Common threat categories:
| Threat Category | Examples |
|---|---|
| Natural | Floods, earthquakes, tornados, power failures |
| Human (Intentional) | Hacking, malware, ransomware, social engineering, insider threats |
| Human (Unintentional) | Accidental deletion, misdirected emails, lost devices, improper disposal |
| Environmental | HVAC failure, water damage, electrical surges, hardware failure |
Identify vulnerabilities that could be exploited by the threats above.
| System | Vulnerability | Threat Source | Existing Controls |
|---|---|---|---|
For each threat-vulnerability pair, determine the likelihood of occurrence and the potential impact, then assign a risk level.
| Rating | Definition |
|---|---|
| High | The threat source is highly motivated and capable, and controls to prevent the vulnerability are ineffective. |
| Medium | The threat source is motivated and capable, but controls are in place that may impede exploitation. |
| Low | The threat source lacks motivation or capability, or controls are in place to prevent or significantly impede exploitation. |
| Rating | Definition |
|---|---|
| High | Exploitation could result in significant financial loss, harm to individuals, legal action, or loss of reputation. Major breach notification required. |
| Medium | Exploitation could result in moderate financial loss or limited harm. May require breach notification. |
| Low | Exploitation could result in minor financial loss or inconvenience. Breach notification unlikely. |
| Low Impact | Medium Impact | High Impact | |
|---|---|---|---|
| High Likelihood | Medium | High | Critical |
| Medium Likelihood | Low | Medium | High |
| Low Likelihood | Low | Low | Medium |
Document each identified risk, its level, and planned corrective actions.
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This risk assessment has been reviewed and approved by the following individuals: