HIPAA SECURITY RISK ASSESSMENT
SECURITY RULE RISK ANALYSIS DOCUMENTATION
ORGANIZATION INFORMATION
Organization Name: [________________________________]
Address: [________________________________]
City, State, ZIP: [________________________________]
Organization Type:
☐ Healthcare Provider
☐ Health Plan
☐ Healthcare Clearinghouse
☐ Business Associate
NPI (if applicable): [________________________________]
ASSESSMENT INFORMATION
Assessment Date: [__/__/____]
Assessment Period Covered: [__/__/____] to [__/__/____]
Assessment Type:
☐ Initial Assessment
☐ Periodic Assessment
☐ Post-Incident Assessment
☐ Pre-Implementation Assessment
☐ Other: [________________________________]
Assessment Team:
| Name | Title | Role in Assessment |
|---|---|---|
| [________________________________] | [________________________________] | [________________________________] |
| [________________________________] | [________________________________] | [________________________________] |
| [________________________________] | [________________________________] | [________________________________] |
Security Officer: [________________________________]
Contact Information: [________________________________]
SECTION 1: EXECUTIVE SUMMARY
1.1 Purpose
This Security Risk Assessment is conducted in accordance with the HIPAA Security Rule requirement at 45 CFR § 164.308(a)(1)(ii)(A) to conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of electronic protected health information (ePHI) held by the organization.
1.2 Scope
This assessment covers:
☐ All electronic protected health information (ePHI) created, received, maintained, or transmitted by the organization
☐ All information systems that contain, process, or transmit ePHI
☐ All physical locations where ePHI is accessed or stored
☐ All workforce members with access to ePHI
☐ All business associates that create, receive, maintain, or transmit ePHI on behalf of the organization
1.3 Assessment Summary
Total Number of Risks Identified: [____]
Risk Distribution:
| Risk Level | Count | Percentage |
|---|---|---|
| Critical | [____] | [____]% |
| High | [____] | [____]% |
| Medium | [____] | [____]% |
| Low | [____] | [____]% |
Key Findings:
[________________________________]
[________________________________]
[________________________________]
SECTION 2: ePHI INVENTORY
2.1 ePHI Data Types
Identify all types of ePHI created, received, maintained, or transmitted:
☐ Patient demographics
☐ Medical records
☐ Treatment information
☐ Prescription records
☐ Laboratory results
☐ Imaging/radiology records
☐ Billing and claims information
☐ Insurance information
☐ Appointment schedules
☐ Communications (emails, messages)
☐ Other: [________________________________]
2.2 ePHI Data Flow
How ePHI Enters the Organization:
| Entry Point | Type of ePHI | Volume (approx.) |
|---|---|---|
| [________________________________] | [________________________________] | [________________________________] |
| [________________________________] | [________________________________] | [________________________________] |
| [________________________________] | [________________________________] | [________________________________] |
How ePHI Flows Within the Organization:
[________________________________]
[________________________________]
How ePHI Leaves the Organization:
| Exit Point | Recipient Type | Type of ePHI |
|---|---|---|
| [________________________________] | [________________________________] | [________________________________] |
| [________________________________] | [________________________________] | [________________________________] |
| [________________________________] | [________________________________] | [________________________________] |
2.3 Systems Containing ePHI
| System Name | Description | ePHI Types | Location |
|---|---|---|---|
| [________________________________] | [________________________________] | [________________________________] | [________________________________] |
| [________________________________] | [________________________________] | [________________________________] | [________________________________] |
| [________________________________] | [________________________________] | [________________________________] | [________________________________] |
| [________________________________] | [________________________________] | [________________________________] | [________________________________] |
| [________________________________] | [________________________________] | [________________________________] | [________________________________] |
2.4 Physical Locations
| Location | Address | Type of ePHI Access | # of Workforce |
|---|---|---|---|
| [________________________________] | [________________________________] | [________________________________] | [____] |
| [________________________________] | [________________________________] | [________________________________] | [____] |
| [________________________________] | [________________________________] | [________________________________] | [____] |
SECTION 3: THREAT AND VULNERABILITY IDENTIFICATION
3.1 Threat Sources
Natural Threats:
☐ Floods
☐ Earthquakes
☐ Tornadoes/Hurricanes
☐ Fire
☐ Power failures
☐ Other: [________________________________]
Human Threats (Intentional):
☐ Hackers/Cybercriminals
☐ Malicious insiders
☐ Terrorists
☐ Competitors
☐ Nation-state actors
☐ Social engineers
☐ Other: [________________________________]
Human Threats (Unintentional):
☐ Careless employees
☐ Untrained staff
☐ Third-party contractors
☐ Other: [________________________________]
Environmental Threats:
☐ HVAC failures
☐ Water damage
☐ Structural failures
☐ Hazardous material release
☐ Other: [________________________________]
3.2 Vulnerability Categories
Administrative Vulnerabilities:
☐ Lack of security policies
☐ Inadequate training
☐ No incident response plan
☐ Poor access management
☐ Lack of risk management
☐ Insufficient audit procedures
☐ Other: [________________________________]
Physical Vulnerabilities:
☐ Inadequate facility access controls
☐ Unsecured workstations
☐ Lack of visitor controls
☐ Poor disposal practices
☐ Inadequate environmental controls
☐ Other: [________________________________]
Technical Vulnerabilities:
☐ Unpatched systems
☐ Weak passwords
☐ Lack of encryption
☐ Inadequate access controls
☐ No intrusion detection
☐ Insufficient logging
☐ Vulnerable network architecture
☐ Other: [________________________________]
SECTION 4: ADMINISTRATIVE SAFEGUARDS ASSESSMENT
4.1 Security Management Process (§ 164.308(a)(1))
Risk Analysis - 45 CFR § 164.308(a)(1)(ii)(A) [REQUIRED]
| Assessment Item | Status | Notes |
|---|---|---|
| Conduct accurate and thorough assessment of risks to ePHI | ☐ Implemented ☐ Partially ☐ Not Implemented | [________________________________] |
| Document risk analysis methodology | ☐ Implemented ☐ Partially ☐ Not Implemented | [________________________________] |
| Include all ePHI in scope | ☐ Implemented ☐ Partially ☐ Not Implemented | [________________________________] |
| Identify threats and vulnerabilities | ☐ Implemented ☐ Partially ☐ Not Implemented | [________________________________] |
Risk Management - 45 CFR § 164.308(a)(1)(ii)(B) [REQUIRED]
| Assessment Item | Status | Notes |
|---|---|---|
| Implement security measures to reduce risks | ☐ Implemented ☐ Partially ☐ Not Implemented | [________________________________] |
| Document risk management decisions | ☐ Implemented ☐ Partially ☐ Not Implemented | [________________________________] |
Sanction Policy - 45 CFR § 164.308(a)(1)(ii)(C) [REQUIRED]
| Assessment Item | Status | Notes |
|---|---|---|
| Apply appropriate sanctions for violations | ☐ Implemented ☐ Partially ☐ Not Implemented | [________________________________] |
| Document sanctions applied | ☐ Implemented ☐ Partially ☐ Not Implemented | [________________________________] |
Information System Activity Review - 45 CFR § 164.308(a)(1)(ii)(D) [REQUIRED]
| Assessment Item | Status | Notes |
|---|---|---|
| Implement procedures to review activity | ☐ Implemented ☐ Partially ☐ Not Implemented | [________________________________] |
| Review audit logs, access reports | ☐ Implemented ☐ Partially ☐ Not Implemented | [________________________________] |
4.2 Assigned Security Responsibility (§ 164.308(a)(2)) [REQUIRED]
| Assessment Item | Status | Notes |
|---|---|---|
| Identify Security Official | ☐ Implemented ☐ Partially ☐ Not Implemented | [________________________________] |
| Document responsibilities | ☐ Implemented ☐ Partially ☐ Not Implemented | [________________________________] |
Security Official Name: [________________________________]
4.3 Workforce Security (§ 164.308(a)(3))
Authorization and/or Supervision - 45 CFR § 164.308(a)(3)(ii)(A) [ADDRESSABLE]
| Assessment Item | Status | Notes |
|---|---|---|
| Implement authorization procedures | ☐ Implemented ☐ Addressed ☐ Not Applicable | [________________________________] |
Workforce Clearance Procedure - 45 CFR § 164.308(a)(3)(ii)(B) [ADDRESSABLE]
| Assessment Item | Status | Notes |
|---|---|---|
| Implement clearance procedures | ☐ Implemented ☐ Addressed ☐ Not Applicable | [________________________________] |
Termination Procedures - 45 CFR § 164.308(a)(3)(ii)(C) [ADDRESSABLE]
| Assessment Item | Status | Notes |
|---|---|---|
| Implement termination procedures | ☐ Implemented ☐ Addressed ☐ Not Applicable | [________________________________] |
4.4 Information Access Management (§ 164.308(a)(4))
Isolating Healthcare Clearinghouse Functions - 45 CFR § 164.308(a)(4)(ii)(A) [REQUIRED]
| Assessment Item | Status | Notes |
|---|---|---|
| Isolate clearinghouse functions (if applicable) | ☐ Implemented ☐ Partially ☐ Not Applicable | [________________________________] |
Access Authorization - 45 CFR § 164.308(a)(4)(ii)(B) [ADDRESSABLE]
| Assessment Item | Status | Notes |
|---|---|---|
| Implement policies for granting access | ☐ Implemented ☐ Addressed ☐ Not Applicable | [________________________________] |
Access Establishment and Modification - 45 CFR § 164.308(a)(4)(ii)(C) [ADDRESSABLE]
| Assessment Item | Status | Notes |
|---|---|---|
| Implement procedures for establishing/modifying access | ☐ Implemented ☐ Addressed ☐ Not Applicable | [________________________________] |
4.5 Security Awareness and Training (§ 164.308(a)(5))
Security Reminders - 45 CFR § 164.308(a)(5)(ii)(A) [ADDRESSABLE]
| Assessment Item | Status | Notes |
|---|---|---|
| Implement periodic security reminders | ☐ Implemented ☐ Addressed ☐ Not Applicable | [________________________________] |
Protection from Malicious Software - 45 CFR § 164.308(a)(5)(ii)(B) [ADDRESSABLE]
| Assessment Item | Status | Notes |
|---|---|---|
| Implement procedures for guarding against malware | ☐ Implemented ☐ Addressed ☐ Not Applicable | [________________________________] |
Log-in Monitoring - 45 CFR § 164.308(a)(5)(ii)(C) [ADDRESSABLE]
| Assessment Item | Status | Notes |
|---|---|---|
| Implement procedures for monitoring log-in attempts | ☐ Implemented ☐ Addressed ☐ Not Applicable | [________________________________] |
Password Management - 45 CFR § 164.308(a)(5)(ii)(D) [ADDRESSABLE]
| Assessment Item | Status | Notes |
|---|---|---|
| Implement procedures for password management | ☐ Implemented ☐ Addressed ☐ Not Applicable | [________________________________] |
4.6 Security Incident Procedures (§ 164.308(a)(6))
Response and Reporting - 45 CFR § 164.308(a)(6)(ii) [REQUIRED]
| Assessment Item | Status | Notes |
|---|---|---|
| Identify security incidents | ☐ Implemented ☐ Partially ☐ Not Implemented | [________________________________] |
| Respond to security incidents | ☐ Implemented ☐ Partially ☐ Not Implemented | [________________________________] |
| Mitigate harmful effects | ☐ Implemented ☐ Partially ☐ Not Implemented | [________________________________] |
| Document incidents and outcomes | ☐ Implemented ☐ Partially ☐ Not Implemented | [________________________________] |
4.7 Contingency Plan (§ 164.308(a)(7))
Data Backup Plan - 45 CFR § 164.308(a)(7)(ii)(A) [REQUIRED]
| Assessment Item | Status | Notes |
|---|---|---|
| Establish procedures for data backup | ☐ Implemented ☐ Partially ☐ Not Implemented | [________________________________] |
Disaster Recovery Plan - 45 CFR § 164.308(a)(7)(ii)(B) [REQUIRED]
| Assessment Item | Status | Notes |
|---|---|---|
| Establish procedures to restore lost data | ☐ Implemented ☐ Partially ☐ Not Implemented | [________________________________] |
Emergency Mode Operation Plan - 45 CFR § 164.308(a)(7)(ii)(C) [REQUIRED]
| Assessment Item | Status | Notes |
|---|---|---|
| Establish procedures for emergency operations | ☐ Implemented ☐ Partially ☐ Not Implemented | [________________________________] |
Testing and Revision Procedures - 45 CFR § 164.308(a)(7)(ii)(D) [ADDRESSABLE]
| Assessment Item | Status | Notes |
|---|---|---|
| Implement procedures for testing contingency plans | ☐ Implemented ☐ Addressed ☐ Not Applicable | [________________________________] |
Applications and Data Criticality Analysis - 45 CFR § 164.308(a)(7)(ii)(E) [ADDRESSABLE]
| Assessment Item | Status | Notes |
|---|---|---|
| Assess relative criticality of systems | ☐ Implemented ☐ Addressed ☐ Not Applicable | [________________________________] |
4.8 Evaluation (§ 164.308(a)(8)) [REQUIRED]
| Assessment Item | Status | Notes |
|---|---|---|
| Perform periodic technical and non-technical evaluation | ☐ Implemented ☐ Partially ☐ Not Implemented | [________________________________] |
SECTION 5: PHYSICAL SAFEGUARDS ASSESSMENT
5.1 Facility Access Controls (§ 164.310(a)(1))
Contingency Operations - 45 CFR § 164.310(a)(2)(i) [ADDRESSABLE]
| Assessment Item | Status | Notes |
|---|---|---|
| Establish procedures for facility access during emergencies | ☐ Implemented ☐ Addressed ☐ Not Applicable | [________________________________] |
Facility Security Plan - 45 CFR § 164.310(a)(2)(ii) [ADDRESSABLE]
| Assessment Item | Status | Notes |
|---|---|---|
| Implement policies for safeguarding facility | ☐ Implemented ☐ Addressed ☐ Not Applicable | [________________________________] |
Access Control and Validation Procedures - 45 CFR § 164.310(a)(2)(iii) [ADDRESSABLE]
| Assessment Item | Status | Notes |
|---|---|---|
| Implement procedures to control facility access | ☐ Implemented ☐ Addressed ☐ Not Applicable | [________________________________] |
Maintenance Records - 45 CFR § 164.310(a)(2)(iv) [ADDRESSABLE]
| Assessment Item | Status | Notes |
|---|---|---|
| Document repairs and modifications to facility | ☐ Implemented ☐ Addressed ☐ Not Applicable | [________________________________] |
5.2 Workstation Use (§ 164.310(b)) [REQUIRED]
| Assessment Item | Status | Notes |
|---|---|---|
| Implement policies for proper workstation use | ☐ Implemented ☐ Partially ☐ Not Implemented | [________________________________] |
5.3 Workstation Security (§ 164.310(c)) [REQUIRED]
| Assessment Item | Status | Notes |
|---|---|---|
| Implement physical safeguards for workstations | ☐ Implemented ☐ Partially ☐ Not Implemented | [________________________________] |
5.4 Device and Media Controls (§ 164.310(d)(1))
Disposal - 45 CFR § 164.310(d)(2)(i) [REQUIRED]
| Assessment Item | Status | Notes |
|---|---|---|
| Implement policies for disposal of ePHI media | ☐ Implemented ☐ Partially ☐ Not Implemented | [________________________________] |
Media Re-Use - 45 CFR § 164.310(d)(2)(ii) [REQUIRED]
| Assessment Item | Status | Notes |
|---|---|---|
| Implement procedures for removing ePHI before re-use | ☐ Implemented ☐ Partially ☐ Not Implemented | [________________________________] |
Accountability - 45 CFR § 164.310(d)(2)(iii) [ADDRESSABLE]
| Assessment Item | Status | Notes |
|---|---|---|
| Maintain records of hardware and media movements | ☐ Implemented ☐ Addressed ☐ Not Applicable | [________________________________] |
Data Backup and Storage - 45 CFR § 164.310(d)(2)(iv) [ADDRESSABLE]
| Assessment Item | Status | Notes |
|---|---|---|
| Create retrievable copies of ePHI before moving equipment | ☐ Implemented ☐ Addressed ☐ Not Applicable | [________________________________] |
SECTION 6: TECHNICAL SAFEGUARDS ASSESSMENT
6.1 Access Control (§ 164.312(a)(1))
Unique User Identification - 45 CFR § 164.312(a)(2)(i) [REQUIRED]
| Assessment Item | Status | Notes |
|---|---|---|
| Assign unique identifiers to users | ☐ Implemented ☐ Partially ☐ Not Implemented | [________________________________] |
Emergency Access Procedure - 45 CFR § 164.312(a)(2)(ii) [REQUIRED]
| Assessment Item | Status | Notes |
|---|---|---|
| Establish procedures for obtaining ePHI in emergency | ☐ Implemented ☐ Partially ☐ Not Implemented | [________________________________] |
Automatic Logoff - 45 CFR § 164.312(a)(2)(iii) [ADDRESSABLE]
| Assessment Item | Status | Notes |
|---|---|---|
| Implement automatic logoff after inactivity | ☐ Implemented ☐ Addressed ☐ Not Applicable | [________________________________] |
Encryption and Decryption - 45 CFR § 164.312(a)(2)(iv) [ADDRESSABLE]
| Assessment Item | Status | Notes |
|---|---|---|
| Implement mechanism to encrypt/decrypt ePHI | ☐ Implemented ☐ Addressed ☐ Not Applicable | [________________________________] |
6.2 Audit Controls (§ 164.312(b)) [REQUIRED]
| Assessment Item | Status | Notes |
|---|---|---|
| Implement hardware, software, procedural audit mechanisms | ☐ Implemented ☐ Partially ☐ Not Implemented | [________________________________] |
6.3 Integrity (§ 164.312(c)(1))
Mechanism to Authenticate ePHI - 45 CFR § 164.312(c)(2) [ADDRESSABLE]
| Assessment Item | Status | Notes |
|---|---|---|
| Implement electronic mechanisms to confirm ePHI integrity | ☐ Implemented ☐ Addressed ☐ Not Applicable | [________________________________] |
6.4 Person or Entity Authentication (§ 164.312(d)) [REQUIRED]
| Assessment Item | Status | Notes |
|---|---|---|
| Implement procedures to verify identity of persons seeking ePHI | ☐ Implemented ☐ Partially ☐ Not Implemented | [________________________________] |
6.5 Transmission Security (§ 164.312(e)(1))
Integrity Controls - 45 CFR § 164.312(e)(2)(i) [ADDRESSABLE]
| Assessment Item | Status | Notes |
|---|---|---|
| Implement measures to ensure ePHI is not improperly modified during transmission | ☐ Implemented ☐ Addressed ☐ Not Applicable | [________________________________] |
Encryption - 45 CFR § 164.312(e)(2)(ii) [ADDRESSABLE]
| Assessment Item | Status | Notes |
|---|---|---|
| Implement mechanism to encrypt ePHI during transmission | ☐ Implemented ☐ Addressed ☐ Not Applicable | [________________________________] |
SECTION 7: RISK ASSESSMENT MATRIX
7.1 Risk Scoring Methodology
Likelihood Scale:
| Rating | Description | Criteria |
|---|---|---|
| 1 - Rare | Very unlikely to occur | Less than 1% chance annually |
| 2 - Unlikely | Could occur but not expected | 1-10% chance annually |
| 3 - Possible | Might occur at some time | 10-50% chance annually |
| 4 - Likely | Will probably occur | 50-90% chance annually |
| 5 - Almost Certain | Expected to occur | Greater than 90% chance annually |
Impact Scale:
| Rating | Description | Criteria |
|---|---|---|
| 1 - Negligible | Minimal impact | Minor inconvenience, no PHI exposure |
| 2 - Minor | Limited impact | Small amount of PHI, limited harm |
| 3 - Moderate | Significant impact | Moderate PHI exposure, potential harm |
| 4 - Major | Serious impact | Large PHI exposure, significant harm |
| 5 - Catastrophic | Severe impact | Massive PHI exposure, severe harm |
Risk Level Matrix:
| Likelihood \ Impact | 1 | 2 | 3 | 4 | 5 |
|---|---|---|---|---|---|
| 5 | Medium | Medium | High | Critical | Critical |
| 4 | Low | Medium | High | High | Critical |
| 3 | Low | Medium | Medium | High | High |
| 2 | Low | Low | Medium | Medium | High |
| 1 | Low | Low | Low | Medium | Medium |
7.2 Identified Risks
| Risk ID | Description | Threat | Vulnerability | Likelihood | Impact | Risk Level |
|---|---|---|---|---|---|---|
| R-[____] | [________________________________] | [________________________________] | [________________________________] | [____] | [____] | [________________________________] |
| R-[____] | [________________________________] | [________________________________] | [________________________________] | [____] | [____] | [________________________________] |
| R-[____] | [________________________________] | [________________________________] | [________________________________] | [____] | [____] | [________________________________] |
| R-[____] | [________________________________] | [________________________________] | [________________________________] | [____] | [____] | [________________________________] |
| R-[____] | [________________________________] | [________________________________] | [________________________________] | [____] | [____] | [________________________________] |
SECTION 8: RISK MANAGEMENT PLAN
8.1 Risk Response Options
For each identified risk, document the selected response:
☐ Mitigate - Implement controls to reduce risk
☐ Accept - Accept the risk with management approval
☐ Transfer - Transfer risk through insurance or contracts
☐ Avoid - Eliminate the risk by removing the source
8.2 Risk Treatment Plan
| Risk ID | Response | Control/Action | Responsible Party | Target Date | Status |
|---|---|---|---|---|---|
| R-[____] | [________________________________] | [________________________________] | [________________________________] | [__/__/____] | [________________________________] |
| R-[____] | [________________________________] | [________________________________] | [________________________________] | [__/__/____] | [________________________________] |
| R-[____] | [________________________________] | [________________________________] | [________________________________] | [__/__/____] | [________________________________] |
| R-[____] | [________________________________] | [________________________________] | [________________________________] | [__/__/____] | [________________________________] |
| R-[____] | [________________________________] | [________________________________] | [________________________________] | [__/__/____] | [________________________________] |
SECTION 9: APPROVAL AND CERTIFICATION
Assessment Certification
I certify that this Security Risk Assessment has been conducted in accordance with 45 CFR § 164.308(a)(1)(ii)(A) and represents an accurate and thorough assessment of potential risks and vulnerabilities to ePHI.
Assessed by:
Name: [________________________________]
Title: [________________________________]
Date: [__/__/____]
Signature: [________________________________]
Reviewed by:
Name: [________________________________]
Title: [________________________________]
Date: [__/__/____]
Signature: [________________________________]
Approved by:
Name: [________________________________]
Title: [________________________________]
Date: [__/__/____]
Signature: [________________________________]
SECTION 10: NEXT STEPS
☐ Review and approve risk management plan
☐ Implement high-priority risk mitigation measures
☐ Update policies and procedures as needed
☐ Conduct workforce training
☐ Schedule follow-up assessment
☐ Document residual risks
Next Assessment Date: [__/__/____]
SOURCES AND REFERENCES
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