Risk Analysis
“Security is always going to be a cat and mouse game because there’ll be people out there that are hunting for the zero day award, you have people that don’t have configuration management, don’t have vulnerability management, don’t have patch management.”
Control 164.308(a)(1)(ii)(A)
The HIPAA Security Rule 164.308(a)(1)(ii)(A) requires covered entities and business associates to:
"Conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of electronic protected health information held by the covered entity or business associate.”
This rule is a crucial component of the Security Management Process and forms the foundation for implementing appropriate security measures to protect ePHI.
Key Components of a HIPAA Risk Analysis
1. Scope of the Analysis
Identify all systems, applications, and processes that create, receive, maintain, or transmit ePHI.
Example: A multi-specialty medical clinic conducts an inventory and identifies the following systems handling ePHI:
Electronic Health Record (EHR) system
Practice Management System for scheduling and billing
Radiology Information System (RIS) and Picture Archiving and Communication System (PACS)
Laboratory Information System (LIS)
Email system used for communication with patients
Mobile devices used by physicians for remote access
Cloud-based backup system for data storage
2. Data Collection
Gather relevant data about ePHI flows, current security measures, and system capabilities.
Example: The clinic's IT team conducts interviews with department heads and system administrators, reviews system documentation, and uses network scanning tools to map data flows. They discover:
The EHR system exchanges data with the LIS and RIS via HL7 interfaces
Physicians regularly email test results to patients, sometimes from personal devices
The cloud backup system is configured to store data in encrypted form, but the encryption key management process is informal
3. Identify and Document Potential Threats and Vulnerabilities
List all potential threats (both internal and external) and vulnerabilities that could compromise ePHI.
Example: The clinic identifies the following threats and vulnerabilities:
The clinic, after a thorough risk assessment, has identified a range of potential threats and vulnerabilities that could jeopardize the security and privacy of their patients' electronic protected health information (ePHI). External threats loom large, with the specter of malware infections like ransomware specifically targeting healthcare organizations. Phishing attacks, aimed at tricking staff into revealing credentials or downloading malicious software, pose a constant threat. Internally, insider threats – whether from curious employees accessing sensitive records or disgruntled staff seeking revenge – cannot be ignored. The clinic's location in a flood-prone area also leaves it susceptible to natural disasters that could damage equipment and compromise data.
On the technology front, several vulnerabilities have come to light. Some workstations still operate on the outdated and unsupported Windows 7, leaving them exposed to known exploits. Weak password policies, demanding only minimal complexity and infrequent changes, create an easy entry point for attackers. The lack of encryption on certain mobile devices poses a risk if they are lost or stolen. Moreover, inconsistent patch management practices mean that software vulnerabilities might not be addressed in a timely manner, leaving the clinic's systems open to attack.
4. Assess Current Security Measures
Example: The clinic reviews its current security measures:
Firewall and antivirus software are in place and regularly updated
Two-factor authentication is used for remote access to the EHR
Annual HIPAA training is provided to all staff
Encryption is used for data backups
However, they find that:
Network segmentation is minimal, with all medical devices on the same network as general workstations
Audit logging is enabled but logs are not regularly reviewed
There's no formal process for managing USB devices, which could be used to exfiltrate data
5. Determine the Likelihood of Threat Occurrence
Assess the probability of potential threats exploiting vulnerabilities.
Example: The clinic rates the likelihood of various scenarios:
High Likelihood:
Phishing attack succeeding due to lack of ongoing security awareness training
Malware infection on an unpatched workstation
Medium Likelihood:
Insider snooping on patient records due to overly broad access rights
Data breach via lost or stolen unencrypted mobile device
Low Likelihood:
Complete data loss due to natural disaster (because of offsite backups)
Hack of the EHR system due to strong access controls
6. Determine the Potential Impact
Evaluate the potential consequences if a threat exploits a vulnerability.
Example: The clinic assesses potential impacts:
High Impact:
Ransomware attack encrypting all patient data: could halt operations and cost millions in recovery and fines
Breach of celebrity patient data: could result in lawsuits, reputation damage, and regulatory penalties
Medium Impact:
Temporary loss of access to the LIS: could delay test results and impact patient care
Unauthorized access to a single patient's record: could result in a reportable breach and undermine patient trust
Low Impact:
Brief email system outage: might cause minor inconvenience but wouldn't significantly impact patient care
7. Determine the Level of Risk
Combine the likelihood of occurrence with the potential impact to prioritize risks.
Example: The clinic creates a risk matrix:
High Risk:
Phishing attack leading to unauthorized ePHI access (High Likelihood, High Impact)
Malware infection on unpatched systems (High Likelihood, High Impact)
Medium Risk:
Insider snooping on patient records (Medium Likelihood, Medium Impact)
Data breach via lost/stolen unencrypted device (Medium Likelihood, High Impact)
Low Risk:
Complete data loss from natural disaster (Low Likelihood, High Impact)
Brief email system outage (Medium Likelihood, Low Impact)
8. Documentation
Thoroughly document all findings, methodologies, and results of the risk analysis.
Example: The clinic produces a comprehensive risk analysis report including:
Executive summary of key findings and recommended actions
Detailed inventory of all systems handling ePHI
Threat and vulnerability assessment for each system
Risk matrix showing prioritized risks
Appendices with raw data from interviews, system scans, and other information gathering activities
Best Practices for Conducting a HIPAA Risk Analysis
Make it comprehensive: Ensure all ePHI systems and processes are included in the scope.
Use multiple data gathering techniques: Combine interviews, documentation review, and technical testing for a complete picture.
Involve the right people: Include IT staff, department heads, and senior management in the process.
Consider all types of threats: Don't focus solely on technical threats; consider physical, natural, and human threats as well.
Be realistic about impact: Consider both direct costs (e.g., breach notification) and indirect costs (e.g., reputation damage).
Update regularly: Conduct a full risk analysis annually and update it whenever there are significant changes to your ePHI environment.
