Understanding Patient Data Security Risk Management Requirements for HIPAA 

Organizations within and adjacent to the healthcare industry must comply with HIPAA regarding their interactions involving protected health information (PHI). The HIPAA Security Rule outlines safeguards for patient data security risk management to help healthcare organizations minimize risk to PHI. Managing risks to PHI security is of the utmost importance and can help your organization mitigate data breaches. Read on to learn how. 

 

Best Practices for Patient Data Security Risk Management 

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) was established to protect the integrity and sensitivity of patient data. This regulation stipulates compliance requirements for organizations involved in the receipt, storage, or transmission of PHI. 

Specifically, the HIPAA Security Rule outlines requirements for patient data security risk management best practices that include:

• Risk analysis 
• Threat and vulnerability assessment
• Security measure implementation
• Security measure evaluation and monitoring

The overarching goal of the HIPAA Security Rule is to help organizations achieve patient data protection and confidentiality. Regardless of the size, complexity, or business focus of healthcare organizations, HIPAA compliance is critical to protecting PHI. 

Working with a HIPAA compliance partner can help inform your organization’s patient data security risk management.

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What is the HIPAA Security Rule?

The HIPAA Security Rule primarily extends protections from PHI to electronic PHI (ePHI), helping organizations within and adjacent to the healthcare industry define appropriate cybersecurity protections.

Covered entities and their business associates (defined by the HIPAA Privacy Rule) are required to comply with electronic patient data protections by establishing processes for:

• Maintaining confidentiality and integrity of ePHI received, stored, or transmitted
• Identifying and protecting ePHI against any anticipated threats
• Protecting against misuse of permitted uses and disclosures
• Ensuring workforce compliance with HIPAA regulations

The HIPAA Security Rule helps your organization define policies and processes for patient data security risk management.

 

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HIPAA Security Rule Safeguards

The Security Rule contains specific safeguards for implementing robust patient data risk management. Covered entities and their business associates can implement HIPAA-compliant safeguards, including:

• Administrative safeguards – A set of management processes to help organizations address vulnerabilities in the processing of PHI. Safeguards include:
  • Security management to identify and mitigate threats to ePHI
  • Security personnel designation to manage and implement security processes
  • Information access control to minimize risks to ePHI uses and disclosures via unauthorized access
  • Workforce training and management to strengthen personnel adherence to security policies
  • Periodic evaluation of security policies to address gaps in Security Rule compliance
• Physical safeguards – Processes to minimize unauthorized physical access to ePHI, including:
  • Minimized access to facilities containing ePHI, except for business-use access
  • Workstation and device security to prevent unauthorized removal, modification, or disposal of ePHI
• Technical safeguards – A set of technical measures to limit unauthorized access to PHI. Specific measures include:
  • Access control measures to prevent unauthorized access to ePHI outside of business legitimacy
  • Audit controls to monitor unusual activity in secure ePHI environments (e.g., access or modification events)
  • Integrity controls to ensure that ePHI is not wrongly modified, deleted, or transferred from a secure PHI environment
  • Transmission security protocols to ensure encryption of ePHI during transit 

The HIPAA Security Rule safeguards can help implement patient data risk management and overall ePHI protection.

 

HIPAA Risk Analysis Methodology

Patient data security risk management starts with defining risks to ePHI. The Security Rule defines risk as a combination of threats and vulnerabilities which can impact patient data security if exploited. Your organization can benefit from implementing a methodology to analyze risks to ePHI, which can help guide and maximize overall patient data protection. 

 

Risk Definition Criteria

Your organization can define risks to ePHI with the help of resources such as the NIST Special Publication 800-30. Per the NIST SP 800-30:

• Vulnerabilities are flaws in security system processes (e.g., design, implementation, or controls), which result in data breaches if exploited. Categories of vulnerabilities associated with processing ePHI include:
  • Technical vulnerabilities (e.g., flaws or misconfigurations in IT systems)
  • Non-technical vulnerabilities (e.g., ineffective policies, procedures, guidelines)
• Threats are potential persons or things that can trigger or exploit a vulnerability. Threats to patient data protection include:
  • Natural threats (e.g., floods, earthquakes, tornados)
  • Human threats, intentionally or unintentionally initiated (e.g., malicious uploads, unauthorized access to ePHI, deletion or modification of ePHI)
  • Environmental threats (e.g., power failures, chemicals) 

Defining risks, vulnerabilities, and threats to ePHI can help your organization effectively implement patient data security risk management.

 

Risk Analysis of Threats and Vulnerabilities to ePHI

Analyzing risks specific to ePHI is critical to patient data security risk management. Methods for conducting risk analysis for threats and vulnerabilities that can compromise ePHI include:

• Analyzing the processing of ePHI – Identifying the risks and vulnerabilities to ePHI during receipt, maintenance, and transmission helps point out security gaps in your organization’s systems. You can protect patient data by analyzing risk to sources of ePHI storage, including:
  • Electronic media (e.g., hard drives, CDs, DVDs)
  • Personal digital assistants
  • Transmission media
  • Portable storage media 
  • Network locations
  • Cloud storage and services
• Collecting data on ePHI processing – For some organizations, ePHI is stored in multiple areas (e.g., networks, decommissioned devices, less frequently used workstations), requiring comprehensive risk analysis for all forms of storage. The Security Rule requires organizations to document data collected during risk analysis methods to help guide security policies. Your organization can identify risks to broader ePHI storage by collecting data via:
  • Reviews of past and existing projects
  • Interviews
  • Documentation review
• Identifying and documenting potential threats – Threat identification measures should account for a healthcare organization’s digital assets to identify:
  • Threats unique to PHI environment (e.g., networks, applications, systems)
  • Vulnerability exploits that can compromise access to ePHI

Defining risks posed by threats and vulnerabilities specific to ePHI will strengthen patient data security risk management.

 

ePHI Threat and Vulnerability Assessment Criteria

The HIPAA Security Rule does not require organizations to follow a specific format when conducting patient data security risk management. However, organizations must determine the most effective path to complying with the Security Rule requirements and protecting sensitive patient data. 

The Security Rule requires healthcare organizations to assess ePHI environments for threats and vulnerabilities, focusing on:

• Threat occurrence likelihood
• Impact of threat occurrence
• Threat and vulnerability risk levels

Based on the above considerations, your organization can conduct a comprehensive assessment of threats and vulnerabilities to ePHI, effectively addressing gaps in patient data security risk management.

 

How Likely are Threats to Occur?

The Security Rule guidance for patient data protection requires organizations within and adjacent to the healthcare industry to assess the materialization of risks to ePHI. Defining anticipated threats can help your organization determine cybersecurity strengthening measures, especially for reasonably anticipated threats.

The critical considerations for determining the likelihood of threat occurrence include:

• Highly anticipated threats and vulnerabilities
• Combinations of threats and vulnerabilities
• Outcomes associated with anticipated threats

The Security Rule requires organizations to document the results of threat likelihood assessments. Determining the likelihood of threats to ePHI will guide cybersecurity protocols and provide the best ROI on patient data protection.

 

What is the Potential Impact of Threats?

Patient data security risk management also mandates that healthcare organizations assess the impact of threats to ePHI, should they occur. Specific requirements stipulated by the Security Rule include:

• Assessment of threat impact due to triggered or exploited vulnerabilities
• Quantitative or qualitative determination of threat impact to business operations

Once completed, your organization should document all the potential threats identified to compromise the integrity and confidentiality of ePHI. 

Assessment of threat impact helps guide incident response protocols, ensuring appropriate responses to high-impact threats. Your organization can develop robust threat intelligence tools to address patient data risk management with the help of a threat and vulnerability management partner.

 

What are the Levels of Threat and Vulnerability Risks?

As part of their periodic risk assessment efforts, organizations within and adjacent to the healthcare industry must assign risk levels to patient data threats and vulnerabilities identified during risk analysis. Risk level classification is essential to patient data risk management because it helps to determine:

• Likelihood of threat occurrence – Some threats are more likely to occur than others. Common threats to ePHI include:

1. Access control gaps (e.g., poor password policies, misuse of privileged access)
2. Personnel negligence (e.g., transferring ePHI out of secure environments)
3. Social engineering attacks (e.g., phishing, tailgating)

• Impact of threat occurrence – Some threats can cause more harm than others if targeted towards critical networks or systems. Most high-impact threats target databases or networks containing ePHI, resulting in sensitive data breaches. High impact threats include:

1. Phishing attacks provide threat actor access to networks containing PHI
2. Loss or theft of personal devices lacking appropriate encryption security

Healthcare organizations must develop appropriate threat mitigation measures to address threats that are highly likely to occur or those that could compromise ePHI. Assessing threat and vulnerability risk levels helps your organization implement robust patient data risk management.

 

Security Measure Implementation

Following risk analysis and assessment of threats and vulnerabilities to ePHI, the next step in patient data risk management is implementing appropriate security measures for ePHI. Compliance is of the utmost importance when implementing security measures. Your organization can choose whichever methods fit business needs, budget, and other considerations.

Common practices for implementing patient data protection security measures include:

• Penetration testing – Also called “ethical hacking,” penetration testing can help identify gaps in your organization’s security by simulating cyber attacks utilizing commonly exploited vectors. Common types of penetration tests include:
  • Social engineering pen testing
  • Hardware pen testing
  • Network pen testing
• Patch management – Gaps in security patches to systems can present vulnerabilities for hackers to exploit in attempting to breach ePHI networks. Patch management addresses these gaps to ensure up-to-date security for your organization’s cyberdefenses.
• Identity and access management – Access control vulnerabilities can be mitigated by robust identity and access management, helping organizations develop and enforce best practices for:
  • Strengthening user credentials (e.g., strong password use policies)
  • Secure authentication (i.e., multi-factor authentication)
  • User account monitoring to identify privileged account misuse
• Third-party risk management – As a HIPAA-covered entity or business associate, you are responsible for Security Rule compliance, even for operations involving third-party vendors. Managing third-party risks to ePHI complies with the Security Rule and protects ePHI integrity and sensitivity.
• Security training – Many HIPAA access control vulnerabilities result from personnel practices (e.g., poor password use practices, privileged account misuse). However, other vulnerabilities to ePHI arise from lack of training in security practices such as:
  • Detecting and blocking possible phishing attempts
  • Ensuring personal device encryption
  • Identifying signs of sophisticated hacking attempts (e.g., websites lacking SSL certificates)

Implementing appropriate security measures helps protect ePHI from threat attacks. Working with a managed security services provider (MSSP) will help your organization address existing and unknown gaps within patient data security risk management. 

 

Evaluating and Monitoring Security Measures

The last step in patient data security risk management is evaluating and monitoring implemented security measures. Threat actors are consistently devising newer, more sophisticated attack vectors to breach ePHI, underscoring the need for ongoing security.

Evaluating and monitoring security measures requires a periodic review of your organization’s digital infrastructure to identify:

• Changes to system components in ePHI environments
• Gaps in existing security measures, remediable by security updates
• Changes to previously defined levels of threat risk

The Security Rule does not have specific requirements for how frequently healthcare organizations should assess their security measures. However, organizations must use appropriate judgment when implementing HIPAA-compliant security measures, ensuring ongoing assessment of security measures (whether quarterly, semi-annually, or annually).

A critical component of patient data security risk management is evaluating new technologies or devices for HIPAA compliance. Specifically, the Security Rule requires organizations within and adjacent to the healthcare industry to conduct risk analysis and risk management on any new technologies before implementation, minimizing risks to ePHI to reasonable and appropriate levels.

 

Manage Risks to Patient Data with HIPAA Compliance

As a HIPAA-covered entity or business associate thereof, protecting ePHI from threat risks is critical to achieving HIPAA compliance. With the help of RSI Security as a HIPAA compliance partner, your organization can implement robust patient data security risk management, protecting your organization from the legal, financial, and reputational consequences of breaches to ePHI. 

Contact RSI Security today to learn more about our HIPAA compliance services.