The HIPAA Security Rule protects the confidentiality, integrity, and availability of protected health information (PHI). To stay compliant, organizations must conduct regular HIPAA security risk assessments and implement administrative, technical, and physical safeguards. These measures help identify vulnerabilities, reduce risks, and ensure ongoing compliance.
If your organization needs expert guidance on HIPAA security requirements, RSI Security can help — schedule a free consultation today.
HIPAA Risk Assessment and Management 101
The Health Insurance Portability and Accountability Act (HIPAA) requires all covered entities and business associates to safeguard protected health information (PHI) against unauthorized access. Two key components of the HIPAA Security Rule help organizations achieve this:
- HIPAA security risk assessment – Identifying potential vulnerabilities that could expose PHI.
- HIPAA risk management – Implementing preventive and corrective controls to mitigate risks.
Together, these measures form the foundation of HIPAA security compliance. The most effective way to meet these requirements is by partnering with a trusted compliance advisor who can help scope, implement, and maintain your risk management program.
HIPAA Security Risk Assessment
The HIPAA Security Rule ensures the confidentiality, integrity, and availability of protected health information (PHI). Under this rule, the Department of Health and Human Services (HHS) requires organizations to prevent PHI from being:
- Accessed without proper authorization
- Changed or deleted inappropriately
- Made unavailable for legitimate use or disclosure
To comply, organizations must conduct a HIPAA security risk assessment that includes:
- Evaluating the likelihood and potential impact of risks
- Implementing measures to prevent risks from occurring
- Documenting safeguards and the rationale behind them
- Maintaining up-to-date protections on a continuous basis
To support compliance, HHS provides two HIPAA security risk assessment tools: the HealthIT.gov assessment tool and a toolkit developed with the National Institute of Standards and Technology (NIST).
The HIPAA Risk Assessment Process
The HIPAA Security Rule does not prescribe a single method for risk assessments. Instead, it provides a flexible framework that allows organizations to choose safeguards that fit their size, complexity, and technical environment. Still, the Department of Health and Human Services (HHS) outlines several core phases that every HIPAA security risk assessment should cover:
- Data Collection – Document all hardware, software, and networks that store, transmit, or process PHI, as well as who has access to them.
- Threat and Vulnerability Identification – Identify system weaknesses (vulnerabilities) and potential sources of attacks or errors (threats).
- Security Measure Evaluation – Assess protections in place to segment PHI, monitor access, and contain incidents.
- Incident Likelihood Determination – Estimate the probability of cyberattacks, human errors, or environmental hazards impacting PHI.
- Impact Determination – Evaluate the potential damage if PHI is compromised, including risks of re-identification.
- Risk Identification – Assign risk levels (e.g., “high,” “medium,” “low”) to prioritize threats and address the most critical vulnerabilities.
Importantly, HIPAA risk analysis is not a one-time project. It must be an ongoing, cyclical process that adapts to new threats and technologies. Regular reassessments and reviews of your methods are essential to maintaining HIPAA security compliance.
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HIPAA Risk Management Requirements
Beyond conducting risk assessments, the HIPAA Security Rule also requires organizations to actively manage any risks that are identified. Covered Entities, such as healthcare providers, health plans, and clearinghouses, must take proactive steps to:
- Eliminate vulnerabilities
- Neutralize potential threats
- Reduce the likelihood of risks impacting protected health information (PHI)
These requirements also extend to Business Associates, regardless of industry, if they handle PHI on behalf of a Covered Entity.
Similar to the assessment process, the Department of Health and Human Services (HHS) does not mandate specific controls. Instead, it provides flexibility, allowing organizations to choose safeguards that align with their size, systems, and complexity. However, all selected measures must address the three core categories of HIPAA security safeguards: administrative, technical, and physical.
Required Administrative Safeguards
Covered Entities must implement top-down governance measures to ensure HIPAA security compliance. These include:
- Security Management Process – Develop clear policies for PHI protection, including HIPAA security risk assessments, and make them accessible.
- Assigned Security Personnel – Designate individuals with defined roles and responsibilities for overseeing PHI security.
- Information Access Management – Establish identity and access management (IAM) policies to control who can view or use PHI.
- Workforce Security Training – Provide ongoing education to all personnel about HIPAA security risks, threats, and responsibilities.
- Regular Security Evaluations – Continuously assess and update security policies to adapt to evolving risks.
These administrative safeguards ensure that insights from HIPAA risk analysis are applied across the organization.
Required Physical HIPAA Security Safeguards
Covered Entities must also enforce physical protections for facilities and devices, such as:
- Facility Access and Control – Restrict physical access to buildings, rooms, and systems containing PHI.
- Device and Media Controls – Secure devices and storage media throughout their lifecycle, including secure disposal or destruction.
These safeguards protect the physical environments where PHI is stored and processed.
Required Technical HIPAA Security Safeguards
Finally, Covered Entities must enforce technical measures to protect PHI within digital systems, including:
- Access Controls – Implement IAM protections such as multi-factor authentication (MFA) for all PHI-related systems.
- Audit Controls – Monitor system activity and log all access, with the ability to suspend or revoke credentials if necessary.
- Integrity Controls – Track and analyze any changes to PHI files to detect unauthorized modifications.
- Transmission Security – Secure PHI transmitted over networks, especially when data travels through unrecognized or unsecured channels.
These technical safeguards ensure HIPAA security protections extend across all systems where PHI is stored, transmitted, or processed.
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Other HIPAA Compliance Considerations
In addition to the Privacy and Security Rules, HIPAA includes the Breach Notification Rule. This requires Covered Entities to notify:
- All impacted parties in the event of a breach
- The Secretary of the Department of Health and Human Services (HHS)
- Local media, if a breach affects 500 or more individuals
Any violation of the Privacy, Security, or Breach Notification Rules can trigger HIPAA enforcement. Investigations are typically led by the Office for Civil Rights (OCR) and, in some cases, the Department of Justice (DOJ). Penalties can be severe — up to $2 million in annual Civil Monetary Penalties and as much as 10 years in prison for individuals found responsible.
Unlike other regulatory frameworks, HIPAA does not mandate routine audits or third-party assessments. However, organizations benefit greatly from regularly validating their compliance status. One of the most effective ways to achieve this assurance is through HITRUST Certification. The HITRUST CSF maps directly to HIPAA security requirements, along with many other frameworks, enabling organizations to “assess once, report many.”
If your organization must comply with HIPAA and additional regulations, working with a HITRUST advisor can streamline your security program, reduce redundancy, and maximize your return on compliance efforts.
Optimize Your HIPAA Compliance Today!
HIPAA compliance is mandatory for most healthcare organizations and their partners. Conducting HIPAA security risk assessments and implementing risk management measures are essential to protecting PHI, and avoiding costly penalties for non-compliance. Working with a dedicated HIPAA security advisor makes the process smoother and more effective.
At RSI Security, we specialize in helping organizations strengthen their HIPAA security compliance programs. Our team will collaborate with your internal staff to design, implement, and continuously assess safeguards that protect PHI and other sensitive data.
With RSI Security, you gain a trusted partner committed to achieving and maintaining HIPAA compliance, while strengthening your overall cyberdefense.
Learn how RSI Security can help your organization. Request a Free Consultation
