Table of Contents
What is the HIPAA Security Rule?
What is the HIPAA Privacy Rule?
What are the 3 Security Rule Safeguards?
What is the Security Rule's Risk Analysis and Management Requirement?
What happens if I don't comply with the HIPAA Security Rule?
HIPAA Compliance Requirements
How Isora GRC from SaltyCloud can help
This guide explores the HIPAA Security Rule, covering principles, safeguards, risk assessments, and compliance strategies to help organizations secure health data and maintain ePHI protection amid growing cyber threats and changing regulations.
Securing sensitive health data is crucial in the ever-evolving digital landscape. As breaches and cyberattacks become increasingly common, compliance and risk management are no longer optional but integral components of a robust, patient-centric healthcare system.
For organizations operating within the healthcare industry, the HIPAA Security Rule is the cornerstone of patient privacy protection, and understanding its intricacies is indispensable.
The HIPAA Security Rule is the cornerstone of patient privacy protection for organizations operating in the healthcare industry.
This guide unravels the complexities of the Security Rule, shedding light on its importance for organizations striving to maintain patient trust and adhere to stringent federal regulations. Here, we dive into its fundamental principles, explore the three categories of safeguards, and offer practical insights into risk assessments and compliance strategies.
By the end of this guide, your organization will be better equipped to navigate the challenges of safeguarding electronic protected health information (ePHI) while staying ahead in the risk and compliance arena.
What is the HIPAA Security Rule?
The HIPAA Security Rule, a federal regulation originating from the 1996 Health Insurance Portability and Accountability Act, requires organizations to implement security measures for ePHI, setting standards and introducing various safeguards to complement the Privacy Rule.
The HIPAA Security Rule is a federal regulation designed to protect patient information by requiring organizations to implement various security measures. The Rule applies to covered entities (such as healthcare providers, health plans, and healthcare clearinghouses) and business associates. It establishes a comprehensive approach for safeguarding the confidentiality, integrity, and availability of electronic protected health information. ePHI includes a wide range of data such as medical records, lab results, insurance information, and any other health-related information linked to an individual on electronic information systems.
The HIPAA Security Rule establishes a comprehensive framework for safeguarding the confidentiality, integrity, and availability of ePHI, which includes a wide range of data.
The Security Rule emerged from the Health Insurance Portability and Accountability Act of 1996 (HIPAA) enacted by the US Congress. Initially aimed at improving healthcare coverage and addressing fraud and abuse, HIPAA’s scope eventually expanded to patient information as technology advanced. In 2000, the US Department of Health and Human Services (HHS) proposed the Security Rule to safeguard ePHI. After several modifications and public consultations, the HHS published the final Rule in 2003.
Over time, the HITECH Act of 2009 and the Omnibus Rule of 2013 enhanced HIPAA rule enforcement. They extended the Security Rule’s obligations to business associates of covered entities, further emphasizing the need for robust security measures to protect patient information.
The Security Rule complements the Privacy rule by setting security standards for protecting ePHI and introducing administrative, physical, and technical safeguards.
Today, the Security Rule complements the earlier-established Privacy Rule by setting security standards for protecting ePHI. The Rule also introduced three types of safeguards: administrative, physical, and technical. Together, these rules serve distinctive but corresponding purposes in safeguarding health information.
What is the HIPAA Privacy Rule?
The HIPAA Privacy Rule establishes national standards for health information protection, regulating PHI use and disclosure, granting patients rights, and mandating privacy policies, officer designation, workforce training, patient consent, and minimum necessary sharing.
The HIPAA Privacy Rule sets the national standard for protecting the privacy of individuals’ health information and governs the use and disclosure of protected health information (PHI) in any form, whether electronic, paper, or oral.
The Privacy Rule sets the national standard for protecting individuals’ health information and governs the use and disclosure of PHI in any form.
The Privacy Rule grants patients certain rights over their personal health information, such as the right to access, amend, and receive an accounting of disclosures. Under the Privacy Rule, covered entities must implement privacy policies and procedures, designate a privacy officer, and train the workforce on privacy practices.
Additionally, HIPAA-covered entities must obtain patient consent for specific uses and disclosures of individually identifiable health information and follow the “minimum necessary” standard, sharing only the least amount of PHI required to accomplish a given purpose.
While the Privacy Rule standardizes the protection, use, and disclosure of PHI in all forms, the Security Rule specifically focuses on the protection of ePHI through safeguards and provides a clear framework for procedures and best practices for maintaining HIPAA compliance.
What are the 3 Security Rule Safeguards?
The Security Rule prescribes three safeguard categories: administrative (risk analysis, policies, and training), physical (facility access and workstation security), and technical (access controls, data integrity, and transmission security).
The Security Rule outlines three categories of safeguards: administrative, physical, and technical.
- Administrative safeguards: focus on risk analysis, security management, workforce training, and establishing policies and procedures.
- Physical safeguards: include facility access controls, workstation security measures, and the proper handling of electronic media containing ePHI.
- Technical safeguards: encompass access controls, audit controls, data integrity measures, authentication, and transmission security.
Administrative safeguards comprise policies, procedures, and guidelines to manage ePHI protection, including risk management, security responsibility, workforce security, information access management, training, incident response, contingency planning, and evaluation.
Administrative safeguards are a set of policies, procedures, and guidelines that a covered entity and its business associates must implement to manage the protection of ePHI. They account for over half of the Rule’s requirements and include the following:
- Security Management Process: Develop, implement, and maintain a process to identify and reduce potential risks to ePHI by conducting regular risk assessments, creating a risk management plan, and applying appropriate security measures to address identified vulnerabilities.
- Assigned Security Responsibility: Designate a security official responsible for developing, implementing, and maintaining security policies and procedures to ensure compliance.
- Workforce Security: Ensure only authorized members of a covered entity’s workforce can access ePHI by determining appropriate access levels, implementing authorization and supervision protocols, and maintaining workforce clearance procedures.
- Information Access Management: Prevent unauthorized access to ePHI by implementing role-based access controls (RBAC), restricting access to the minimum necessary information, and managing access.
- Security Awareness Training: Provide regular training for all workforce members that covers password management, malware protection, and reporting security incidents.
- Security Incident Procedures: Implement policies and procedures that outline a process for identifying, responding to, and reporting security incidents, including developing an incident response plan, analyzing incidents, and documenting the organization’s response to mitigate risks and prevent future occurrences.
- Contingency Plan: Establish a contingency plan to ensure the availability of ePHI during emergencies (including natural and environmental hazards) or system failures by developing data backup, disaster recovery, and emergency mode operation plans and periodically testing and revising these plans as needed.
- Evaluation: Regularly evaluate security policies and procedures to ensure ongoing effectiveness and compliance, including monitoring changes in the organization’s environment, performing audits, and making necessary adjustments.
Physical safeguards protect ePHI from unauthorized access, theft, and damage through facility access controls, workstation use and security measures, and device and media controls.
Physical safeguards are security measures designed to protect ePHI from unauthorized access, theft, and damage in physical environments and include the following requirements:
- Facility Access Controls: Limit physical access to facilities while providing authorized access to workforce members by creating access control and validation procedures, implementing a visitor management system, and maintaining appropriate security measures such as cards, locks, and alarms.
- Workstation Use: Establish appropriate use and functions of workstations that access ePHI by defining the physical attributes of workstations, setting access restrictions, and ensuring that workstations are used only for authorized purposes.
- Workstation Security: Implement physical measures to prevent unauthorized access to workstations containing ePHI by positioning workstations away from public view, using privacy screens, and employing additional security measures such as cable locks and secure enclosures.
- Device and Media Controls: Properly handle electronic media containing ePHI by creating guidelines for the disposal and reuse of media, maintaining an inventory of media devices, implementing data backup and storage procedures, and ensuring secure transport of ePHI when moving it between locations.
Technical safeguards employ technology-based measures to protect ePHI from unauthorized access, alteration, or destruction, including access control, audit controls, integrity protection, authentication, and transmission security.
Technical safeguards are technology-based measures designed to protect ePHI from unauthorized access, alteration, or destruction and include the following requirements:
- Access Control: Control access to ePHI on electronic systems by using unique user identification, implementing RBACs, establishing emergency access procedures, and utilizing automatic logoff features to prevent unauthorized intrusion.
- Audit Controls: Deploy hardware, software, or procedural mechanisms that record and examine activity in electronic systems containing ePHI to help monitor access, detect potential security incidents, and maintain accountability.
- Integrity: Protect ePHI from improper alteration or destruction by using mechanisms to authenticate ePHI, ensuring it has not been tampered with or altered, and employing data validation techniques such as checksums or digital signatures to maintain data integrity.
- Authentication: Verify that a person or entity seeking access to ePHI is who they claim to be by using various authentication methods, such as passwords, biometrics, or multi-factor authentication (MFA) systems.
- Transmission Security: Implement technical security measures to protect ePHI during transmission over electronic networks by using encryption technologies to safeguard data in transit, employing secure communication protocols such as SSL/TLS, and implementing integrity controls to detect unauthorized changes during transmission.
What is the Security Rule’s Risk Analysis and Management Requirement?
To comply with the Risk Analysis and Management requirement, organizations should identify ePHI, evaluate risks, implement security measures, and review and update regularly.
One of the key components of the Security Rule is Risk Analysis and Management, which aims to ensure that organizations are proactively identifying and mitigating risks to ePHI. The process can be broken down into four main steps:
- Identify ePHI: The first step is to identify all the locations where ePHI is stored, processed, or transmitted within your organization. This includes electronic health record systems, email, file storage, mobile devices, and any other systems that handle ePHI. Creating an inventory of these systems and data flows is essential for understanding the scope of the risk analysis.
- Evaluate risks: Once you have identified the ePHI locations, it is crucial to evaluate the risks associated with each. This involves identifying potential threats and vulnerabilities to the confidentiality, integrity, and availability of ePHI. Threats may be natural (e.g., floods, earthquakes), human (e.g., unauthorized access, phishing attacks), or environmental (e.g., power failures, HVAC issues). Vulnerabilities are weaknesses in systems or processes that could be exploited by these threats. A thorough risk assessment will consider the likelihood and impact of each identified threat and vulnerability.
- Implement security measures: After evaluating risks, the next step is to implement security measures (administrative, technical, and physical safeguards) to reduce the risks to a reasonable and appropriate level. The Security Rule does not prescribe specific measures, as it allows organizations to adopt a flexible approach based on their size, complexity, and resources. However, some examples of security measures include access controls, encryption, intrusion detection systems, workforce training, and contingency plans.
- Review and update regularly: Risk analysis and management is not a one-time activity. Organizations must periodically review and update their risk assessments to address new risks, changes in technology, or changes in the organization’s environment. Regular reviews help ensure that security measures remain effective and up-to-date. The frequency of reviews will depend on the organization, but conducting a review at least annually is a good practice.
What Happens if I Don’t Comply with the HIPAA Security Rule?
Non-compliance with HIPAA can lead to investigations, corrective action plans, fines and penalties, legal action, and significant reputational damage for covered entities.
Non-compliance can seriously affect covered entities. HIPAA violations may result in the following:
- Investigations: The Department of Health and Human Services Office for Civil Rights (OCR) enforces the Security Rule. They may initiate investigations in response to complaints, reported breaches, or through random compliance audits. A covered entity found non-compliant may be required to take corrective actions.
- Corrective Action Plans (CAPs): Sometimes, the OCR may require non-compliant organizations to implement a corrective action plan (CAP). CAPs outline specific actions organizations must take to address identified deficiencies, improve security posture, and ensure future compliance. The OCR will closely monitor organizations during the CAP implementation period.
- Fines and penalties: Non-compliant organizations can face significant financial penalties and sanctions, depending on the nature and extent of the violation. Fines range from $100 to $50,000 (or per record), with an annual maximum of $1.5 million for identical violations. Penalties may be higher if the violation is due to willful neglect and not corrected within the required timeframe.
- Legal action: In extreme cases, non-compliant covered entities may face criminal charges, resulting in imprisonment for individuals responsible for the violations. Criminal penalties typically apply in deliberate, fraudulent, or malicious actions involving unauthorized access or disclosure of ePHI.
- Reputational damages: Non-compliance can seriously harm the reputation of a covered entity. News of security breaches or violations can undermine patient trust, damage relationships with business partners, and potentially result in lost business.
Recent examples of HIPAA violations
Here are some recent examples of HIPAA Security Rule violations to further underscore the risks associated with non-compliance:
- Premera Blue Cross: In March of 2020, health plan provider Premera Blue Cross agreed to pay a $6.85 million fine to the OCR for a data breach that affected more than 10.4 million people. The breach resulted from a cyberattack that exposed ePHI, including names, addresses, birth dates, Social Security numbers, and health data.
- Lifespan Health System Affiliated Covered Entity (Lifespan ACE): In July of 2020, healthcare provider Lifespan ACE agreed to pay $1.04 million to the OCR after an employee’s unencrypted laptop was stolen, compromising the ePHI of more than 20,000 patients.
- Athens Orthopedic Clinic PA: In September 2020, Athens Orthopedic Clinic in Georgia agreed to pay $1.5 million to the OCR after a data breach compromised the ePHI of more than 200,000 patients. The breach occurred when a hacker group gained unauthorized access to the clinic’s electronic health record system using a vendor’s credentials.
HIPAA Compliance Requirements
To safeguard ePHI and build patient trust, organizations should implement requirements, including IT asset management, vendor risk management, security frameworks, and the SRA Tool.
Ensuring compliance is critical for safeguarding ePHI and building patient trust. Organizations should implement the following requirements to better control and protect their IT infrastructure, manage third-party relationships, and mitigate potential risks associated with ePHI breaches and non-compliance.
Conduct IT Asset Management
IT asset management helps organizations reduce security risks and ensure HIPAA compliance by tracking and safeguarding IT assets, implementing appropriate security measures, prioritizing resources, establishing access controls, and securely disposing of IT assets containing ePHI.
IT asset management involves managing, tracking, and safeguarding IT assets throughout their lifecycle, including hardware, software, and data. Effective IT asset management can help organizations address several requirements of the HIPAA Security Rule, reduce security risks, and ensure compliance.
A complete inventory of IT assets allows a covered entity to identify and track all devices and systems that store, process, or transmit ePHI. This knowledge enables organizations to implement the appropriate security measures and prioritize resources based on the level of risk each asset poses. By understanding the IT assets in their environment, covered entities can better assess the risks associated with each and devise an information security risk management plan that details the controls and safeguards necessary to address them.
A complete inventory of IT assets allows a covered entity to identify and track all devices that store, process, or transmit ePHI, implement the appropriate security measures and prioritize resources based on the level of risk each asset poses.
With a comprehensive IT asset inventory, organizations can gain visibility into their technology landscape and identify potential vulnerabilities. A well-maintained inventory can provide a clear view of the organization’s hardware, software, and information assets, along with their locations, owners, data classification, and configurations. This knowledge can help when making informed decisions about technology investments, infrastructure changes, and security strategies.
IT asset inventories also help organizations identify the areas with the highest risk. By mapping the relationships between assets, data flows, and business processes, organizations can pinpoint the most critical systems and data repositories to prioritize risk mitigation efforts and allocate resources more effectively. Understanding the current state of their assets can help organizations decide where to invest in upgrades, replacements, or additional security controls. Ultimately, a data-driven approach can ensure that budgeting is based on actual needs and priorities, rather than opinions or assumptions.
Additionally, a thorough IT asset inventory can help organizations identify low-hanging fruit, such as common vulnerabilities and areas where simple, cost-effective measures can significantly improve security posture. Examples include outdated software, unpatched systems, and unnecessary services running on network devices.
Finally, a comprehensive IT asset inventory enables focused risk management efforts on the most critical areas by understanding asset dependencies and relationships, which can lead to more targeted risk mitigation strategies that prioritize the highest risks.
Implement Vendor Risk Management
VRM is vital for compliance and reducing risk, involving due diligence, monitoring security practices, developing incident response plans, and ensuring secure return or destruction of ePHI upon contract termination.
Vendor risk management (VRM) is another critical component of maintaining compliance and reducing risk, as healthcare organizations increasingly rely on third-party vendors and business associates for various services. Effective VRM helps mitigate risks associated with sharing sensitive information and maintain the overall security of ePHI.
Effective VRM helps mitigate risks associated with sharing sensitive information and maintain the overall security of ePHI.
Conducting thorough due diligence on potential vendors is one method for identifying potential third-party risks before they cause harm. Assessing vendors’ security practices, and policies can help organizations select reliable partners committed to protecting sensitive data.
Monitoring and assessing vendors’ security practices is crucial for identifying potential vulnerabilities and ensuring continued compliance. Since HIPAA extended compliance requirements to covered entities and their business associates, ensuring third-party vendors satisfy the Security Rule safeguards is mandatory. To do so, organizations should conduct periodic audits or assessments to verify that vendors maintain appropriate safeguards to protect ePHI throughout their relationship.
Organizations should conduct periodic audits or assessments to verify that vendors maintain appropriate safeguards to protect ePHI.
Here are some recent examples of HIPAA violations involving business associates to further emphasize the importance of conducting vendor risk management:
- Catholic Health Care Services of the Archdiocese of Philadelphia: In June of 2016, Caltholic Health Care Services (CHCS), a business associate providing management and information technology services to nursing homes, agreed to pay $650,000 to the OCR after a data breach. The incident occurred when an unencrypted iPhone containing ePHI of 412 nursing home residents was stolen.
- Filefax, Inc.: In February of 2018, Filefax, a business associate that provided medical record storage, maintenance, and disposal services for covered entities, agreed to pay $100,000 to the OCR after an investigation found that it had left unsecured medical records containing PHI in an unlocked truck in the Filefax parking lot.
- Advanced Care Hospitals PL: In December of 2018, Advanced Care Hospitals (ACH), a Florida-based contractor of hospitalists, agreed to pay $500,000 to the OCR after a data breach that affected 9,000 patients. The breach occurred when patient information was viewable on the website of ACH’s billing services provider, a business associate.
Organizations must also collaborate with their vendors to develop and implement incident response plans that outline the processes and procedures for identifying, responding to, and reporting security incidents involving ePHI. Prompt incident reporting and response can help minimize the impact of a breach and prevent further data loss.
An effective VRM program should also include provisions for the termination of agreements when vendors fail to comply or adequately protect ePHI. And organizations should ensure that vendors securely return or destroy any ePHI upon the termination of their contract.
Choose a Security Framework
Adopting a security framework helps organizations achieve HIPAA compliance, manage and protect ePHI, benchmark against industry standards, and foster continuous improvement while adapting to evolving threats and regulations.
Aligning with a security framework can significantly help organizations achieve compliance with the HIPAA Security Rule. Security frameworks provide structured guidance, best practices, and standardized processes to help organizations manage and protect ePHI.
Security frameworks provide structured guidance, best practices, and standardized processes to help organizations manage and protect ePHI.
A holistic approach to information security can help organizations address all aspects of their security posture, enabling them to implement administrative, physical, and technical safeguards. Implementing a security framework can also help organizations reduce the likelihood of security incidents, breaches, and non-compliance, protect patient information, and preserve the organization’s reputation.
Finally, using a security framework can help organizations benchmark their security practices against industry standards and identify areas for improvement. Since security frameworks are scalable and flexible, organizations of different sizes and complexities can adapt them to their specific needs, which makes it easier for them to grow and evolve as regulations and threats change. By fostering a culture of continuous improvement, security frameworks can help organizations stay current amid transformations.
A security framework can help organizations reduce the likelihood of security incidents, breaches, and non-compliance, protect patient information, and preserve the organization’s reputation.
When selecting a security framework, organizations should consider factors such as compatibility with the HIPAA Security Rule, industry relevance, organizational size and complexity, and available resources. Examples of widely-accepted security frameworks that can help achieve HIPAA compliance include the NIST Cybersecurity Framework (NIST CSF), NIST SP 800-66r2, the HITRUST Common Security Framework (CSF), and the ISO/IEC 2700 series. However, organizations should keep in mind that implementing and maintaining compliance with HITRUST CSF and ISO 27001 can be pricey due to the high cost of initial investments, external resources, staff training, ongoing maintenance, and certification and renewal expenses.
Use the Security Risk Assessment Tool
The SRA Tool helps small to medium-sized businesses conduct comprehensive risk assessments aligned with the HIPAA Security Rule, providing resources, guidance, and documentation to help ensure compliance and manage risks and a question set by which to assess the HIPAA Security Rule safeguards.
The Security Risk Assessment (SRA) tool is a software application designed to assist organizations, particularly healthcare providers and their business associates, in complying with the HIPAA Security Rule. The tool is based on the question set derived from the National Institute of Standards and Technology (NIST) Special Publication (SP) 800-30, which provides guidelines for conducting risk assessments. As a software application, the SRA tool helps organizations identify risks and vulnerabilities to ePHI and provides guidance on implementing appropriate safeguards to protect ePHI.
However, the SRA tool is not scalable for large organizations–like hospitals or universities–due to its limited capacity to manage complex and diverse IT environments. The tool is primarily designed for small to medium-sized organizations with simpler IT footprints, and it lacks end-to-end compliance features such as automated data collection, real-time risk monitoring, and integration with other security tools that large organizations typically require.
Despite these limitations, the SRA tool can be used as a framework for HIPAA compliance rather solely as a piece of software. Organizations can leverage the question set and guidance provided by the tool to develop their own customized risk assessment processes, policies, and procedures that suit their unique IT environments.
As a framework, the SRA can be used as a starting point by healthcare organizations and their business associates to identify potential risks and vulnerabilities.
As a framework, the SRA can be used as a starting point by healthcare organizations and their business associates who are required to comply with HIPAA regulations. The SRA helps these entities identify potential risks and vulnerabilities to the confidentiality, integrity, and availability of ePHI. After completing an SRA, organizations may decide to adopt more comprehensive security frameworks, like NIST 800-53, to further enhance their information security posture.
The SRA framework is particularly suitable for organizations without much risk management in place or those looking to set a standard for establishing a security posture. By using the SRA tool as a starting point, organizations can build a robust and customized risk assessment process that addresses their specific needs, while ensuring compliance with the HIPAA Security Rule by generating reporting for each unit to better determine the direction of their overall risk management program.
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