5 min read

The basics of HIPAA compliance

Liyanda Tembani Sep 17, 2024 3:52:53 PM

HIPAA Compliance

HIPAA compliance involves protecting patient health information through the key regulations: the Privacy Rule, the Security Rule, and the Breach Notification Rule. Additional steps for maintaining HIPAA compliance include conducting risk assessments, training employees, implementing business associate agreements (BAAs), and ensuring robust physical and technical safeguards.

Key components of HIPAA

The Privacy Rule

The HIPAA Privacy Rule establishes national standards for protecting patient information. According to the Department of Health and Human Services, "A major purpose of the Privacy Rule is to define and limit the circumstances in which an individual's protected health information may be used or disclosed by covered entities. A covered entity may not use or disclose protected health information, except either: (1) as the Privacy Rule permits or requires; or (2) as the individual who is the subject of the information (or the individual's personal representative) authorizes in writing."

Permitted uses and disclosures:

Treatment: PHI can be shared with other healthcare providers involved in the patient's care.
Payment: Information can be shared with insurance companies for billing purposes.
Healthcare operations: PHI can be used for administrative, financial, and legal purposes within a healthcare organization.
Business associates: Covered entities can disclose PHI to business associates (like billing services) under strict agreements.
Minimum necessary rule: This principle ensures that only the necessary PHI is used or disclosed. For instance, if a patient is visiting a specialist, only the relevant medical history should be shared.

Patient rights:

Access to medical records: Patients have the right to access their medical records.
Amendment of records: Patients can request changes to their medical records if they believe there are errors.
Notice of privacy practices: Patients must receive a notice explaining how their PHI will be used and protected.
Restrictions on PHI use and disclosure: Patients can request restrictions on how their PHI is used and disclosed.
Confidential communications: Patients can request that communications about their PHI be conducted in a particular manner or location.

Read more: FAQs: Patient rights under HIPAA

The Security Rule

The HIPAA Security Rule focuses on protecting electronic PHI. The HHS states that "The Security Rule requires covered entities to maintain reasonable and appropriate administrative, technical, and physical safeguards for protecting e-PHI.".

Administrative safeguards:

Risk analysis and management: Identifying potential threats to ePHI and implementing mitigation measures.
Workforce security: Ensuring that employees with access to ePHI are properly vetted and trained.
Security management process: Establishing policies and procedures to prevent, detect, and correct security violations.

Physical safeguards:

Facility access controls: Limiting access to physical locations where ePHI is stored.
Workstation security policies: Protecting workstations from unauthorized access and use.
Device and media controls: Managing the disposal and reuse of devices and media that store ePHI.

Technical safeguards:

Access control mechanisms: Implementing methods such as passwords and biometrics to control access to ePHI.
Audit controls: Recording system and network activity to detect and respond to security incidents.
Integrity controls: Ensuring the accuracy and completeness of ePHI.
Person or entity authentication: Verifying the identity of individuals accessing ePHI.
Encryption: Converting data into a code to protect it during storage and transmission.

The Breach Notification Rule

According to the HHS, "A breach is, generally, an impermissible use or disclosure under the Privacy Rule that compromises the security or privacy of the protected health information. " The Breach Notification Rule requires covered entities to notify affected individuals and the Department of Health and Human Services (HHS) in case of a data breach involving unsecured PHI.

Affected individuals must be notified without unreasonable delay and no later than 60 days following the discovery of the breach. The HHS must be notified if the breach involves 500 or more individuals. Healthcare organizations may also need to inform the media if the breach involves more than 500 individuals in a particular state or jurisdiction.

Essential steps for HIPAA compliance

Conducting a risk assessment

A comprehensive risk assessment helps identify vulnerabilities in an organization's systems and processes.

Identifying assets and PHI: Determine what information needs to be protected.
Assessing vulnerabilities and threats: Evaluate potential threats and weaknesses.
Analyzing risks: Determine the likelihood and impact of potential threats.
Implementing safeguards: Put measures in place to mitigate risks.
Monitoring and reviewing: Regularly reassess risks and update safeguards.

Employee training

Employee training ensures that all staff members understand HIPAA regulations and their responsibilities. An effective HIPAA training program should cover several key elements. First, provide an overview of HIPAA regulations and their importance, emphasizing the necessity of protecting patient information. Role-specific training should be included, ensuring employees understand how HIPAA applies to their specific job functions. Educate staff on security best practices, including procedures for safeguarding PHI. Teach them the steps for incident reporting so they know how to report potential breaches promptly. Lastly, educate employees on HIPAA updates and best practices to keep everyone informed and compliant.

Business associate agreements (BAAs)

Covered entities must have contracts in place with business associates who handle PHI. A business associate is any entity that performs activities involving the use or disclosure of PHI on behalf of a covered entity.

Key components of a BAA include a description of permitted uses and disclosures of PHI, safeguards to protect PHI, and reporting requirements for breaches. Regular audits and reviews ensure that business associates adhere to HIPAA requirements.

Implementing physical and technical safeguards

Effective physical and technical safeguards are necessary to protect PHI.

Examples of physical safeguards:

Secure facility access: Implementing measures to control access to physical locations where PHI is stored.
Workstation security policies: Ensuring workstations are used appropriately and protected from unauthorized access.

Examples of technical safeguards:

Access control mechanisms: Using passwords, biometrics, or other methods to control access to ePHI.
Encryption of data: Encrypting ePHI both at rest and in transit to protect it from unauthorized access.
Regular system audits: Monitoring and reviewing system activity to detect potential security incidents.

Additional considerations for HIPAA compliance

The HIPAA Omnibus Rule

The HIPAA Omnibus Rule, enacted in 2013, introduced significant changes and expansions to HIPAA regulations.

Key changes and additions:

Business associates: "The Omnibus Rule expands the definition of a ‘business associate’ to include all entities that create, receive, maintain, or transmit PHI on behalf of a covered entity, making clear that companies that store PHI on behalf of health care providers and health plans are business associates," states an article on the implications of the HIPAA Omnibus Rule for public health policy and practice.
Enforcement and penalties: Increased penalties for non-compliance and strengthened enforcement measures.
Impact on business associates: Business associates are now directly liable for compliance with certain HIPAA requirements and are subject to audits and penalties for non-compliance.

HITECH Act

The Health Information Technology for Economic and Clinical Health (HITECH) Act, enacted in 2009, introduced new HIPAA requirements and incentives for adopting electronic health records (EHR). The HITECH Act encourages the adoption and meaningful use of EHR technology to improve healthcare delivery. Key provisions related to HIPAA include expanded breach notification requirements, which ensure that patients are informed about any potential compromises to their PHI. Additionally, the Act provided financial incentives for healthcare organizations to adopt EHR technology, promoting a more efficient, secure, and interoperable healthcare system.

Best practices for ongoing compliance

Regular audits and assessments

Regular compliance checks help maintain HIPAA compliance by ensuring ongoing adherence to requirements and identifying areas for improvement. Review policies and procedures to ensure they are up-to-date and compliant with HIPAA regulations when conducting internal audits. Assess security measures, evaluating the effectiveness of physical, administrative, and technical safeguards. Identify and address gaps by implementing corrective actions to rectify any vulnerabilities or non-compliance issues found during the audit.

Incident response planning

Developing an incident response plan helps effectively manage security breaches. Components of the plan should include procedures for identifying, reporting, and responding to security incidents. In case of a breach, the steps to take are to contain it, assess its impact, notify affected individuals and authorities, and implement measures to prevent future breaches. This structured approach ensures that breaches are handled promptly and efficiently, minimizing damage and maintaining compliance.

Patient communication and education

Informing patients of their rights and providing clear information on privacy practices maintains trust and compliance. Ensure patients know their rights under HIPAA, such as access to their medical records and the ability to request amendments. Additionally, provide clear and accessible information on privacy practices by distributing the notice of privacy practices and ensuring it is readily available to patients. Transparency helps promote trust and ensures patients are informed about how their information is protected.

FAQs

Can a healthcare organization use PHI for research purposes?

Yes, but only if the use is approved by an Institutional Review Board (IRB) and proper de-identification or patient consent is obtained per HIPAA regulations.

Are there any specific HIPAA requirements for mobile devices used in healthcare?

HIPAA requires that mobile devices used to access or store ePHI be secured with strong passwords, encryption, and remote wipe capabilities to protect against unauthorized access and data breaches.

How does HIPAA handle the use of social media by healthcare professionals?

HIPAA prohibits the posting of any PHI on social media, including patient details or images. Healthcare professionals must ensure that their social media activities do not violate patient privacy or disclose sensitive information.

FTC and HIPAA Breach Notification Rules: What's the difference?