What is HIPAA Compliance

HIPAA Compliance establishes national guidelines to protect people's medical records and personal health information. Organizations must adhere to data compliance standards like HIPAA to fulfill legal requirements and maintain trust and security. By complying with HIPAA, organizations significantly reduce the risk of data breaches, thereby minimizing potential financial losses and reputational damage.

This blog will explain HIPAA Compliance, including who must comply, what constitutes Protected Health Information (PHI) and its identifiers, physical and technical safeguards in HIPAA regulations, other HIPAA rules to follow, HIPAA Compliance requirements, and a checklist for HIPAA Compliance.

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What is HIPAA Compliance?

HIPAA, or the Health Insurance Portability and Accountability Act of 1996, establishes standards for the proper use and sharing of protected health information (PHI). The Department of Health and Human Services (HHS) oversees HIPAA compliance, while the Office for Civil Rights (OCR) enforces it.

The OCR regularly provides guidance on emerging healthcare issues and investigates common HIPAA violations to uphold medical HIPAA compliance. Healthcare organizations must integrate HIPAA compliance as an ongoing culture in their operations to safeguard the confidentiality, security, and accuracy of protected health information.

Need for HIPAA Compliance

HHS emphasizes that as healthcare providers and other organizations handling PHI transition to computerized operations like CPOEsystems, EHR, and radiology, pharmacy, and laboratory systems, HIPAA compliance becomes increasingly crucial.

Health plans also offer access to claims, care management, and self-service applications. While these electronic methods enhance efficiency and mobility, they also increase the security risks associated with healthcare data.

The Security Rule safeguards the confidentiality of individuals' health information while enabling covered entities to embrace new technologies that enhance patient care quality and efficiency. The rule's flexible design allows covered entities to implement policies, procedures, and technologies tailored to their size, organizational structure, and the risks related to patients' and consumers' e-PHI.

Who must Comply with HIPAA?

HIPAA Compliance categorizes two types of organizations that must comply with HIPAA regulations.

Covered Entities

HIPAA regulation identifies a covered entity as any organization that electronically collects, generates, or transmits PHI. This category includes healthcare providers, healthcare clearinghouses, and health insurance providers.

Business Associates

HIPAA regulation classifies a business associate as any organization that handles PHI while performing contracted work for a covered entity. The broad range of service providers that may handle, transmit, or process PHI results in numerous examples of business associates.

HIPAA rules affect various business associates, including billing companies, practice management firms, third-party consultants, EHR platforms, MSPs, IT providers, faxing companies, shredding companies, physical storage providers, cloud storage providers, email hosting services, attorneys, accountants, and many others.

What is Protected Health Information?

The U.S. Department of Health & Human Services defines PHI as individually identifiable health information that a covered entity or its business associate maintains or transmits in electronic, paper, or oral form.

PHI encompasses medical records, billing information, treatment plans, test results, and insurance claims data, all relating to an individual's physical or mental health. Organizations must safeguard PHI to maintain patient confidentiality, protect data, and adhere to regulations.

• Patient Confidentiality: Organizations must keep personal information private and confidential to uphold patient trust. Unauthorized disclosure of health details can lead to embarrassment and discrimination against affected individuals.

• Data Protection: Healthcare organizations must protect vast amounts of sensitive patient data from cybercriminals who target it for financial gain. Proper PHI protection prevents unauthorized access and potential data breaches.

• Compliance with Federal Regulations: Organizations that fail to comply with HIPAA regulations face significant penalties, including fines up to $1.5 million per violation category per year, reputational damage, and potential criminal charges.

Identifiers of PHI

HIPAA regulations require the removal of 18 specific identifiers from health information to ensure de-identification. Common examples include:

• Names and addresses.

• Social Security numbers (SSNs).

• Dates of birth (DOBs).

• Contact information, including email addresses, phone numbers, and fax numbers.

• Medical records or account numbers.

• Fingerprints and facial images.

• Certificate or license numbers.

• Internet Protocol (IP) addresses.

• Health plan identification numbers.

• Vehicle and serial numbers, including license plates.

Physical, Technical Safeguards and Policies in HIPAA Compliance

Organizations must establish a combination of physical and technical safeguards along with clearly defined policies to comply with HIPAA regulations. Implementing these safeguards and policies secures PHI effectively.

Physical Safeguards

• Control of Facility Access: Restrict access to PHI facilities by implementing strict procedures. Enhance security with access control cards, surveillance cameras, or biometric authentication. Regularly audit and update access logs to ensure that only authorized personnel enter sensitive areas.

• Security of Workstations: Protect workstations handling PHI from unauthorized access. Enforce guidelines for proper workstation use when dealing with sensitive data. Use privacy screens or monitors away from public view.

• Manage Electronic Media: Effectively manage electronic media containing PHI. Develop policies for secure device disposal or reuse, ensuring complete data wiping before disposal or reuse. Implement inventory tracking systems to monitor all PHI-containing devices throughout their lifecycle.

Technical Safeguards

• Data Encryption: Employ encryption technologies, such as SSL/TLS certificates, to protect data from unauthorized access during transmission over networks or while stored on devices like laptops and smartphones.

• User Authentication: Assign unique identification credentials to each individual accessing PHI for system traceability. Implement username and password combinations and use multi-factor authentication methods like tokens or biometrics.

• Audit Controls: Establish mechanisms to record and review activities on systems that handle PHI. Conduct regular audits to identify potential security incidents, track user access, and ensure policy compliance.

Policies & Procedures

• Risk Analysis: Conduct comprehensive risk assessments regularly to identify vulnerabilities in organizations’s infrastructure. Evaluate physical locations where PHI is stored and review encryption methods and other technical safeguards.

• Training Programs: Train all employees handling PHI regularly on HIPAA regulations and best practices for data privacy. Offer training through online courses, workshops, or seminars tailored to the organization's needs.

• Breach Notification Policy: Notify affected individuals promptly of any data breach involving unsecured PHI, as required by law. Develop a clear policy for managing breaches to ensure a swift response and minimize the impact of unauthorized disclosure.

Key HIPAA Rules for Organizations

Organizations must adhere to several key rules to ensure compliance with the Health Insurance Portability and Accountability Act (HIPAA). These rules protect the privacy and security of protected health information (PHI). The main HIPAA rules include:

1. HIPAA Privacy Rule: Establishes national standards for PHI protection. It gives patients rights over their health information, including access to records and correction requests. Organizations must control PHI use and disclosure, obtaining patient consent when necessary.

2. HIPAA Security Rule: Outlines safeguards for electronic protected health information (ePHI). It requires administrative, physical, and technical safeguards to ensure ePHI confidentiality, integrity, and availability. This includes implementing access controls, encryption, and regular security assessments.

3. HIPAA Breach Notification Rule: Organizations must notify affected individuals and the Department of Health and Human Services (HHS) of PHI data breaches. They must assess the breach's impact and promptly notify individuals. For breaches affecting 500 or more individuals, organizations must also notify prominent media outlets serving the state or jurisdiction where the affected individuals reside.

4. Administrative Safeguards: Organizations must develop written PHI security policies and procedures, conduct workforce HIPAA compliance training, and appoint privacy and security officers to oversee compliance efforts. They must also perform regular risk assessments to identify and address potential vulnerabilities in their PHI handling processes.

5. HIPAA Transaction Rule: Standardizes electronic health-related information exchange. It requires specific transaction standards and code sets for healthcare data processing, ensuring industry-wide consistency and efficiency. Key standards include ANSI X12 and NCPDP formats for electronic transactions covering claims, enrollment, eligibility, payment, and benefits coordination.

6. HIPAA Enforcement Rule: Establishes procedures for investigating violations and imposing non-compliance penalties. The Office for Civil Rights (OCR) conducts investigations, audits, and imposes fines based on culpability levels. It includes a tiered penalty structure and shifts the burden of proof to covered entities.

7. HIPAA Identifiers Rule: Requires unique identifiers for entities involved in healthcare transactions, including the Employer Identification Number (EIN), National Provider Identifier (NPI), and Health Plan Identifier (HPID). These identifiers promote standardization and improve electronic transaction efficiency.

8. HIPAA Omnibus Rule: Strengthens the Privacy, Security, Breach Notification, and Enforcement Rules. It expands HIPAA compliance to include business associates and subcontractors, introduces stricter breach notification requirements, enhances patient rights, and increases non-compliance penalties.

HIPAA Compliance Requirements

HIPAA regulation establishes a set of nationwide standards that all covered entities and business associates must adhere to.

• Internal Audits: Security engineers must perform yearly audits of their organization to evaluate compliance with HIPAA Privacy and Security standards across Administrative, Technical, and Physical domains. Conducting a Security Risk Assessment alone does not suffice for compliance, as it represents just one of the necessary audits required to maintain ongoing HIPAA compliance.

• Corrective Action Plans: After identifying compliance deficiencies through internal audits, security engineers must execute plans to address and rectify these compliance breaches. They must thoroughly document these plans and include specific resolution dates. Additionally, security engineers should establish a follow-up process to ensure that corrective actions are implemented effectively and on time.

• Policies, Procedures, and Staff Training: Organizations must create Policies and Procedures that align with HIPAA regulatory standards outlined in the HIPAA Rules. Security engineers should regularly update these policies and procedures to reflect organizational changes. Additionally, they must conduct mandatory annual staff training on these Policies and Procedures, with employees providing documented confirmation of their understanding.

• Record-keeping: Organizations must meticulously document all efforts to achieve HIPAA compliance. They should maintain comprehensive records of risk assessments, policy implementations, and staff training initiatives. This thorough documentation serves as a critical resource during HIPAA investigations conducted by the Department of Health and Human Services' Office for Civil Rights (HHS OCR).

• Managing Business Associates: Organizations must document all vendors with whom they share PHI and establish Business Associate Agreements to ensure secure PHI handling and mitigate liabilities. They should review these agreements annually to accommodate changes in vendor relationships and execute them before sharing any PHI.

HIPAA Compliance Checklist

A HIPAA compliance checklist serves as a critical tool for organizations handling Protected Health Information (PHI). It helps them meet the stringent regulatory requirements imposed by the Health Insurance Portability and Accountability Act (HIPAA). Below is an overview of the key components typically included in a HIPAA compliance checklist:

Designate a Privacy and Security Officer

Organizations must appoint a dedicated Privacy Officer and a Security Officer as a fundamental step in achieving HIPAA compliance. These individuals oversee the organization's HIPAA compliance program, ensuring correct implementation and adherence to all policies and procedures. The Privacy Officer manages and protects PHI, while the Security Officer safeguards electronic PHI (ePHI). Both roles play crucial parts in maintaining a robust compliance posture.

Policies and Procedures

Organizations should create and maintain comprehensive policies and procedures addressing the requirements of the HIPAA Privacy Rule, Security Rule, and Breach Notification Rule. They must document these policies well, update them regularly, and make them easily accessible to all employees. The documentation should cover everything from data access and usage guidelines to incident response plans, preparing the organization to handle any potential compliance challenges.

Train Workforce

Organizations must provide regular and comprehensive training for all employees who handle PHI. This training should cover HIPAA regulations, the organization's specific policies and procedures, and the importance of safeguarding PHI. By ensuring well-informed employees, organizations can significantly reduce the risk of accidental breaches and improve overall compliance.

Business Associate Agreements (BAAs)

Organizations must establish and maintain Business Associate Agreements (BAAs) with any third-party service providers that handle PHI on their behalf. These agreements should clearly outline each party's responsibilities regarding PHI protection and ensure business associates comply with HIPAA regulations. Organizations should regularly review and update BAAs to reflect any changes in the relationship or regulatory requirements.

Breach Notification Process

Organizations must implement a clear and effective breach notification process in case of a PHI breach. This process should include protocols for promptly notifying affected individuals, the Department of Health and Human Services (HHS), and, if necessary, the media. The notification must comprehensively detail the nature of the breach, the information affected, and steps taken to mitigate the damage.

Conduct Regular Audits and Reviews

To maintain ongoing compliance, organizations should implement a schedule for regular audits of their HIPAA compliance practices and policies. These audits help identify areas for improvement, ensure all safeguards function correctly, and verify that the organization remains compliant with HIPAA regulations. Audits should cover all aspects of the compliance program, including risk assessments, training programs, and the effectiveness of implemented safeguards.

Final Thoughts

Application security engineers must adhere to HIPAA standards to ensure they meet legal requirements and protect sensitive information against breaches. This commitment to compliance builds trust among users and clients and lays the foundation for successful and secure digital solutions.

Akto automates compliance checks, manages data encryption practices, and ensures access controls meet stringent standards. Security teams using Akto can meet compliance mandates more efficiently, focus on product development, and maintain the highest levels of data security and privacy.

Are you ready to enhance the compliance plan? Explore how Akto's innovative solutions can accelerate the compliance process and ensure the security, compliance, and advanced status of your organization. To learn more, book a demo now.