Complying with HIPAA

The Health Insurance Portability and Accountability Act (HIPAA), enacted in 1996, is a U.S. federal law designed to protect PHI and other sensitive patient health information. HIPAA establishes the standards for protecting the security and privacy of protected health information (PHI) while ensuring the secure electronic transmission of medical information.

HIPAA applies to healthcare providers, healthcare clearinghouses, health plans, and a wide range of entities, including any business associates that handle patient information. Ensuring compliance with HIPAA is crucial to protect patient privacy, maintain trust, and avoid legal penalties.

Purpose of HIPAA

The primary goal of HIPAA is to create consistent standards that protect patient information, enhance data privacy, and allow for the efficient flow of healthcare data while protecting individuals’ rights. Specifically, HIPAA was created to:

Safeguard Patient Privacy: HIPAA ensures that patients have control over their personal health information, including who can access it and for what purpose.
Improve Data Security: By setting standards for the electronic exchange and protection of PHI, HIPAA enhances data security.
Enhance Portability: The law also provides measures that make healthcare coverage more portable for employees changing jobs, ensuring continuity of health coverage.

In short, HIPAA helps patients understand their rights, feel secure that their information is kept confidential, and gives healthcare professionals guidelines for data handling.

Enforcement of HIPAA

The Department of Health and Human Services (HHS) oversees HIPAA compliance. Within the HHS, the following authorities play specific roles:

Office for Civil Rights (OCR): The OCR is primarily responsible for enforcing HIPAA privacy and security regulations. It investigates complaints, conducts compliance reviews, and provides guidance on how organizations can comply with HIPAA requirements.
Centers for Medicare & Medicaid Services (CMS): CMS plays a role in enforcing administrative simplification standards, especially focusing on transactions, code sets, and identifiers.
State Attorneys General: State attorneys general also have the authority to bring civil actions in order to enforce HIPAA provisions on behalf of their residents.

Key Provisions of HIPAA

HIPAA has several key provisions, each serving a different function for safeguarding health information:

HIPAA Privacy Rule: The HIPAA Privacy Rule protects all identifiable health information of individuals, also known as protected health information (PHI). It sets the standards for how PHI can be used and disclosed by healthcare organizations and gives patients specific rights regarding their medical information, including the right to access and amend their records.
HIPAA Security Rule: The HIPAA Security Rule sets standards for ensuring that ePHI or electronic protected health information is secure. It includes administrative, physical, and technical safeguards:

Administrative Safeguards: Policies and procedures to manage data security.
Physical Safeguards: Controls that limit access to physical facilities and workstations where ePHI is stored.
Technical Safeguards: Measures like encryption to protect ePHI from unauthorized access.

Learn more about the details of the HIPAA Security Rule.

HIPAA Breach Notification Rule: As per the Breach Notification rule, covered entities are required to inform affected individuals, the HHS, and, in some cases, the media if there is a data breach involving unsecured PHI. This notification must occur within 60 days of discovering the breach.
HIPAA Enforcement Rule: The HIPAA Enforcement Rule outlines how HHS can investigate potential HIPAA violations and impose fines or penalties on organizations or individuals who are found non-compliant.

Industries impacted by HIPAA

HIPAA primarily impacts a wide array of healthcare-related entities, including those that directly handle PHI and support businesses. Below are the key industries affected by HIPAA:

Healthcare Providers: Doctors, hospitals, clinics, dentists, and pharmacies are directly covered by HIPAA. These providers collect and use sensitive patient information, and HIPAA ensures that this data is properly safeguarded to maintain privacy and confidentiality.
Health Plans: Insurance companies, HMOs, employer-sponsored health plans, & government programs such as Medicare and Medicaid are all considered covered entities under HIPAA. They must comply with privacy and security standards when processing, storing, and transmitting PHI.
Healthcare Clearinghouses: Clearinghouses are entities that process nonstandard health information received from another entity into a standard format, or vice versa. These organizations must comply with HIPAA regulations concerning the protection of PHI.
Business Associates: A business associate is any third party that performs functions involving the use of PHI on behalf of a covered entity. This can include companies that provide billing services, IT services, data storage, or even legal or accounting services for healthcare organizations. Business associates must also adhere to HIPAA standards.
Health Technology and Telehealth Providers: Companies that provide health & medical technology solutions like electronic health records (EHRs) or telehealth services are also covered under HIPAA. They have to ensure that their technology includes necessary safeguards to protect patient privacy.
Medical Device Manufacturers: Manufacturers of connected medical devices that store or transmit health information must ensure that their devices comply with HIPAA standards, particularly when dealing with patient data.
Pharmacy Benefit Managers (PBMs): PBMs manage the prescription drug plans for health insurers. These organizations handle extensive PHI and, therefore, are also subject to the strict requirements outlined by HIPAA.

Learn more about Who is covered under HIPAA.

Penalties for Non-Compliance with HIPAA

HIPAA violations can result in severe consequences for both individuals and organizations. Penalties for non-compliance can vary depending on the severity of negligence and the nature of the violation:

Civil Penalties: Depending on the level of negligence, the Office for Civil Rights (OCR) can impose civil penalties ranging from $100 to $50,000 per violation. Annual fines can reach over $2 million for each type of violation. All fines & penalties may be higher when adjusted for inflation every year.
Criminal Penalties: HIPAA also allows for criminal penalties for knowing misuse or wrongful disclosure of PHI. These can range from fines of $50,000 to $250,000 and imprisonment of up to 10 years for offenses involving personal gain or malicious intent.
Reputation Damage: Beyond financial penalties, a breach of HIPAA can result in significant reputation damage. Patients expect their personal data to remain confidential, and failing to safeguard this information can lead to a loss of trust, negative media coverage, and damaged relationships.

Employee Responsibilities under HIPAA

Employees are crucial to ensuring that our organization remains HIPAA compliant. Understanding your responsibilities will help prevent unauthorized access or use of PHI:

Protect PHI at All Times: Employees must understand the nature of protected health information (PHI) and follow policies to protect it. This includes ensuring PHI is only accessed by authorized individuals and stored securely.
Limit Data Sharing: PHI should be shared only when necessary for providing patient care or fulfilling other authorized functions. Employees should follow the minimum necessary standard, ensuring only essential information is shared.
Secure Devices and Workspaces: Employees must ensure that devices containing PHI are password-protected and use encryption when transmitting sensitive information. Workstations should be locked, and paper records should be securely stored.
Recognize and Report Security Incidents: If you suspect that there has been unauthorized access to PHI or witness suspicious activities, it is crucial to report it immediately to the Privacy Officer or compliance team. Timely reporting can prevent further breaches.
Provide Privacy Notices: Employees should ensure patients are informed of their privacy rights and how their data is used. This includes distributing Notice of Privacy Practices (NPP) and answering patient questions about their rights.

Best Practices for HIPAA Compliance

Maintain Strong Passwords and Use Encryption: Use strong passwords and change them regularly. You also need to encrypt all sensitive data in order to protect it from unauthorized access during storage or transmission.
Limit Access to PHI: Only individuals who need access to PHI to fulfill their job responsibilities should have access. Implement role-based access controls to ensure this principle is enforced.
Train Employees Regularly: HIPAA compliance training should be conducted on an annual basis or whenever there are changes in privacy policies. Employees need to be aware of how to properly handle PHI, recognize potential risks, and follow security best practices.
Audit and Monitor Systems: Implement regular audits to ensure systems containing protected health information are secure. Audits help detect unauthorized access and pinpoint vulnerabilities that may lead to breaches.
Dispose of PHI Properly: Ensure PHI, whether electronic or physical, is disposed of securely. Use shredding for paper records and proper deletion methods for digital files to avoid unauthorized recovery.
Implement Physical Safeguards: Restrict access to physical locations where PHI is stored. This includes using badge readers, locking doors, and securing paper records to limit access to authorized personnel only.

The Health Insurance Portability and Accountability Act (HIPAA) provides comprehensive guidelines to ensure that patients’ health information remains confidential, accurate, and protected. HIPAA impacts a wide range of industries related to healthcare, and each employee plays an important role in compliance.

By adhering to HIPAA’s Privacy, Security, and Breach Notification Rules, employees ensure that PHI is protected from unauthorized access, patients’ rights are respected, and the organization’s reputation remains intact.

Additional Resources: Can you have a Ransomware Attack if you are HIPAA-compliant?

How databrackets can help you prove your compliance with HIPAA

At databrackets, we are a team of certified and experienced security experts with over 12 years of experience across industries. We have helped organizations of all sizes comply with cybersecurity best practices and prove their compliance with a wide variety of security standards to enable them to expand their business opportunities and assure existing clients of their commitment to protecting sensitive information and maintaining high standards of security and privacy.

We offer 3 Engagement Options to help you prove your compliance with HIPAA – our DIY Toolkit (ideal for MSPs and mature in-house IT teams), and Hybrid or Consulting Services. We have HIPAA Training Modules for staff and privacy officers which can be customized to include your privacy policies. You can partner with us to prove your compliance on an annual basis and engage our team to support your organization if you are audited.

Overview of databrackets

Our team of security experts has supported organizations across a wide variety of industries to align their processes with security frameworks like ISO 27001:2022, SOC 2, HIPAA, 21 CFR Part 11, NIST SP 800-53, NIST Cybersecurity Framework, NIST SP 800-171, GDPR, CMMC etc. We are an authorized certifying body for ISO 27001 and a Registered Practitioner Organization for CMMC. We also have partnerships to help clients prepare for and obtain other security certifications.

We are constantly expanding our library of assessments and services to serve organizations across industries. Schedule a Consultation if you would like to Connect with an Expert to understand how we can customize our services to meet your specific requirements.

Author: Aditi Salhotra, Digital Marketing and Business Development, databrackets.com

Aditi is a Digital Marketing and Business Development Professional at databrackets.com. She graduated with honors in Marketing from Sheridan College, Canada. In addition to her current profile, she contributes to Product Development and Content Creation. She is a strong advocate of Good Cyber Hygiene and white hat SEO techniques. She is proud of the company’s mission to safeguard organizations from cyber threats and ensure their business continuity in adverse situations.

Technical Expert: Srini Kolathur, Director, databrackets.com

The technical information presented in this blog has been carefully reviewed and verified by our Director, Srini Kolathur. Srini is results-driven security and compliance professional with over 20 years of experience supporting, leading, and managing global IT security, compliance, support, and risk assessment in fortune 100 companies. Some of his key areas of focus are SOC 2, ISO 27001, NIST 800-171, NIST 800-53, NIST Cybersecurity Framework, HIPAA, Security Risk Assessment, CMMC 2.0 among others. He is a CMMC Registered Practitioner (RP), CISSP, CISA, CISM, MBA. He is active in several community groups including Rotary International and TiE.

HIPAA applies to healthcare providers, healthcare clearinghouses, health plans, and a wide range of entities, including any business associates that handle patient information. Ensuring compliance with HIPAA is crucial to protect patient privacy, maintain trust, and avoid legal penalties.

Purpose of HIPAA

The primary goal of HIPAA is to create consistent standards that protect patient information, enhance data privacy, and allow for the efficient flow of healthcare data while protecting individuals’ rights. Specifically, HIPAA was created to:

Safeguard Patient Privacy: HIPAA ensures that patients have control over their personal health information, including who can access it and for what purpose.

Improve Data Security: By setting standards for the electronic exchange and protection of PHI, HIPAA enhances data security.

Enhance Portability: The law also provides measures that make healthcare coverage more portable for employees changing jobs, ensuring continuity of health coverage.

In short, HIPAA helps patients understand their rights, feel secure that their information is kept confidential, and gives healthcare professionals guidelines for data handling.

Enforcement of HIPAA

The Department of Health and Human Services (HHS) oversees HIPAA compliance. Within the HHS, the following authorities play specific roles:

Office for Civil Rights (OCR): The OCR is primarily responsible for enforcing HIPAA privacy and security regulations. It investigates complaints, conducts compliance reviews, and provides guidance on how organizations can comply with HIPAA requirements.

Centers for Medicare & Medicaid Services (CMS): CMS plays a role in enforcing administrative simplification standards, especially focusing on transactions, code sets, and identifiers.

State Attorneys General: State attorneys general also have the authority to bring civil actions in order to enforce HIPAA provisions on behalf of their residents.

Key Provisions of HIPAA

HIPAA has several key provisions, each serving a different function for safeguarding health information:

HIPAA Security Rule: The HIPAA Security Rule sets standards for ensuring that ePHI or electronic protected health information is secure. It includes administrative, physical, and technical safeguards:

Administrative Safeguards: Policies and procedures to manage data security.

Physical Safeguards: Controls that limit access to physical facilities and workstations where ePHI is stored.

Technical Safeguards: Measures like encryption to protect ePHI from unauthorized access.

Learn more about the details of the HIPAA Security Rule.

HIPAA Breach Notification Rule: As per the Breach Notification rule, covered entities are required to inform affected individuals, the HHS, and, in some cases, the media if there is a data breach involving unsecured PHI. This notification must occur within 60 days of discovering the breach.

HIPAA Enforcement Rule: The HIPAA Enforcement Rule outlines how HHS can investigate potential HIPAA violations and impose fines or penalties on organizations or individuals who are found non-compliant.

Industries impacted by HIPAA

HIPAA primarily impacts a wide array of healthcare-related entities, including those that directly handle PHI and support businesses. Below are the key industries affected by HIPAA:

Healthcare Providers: Doctors, hospitals, clinics, dentists, and pharmacies are directly covered by HIPAA. These providers collect and use sensitive patient information, and HIPAA ensures that this data is properly safeguarded to maintain privacy and confidentiality.

Health Plans: Insurance companies, HMOs, employer-sponsored health plans, & government programs such as Medicare and Medicaid are all considered covered entities under HIPAA. They must comply with privacy and security standards when processing, storing, and transmitting PHI.

Healthcare Clearinghouses: Clearinghouses are entities that process nonstandard health information received from another entity into a standard format, or vice versa. These organizations must comply with HIPAA regulations concerning the protection of PHI.

Health Technology and Telehealth Providers: Companies that provide health & medical technology solutions like electronic health records (EHRs) or telehealth services are also covered under HIPAA. They have to ensure that their technology includes necessary safeguards to protect patient privacy.

Medical Device Manufacturers: Manufacturers of connected medical devices that store or transmit health information must ensure that their devices comply with HIPAA standards, particularly when dealing with patient data.

Pharmacy Benefit Managers (PBMs): PBMs manage the prescription drug plans for health insurers. These organizations handle extensive PHI and, therefore, are also subject to the strict requirements outlined by HIPAA.

Learn more about Who is covered under HIPAA.

Penalties for Non-Compliance with HIPAA

HIPAA violations can result in severe consequences for both individuals and organizations. Penalties for non-compliance can vary depending on the severity of negligence and the nature of the violation:

Criminal Penalties: HIPAA also allows for criminal penalties for knowing misuse or wrongful disclosure of PHI. These can range from fines of $50,000 to $250,000 and imprisonment of up to 10 years for offenses involving personal gain or malicious intent.

Reputation Damage: Beyond financial penalties, a breach of HIPAA can result in significant reputation damage. Patients expect their personal data to remain confidential, and failing to safeguard this information can lead to a loss of trust, negative media coverage, and damaged relationships.

Employee Responsibilities under HIPAA

Employees are crucial to ensuring that our organization remains HIPAA compliant. Understanding your responsibilities will help prevent unauthorized access or use of PHI:

Protect PHI at All Times: Employees must understand the nature of protected health information (PHI) and follow policies to protect it. This includes ensuring PHI is only accessed by authorized individuals and stored securely.

Limit Data Sharing: PHI should be shared only when necessary for providing patient care or fulfilling other authorized functions. Employees should follow the minimum necessary standard, ensuring only essential information is shared.

Secure Devices and Workspaces: Employees must ensure that devices containing PHI are password-protected and use encryption when transmitting sensitive information. Workstations should be locked, and paper records should be securely stored.

Recognize and Report Security Incidents: If you suspect that there has been unauthorized access to PHI or witness suspicious activities, it is crucial to report it immediately to the Privacy Officer or compliance team. Timely reporting can prevent further breaches.

Provide Privacy Notices: Employees should ensure patients are informed of their privacy rights and how their data is used. This includes distributing Notice of Privacy Practices (NPP) and answering patient questions about their rights.

Best Practices for HIPAA Compliance

Maintain Strong Passwords and Use Encryption: Use strong passwords and change them regularly. You also need to encrypt all sensitive data in order to protect it from unauthorized access during storage or transmission.

Limit Access to PHI: Only individuals who need access to PHI to fulfill their job responsibilities should have access. Implement role-based access controls to ensure this principle is enforced.

Train Employees Regularly: HIPAA compliance training should be conducted on an annual basis or whenever there are changes in privacy policies. Employees need to be aware of how to properly handle PHI, recognize potential risks, and follow security best practices.

Audit and Monitor Systems: Implement regular audits to ensure systems containing protected health information are secure. Audits help detect unauthorized access and pinpoint vulnerabilities that may lead to breaches.

Dispose of PHI Properly: Ensure PHI, whether electronic or physical, is disposed of securely. Use shredding for paper records and proper deletion methods for digital files to avoid unauthorized recovery.

Implement Physical Safeguards: Restrict access to physical locations where PHI is stored. This includes using badge readers, locking doors, and securing paper records to limit access to authorized personnel only.