With the increased use of data, the government, organizations and corporations have established different regulations and compliance standards to prevent unauthorized access, use and disclosure of sensitive information. One of these relevant laws is the Health Insurance Portability and Accountability Act (HIPAA), which was implemented particularly for the healthcare industry and medical practices, where personal data is more vulnerable to leaks.
This guide helps equip you with essential information about HIPAA by exploring its definition, rules, requirements and other relevant details.
What Is HIPAA?
The HIPAA Act of 1996 is a US federal law designed to safeguard sensitive patient health information from unauthorized disclosure without the patient’s explicit consent. Compliance with HIPAA signifies adherence to its regulations concerning the management of Protected Health Information (PHI). This requires that all healthcare entities implement appropriate safeguards to protect patient data and prevent unauthorized access to patient files.
Summary of HIPAA Rules for Compliance
The HIPAA is composed of several core rules to address different aspects of the security and privacy information. The following is a comprehensive summary of the rules for your reference:
HIPAA Privacy Rule
The HIPAA Privacy Rule regulates the use and disclosure of Protected Health Information (PHI) by covered entities and their business associates, ensuring that patient privacy is upheld. It grants individuals essential rights, including the ability to access their health records, request corrections and receive a Notice of Privacy Practices during their initial encounter with a healthcare provider.
Additionally, the rule specifies circumstances under which PHI can be shared without patient consent, such as for public health activities or legal proceedings. It enforces the minimum necessary standard, requiring that covered entities disclose only the minimum necessary information for specific purposes, safeguarding patient data while allowing for necessary information sharing.
HIPAA Security Rule
The HIPAA Security Rule focuses on the protection of electronic Protected Health Information (ePHI) through a framework of safeguards designed to enhance data security. This includes administrative safeguards, which encompass policies and procedures for selecting, developing, implementing, and maintaining security measures, along with workforce training and management practices.
Physical safeguards protect the physical access to ePHI, ensuring that facilities and equipment are secure from unauthorized entry. Technical safeguards involve technology-based protections such as encryption and secure access controls, collectively ensuring that ePHI remains confidential, secure, and accessible only to authorized individuals.
Breach Notification Rule
In the event of a data breach involving PHI, covered entities must notify affected individuals within 60 days. For breaches affecting 500 or more individuals, the Department of Health and Human Services (HHS) must also be notified within the same timeframe, along with local media if required.
Omnibus Rule
This rule expanded HIPAA protections under the HITECH Act, including extending compliance requirements to business associates and imposing stricter penalties for violations. It also prohibits the use of PHI for marketing without explicit patient authorization.
Enforcement Rule
This rule outlines how violations are investigated and penalties imposed. The Office for Civil Rights (OCR) has the authority to impose civil monetary penalties for non-compliance, and in cases of willful neglect or criminal conduct, investigations may be referred to the Department of Justice.
Who Needs To Ensure HIPAA Compliance?
HIPAA applies to the healthcare industry, here are specific entities responsible for ensuring its compliance:
Covered Entities
Covered entities are organizations that engage in treatment, payment, or healthcare operations. This includes healthcare providers such as hospitals, doctors, dentists, and other professionals who electronically transmit Protected Health Information (PHI). Health plans, which consist of insurance companies and health maintenance organizations, are responsible for managing health benefits for individuals. Additionally, healthcare clearing houses are considered one of the covered entities as well, as they play a vital role in processing or facilitating the exchange of health information among different parties.
Business Associates
Business associates are individuals or entities that perform functions on behalf of a covered entity and involve the use or disclosure of PHI. This category includes billing companies that manage billing and collections for healthcare providers, as well as IT service providers responsible for overseeing electronic health records or offering cloud storage solutions for healthcare data. Consultants and contractors also qualify as business associates when they access PHI while executing their duties for covered entities.
Subcontractors
Subcontractors of business associates must comply with HIPAA regulations if they access PHI while carrying out their responsibilities. This requirement ensures that all third-party individuals or organizations involved in handling PHI uphold the same standards of privacy and security as the primary business associates and covered entities.
Other Entities
Certain additional organizations may also be subject to HIPAA regulations. Research institutions conducting studies that involve PHI are included, as well as public health authorities that handle health data for public health initiatives. Educational institutions, such as schools and universities that maintain health records for their students, also fall under the scope of entities required to comply with HIPAA standards.
What Data Is Protected under HIPAA Compliance?
The data protected under HIPAA compliance is known as Protected Health Information (PHI). According to the HIPAA, PHI is defined as health-related data that is created, received, maintained, or transmitted by covered entities and their business associates. It can be any individually identifiable health information that concerns a person’s past, current and future health conditions, information related to the provision of healthcare services to that person, and specific payment they make for their healthcare services.
There are 18 specific types of identifiers outlined by HIPAA:
- Names
- Medical record numbers
- Social Security numbers
- Dates (excluding year)
- Telephone numbers
- IP addresses
- Certificate/license numbers
- Vehicle identifiers and serial numbers
- Geographic data (smaller than state level)
- Unique identifying numbers or codes
- Fax numbers
- Email addresses
- Account numbers
- Health plan beneficiary numbers
- Web URLs
- Device identifiers and serial numbers
- Full-face photos and similar images
- Biometric identifiers (e.g., fingerprints, retinal scans)
In addition, documents that contain these identifiers in conjunction with health information are considered to be protected by HIPAA regulations as well.
What Common Violations of HIPAA Compliance Are Frequently Observed?
Some common types of violations of HIPAA compliance include the following:
- Intrusion on Healthcare Records: Unauthorized access to patient records, often driven by personal curiosity about friends or celebrities, is a widespread violation of HIPAA.
- Failure to Perform Risk Analysis: Organizations are required to conduct thorough risk assessments to identify vulnerabilities in their handling of Protected Health Information (PHI).
- Inadequate Access Controls: Sufficient measures should be implemented to restrict access to ePHI, which should only be accessible to authorized personnel.
- Denying Patient Access to Records: Patients have the right to access their health records within a specified timeframe, typically 30 to 60 days.
- Improper Disposal of PHI: Failure to securely dispose of physical or digital records containing PHI is another frequent violation. This includes practices such as discarding documents without shredding them or inadequately wiping digital devices before disposal.
- Lack of Business Associate Agreements: Healthcare providers must ensure that all vendors with access to PHI enter into HIPAA-compliant business associate agreements.
- Insufficient Security Measures for ePHI: Not utilizing encryption or other security measures for ePHI, particularly on portable devices, leaves sensitive information vulnerable to unauthorized access and breaches, which is a critical compliance issue.
- Impermissible Disclosures of PHI: Sharing patient information without proper authorization, whether intentional or accidental, constitutes a violation of HIPAA. This includes discussing patient cases in unsecured environments or posting about them on social media.
- Failure to Notify Breaches Timely: Organizations are mandated to notify affected individuals and the Department of Health and Human Services within 60 days of discovering a breach.
- Device Theft or Loss: Theft or loss of devices containing unencrypted ePHI presents a significant risk and is a common cause of data breaches under HIPAA regulations.
Step-by-Step Checklist for Achieving HIPAA Compliance
To ensure that your organization can successfully achieve HIPAA compliance, the following is a comprehensive checklist to guide you through the process.
Determine Applicability
Begin by assessing whether your organization is required to comply with HIPAA. Identify if you qualify as a covered entity, such as healthcare providers, health plans, or clearinghouses, or if you are a business associate that handles PHI.
Define Your Requirement for Compliance
Learn which PHI identifiers your data is classified as and qualified as, which will lead you to determine which systems and personnel are required for the HIPAA compliance.
Appoint Compliance Personnel
It’s important to appoint a HIPAA Privacy Officer, who will be responsible for overseeing compliance efforts, managing policies, and ensuring staff training. If your organization deals with electronic PHI (ePHI), consider appointing a Security Officer to focus specifically on security measures.
Conduct a Risk Assessment
Identify all PHI your organization creates, receives, stores, and transmits. Assess the risks and examine potential threats to the confidentiality and integrity of PHI, taking into account human errors and environmental concerns, while documenting your findings.
Develop Policies and Procedures
Establish comprehensive policies that address privacy practices, data access management, breach notification processes, and employee sanctions for non-compliance.
Implement Security Measures
Put in place physical safeguards to control access to locations where PHI is stored. Additionally, adopt technical safeguards such as encryption for ePHI, secure passwords, and access controls to prevent unauthorized entry. These measures should be documented under HIPAA regulations.
Business Associate Agreements (BAAs)
Review all existing Business Associate Agreements to ensure that contracts with business associates include HIPAA compliance provisions. Conduct due diligence to confirm that these associates have the necessary safeguards in place to protect PHI.
Establish Breach Notification Procedures
Develop a breach response plan that outlines the steps for identifying, reporting, and addressing data breaches in line with the Breach Notification Rule. Ensure that affected individuals are promptly notified after a breach is discovered.
Documentation and Record Keeping
All compliance efforts must be meticulously documented to demonstrate adherence during audits by the OCR. Therefore, it’s imperative for you to keep thorough records of all policies, training logs, risk assessments, incident reports, and communications related to PHI. These documents should be stored securely and organized for easy access during audits or investigations.
Regular Audits and Monitoring
Conduct regular self-audits to assess compliance with HIPAA regulations and identify areas for improvement. Continuously monitor compliance and update policies as needed in response to changes in regulations or organizational practices.
How Sangfor Helps You Ensure Compliance with HIPAA?
Sangfor Access Secure, a Secure Access Service Edge (SASE) solution, supports organizations in enhancing their security posture with robust features such as Zero Trust Network Access (ZTNA), Endpoint Detection and Response (EDR), data encryption, intrusion prevention and secure web gateway. These allow authorized users to access sensitive health information, protecting patient data and ePHI from unauthorized access. For comprehensive HIPAA compliance, organizations should combine these technical safeguards with administrative and physical measures. Get in touch with Sangfor to learn more about how our solutions can ensure your compliance with the relevant data privacy laws.
Frequently Asked Questions
Failure to comply with HIPAA regulations can lead to severe consequences for healthcare organizations and individuals. The penalties include:
- Financial Penalties: Civil monetary fines range from USD 141 to over USD 2 million per violation, depending on the severity and nature of the breach. For willful neglect that is not corrected, fines can escalate significantly, reaching up to USD 2.1 million annually.
- Criminal Charges: Serious violations may result in criminal penalties, including fines up to USD 250,000 and imprisonment for up to 10 years for malicious intent or personal gain.
- Reputational Damage: Organizations may suffer loss of trust from patients and the public, leading to decreased patient retention and potential loss of business contracts.
- Legal Actions: Non-compliance can result in lawsuits from affected individuals, further exacerbating financial and reputational harm.
The key security features to look for when choosing a technology solution for HIPAA compliance include robust data encryption, strict access controls and user management measures. These features will ensure that you can protect sensitive health information, secure communications for data transmissions, and prevent breaches. For example, having Multi-Factor Authentication (MFA) in the solution will help block unauthorized access. Other functions that should be included are audit logging and monitoring capabilities to follow the activities and movement of a user to prevent data leakage.