HIPAA, the Health Insurance Portability and Accountability Act of 1996, is a U.S. law designed to protect the privacy and security of individuals’ medical information.
Whether you’re a healthcare provider or a supporting business, understanding and implementing HIPAA safeguards is vital as healthcare becomes increasingly digital. Beyond avoiding significant financial penalties, HIPAA compliance is also about respecting the rights and dignity of all patients.
Our detailed guide explains HIPAA compliance, including the key rules and requirements for protecting medical data responsibly. We also provide a simple checklist to keep you on track with best compliance practices.
What Is HIPAA?
The Health Insurance Portability and Accountability Act of 1996, better known as HIPAA, prioritizes patient privacy and medical data integrity in the United States, where information breaches have affected over 176 million patients.
HIPAA’s broad purpose is twofold:
- To protect the confidentiality of patients’ medical data. The defined focus here is Protected Health Information (PHI). PHI includes medical records and is defined as individually identifiable health information.
This is information containing an identifier that could be linked to the patient (e.g., name, date of birth, images that can identify them). - To protect health insurance portability for workers changing jobs. In other words, it helps workers keep their health insurance when they switch or lose jobs by limiting how insurers can deny coverage or impose long waiting periods for pre-existing conditions.
In addition to the above, HIPAA contributes to reducing healthcare fraud and abuse. Over time, the law has been updated to keep up with the rise of electronic health records and digital systems, ensuring patient data stays safe.
HIPAA is overseen and enforced by the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR). For criminal violations (e.g., intentional abuse of protected health information for personal gain), enforcement falls to the U.S. Department of Justice (DOJ).
Patients have the right to file a complaint with the Office for Civil Rights (OCR) if they believe their HIPAA rights have been violated.
What Is HIPAA Compliance?
HIPAA compliance entails adhering to the set of administrative, physical, and technical safeguards required by the law. Compliance is an ongoing responsibility designed to keep PHI safe from unauthorized access, use, or disclosure.
Who must comply?
The law defines two main groups that are subject to compliance:
- Covered Entities: These are the primary providers and payers in the healthcare system, including:
- Hospitals
- Doctors offices
- Clinics
- Pharmacies
- Dentists
- Health insurance companies
- HMOs (Health Maintenance Organizations)
- Business Associates: These are supporting vendors to health care providers, typically third-party individuals or organizations that handle, use, or transmit PHI on behalf of covered entities. The group includes:
- Billing services
- IT service providers
- Legal firms
- Data analytics companies
- Telehealth platform providers
- Cloud storage companies
- Third-party administrators for health plans
- Medical device companies with connected apps
HIPAA applies regardless of whether the covered entity/business associate is a solo practitioner, small startup, or large corporation. Size doesn’t exempt an organization. If they create, receive, maintain, or transmit PHI, they are bound by this law.
What Does HIPAA Protect?
As mentioned, HIPAA protects patients’ medical records and other individually identifiable health information (defined as PHI).
To give you an idea of the wide scope of protection, it covers a person’s past, present, or future data in any available form (electronic, paper, or verbal).
Examples of protected information include:
- Patient names, addresses, birth dates, telephone numbers, email addresses, and Social Security Numbers.
- Medical records and test results.
- Photographs and biometric data.
- Treatment histories.
- Billing and payment information.
- Health plan details.
- Any other unique identifying numbers, codes, or characteristics.
Key HIPAA Rules
HIPAA compliance is governed by four core rules, addressing specific data protection requirements. Here’s a clear look at each one:
Spear phishing will evolve and likely become an even more dangerous threat due to factors like:
The Privacy Rule
The HIPAA Privacy Rule sets national standards for the protection of medical records and protected health information. It governs the circumstances under which a covered entity can use or disclose patient information with consent. For example, healthcare professionals are allowed to breach confidentiality in the case of:
- Gunshot and stab wounds, and injuries sustained during a crime.
- Abuse of children or the elderly.
- Infectious and communicable diseases.
The rule also gives patients rights, such as requesting copies of their records or asking for corrections to inaccurate information.
The Security Rule
The Security Rule requires covered entities to implement safeguards to protect Electronic Protected Health Information (ePHI). The rule has three primary focuses:
- Administrative safeguards: These are management policies and procedures, such as security awareness training and risk analysis.
- Physical safeguards: Physical safeguards relate to protecting physical electronic systems and data, such as locked doors for server rooms and policies for handling devices.
- Technical safeguards: These are the technological security measures, such as data encryption, access controls, and audit logs.
The Breach Notification Rule
The Breach Notification Rule requires covered entities and business associates to notify affected parties and regulatory bodies following a breach of unsecured PHI.
Once a covered entity becomes aware of a breach, the alerts must be sent within 60 days. If the breach impacts more than 500 people, the HHS must be informed as soon as the incident is discovered.
The regulations require the following parties to be alerted:
- Affected individuals.
- Health and Human Services (HHS).
- Media, if necessary (e.g., press advisory and spokesperson’s statements).
Business associates of a covered entity must also inform their covered entity.
The HIPAA Enforcement Rule
The Enforcement Rule was introduced in 2006, outlining clear procedures for investigating violations and imposing penalties under HIPAA.
The rule recognizes different levels of misuse of patient data and applies structured, tiered civil penalties based on how serious the transgression is. The tiers, from least to most serious, are:
- Lack of knowledge: The violation occurred without the covered entity/business associate knowing and, by exercising reasonable diligence, they could not have known.
- Lack of oversight: The violation resulted from reasonable cause, such as insufficient oversight or failure to follow policies, but without willful neglect.
- Willful neglect: A conscious, intentional failure or reckless indifference to HIPAA obligations.
- Willful neglect not corrected within 30 days: Willful neglect where no timely corrective action was taken after discovery.
HIPAA enforcement options include action plans, fines and penalties (over $2 million annually), and even criminal prosecution.
HIPAA Compliance Requirements
The first step to compliance is understanding HIPAA rules and conducting a thorough assessment to verify that your organization is meeting the expected standards. The focus here should be both internal and external.
Internal compliance requirements
Compliance policy: Organizations are required to maintain written policies for handling PHI properly, responding to incidents, and enforcing HIPAA rules internally.
Privacy rule compliance: Providers must practice ongoing vigilance around patient information. Care should be taken to limit PHI use and disclosure unless it’s necessary for treatment or business reasons. Organizations must provide channels for patients to access their records and allow them to request corrections.
Security rule compliance: Providers are required to implement administrative, physical, and technical safeguards to protect electronic PHI (ePHI). This should include:
- Risk assessments
- Data security protocols
- Data encryption
- Secure workstations
- Storage and access controls (incorporating multi-factor authentication)
Breach notification: Any PHI breaches must be reported to affected individuals, the Health and Human Services, and the media (if necessary), within stipulated timeframes.
Staff training and awareness: HIPAA requires organizations to train all workforce members on privacy, security, and HIPAA compliance policies. The goal is to ensure that everyone who comes into contact with protected information understands their responsibilities for safeguarding it.
Who should receive HIPAA training?
- Full-time and part-time employees.
- Temporary staff and contractors.
- Students, trainees, and interns.
- Volunteers who handle PHI.
- Management and administrative staff.
- IT and technical teams supporting PHI systems.
External compliance
Business Associate Agreements (BAAs): Covered entities must have a signed HIPAA-compliant Business Associate Agreement with every vendor or partner that accesses, uses, or transmits PHI on their behalf.
This agreement legally binds the business associate to protect patient information according to HIPAA rules. Without a BAA, a covered entity may be held liable for its vendor’s security failures.
HIPAA Compliance Checklist
Staying compliant is an ongoing process. Use this checklist to keep your organization on the right path:
- Security safeguards: Implement and update the necessary administrative, physical, and technical controls. This includes antivirus and malware protections, multi-factor authentication, and data encryption (in transit and at rest). Also, enforce strict access controls by role to ensure PHI is only viewed by authorized personnel.
- Train staff: Educate all employees who handle PHI on HIPAA policies, best practices, and how to identify potential threats like phishing. Training should ideally take place twice a year (and when new regulations are introduced).
- Maintain a breach response plan: Develop and document clear procedures for responding to potential breaches or privacy incidents. Your plan should cover immediate containment steps, investigation procedures, and notification requirements. Test your plan periodically to make sure it works.
- Review and update HIPAA policies: Regularly review and update your HIPAA policies and procedures. Healthcare technology and security threats change constantly, so your policies need to keep up.
- Sign Business Associate Agreements (BAAs): Make sure you have current, HIPAA-compliant agreements with all vendors and partners who might access patient information. Review these agreements regularly and update them as your business relationships change.
- Documentation and auditing: Maintain records of compliance efforts. Regularly audit your practices to verify you’re following your own policies and meeting HIPAA requirements.
- Perform risk assessments: Conduct regular assessments to identify vulnerabilities in how you handle patient information. Look at your physical facilities, electronic systems, and administrative processes.
How to Become HIPAA Compliant?
HIPAA compliance starts with a thorough evaluation of your organization’s current practices. The process identifies any gaps so immediate remedial action can be taken, reducing the risk of violations. This forms the foundation for subsequent security measures.
The checklist above highlights the essential components of HIPAA compliance, from policies and training to audits and response plans, all working together to protect patient data.
But HIPAA compliance isn’t a one-and-done task. Rather, it’s an ongoing commitment to ensuring your organization continually meets standards and respects patients’ right to privacy.
Acrisure Cyber can help you!
At Acrisure Cyber, we understand that navigating HIPAA’s complex rules can be tough for businesses. We’re here to make it easier.
With two decades of experience supporting healthcare clients nationwide, we can guide your organization through every step of HIPAA compliance. From assessments to strategy, training, and risk management, we provide tailored solutions that keep your data safe and your organization confidently compliant.
to see how our skilled team makes HIPAA simpler and smarter.
FAQs
Who enforces HIPAA?
HIPAA is enforced by the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR). For cases involving criminal intent, such as knowingly selling or misusing protected health information, the Department of Justice (DOJ) can get involved, pursuing fines and imprisonment. Enforcement can include corrective action plans, penalties, and, in serious cases, criminal prosecution.
What are Common HIPAA Violations?
Examples of common HIPAA violations include:
- Unauthorized access to PHI – For example, a hospital receptionist using a colleague’s login to view a family member’s medical chart without a valid reason.
- Lost or stolen devices without encryption – When laptops, phones, or tablets get lost or stolen without proper encryption, anyone who finds them can potentially access the health information stored on them.
- Failure to sign a BAA – A Business Associate Agreement legallyholds third-party vendors (like a billing company or IT service provider) to the same HIPAA standards as the healthcare provider. If a doctor’s office sends patient data to a new marketing firm without a BAA in place, they’re effectively breaking the law.
- Delay in breach notification – For example, if a clinic learns of a data breach and drags its heels in notifying patients beyond the 60-day deadline.
- Sharing PHI via unsecured channels – For instance, if a doctor sends a patient’s lab results to a colleague using their personal Gmail account instead of the hospital’s secure communications.
What does HIPAA stand for?
HIPAA stands for the Health Insurance Portability and Accountability Act of 1996. It is one of the major U.S. data privacy laws, protecting patient information in the country’s healthcare sector.
Do small clinics need to comply with HIPAA?
Yes, small clinics need to comply with HIPAA regulations. HIPAA compliance is based on the type of services provided and how patient data is handled, not the number of employees or patients.
If a small clinic outsources billing or IT services, it must ensure those business associates also comply with HIPAA.
What happens if I violate HIPAA?
Violating HIPAA can lead to serious consequences, including hefty fines and, in some cases, criminal charges. The penalties depend on the severity of the violation, ranging from unintentional mistakes to deliberate neglect.
For example, civil fines can range from $141 (for a minor, unknowing violation) to an annual penalty capped at $2,134,831 (for an uncorrected, willful violation).
In the most severe cases, the DOJ can pursue criminal charges, which can include 7-figure fines and up to 10 years in prison. A single company, Anthem Inc., incurred penalties of almost $180 million following a breach of 78.8 million records in 2015.
Does HIPAA apply to mental health records?
Protected information encompass psychotherapy notes, diagnoses, treatment plans, and other mental health information – past, present, and future.
Are small healthcare practices exempt from HIPAA?
Small healthcare practices are not exempt from HIPAA. If a practice is a covered entity, meaning it provides healthcare services and handles Protected Health Information (PHI), it must comply with all HIPAA rules, regardless of its revenue, employee headcount, and number of patients.
Are health care clearinghouses subject to HIPAA?
Healthcare clearinghouses are businesses that process health information into standardized electronic formats for submission to health insurers. Because they handle protected health information, they must also comply with HIPAA rules to ensure the data is secure and not misused.
What’s the difference between “data at rest” and “data in transit” under HIPAA?
Data at rest is stored information (e.g., in databases, hard drives), while data in transit is moving across a network (e.g., sending an email). Both must be protected under HIPAA.