Who Is Bound By HIPAA?

When it comes to protecting patient information, the Health Insurance Portability and Accountability Act (HIPAA) sets the standard for confidentiality and security in healthcare. But who exactly is bound by these regulations? Determining the scope of HIPAA’s reach is important for anyone involved in handling health data.
In this blog, we will delve into the specifics of who must comply with HIPAA, as well as the types of information it protects, enforcement mechanisms, the consequences of violating HIPAA regulations, and more.
What Is HIPAA?
HIPAA, the Health Insurance Portability and Accountability Act of 1996, was enacted to address the challenges of managing patient information in an increasingly digital world. Its primary goals are to improve the efficiency and effectiveness of the healthcare system, protect patient privacy, and ensure the security of health information. HIPAA compliance is mandatory for entities that handle protected health information (PHI).
Who Enforces HIPAA?
HIPAA enforcement is primarily the responsibility of the U.S. Department of Health and Human Services (HHS), specifically the Office for Civil Rights (OCR). The OCR investigates complaints, conducts compliance reviews, and can impose penalties for non-compliance.
Additionally, the HHS Office of Inspector General (OIG) and the Department of Justice (DOJ) also play a role in enforcing HIPAA regulations, especially in cases involving criminal violations.
What Type of Information Is Protected?
HIPAA protects any information that can be used to identify a patient and relates to their health, medical history, treatment, or payment for healthcare services. This includes:
- Personal Identifiable Information (PII): Names, addresses, birth dates, and Social Security numbers.
- Medical Records: Diagnoses, treatment plans, test results, and medical histories.
- Billing Information: Insurance details, billing records, and payment histories.
- Communication Records: Emails, phone calls, and any other forms of communication containing PHI.
The HIPAA Privacy Rule sets national standards for the protection of health information and gives patients rights over their health data, including the right to access and request corrections to their records.
What Type of Information Is Not Protected?
HIPAA only protects information held by certain healthcare entities. For example, healthcare information on your iPhone or Fitbit is not covered by HIPAA. Similarly, genetic data on sites like 23AndMe or Ancestry.com is also not protected.
Additionally, apps that help you regulate your blood pressure might also not be covered under HIPAA. While other agreements or laws, such as privacy disclosures required by some apps, may secure your information, HIPAA does not.
Employers are generally not covered under HIPAA, and the law does not apply to them. If necessary, your employer can share that you are ill with others to help maintain safety. However, other laws, like the Americans with Disabilities Act, may prevent the disclosure of your protected health information (PHI).
Administrative Simplification Provisions
However, understanding who HIPAA applies to can still be confusing. The Administrative Simplification Provisions add to this complexity. The language in these provisions suggests that HIPAA mainly applies to electronic transactions and conduct.
While it’s clear that the standards apply to most healthcare entities, the provisions emphasize electronic transactions. Only in the final section is there a reference to PHI privacy standards. This section requires the Secretary of Health and Human Services (HHS) to enforce PHI protection if Congress does not act within three years.
This gives state Congress more discretionary power in HIPAA enforcement, which can slow down the process due to the need for collective decision-making. Big decisions like this take time and responsibility.
What Is a Covered Entity?
A covered entity under HIPAA includes any organization or individual that directly handles PHI. These entities must comply with HIPAA regulations to ensure the confidentiality, integrity, and availability of PHI. Covered entities in HIPAA include:
- Healthcare Providers: Doctors, nurses, clinics, hospitals, psychologists, dentists, chiropractors, nursing homes, pharmacies, and other healthcare facilities that provide medical services and handle PHI.
- Health Plans: Health insurance companies, HMOs, company health plans, government programs like Medicare and Medicaid, and other entities that provide or pay for medical coverage
- Healthcare Clearinghouses: Entities that process non-standard health information they receive from another entity into a standard format.
Who Is a Business Associate?
In addition to covered entities, HIPAA also applies to business associates. This refers to individuals or organizations that perform services for covered entities involving the use or disclosure of PHI. Examples include billing companies, third-party administrators, and IT service providers.
Business associates must sign a HIPAA-compliant agreement. These associates include entities like:
- Process claims handlers
- Administrative service providers
- Billing and payment processors
- Collection agencies
- Quality assurance firms
- Data analysts
- Consultants
- Accountants
- Data storage agencies
- Attorneys
- Data management firms
HIPAA also applies to subcontractors of business associates. If a business associate contracts work to another entity that must use or access PHI, they must comply with HIPAA. Therefore, business associates must also enter into agreements with their subcontractors, ensuring they understand their responsibilities regarding PHI.
What Are the Consequences of Violating HIPAA?
Both individuals and organizations can be charged with knowingly and wrongfully disclosing individually identifiable health information without authorization if the OCR believes a criminal HIPAA violation has occurred. The minimum fine for criminal HIPAA violations is $50,000, and the maximum penalty for an individual can be $250,000, with possible restitution to victims. Additionally, jail terms are possible for criminal violations of HIPAA Rules.
Similar to penalties for HIPAA violations by covered entities and business associates, there are penalty tiers for jail terms:
- Negligent violations can result in up to 1 year in prison.
- Obtaining PHI under false pretenses can result in up to 5 years in prison.
- Knowingly disclosing PHI with malicious intent or for personal/commercial gain can lead to up to 10 years in prison.
- Aggravated identity theft carries a mandatory two-year jail term.
In addition to civil and criminal penalties for violating HIPAA, individuals and organizations may also face fines or charges for violating state laws. State laws are increasingly used to bring private rights of action for HIPAA violations and to sanction individuals who disclose PHI on social media.
FAQs: HIPAA
If you still have questions about HIPAA, we’ve answered common HIPAA questions:
Are Researchers Covered Under HIPAA?
Researchers are covered under HIPAA if they have authorization to use and disclose PHI for research purposes. Covered entities can share PHI with researchers without needing a business associate agreement, but they must have a data use agreement in place. This ensures compliance with HIPAA while sharing a limited set of data for research.
Is HIPAA Applicable In Public Health Emergencies?
During a declared disaster or public health emergency, the Secretary of Health and Human Services can waive enforcement of certain HIPAA compliance requirements. However, not all Privacy Rule provisions are waived. For the latest HIPAA updates related to global events, visit the official HHS website.
Does HIPAA Require Encryption?
HIPAA does not explicitly mandate encryption but considers it an addressable implementation specification under the Security Rule. Covered entities and business associates must analyze risks to ePHI and determine if encryption is appropriate. If so, its use is encouraged. However, they have the flexibility to choose alternative measures if encryption is not suitable for their specific circumstances.
Does HIPAA Apply to Minors?
Yes, HIPAA protects the PHI of individuals of all ages, including minors. Minors have the same privacy rights as adults under HIPAA. Healthcare providers and covered entities must follow HIPAA regulations when handling and disclosing minors' PHI. However, parental or guardian consent may be required in some cases, such as for psychotherapy notes or substance abuse treatment records.
Is HIPAA International?
HIPAA is a U.S. federal law primarily applicable within the United States. However, international entities handling PHI from the U.S. must comply with HIPAA by entering agreements with covered entities. International organizations interacting with U.S.-based healthcare entities should consider HIPAA's privacy and security requirements. Additionally, other countries have their own data protection laws, such as the GDPR in the European Union.
What Is HIPAA Training?
HIPAA training is a mandatory requirement in the healthcare industry to ensure compliance with HIPAA regulations and uphold patient privacy and security. It educates healthcare professionals, employees, and staff members about the regulations, guidelines, and best practices outlined in HIPAA.
Does HIPAA Certification Expire?
Although there is no expiration for HIPAA certification, organizations may undergo periodic audits or assessments to validate their compliance with HIPAA requirements. This typically means renewing your certification once per year. Compliance with HIPAA is an ongoing responsibility, with organizations expected to maintain and regularly review their practices to ensure continued adherence.
Where Can I Complete My HIPAA Training?
While there are free HIPAA training courses available, they are typically lower in quality and provide the basics, which is a problem because, in HIPAA compliance, every detail matters. However, HIPAA training from a trusted provider, like 360training, will provide high-quality and in-depth training, adding value and making it worth the price.
HIPAA Compliance Made Easy With 360training
Now that you have access to reliable HIPAA information that simplifies compliance, you are closer to ensuring that you and your associates meet HIPAA requirements.
However, it can still be challenging to determine who is subject to HIPAA coverage. If you're struggling to navigate HIPAA compliance challenges, our compliance courses and HIPAA training are very helpful.
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