Can a business associate be considered a HIPAA-covered entity?

by | Jan 25, 2023 | HIPAA News and Advice

No, a business associate cannot be considered a HIPAA-covered entity; rather, they are external entities that handle PHI on behalf of covered entities, such as healthcare providers or health plans, and are subject to HIPAA regulations through business associate agreements. HIPAA describes the responsibilities and obligations of various entities that handle PHI. Among these entities, two distinct categories are HIPAA-covered entities and business associates. While both play important roles in maintaining the integrity of patient data, their roles and regulatory obligations differ.

HIPAA-Covered EntitiesBusiness Associates
Include healthcare providers, health plans, and healthcare clearinghouses.External entities that handle PHI on behalf of covered entities.
Engage in electronic transactions involving health information.Perform functions involving the use, disclosure, or management of PHI.
Directly subject to HIPAA regulations.Subject to HIPAA regulations through business associate agreements (BAAs).
Responsible for maintaining patient data privacy and security.Obliged to adhere to data protection standards outlined in BAAs.
Play a primary role in patient care.Support covered entities by providing specialized services involving PHI.
Must implement administrative, technical, and physical safeguards.Encompass entities like medical billing companies, IT support firms and transcription services.
Required to comply with HIPAA provisions.Held directly liable for specific HIPAA requirements since the Omnibus Rule.
Cover a range of healthcare functions.Include entities like medical billing companies, IT support firms, and transcription services.
Have a direct relationship with patients.Often act as intermediaries in handling and safeguarding PHI.
Recognized as responsible for patient data security.Share responsibility for data protection and privacy within the healthcare ecosystem.
Table: Comparison Between HIPAA-Covered Entities and Business Associates

A HIPAA-covered entity refers to a healthcare provider, health plan, or healthcare clearinghouse that transmits any health information in electronic form for transactions such as claims, enrollment, and payment. These entities are at the forefront of patient care and are inherently responsible for maintaining the privacy and security of patient data. Covered entities are directly subject to the provisions of HIPAA and must adhere to its regulations to ensure the confidentiality and protection of PHI. They are required to implement administrative, technical, and physical safeguards to prevent unauthorized access, use, or disclosure of patient information.

A business associate is an external entity or organization that performs functions or activities involving the use, disclosure, or handling of PHI on behalf of a covered entity. Business associates can include different entities, including but not limited to medical billing companies, transcription services, IT support firms and legal consultants. Business associates can also be subcontractors engaged by other business associates, thus extending the regulatory web.

The role of business associates under HIPAA is important serving as intermediaries and support systems for covered entities. They often possess specialized expertise or resources that a covered entity may not have in-house, thereby necessitating the sharing of PHI. Given the sensitive nature of the information involved, HIPAA requires business associates to adhere to the same level of data protection and privacy as covered entities. This is achieved through the establishment of business associate agreements (BAAs) between the covered entity and the business associate. A BAA is a legally binding contract that outlines the specific responsibilities and obligations of the business associate concerning the protection and use of PHI. It serves as a tool for ensuring compliance with HIPAA regulations and maintaining the security and confidentiality of patient data throughout its lifecycle. The BAA typically addresses things such as permissible uses of PHI, security safeguards, breach notification requirements, and the allocation of responsibilities in the event of a security incident.

While business associates are not HIPAA-covered entities themselves, they are undeniably linked to the healthcare ecosystem’s commitment to data protection. The inclusion of business associates under the regulatory umbrella of HIPAA recognizes their potential impact on patient privacy. A breach or mishandling of PHI by a business associate could have consequences on the affected patients, the covered entity, and the business associate itself. The HIPAA Omnibus Rule, implemented in 2013, enhanced the regulatory framework involving business associates. It clarified that business associates are directly liable for complying with certain aspects of the HIPAA Security Rule and Privacy Rule. This expansion of obligations stresses the recognition of business associates as important stakeholders in maintaining the integrity of patient data. Business associates are required to implement robust security measures, conduct regular risk assessments, and train their workforce on HIPAA compliance.

The relationship between HIPAA-covered entities and business associates can be likened to a chain of responsibility, where the goal is to ensure the protection and privacy of patient data. Covered entities entrust business associates with the handling of PHI, and business associates are obligated to fulfill this role with diligence. The interconnectedness of these roles emphasizes the collaborative nature of healthcare operations while placing patient privacy and data security at the forefront.


While a business associate is not classified as a HIPAA-covered entity, its role within the healthcare system is important to the protection of patient information. Business associates operate as external entities that handle PHI on behalf of covered entities, necessitating their compliance with HIPAA regulations through the establishment of business associate agreements. This regulatory structure emphasizes the shared responsibility for maintaining patient privacy and data security across the healthcare ecosystem, involving both covered entities and their business associates. Adherence to these regulations contributes to maintaining the principles of patient confidentiality and data integrity within the framework of modern healthcare.

HIPAA Covered Entity Topics

What is the definition of a HIPAA-covered entity?
How does an organization determine if it is a HIPAA-covered entity?
Are all healthcare providers considered HIPAA-covered entities?
What obligations does an entity covered by HIPAA have concerning patient data?
Do insurance companies fall under the category of entities covered by HIPAA?
What is a covered entity under HIPAA?
Who would not be considered a covered entity under HIPAA?
Is an employer a covered entity under HIPAA?
Who should HIPAA complaints be directed to within the covered entity?
What are the penalties for a HIPAA-covered entity that breaches patient confidentiality?
Are health technology companies automatically considered HIPAA-covered entities?
What distinguishes a HIPAA entity from non-covered entities?
Can a HIPAA-covered entity share medical records with another such entity without patient consent?
How often should HIPAA-covered entities review their compliance procedures?
What types of training must employees of an entity covered by HIPAA undergo?
How do entities covered by HIPAA handle data breaches?
What is the role of a privacy officer in a HIPAA-covered entity?
Are dental practices considered HIPAA-covered entities?
Can a patient sue a HIPAA-covered entity for a data breach?
How are HIPAA-covered entities audited for compliance?
What are the reporting obligations of a HIPAA entity in case of data exposure?
How do third-party vendors interact with HIPAA-covered entities?
Can a business associate be considered a HIPAA-covered entity?
How should a HIPAA entity respond to unauthorized access to protected health information?
What security measures must entities covered by HIPAA implement?
Are there exemptions for certain types of entities covered by HIPAA?
How long must a HIPAA-covered entity retain medical records?
What patient rights are recognized by entities covered by HIPAA concerning their personal data?
Are telemedicine platforms typically classified as HIPAA-covered entities?
What distinguishes business associates from HIPAA-covered entities?
How can patients file complaints against a HIPAA entity?
What is the significance of the Notice of Privacy Practices for a HIPAA-covered entity?
How do international medical tourism practices intersect with HIPAA-covered entities?
Are there specific encryption standards that a HIPAA-covered entity must adhere to?
How do federal and state laws regarding patient privacy relate to HIPAA-covered entities?
How do HIPAA-covered entities handle minor patient information?
Are pharmacies and drug stores universally categorized as HIPAA-covered entities?
How can a HIPAA-covered entity ensure compliance when integrating new technologies?
What are the key differences between a HIPAA-covered entity and a HIPAA business associate?
Are research institutions always considered HIPAA-covered entities?
What are the boundaries of marketing activities for an entity covered by HIPAA?
Can cloud service providers be classified as HIPAA-covered entities?
How should a HIPAA entity prepare for an official audit or review?
What documentation is essential for a HIPAA-covered entity’s compliance processes?
How often do regulations impacting HIPAA-covered entities get updated?
Do educational institutions fall under the scope of entities covered by HIPAA?
How do mobile health apps and digital health tools intersect with HIPAA-covered entities?
What is the role of electronic health record systems in a HIPAA-covered entity?
How does the Health Information Exchange (HIE) network impact HIPAA-covered entities?
Are mental health professionals bound by the same rules as other HIPAA-covered entities?
How do mergers and acquisitions impact the status of a HIPAA-covered entity?
Can patients access all their health data held by a HIPAA-covered entity?
Are billing and invoicing data handled differently by entities covered by HIPAA than medical data?
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