We came across some useful information from the National Institutes of Health and TechTarget and have combined it into the summary below on the topic of covered entities under the Healthcare Insurance Portability and Accountability Act (HIPAA). Please refer to the original sources below for more detailed information.
Covered entities are defined in the Healthcare Insurance Portability and Accountability Act (HIPAA) rules as (1) health plans, (2) health care clearinghouses, and (3) health care providers who electronically transmit any health information in connection with transactions for which the U.S. Department of Health & Human Services (HHS) has adopted standards. Generally, these transactions concern billing and payment for services or insurance coverage. For example, hospitals, academic medical centers, physicians, and other health care providers who electronically transmit claims transaction information directly or through an intermediary to a health plan are covered entities. Covered entities can be institutions, organizations, or persons.
- For Covered/Hybrid Entities and Business Associates: National Institutes of Health
- For Key Takeaways: TechTarget
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Researchers are covered entities if they are also health care providers who electronically transmit health information in connection with any transaction for which HHS has adopted a standard. For example, physicians who conduct clinical studies or administer experimental therapeutics to participants during the course of a study must comply with the Privacy Rule if they meet the HIPAA definition of a covered entity.
- Health Plan – With certain exceptions, an individual or group plan that provides or pays the cost of medical care (as defined in section 2791(a)(2) of the PHS Act, 42 U.S.C. 300gg-91(a)(2)). The law specifically includes many types of organizations and government programs as health plans.
- Health Care Clearinghouse – A public or private entity, including a billing service, repricing company, community health management information system or community health information system, “value-added” networks, and switches that either process or facilitate the processing of health information received from another entity in a nonstandard format or containing nonstandard data content into standard data elements or a standard transaction, or receive a standard transaction from another entity and process or facilitate the processing of health information into a nonstandard format or nonstandard data content for the receiving entity.
- Health Care Provider – A provider of services (as defined in section 1861(u) of the Act, 42 U.S.C. 1395x(u)), a provider of medical or health services (as defined in section 1861(s) of the Act, 42 U.S.C. 1395x(s)), and any other person or organization who furnishes, bills, or is paid for health care in the normal course of business.
- Health Care – Care, services, or supplies related to the health of an individual, including (1) preventive, diagnostic, therapeutic, rehabilitative, maintenance, or palliative care, and counseling, service, assessment, or procedure with respect to the physical or mental condition, or functional status, of an individual that affects the structure or function of the body; and (2) sale or dispensing of a drug, device, equipment, or other item in accordance with a prescription.
Under the Privacy Rule, any entity that meets the definition of a covered entity, regardless of size or complexity, generally will be subject in its entirety to the Privacy Rule. However, the Privacy Rule provides a means by which many covered entities may avoid global application of the Rule, through the hybrid entity designation provisions. This designation will establish which parts of the entity must comply with the Privacy Rule.
Thus, a hybrid entity is a single legal entity that is a covered entity, performs business activities that include both covered and noncovered functions, and designates its health care components as provided in the Privacy Rule. If a covered entity is a hybrid entity, the Privacy Rule generally applies only to its designated health care components. However, non-healthcare components of a hybrid entity may be affected because the health care component is limited in how it can share PHI with the non-health care component. The covered entity also retains certain oversight, compliance, and enforcement responsibilities.
A person or entity who, on behalf of a covered entity, performs or assists in performance of a function or activity involving the use or disclosure of individually identifiable health information, such as data analysis, claims processing or administration, utilization review, and quality assurance reviews, or any other function or activity regulated by the HIPAA Administrative Simplification Rules, including the Privacy Rule. Business associates are also persons or entities performing legal, actuarial, accounting, consulting, data aggregation, management, administrative, accreditation, or financial services to or for a covered entity where performing those services involves disclosure of individually identifiable health information by the covered entity or another business associate of the covered entity to that person or entity. A member of a covered entity’s workforce is not one of its business associates. A covered entity may be a business associate of another covered entity.
A HIPAA covered entity is any organization or corporation that directly handles Personal Health Information (PHI) or Personal Health Records (PHR). The most common examples of covered entities include hospitals, doctors’ offices and health insurance providers. Covered entities are required to comply with Health Information Portability and Accountability Act (HIPAA) and Health Information Technology for Economic and Clinical Health Act (HITECH) mandates for protection of PHI and PHR.