Who must comply with the HIPAA Privacy Rule?

The HIPAA Privacy Rule is designed to protect the privacy of individuals' health information and applies to a broad range of entities. All covered entities and business associates are required to comply with this rule. Covered entities include healthcare providers who transmit any health information in electronic form, health plans, and healthcare clearinghouses.

Business associates are individuals or entities that perform functions or activities on behalf of, or provide certain services to, a covered entity that involve the use or disclosure of protected health information (PHI). This means that both direct healthcare providers and organizations that interact with them in the handling of health information must adhere to the standards set forth in the HIPAA Privacy Rule.

In contrast, the other options focus on more limited or specific groups, such as large facilities, government programs, or only particular providers and insurers. These options do not encompass the wider regulatory reach of the HIPAA Privacy Rule, which incorporates a diverse range of entities involved in health information management and emphasizes comprehensive compliance to ensure patient privacy across the healthcare system.