Which entities must comply with HIPAA regulations?

The requirement for compliance with HIPAA regulations specifically includes two categories: covered entities and business associates. Covered entities are defined as healthcare providers who transmit any health information in electronic form in connection with a HIPAA transaction, health plans, and healthcare clearinghouses. Business associates are individuals or entities that perform certain functions or activities on behalf of or provide certain services to, a covered entity that involves the use or disclosure of protected health information (PHI).

This means that both covered entities and their business associates must comply with the privacy, security, and breach notification provisions of HIPAA. This regulation ensures that patient information is handled properly across all healthcare scenarios, creating a framework for protecting patients' health information from unauthorized access and ensuring its confidentiality.

The other options do not encompass the full requirement set out by HIPAA. While healthcare providers and insurance companies are considered covered entities, not all healthcare providers and insurance companies are compliant unless they meet specific criteria. Patients are not obligated to comply with HIPAA since it primarily regulates how their information is handled by healthcare entities. Therefore, the most comprehensive answer that reflects who must adhere to HIPAA regulations is the one identifying both covered entities and business associates.