Who must comply with HIPAA regulations?

The correct answer identifies that both covered entities and business associates are required to comply with HIPAA regulations. Covered entities include healthcare providers who transmit any health information in electronic form related to a transaction for which HHS has adopted standards, health plans, and healthcare clearinghouses. Business associates are individuals or entities that perform functions on behalf of or provide certain services to, a covered entity that involves the use or disclosure of protected health information.

This requirement ensures that all parties involved in the handling of protected health information (PHI) adhere to the regulations designed to protect patient privacy and ensure the security of health data. By mandating compliance from both covered entities and their business associates, HIPAA establishes a comprehensive framework for safeguarding sensitive health information across various domains of the healthcare industry.

The other options do not encompass the full scope of those who are obligated to follow HIPAA. Limiting compliance only to healthcare providers or insurance companies ignores the significant role that business associates play in the healthcare system and the necessity for them to also implement protective measures for PHI. Furthermore, patients, while they benefit from HIPAA protections, are not responsible for adhering to the compliance standards set forth by the law.