Final answer:
A covered entity must indeed have an established complaint process to comply with HIPAA regulations, allowing patients to report issues related to the handling of their personal health information.
Step-by-step explanation:
True, a covered entity (CE) must have an established complaint process according to the Health Insurance Portability and Accountability Act (HIPAA). This is a provision to ensure patients can report any issues they might have regarding the handling of their personal health information (PHI). The Department of Health and Human Services (HHS) requires that all covered entities, such as health plans, health care clearinghouses, and health care providers that transmit health information electronically, have procedures in place to receive and resolve complaints from individuals. The process is essential for maintaining patient trust and ensuring compliance with privacy regulations set forth by HIPAA.