HIPAA compliance is mandated by the Health Insurance Portability and Accountability Act of 1996, which establishes standards to protect personal health information (PHI) and electronic protected health information (ePHI). Covered entities, including healthcare providers and businesses associated with them, must undergo HIPAA audits to ensure compliance, implement safeguards, and maintain business associate agreements. Non-compliance can result in significant penalties, including fines and potential criminal charges.