Who must sign the Business Associate Agreement (BAA)?

The requirement for both the covered entity and the business associate to sign a Business Associate Agreement (BAA) is rooted in the need for compliance with HIPAA regulations. A BAA is a legal document that establishes the responsibilities and expectations for both parties concerning the protection of protected health information (PHI).

When both parties sign the agreement, it ensures that the business associate understands its obligations under HIPAA, including how to properly handle PHI, maintain confidentiality, and report any breaches. This mutual agreement is crucial, as it creates a formal relationship in which the business associate agrees to obey the same privacy and security rules that apply to the covered entity, thus helping to safeguard patients' health information.

In contrast, the other choices would not fulfill the requirement set by HIPAA for managing the responsibilities related to PHI. If only the covered entity signed or if business associates were exempt from signing, there would be no formal accountability for handling sensitive health information, increasing the risk of non-compliance and potential breaches.