The Privacy Act of 1974 established the Information Exchange Agreement (IEA). The IEA is a document used when CMS discloses Personally Identifiable Information (PII) to a Department of Health and Human Services (HHS) Operating Division (OpDiv), another federal agency, or a state agency.
The Safety Data Exchange Agreements (SDEAs) are legal written contracts that require business partners to exchange all safety data for medicinal products with Marketing Authorization Holders (MAHs). This in turn ensures that the legal obligations are fulfilled by the MAHs.