Which federal entity provides legal guidelines for electronic recordkeeping?

The Food and Drug Administration (FDA) is responsible for establishing and enforcing regulations regarding electronic recordkeeping, particularly as they apply to the safety and efficacy of drugs and medical devices. This includes ensuring compliance with the Federal Food, Drug, and Cosmetic Act, which governs the standards for electronic records in connection with the approval and monitoring of pharmaceuticals. The FDA has specific guidelines detailing how electronic records should be maintained, allowing for their integrity, security, and accessibility, which are crucial in the context of drug safety and regulation.

In contrast, the other entities mentioned have different scopes of authority. The Drug Enforcement Administration (DEA) focuses primarily on the regulation of controlled substances and enforcement of drug laws rather than comprehensive electronic recordkeeping. The Federal Trade Commission (FTC) primarily deals with consumer protection and antitrust issues, not with the specifics of drug and medical recordkeeping. Lastly, the Department of Health and Human Services (HHS) oversees various health programs and related policy, but it is the FDA that specifies the requirements for electronic records in relation to its regulatory functions. Thus, identifying the FDA as the correct answer highlights its role in guiding practices related to electronic documentation in the pharmaceutical context.