Has the Secretary exceeded the HIPAA statutory by requiring "business associates" to comply with the Privacy Rule, even if that requirement is through a contract?


The HIPAA Privacy Rule does not “pass through” its requirements to business associates or otherwise cause business associates to comply with the terms of the Rule. The assurances that  covered entities must obtain prior to disclosing protected health information to business associates create a set of contractual obligations far narrower than the provisions of the Rule, to protect information generally and help the covered entity comply with its obligations under the Rule.

Business associates, however, are not subject to the requirements of the Privacy Rule, and the Secretary cannot impose civil monetary penalties on a business associate for breach of its business associate contract with the covered entity, unless the business associate is itself a covered entity. For example, covered entities do not need to ask their business associates to agree to appoint a privacy officer, or develop policies and procedures for use and disclosure of protected health information.

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