Abstract

The Department of Health and Human Services (HHS) has struggled with how to create a workable prohibition on marketing, i.e. communications to patients regarding specific products or services, within the framework of the Health Information Portability and Accountability Act (HIPAA) Privacy Rule. In response to modifications to the rule in 2013, a prescription refill reminder company, Adheris, challenged the marketing prohibition as an unconstitutional content-based and speaker-based restrictions on speech. In response to the challenge, HHS settled with Adheris, agreeing to delay enforcement and provide additional guidance. This Article evaluates the unresolved constitutional question presented by Adheris v. Sebelius — whether the HIPAA Marketing prohibition constitutes unconstitutional restrictions on speech. The Article discusses the creation of the marketing prohibition from the initial proposed rulemaking in 1999 to the 2013 Health Information Technology for Economic and Clinical Health (HITECH) Omnibus Rule. The Article then reviews applicable First Amendment law, with particular focus on the prescription detailing cases filed by IMS Health which culminated in Sorrell v. IMS Health and the Supreme Court's heightened review of speaker-based speech restrictions. The Article concludes by setting forth whether and how constitutional prohibitions can be created.

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