Heath services come with the promise of confidentiality.1 The ethical mandate to safeguard the confidentiality of personal health information aligns with legal mandates to do the same. Numerous state and federal laws demand one form of health data confidentiality or another, best illustrated by the Health Insurance Portability and Accountability Act.2 In early 2011, the Department of Health and Human Services decided to take a tougher stand against HIPAA violators, utilizing powers created by the Health Information Technology for Economic and Clinical Health Act.3 Ushering in a new era, the U.S. Department of Health and Human Services imposed an unprecedented civil penalty of $4.3 million on Cignet Health of Prince George’s County, Maryland, for violations of the HIPAA Privacy Rule.4 Cignet had failed to furnish patients with copies of their medical records in a timely fashion as required and then failed to cooperate with government investigators.
But regulators and legislators seeking to promote medical confidentiality in other arenas may find that they cannot be as tough as they think they ought to be. They may run afoul of competing values that the courts deem critical to free societies, such as free speech. In a recent clash in the Supreme Court between ideals of confidentiality and ideals of commercial free speech, commercial free speech was the victor. The field of battle was Sorrell v. IMS Health, Inc.,5 which pitted commercial data miners and prescription drug manufacturers against Vermont lawmakers, represented by their state’s attorney general, William H. Sorrell.
At issue in Sorrell was the constitutionality of Vermont’s Prescription Confidentiality Law. Enacted in 2007, the statute restricted the nonconsensual sale, disclosure, and use of pharmacy records that reveal the prescribing practices of identified physicians. The purpose of the law was to safeguard the integrity of the doctor-patient relationship, protect medical privacy and confidentiality, reduce medical costs, and deter harassment by aggressive drug vendors.6 Data miners who profit from preparing reports for drug companies based on pharmacy records, along with manufacturers of brand-name pharmaceuticals who market their products to physicians, challenged the Vermont statute as a constraint on commercial free speech. The data miners and drug companies argued that free speech for businesses includes the right to gather and convey information.
The Court rejected state lawmakers’ claims and struck down the Vermont statute six to three, in an opinion by Justice Anthony Kennedy. “Speech in aid of pharmaceutical marketing,” Kennedy wrote, “is a form of expression protected by the Free Speech Clause of the First Amendment.” Its suppression “must be subjected to heightened judicial scrutiny.”7 The Court was not unmindful of the impact of technology on the practice of medical and government record-keeping. Kennedy acknowledged that “[t]he capacity of technology to find and publish personal information, including records required by the government, presents serious and unresolved issues with respect to personal privacy and dignity it seeks to secure.”8 Nonetheless, he wrote, the state may not “engage in content-based discrimination to advance its own side of a debate” over safety, effectiveness, and price.
Pointing out that Vermont permitted access to pharmacy information to entities that did not intend to use it for marketing purposes, Kennedy concluded that Vermont had not been coherent and consistent in its zeal to protect privacy or confidentiality. Vermont offered “a limited degree of privacy, but only on terms favorable to speech the state prefers.” Addressing claims that drug representatives spied and engaged in “underhanded” conduct seeking to “subvert” clinical decisions about prescription medication,” Kennedy noted that that no physician is required to entertain solicitations from drug companies.
As a result of the decision in Sorrell, no state may pick and choose who gets to use otherwise available prescribing data. States may not prohibit pharmaceutical manufacturers from strategically marketing products to doctors based on detailed information purchased from pharmacies, health insurers, and similar entities.
Did the Court get it right? The answer hinges on an assessment of how much public health suffers and how much of the public investment in health goes wasted in a world in which drug...