A federal appeals court has disappointed drug data-miners and thrilled privacy advocates when it overturned a trial-court decision and ruled in support of a New Hampshire law that aims to block the use of data on physician and other clinician prescribing patterns for drug marketing.
The decision by the 1st Circuit Court of Appeals in Boston also will establish a legal precedent in a lawsuit by data-miners in Maine, where a similar law was overturned by a federal court there.
It will not have as strong an influence on a third such law in Vermont, which also is tied up in federal court there, because it is in a different federal circuit, according to Maine State Rep. Sharon Treat, who serves as executive director of the National Legislative Association on Prescription Drug Prices, a nonpartisan organization of state legislators looking to lower prescription drug prices.
The New Hampshire law is the broadest of the three. It says that "records relative to prescription information containing patient-identifiable and prescriber-identifiable data shall not be licensed, transferred, used or sold by any pharmacy benefits manager, insurance company, electronic transmission intermediary, retail, mail order or Internet pharmacy or other similar entity, for any commercial purpose, except for the limited purposes of pharmacy reimbursement; formulary compliance; care management; utilization review by a healthcare provider, the patient's insurance provider or the agent of either; healthcare research; or as otherwise provided by law."
The New Hampshire law also defines commercial purposes as "advertising, marketing, promotion, or any activity that could be used to influence sales or market share of a pharmaceutical product, influence or evaluate the prescribing behavior of an individual healthcare professional, or evaluate the effectiveness of a professional pharmaceutical detailing sales force."
Plaintiffs in the New Hampshire case were data-miners IMS Health and Verispan, which was subsequently sold to privately held data-miner SDI Health. Briefs in support of the plaintiffs' position were filed by the eHealth Initiative, the National Alliance for Health Information Technology, the National Association of Chain Drug Stores, SureScripts (now SureScripts-RxHub) and Wolters Kluwer Health. The plaintiffs argued that the state law infringed on their free-speech rights.
According to Treat, the three appeals judges disagreed. "Two of them said it isn't even speech, and one of them said it is speech, but you're entitled to regulate it."
Treat said that the trial court defeat in the New Hampshire case had a chilling effect on state legislators across the country as they wrestled with whether to file bills to curb drug-industry marketing practices.
Now, she said, "I think there is going to be a real surge of legislation on this subject."
In a joint statement by IMS Health and SDI, the companies said: "We are disappointed with the 1st Circuit Court of Appeals decision. Two federal courts previously have examined the issue and validated the view that the First Amendment protects the dissemination of prescriber-identifiable data, which we believe is vital to efforts to improve the quality, efficiency and safety of our healthcare system. We are currently reviewing the decision and evaluating potential next steps."
Patient privacy rights advocates, on the other hand, were ecstatic.
Pam Dixon, executive director of San Diego-based World Privacy Forum, a not-for-profit privacy advocacy group, agreed with Treat, saying the decision in the New Hampshire case "sets a critical precedent."
"As e-prescribing comes online and makes real-time data exchange of prescriber data possible, this case will become even more important," Dixon said. "I fully expect that the decision will be appealed, but that the decision went this way in the first place is wonderful."
And Deborah Peel, the physician founder of the Austin, Texas-based Patient Privacy Rights Foundation, said, "It's about time that a federal court upheld our privacy rights in state law, constitutional law, and medical ethics that require our control of access to protected health information.
"For at least a decade, health IT vendors and healthcare-related corporations have been stealing and selling Americans' (protected health information) believing that no one would notice and that the laws and ethics protecting our rights to health information privacy could be ignored. Sooner rather than later, Congress and the FTC (Federal Trade Commission) will investigate the secret health data-mining industry," Peel said.
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