Patient Consent and the Commercialization of Lab Data

[摘要] Every year, commercial testing labs earn millions of dollars from selling the anonymized results of blood, urine, tissue, and other tests with almost no public scrutiny or debate.2 Few outside the industry know anything about this trade, and lab workers are often in the dark as well.When I tell people about the growing commercial trade in anonymized patient data from sources including electronic health records, insurance claims data, and prescriptions, the sale of lab data from companies such as Quest and LabCorp sparks the greatest surprise and concern. Discussing the secondary use of data unrelated to the direct treatment of the tested patient also makes labs and their data mining clients uneasy. Many prefer to avoid any substantive discussion of the tradeoffs between advancing scientific knowledge by sharing data and protecting patient privacy.LabCorp provides a good example of such reticence. I unsuccessfully tried to contact LabCorp's CEO three times in 2015 while researching my latest book (1) and another two times in 2016 for this article.3 When asked whether LabCorp shares anonymized data with outside companies, and, if so, under what circumstances, privacy officer Don Luu responded: “LabCorp would disclose de-identifiable information to business associates for various purposes related to its business and operations.”4 After I asked for more clarity Luu acknowledged such trade: “LabCorp would share de-identified information outside of its organization as it is permitted by the HIPAA Rules.”5I wrote LabCorp again regarding this article in Clinical Chemistry , and it took a few weeks to receive written responses from the company's chief information officer Lance Berberian. “The use of de-identified and aggregated patient data is a long-standing, widely acknowledged practice that leads to better patient outcomes,” he wrote. “That data includes information derived from diagnostic results (including laboratory tests), prescribing …

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