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The U.S. Food & Drug Administration (FDA) recently released an initial working model for its Software Precertification Program. The FDA proposed the precertification program to create a more efficient process…
Welcome to the first installment of The Privacy Report. Some of you may have been followers of Robinson Bradshaw’s Genomics Law Report blog, which has evolved into this new blog…
As part of its defense of a class action lawsuit that began in 2014, a genetic genealogy company (or DNA ancestry company as they are sometimes called) is challenging the constitutionality of the Alaska Genetic Privacy Act, arguing that the statute’s provisions are unconstitutionally vague. The State of Alaska is…
Last September, I reported on the Federal Trade Commission’s decision upholding its enforcement action against the now-defunct clinical laboratory LabMD, Inc. In 2013, the FTC brought an administrative complaint against LabMD, alleging that its lax cybersecurity practices resulted in the exposure of patient data. As I wrote last year, exposure…
In a recent conversation with John Conley about his April 25 post on the ACB v. Thompson Medical ruling by the Court of Appeal of Singapore, I made a couple of points, and he asked me to write them up to briefly comment on the topic for the Genomics Law Report.…
We mentioned in January that the Ninth Circuit Court of Appeals reversed the District Court’s earlier decision to grant a motion to dismiss and is instead allowing the case of Chadam v. Palo Alto Unified School District to move forward. At that time, we explained that this case should remain…
In its March 22, 2017 decision in ACB v. Thomson Medical, the Court of Appeal of Singapore (the city-state’s supreme court) approved an award of damages for loss of “genetic affinity” against a fertility clinic that negligently fertilized a mother’s egg with sperm from an anonymous donor rather than her…
CRISPR-Cas9 editing of the genome As we noted early last year, a major dispute over patent rights to CRISPR-Cas systems broke out in January 2016 between Feng Zhang, the Broad Institute, and MIT on one side and Jennifer Doudna and the University of California-Berkeley as well as Emmanuelle Charpentier, Krzysztof…
