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In October 2018, I chaired a North Carolina Law Review Symposium on the ethical, legal and policy implications of gene editing. The collected papers from the Symposium are about to…
In today’s environment, the answer is probably “yes!” Organizations of all sizes and types increasingly rely on large amounts of their own or their customers’ data to effectively carry out…
The Centers for Medicare and Medicaid Services (CMS) is once again requesting feedback from health care industry stakeholders in connection with possible future revisions to the federal physician self-referral law (Stark Law). As shown by its recent request for information (RFI), CMS continues to recognize the need for greater flexibility…
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 for vetting and approving medical software and device developments, specifically for developers of Software as a Medical Device (SaMD). The…
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 because—especially with the gene patent wars over for the time being—the content of the GLR was moving in the direction…
What will those lawyers think of next? In one of the most surprising patent strategies ever, the Irish drug company Allergan has assigned six patents on its top-selling dry eye drug Restasis to the Saint Regis Mohawk Tribe of upstate New York, which is one of the colonial-era Iroquois Nations.…
We have been reporting for more than a year about the case of Williams v. Quest Diagnostics (the parent company of Athena Diagnostics), in which the plaintiff has sued Athena and Quest for causing the death of her son by misclassifying a genetic variant when testing the boy’s DNA. That…
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…
