State AG Pulse | CT AG Reacts to Genetic Data Breach
On March 23, 2025, 23andMe, along with its affiliates, filed for voluntary Chapter 11 bankruptcy. The company’s decision to file for bankruptcy follows in the wake of a 2023 data breach affecting close to 7 million customer...more
23andMe’s recent Chapter 11 bankruptcy filing has sparked significant concerns over the privacy and security of genetic data belonging to its 15 million customers. Founded in 2006, 23andMe built its business around...more
23andMe, a pioneer in the DNA testing kit industry, announced that it has filed for Chapter 11 bankruptcy protection and recently asked to select an independent customer data representative regarding any sale of user data....more
Since its 2006 founding, 23andMe’s (the “Company”) service of collecting, analyzing, and reporting customers’ genetic information has raised privacy concerns among many. Worsening those concerns, the Company filed for...more
On March 23, 2025, 23andMe Holding Co. (“23andMe”) filed for bankruptcy in the Eastern District of Missouri, potentially setting in motion the sale of genetic data collected from more than 15 million people. This has led to...more
23andMe files for bankruptcy, Anne Wojcicki steps down as CEO | CNBC - Genetic testing company 23andMe filed for Chapter 11 bankruptcy protection in Missouri federal court. Anne Wojcicki, co-founder and CEO, has resigned...more
Genetic testing company 23andMe has filed for Chapter 11 bankruptcy protection, and its CEO has resigned. It is seeking to sell “substantially all of its assets” through a reorganization plan that will have to be approved by...more
The chapter 11 bankruptcy cases of 23andMe Holding Co. and its affiliated debtors (collectively, “23andMe”), the company that provides direct-to-consumer genetic testing and ancestry services, has prompted a wave of panicked...more
Pharmaceutical company sponsorship of diagnostic testing remains an area with a gaping divide between the views of regulators and industry, with regulators focused on potential fraud and abuse concerns while industry...more
In honor of Rare Disease Day on February 28, 2025, Morgan Lewis is publishing a series of posts on As Prescribed and Health Law Scan throughout the month of February on issues impacting the rare disease community....more
Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more
On December 17, 2024, the Department of Health & Human Services, Office of Inspector General (HHS-OIG) issued its second favorable advisory opinion involving an arrangement in which a drug manufacturer sponsors genetic...more
The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-12 (the “Opinion”) to a pharmaceutical manufacturer (the...more
Direct-to-consumer (“DTC”) genetic testing companies are faced with more scrutiny than ever over their privacy practices, security practices, and data use policies. In December 2023, 23andMe experienced a data breach...more
In November 2023, a class action lawsuit was filed against the genetic testing company, 23andMe. The plaintiffs alleged that a data breach resulted in the unauthorized disclosure of 6.9 million users’ personal and genetic...more
The recent $30 million settlement between 23andMe and 6.4 million users following a major data breach offers important lessons for businesses dealing with sensitive genetic and genomic information....more
The U.S. Food and Drug Administration's (FDA) March 21, 2024, warning letter to Agena Bioscience Inc. (Agena), a genetic diagnostic test developer, generated a lot of immediate commentary among regulatory lawyers and...more
While many have heard of Illinois’ Biometric Information Privacy Act, or “BIPA,” Illinois has a similar, although less infamous, statute covering genetic information – the Genetic Information Privacy Act or “GIPA.” While GIPA...more
There’s a new wave of class action lawsuits hitting Illinois employers, based on a law that has been under the radar for more than 25 years: The Genetic Information Privacy Act, also known as GIPA. Passed in 1998, GIPA...more
The United States Patent and Trademark Office (USPTO) released a Notice on the Federal Register (“the Notice”) today requesting public commentary and input on the current state of the experimental use exception. The USPTO is...more
We have written a couple of times about the 23&Me phenomenon and the chance that those who enter this unknown world come back not just surprised but possibly creeped out by their quest for ancestral knowledge. USA Today...more
Can a person claiming to be the decedent’s biological child out of wedlock obtain a court order directing DNA testing of the decedent’s acknowledged children, in order to verify her claim? In Matter of Estate of McGuire, 203...more
“Cybersecurity” has emerged as one of top risks facing organizations. Considering the steady stream of massive data breaches affecting millions (sometimes billions), the debilitating effects of ransomware on an organization’s...more
Over the last decade, Illinois employers have been faced with a rash of class action lawsuits under the Biometric Information Privacy Act (BIPA), causing many employers to pay hefty sums and alter their biometric timekeeping...more
Washington’s My Health My Data Act implements strict—and separate—consent requirements for the collection and sharing of an individual’s health data, with few exceptions. As of March 31, 2024 the Washington My Health My...more