News & Analysis as of

Genetic Testing

Carr Maloney P.C.

23andMe Reaches Proposed Settlement in Data Breach Class Action

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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

Baker Botts L.L.P.

23andMe’s $30M Settlement: What It Means for Companies Handling Genetic and Genomic Data

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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

Holland & Knight LLP

FDA Warning Letter Marks Significant Shift in Enforcement of Laboratory Developed Tests

Holland & Knight LLP on

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

Clark Hill PLC

Court Allows Two GIPA Cases To Proceed Based on Pre-Employment Physical Exams

Clark Hill PLC on

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

Constangy, Brooks, Smith & Prophete, LLP

Can GIPA be the new BIPA?

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

Womble Bond Dickinson

Codifying the Experimental Use Exception? USPTO Seeks Public Input

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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

Fox Rothschild LLP

Some Resources & Updates Relating to Genetic Testing for Paternity

Fox Rothschild LLP on

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

Goulston & Storrs PC

Surrogate’s Court Orders DNA Testing to Verify Claim to Be Decedent’s Biological Child

Goulston & Storrs PC on

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

Nelson Hardiman, LLP

Hacking and Healing: Nation-States, Cyber Attacks, and Healthcare Law

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Modern warfare is no longer restricted to physical battlefields and professional military. Countries like North Korea and Russia have few qualms about using cyberspace to reach well beyond their physical borders to target...more

Jackson Lewis P.C.

Privacy Versus Cyber – What is the Bigger Risk?

Jackson Lewis P.C. on

“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

Saul Ewing LLP

The Genetic Information Privacy Act: Recent Surge in Class Action Lawsuits Against Illinois Employers

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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

Benesch

REMINDER: Washington’s “My Health My Data” Act Now In Effect

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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

Constangy, Brooks, Smith & Prophete, LLP

Push to restrict sharing of sensitive data heats up in the House

On March 20, the U.S. House of Representatives passed House Resolution 7520, the Protecting Americans’ Data from Foreign Adversaries Act of 2024, targeting companies that sell sensitive information to “foreign adversaries.” ...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

Employers Face New Area of Potential Liability in Genetic Information Privacy Claims

Employers are facing new potential legal risks under the federal Genetic Information Nondiscrimination Act of 2008 (GINA) and the Illinois Genetic Information Privacy Act (GIPA) over inquiries in routine employment physicals...more

Amundsen Davis LLC

Illinois’ Genetic Information Privacy Act Litigation Trends and Why Employers Need to Pay Attention

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The Illinois’ Genetic Information Privacy Act (“GIPA”) has been Illinois law for over twenty years. Yet, only in the last year or two has there been an explosion of lawsuits being filed against companies in various...more

Perkins Coie

The Next Wave of Privacy Litigation: The Illinois Genetic Information Privacy Act

Perkins Coie on

Enacted in 1998, Illinois’ Genetic Information Privacy Act (GIPA) governs the confidentiality and use of genetic testing and genetic information by employers and insurers. The statute was designed to prevent employers and...more

Amundsen Davis LLC

Illinois’ Genetic Information Privacy Act: Litigation Trends in 2024 and Beyond

Amundsen Davis LLC on

The Illinois’ Genetic Information Privacy Act (“GIPA”) has been Illinois law for over twenty years. Yet, only in the last year or two has there been an explosion of lawsuits being filed against companies in various...more

Maynard Nexsen

2024 Alabama Legislative Update: Regular Session - Week Three

Maynard Nexsen on

Diversity, Equity, and Inclusion - On Thursday, the Senate passed a bill sponsored by Senator Will Barfoot that places restrictions on Diversity, Equity, and Inclusion (DEI) programs in the state. The bill passed the...more

Jackson Lewis P.C.

Nebraska Passes Genetic Information Privacy Act

Jackson Lewis P.C. on

On February 13, 2024, Nebraska’s Governor signed Legislative Bill 308, which enacts additional consumer protections for consumers in the state. It is similar to another genetic information law passed by Montana last year. ...more

Fox Rothschild LLP

A 23&ME Update

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Valentine’s Day seemed an odd time to report the subject but CNN posted a five minute story provocatively titled as “I Slept with My Half Sibling.” This recounts the story of a Connecticut social worker who had symptoms of a...more

Foley Hoag LLP

CMMI Releases More Details on New Cell and Gene Therapy Access Model

Foley Hoag LLP on

Model Overview - CMS as Negotiator - Under the model, CMS will negotiate OBAs with participating manufacturers, which will tie pricing for SCD treatments to whether the therapy improves health outcomes for people with...more

King & Spalding

Is Illinois’ GIPA the Next BIPA?

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Perhaps in response to recent success pursuing claims under Illinois’ Biometric Information Privacy Act (BIPA), the plaintiffs’ bar is now also pursuing class actions against employers under another unique Illinois privacy...more

WilmerHale

FTC Calls Out Genetic Data as an Enforcement Priority

WilmerHale on

The Federal Trade Commission (FTC) recently published a post on their Business Guidance Blog discussing lessons learned from three enforcement actions against sellers of genetic testing products. These guidelines address...more

Fish & Richardson

Middle District of North Carolina Finds Public Interest Favors Granting Preliminary Injunction

Fish & Richardson on

On December 27, 2023, Chief Judge Catherine Eagles of the U.S. District Court for the Middle District of North Carolina granted a motion for preliminary injunction by Natera Inc. enjoining NeoGenomics Laboratories Inc. from...more

Epstein Becker & Green

Sponsored Genetic Testing Programs: Compliance Considerations Following DOJ False Claims Act Settlement

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Manufacturer-sponsored genetic testing programs provide several benefits to patients, including expanding access to genetic testing, providing opportunities for patients to participate in research, empowering patients to make...more

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