State AG Pulse | CT AG Reacts to Genetic Data Breach
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
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
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
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
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
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
We previously alerted readers to the fact that the most recent data compromise of 23andMe exposed data related to Ashkenazi Jews and individuals of Chinese descent. It is reported by Ars Technica, citing TechCrunch, that...more
In America we like to identify who we are by what we do. Thus, in almost every encounter when we meet new people the question turns to: “What do you do?” In my case, when the answer is 40 years of family law, the response is...more
After decades of intense scientific research into developing gene editing technologies, and more than a few setbacks, the field has produced a number of success stories in recent years, demonstrating that regulatory agencies...more
On June 16, the Federal Trade Commission (FTC) announced an enforcement action against 1Health.io Inc. (“1Health,” also known as Vitagene, Inc.), a genetic testing company that analyzes consumer-provided DNA samples and uses...more
A recent enforcement action by the Federal Trade Commission (“FTC”) against 1Health.io—which sells “DNA Health Test Kits” to consumers for health and ancestry insights—serves as a reminder that the FTC is increasingly...more
China’s Ministry of Science and Technology (MOST) officially announced on June 1, 2023 the release of the “Detailed Implementation Rules for the Management Regulations of Human Genetic Resources” (the Detailed HGR Rules)....more
China is considering new export restrictions on advanced technologies, including, in particular, in the life sciences sectors. In late December 2022, China’s Ministry of Commerce (“MOFCOM”) issued the proposed amendment to...more
Litigation under the Illinois Biometric Information Privacy Act has recently been making all the headlines, but did you know that Illinois statutes contain protection for genetic information also? Illinois’ lesser-known...more
The investments in Advanced Medicinal Products (ATMPs) that use gene therapy, somatic cell therapy, and engineered tissues for preventing, treating, or curing human diseases probably represent the biggest innovation in the...more
An international cadre of scientists* from almost 70 institutions worldwide recently reported their findings in the scientific journal Nature that the domesticated dog (Canis familiaris) arose from two populations of...more
As gene editing techniques come to the fore in the UK and elsewhere, industry increasingly needs clarity on the breeder's exception to plant variety rights. Originally published on IAM media.com on May 2022....more
Effective January 1, 2022, California Senate Bill 41, the Genetic Information Privacy Act (GIPA), imposes requirements on the collection, use, and disclosure of genetic data collected or derived from direct-to-consumer...more
States continue to enact laws targeting the protection of genetic data with two important developments in California and Florida. California’s Genetic Information Privacy Act (“GIPA”), which came into effect on January 1,...more
I have written about genetic testing kits before, but this subject matter is worth repeating. I find that people don’t always understand the consequences when sending a swab to a genetic testing company. Consumer Reports...more
The Sunday edition of the Philadelphia Inquirer presented a set of stories which are becoming common in a world where Americans can buy DNA kits at the drug store and begin an online search for their ancestry. The sometimes...more
Editor’s Note: In a recent webinar, Manatt Health’s Anthony Fiori, Senior Managing Director, and Alex Dworkowitz, Partner, hosted a panel of innovative thought leaders—including Dr. Sanjiv Shah, Chief Medical Officer of...more