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Genetic Testing Today's Popular Updates

Husch Blackwell LLP

DOJ Announces Largest-Ever National Healthcare Fraud Takedown and Launches New Data Fusion Center

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In June 2025, the Department of Justice (DOJ) announced its 2025 National Health Care Fraud Takedown, marking the largest coordinated healthcare fraud enforcement action in DOJ history. The sweep included charges against a...more

Carr Maloney P.C.

23andMe Reaches Proposed Settlement in Data Breach Class Action

Carr Maloney P.C. on

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

Houston Harbaugh, P.C.

23andMe Hack: The Legal Fallout From the Breach and What it Means in PA

Houston Harbaugh, P.C. on

In October of 2023, a hacker claimed online that they had 23andMe users’ profile information. We know this as a result of 23andMe’s required statement to the U.S. Securities and Exchange Commission (SEC) on December 1, 2023. ...more

Bond Schoeneck & King PLLC

Nearly 7 Million Consumers Impacted by 23andMe Data Breach

On Oct. 6, 2023, a genetic testing company offering ancestry and health reports, 23andMe, announced that its consumers’ data was listed on the dark web. Interestingly, many prominent figures such as Mark Zuckerberg, Elon Musk...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Gene Therapy Approvals Gain Steam in 2023:  Milestones in Second Half Pave Way for Transformative 2024

Gene therapy is part of a new wave of medicine that approaches disease treatment by addressing the root causes rather than focusing on treating or reducing symptoms. Currently, gene therapies are being developed for treatment...more

Jackson Lewis P.C.

Louisiana Legislature Passes Law Requiring Employers to Give Time Off for Genetic Testing and Cancer Screening

Jackson Lewis P.C. on

A new Louisiana law goes into effect on August 1, 2023 requiring employers to provide time off from work for genetic testing and cancer screening. Employer Requirements- The new act requires employers in Louisiana to...more

Epstein Becker & Green

Beyond HIPAA: FTC’s Data Protection Authority Results in Settlement with Genetic Testing Company

Epstein Becker & Green on

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

Morgan Lewis

How China’s Detailed Human Genetic Resources Rules May Impact Multinational Life Science Companies

Morgan Lewis on

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

Hogan Lovells

Gene therapy development in Europe brings layers of liability risks

Hogan Lovells on

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

Harris Beach Murtha PLLC

Summary of Fraud and Abuse Enforcement Yields Insight for Health Care Compliance and Risk Assessment

The following is a summary of the federal Health and Human Services agency’s Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported are based...more

Wyrick Robbins Yates & Ponton LLP

California’s New Genetic Testing Law Applies to 23andMe – AND Me (or my Company)?

Last month, California Governor Gavin Newsom signed Senate Bill 41, the Genetic Information Privacy Act (“GIPA”), a law that regulates “direct-to-consumer genetic testing companies” that handle the “genetic data” of...more

Quarles & Brady LLP

California Governor Signs the Genetic Information Privacy Act

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On October 6, 2021, California Governor Gavin Newsom signed into law the Genetic Information Privacy Act (GIPA). This follows Governor Newsom’s veto of an earlier version of the bill almost exactly one year ago. ...more

Robinson & Cole LLP

Data Privacy + Cybersecurity Insider - October 2019

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Consistent with our experience, security firm McAfee has confirmed in a report that ransomware attacks have doubled in 2019. Medical providers have been hit hard this year, and one provider, Wood Ranch Medical, located in...more

Polsinelli

Genetic Testing Fraud Gains Concern of Congress and Multiple Government Agencies

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Since the United States Department of Health and Human Services Office of Inspector General (HHS-OIG) alerted the industry about genetic testing scams two months ago, the public, multiple government agencies, and Congress...more

Robinson & Cole LLP

Data Privacy + Cybersecurity Insider - June 2019

Robinson & Cole LLP on

Vicious malware continues to be deployed by China-based attackers. A new strain of malware, dubbed “HiddenWasp,” which has the ability to remotely infect computers, has been discovered by a security researcher at Intezar. The...more

Robinson & Cole LLP

Data Privacy + Cybersecurity Insider - February 2019 #2

Robinson & Cole LLP on

To illustrate just how creative phishing campaigns have become, on January 30, 2019, it was reported by multiple credit unions that Bank Secrecy Act officers at credit unions around the country received emails that appeared...more

Patterson Belknap Webb & Tyler LLP

FDA Authorizes First Direct-to-Consumer Test for BRCA Gene Mutations

On March 6, 2018, the U.S. Food and Drug Administration (“FDA”) authorized, with special controls, the first direct-to-consumer test to detect the presence of genetic mutations in the BRCA1 and BRCA2 genes (“BRCA genes”). ...more

Mintz - Health Care Viewpoints

Genetic Testing, Genome Sequencing, and the FDA

In recent years, the Food and Drug Administration has been struggling with how to adapt the regulatory paradigm for in vitro diagnostic devices (IVDs) – any test that detects a disease, condition, or infection – to the...more

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