News & Analysis as of

Genetic Testing

McDonald Hopkins

Managing genetic testing risk and lessons from recent DOJ enforcement

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Over the last several years, federal concern about genetic testing has been steadily growing. Regulators have watched Medicare Part B spending on molecular and genetic tests spike while a relatively small number of...more

Knobbe Martens

Life Science Update | March 2026

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Advances in AI and genomic analysis will allow medical providers to tailor treatment for individual patients at the genome level, but challenges exist for protecting AI-assisted inventions....more

Constangy, Brooks, Smith & Prophete, LLP

The Illinois Genetic Information Privacy Act and a case of no harm, no foul

A recent decision from a federal court in Illinois provides a detailed look at how courts are handling claims under the state’s Genetic Information Privacy Act. The case also demonstrates that not every improper question will...more

McDermott Will & Schulte

FDA proposes new evidence playbook for individualized therapies

On February 23, 2026, the US Food and Drug Administration (FDA) released draft guidance outlining a new “plausible mechanism framework” that offers sponsors of certain individualized rare disease treatments an alternative way...more

Knobbe Martens

AI and Genomics: A New Era of Personalized Medicine

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Genomic analysis has long been a focus of researchers. The advent of the Human Genome Project led to the successful mapping of the human genome and spurred further sequencing advancements. However, traditional tools often...more

Ropes & Gray LLP

Rare Disease in Focus at FDA: New Draft Guidance on Plausible Mechanism Framework for Individualized Therapies

Ropes & Gray LLP on

On February 23, 2026, FDA issued a highly anticipated draft guidance entitled “Considerations for the Use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with...more

Alston & Bird

Genetic Goldmine or Legal Landmine? Tempus AI Confronts GIPA Exposure

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On February 13, 2026, a putative class filed a Complaint in the U.S. District Court for the Northern District of Illinois alleging that Tempus AI, Inc. (“Tempus AI”) violated the Illinois Genetic Information Privacy Act (410...more

Mandelbaum Barrett PC

Elder Law, Probate Litigation and Special Needs Newsletter: January 2026 Issue

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When DNA Tests Meet Estate Plans: Surprise Heirs and the Legal Fallout - For many families, at-home DNA testing kits like 23andMe and Ancestry.com have provided fascinating insights into ancestry and genetic health. But...more

Robinson+Cole Health Law Diagnosis

Medicare Part B Lab Spending Increased in 2024: Here’s what the Latest OIG Report Reveals

Introduction On January 28, 2026, the U.S. Department of Health and Human Services Office of Inspector General (OIG) released a new report analyzing Medicare Part B (Part B) spending on laboratory tests in 2024....more

Robinson+Cole Health Law Diagnosis

DOJ Enforcement of Clinical Laboratories: Trends from Q4 2025

The final quarter of 2025 saw continued enforcement actions against clinical labs and other related healthcare entities. The Office of Inspector General (OIG) and Department of Justice (DOJ) heavily focused on False Claims...more

Foley & Lardner LLP

Personalizing Cancer Therapy For Complex Molecular Blueprints: Insights from the I-PREDICT Trial

Foley & Lardner LLP on

One of the persistent challenges in precision oncology is the fact that most advanced cancers are complex and highly individualized. A recent study published by Jason K. Sicklick, MD and colleagues (J. Clinical Oncology)...more

Goldberg Segalla

Court Grants Motion to Compel Genetic Testing of Plaintiff

Goldberg Segalla on

Jurisdiction: United States District Court for the Eastern District of Louisiana - The district court granted a motion to compel filed by defendant, Illinois Central Railroad Company, to take the blood sample of plaintiff...more

Mandelbaum Barrett PC

When DNA Tests Meet Estate Plans: Surprise Heirs and the Legal Fallout

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For many families, at-home DNA testing kits like 23andMe and Ancestry.com have provided fascinating insights into ancestry and genetic health. But for those of us practicing Elder Law and Estate Administration, they’ve also...more

White & Case LLP

Healthcare fraud enforcement in 2025: A year of aggressive action and expanding risk

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I. 2025 in context: Enforcement accelerates under a new administration - Second, the DOJ's Criminal Division included healthcare fraud as one of its ten priority "high-impact" areas for 2025. This was quickly followed by...more

Cozen O'Connor

DNA Testing in BC Estate Litigation: Key Takeaways for Parentage and Inheritance Disputes

Cozen O'Connor on

Courts in British Columbia continue to evaluate when genetic testing should be used to resolve estate disputes. A recent Supreme Court of British Columbia decision in Morberg Estate (Re), 2025 BCSC 2265 provides important...more

DLA Piper

Food and Beverage News and Trends - December 2025

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This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal, and regulatory landscape. San Francisco sues major food companies over ultra-processed foods (UPFs). The...more

Robinson+Cole Health Law Diagnosis

From Risk to Readiness: Navigating the Payor Audit Landscape

As payer audits become more frequent and complex, laboratories and healthcare providers must be equipped to respond effectively. Labs are especially vulnerable due to high-cost services and billing complexity. Triggers...more

Robinson+Cole Health Law Diagnosis

OIG Greenlights Sponsored Diagnostic Testing in Advisory Opinion 25-07

On July 2, 2025, the Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 25-07, which concluded that a pharmaceutical manufacturer’s proposed arrangement to sponsor a free,...more

Foley & Lardner LLP

From Rare Genes to Precision Health: $80M in New NIH Funding to Study Longer, Healthier Lives

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The Long Life Family Study (LLFS) is a multi-decade, multicenter research program designed to uncover the genetic and biological factors that contribute to exceptional human longevity and healthy aging. First launched in the...more

Womble Bond Dickinson

The Intersection of Genetics and Law: Navigating New Frontiers

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Imagine a couple undergoing in-vitro fertilization with the option to select embryos based on their predicted IQ scores. Embryo 1, 2, or 3? Which one will be smarter?...more

Proskauer - Law and the Workplace

Four Things You May Not Know About …. The Genetic Information Nondiscrimination Act

Genetic information may not be the first thing that comes to mind when employers think about workplace discrimination.  However, federal law provides protections for employees based on their genetic information and that of...more

Morrison & Foerster LLP

A MoFo Privacy Minute: Neural Data Added to Montana’s Genetic Information Privacy Act

Question: How does Montana’s amendment to its Genetic Information Privacy Act (“GIPA”) regulate neurotechnology data, and what obligations might my business face compared to the amendments that were passed in Colorado and...more

Husch Blackwell LLP

Nielsen’s Novel Approach to BAP1 and Mesothelioma

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Recent reviews of genetic research continue to challenge long-held assumptions about the causes of malignant mesothelioma. While plaintiffs’ attorneys often cite to asbestos exposure as the only cause of mesothelioma, a...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 246: The Next Generation of Treatment for Alzheimer's...

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Lynnsey and Matthew are joined by Neal Goodwin and Pawel Krysiak of Jaya Bio, a preclinical life sciences company developing gene therapies for genetically defined neurodegenerative diseases. They share how their team is...more

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

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