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Genetic Testing Regulatory Requirements

Womble Bond Dickinson

The Intersection of Genetics and Law: Navigating New Frontiers

Womble Bond Dickinson on

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

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

Orrick, Herrington & Sutcliffe LLP

Navigating Privacy Gaps and New Legal Requirements for Companies Processing Genetic Data

Interest in genetic data is on the rise, driven by the growth of direct-to-consumer (DTC) genetic testing and its value for AI in drug development and personalized medicine. Historically, gaps in privacy laws have sometimes...more

Faegre Drinker Biddle & Reath LLP

The Latest on Pharmaceutical Company-Sponsored Diagnostic Testing Programs

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

Morgan Lewis - Health Law Scan

HHS OIG Sets Out Limited Guardrails for Patient Assistance Arrangements

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

Arnall Golden Gregory LLP

OIG Approves Pharmaceutical Manufacturer’s Proposed Free Genetic Testing

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

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

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