News & Analysis as of

Genetic Testing Direct to Consumer Sales

Hogan Lovells

California and Florida contribute to web of state genetic privacy protections

Hogan Lovells on

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

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

Hinshaw & Culbertson - Privacy, Cyber & AI...

Privacy Law Essentials: California's Genetic Information Privacy Act

California Governor Newsom signed the Genetic Information Privacy Act (GIPA) into law on October 6, 2021. GIPA requires direct-to-consumer genetic testing companies to comply with certain privacy and data security...more

Sheppard Mullin Richter & Hampton LLP

New State Genetic Privacy Law Directed at Consumer Genetic Tests

Utah recently signed into law SB 227, creating the Genetic Information Privacy Act (GIPA). The law, which is anticipated to go into effect in May 2021, is aimed at protecting genetic data collected from direct-to-consumer...more

Sheppard Mullin Richter & Hampton LLP

California Governor Pulls the Plug on Genetic Information Privacy Act

Governor Gavin Newsom of California vetoed a bill that would have created new limitations on data sharing for direct-to-consumer genetic testing companies. The Genetic Information Privacy Act (GIPA) asked testing companies...more

Knobbe Martens

California Passes the Genetic Information Privacy Act

Knobbe Martens on

UPDATE: On September 25, 2020, Governor Gavin Newsom vetoed the California Genetic Information Privacy Act (“GIPA”). On August 31, 2020, the California Legislature passed the Genetic Information Privacy Act (“GIPA”),...more

Hogan Lovells

California Governor vetoes bill to establish the Genetic Information Privacy Act

Hogan Lovells on

California’s “Genetic Information Privacy Act” (SB 980), vetoed on September 25, 2020 by Governor Gavin Newsom, would have established obligations for direct-to-consumer (“DTC”) genetic testing companies and others that...more

Bass, Berry & Sims PLC

FDA Warns Against Direct-to-Consumer Lab Developed Tests

Bass, Berry & Sims PLC on

Despite it being a continual topic of discussion, the Food and Drug Administration (FDA) enforcement in the realm of laboratory developed tests (LDTs) has been relatively quiet in recent years. That is, until earlier this...more

Mintz - Health Care Viewpoints

Maryland Legislature Passes Bill Allowing Direct Advertising of Certain Laboratory Tests

The Maryland General Assembly recently passed a bill that permits any person to directly or indirectly advertise diagnostic laboratory tests in the state, with certain limitations. The bill currently awaits the Governor’s...more

Carlton Fields

How State and Federal Laws Are Addressing the Use of Direct-to-Consumer Genetic Testing by Insurance

Carlton Fields on

While life insurers traditionally have set premiums based on a multitude of complex actuarial tables, the recent boom in direct-to-consumer DNA testing produces, such as 23andMe and AncestryDNA, is expanding the universe of...more

Bradley Arant Boult Cummings LLP

The Uncertain Legal Intersection of Genetic Tests and Life Insurance

The growth of direct-to-consumer DNA kits is a big deal with significant ramifications for the life insurance industry. Direct-to-consumer DNA kits, commonly used to track ancestry roots, increasingly allow individuals to...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

McDonnell Boehnen Hulbert & Berghoff LLP

FDA Relents, Grants Premarket Authorization to 23andMe Genetic Diagnostics Test

On April 6th, the U.S. Food and Drug Administration (FDA) continued to loosen the reins on the genetic diagnostic and DNA analysis company 23andMe with regarding to direct-to-consumer (DTC) genetic testing related to...more

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