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Department of Health and Human Services (HHS) Genetic Materials

Holland & Knight LLP

FDA Warning Letter Marks Significant Shift in Enforcement of Laboratory Developed Tests

Holland & Knight LLP on

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

Dickinson Wright

Ensuring Data Privacy in Genomic Medicine: Legal Challenges and Opportunities

Dickinson Wright on

As the intersection of technology and healthcare becomes increasingly nuanced, the field of genomic medicine is rapidly evolving and expanding. Genomic medicine, or personalized medicine focusing on the data holding...more

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

Robinson & Cole LLP

Data Privacy + Cybersecurity Insider - November 2019

Robinson & Cole LLP on

Cyberliability insurance provider Beazley Insurance Company has analyzed its internal breach response data and determined that in its experience, there has been a thirty-seven percent (37%) increase in ransomware attacks this...more

Franczek P.C.

EEOC Issues Proposed Rule on Wellness Programs and GINA

Franczek P.C. on

The Equal Employment Opportunity Commission (EEOC) has issued a proposed rule amending prior regulations under the Genetic Information Nondiscrimination Act of 2008 (GINA) to address incentives in workplace wellness programs....more

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