Joyce Gresko

Joyce Gresko

Alston & Bird

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To Delete or Not to Delete: Can 23andMe Really Sell Genetic Data Via Bankruptcy?

On March 23, 2025, 23andMe Holding Co. (“23andMe”) filed for bankruptcy in the Eastern District of Missouri, potentially setting in motion the sale of genetic data collected from more than 15 million people.  This has led to...more

4/8/2025  /  23andMe , Bankruptcy Code , Chapter 11 , Consumer Privacy Rights , Data Privacy , FTC Act , Genetic Testing , Health Insurance Portability and Accountability Act (HIPAA) , Privacy Laws , State Privacy Laws

What’s in the FDA Final Rule Regulating Laboratory-Developed Tests as Medical Devices?

Our FDA/Food, Drug & Device Team analyzes the practical considerations for adhering to the Food and Drug Administration’s final rule for laboratory-developed tests (LDTs)....more

5/13/2024  /  CLIA , Clinical Laboratories , Final Rules , Food and Drug Administration (FDA) , Laboratory Developed Tests , Life Sciences , Medical Devices , Regulatory Requirements

What Happens to EUAs for Diagnostic Tests After the COVID-19 Public Health Emergency Is Over?

Our Health Care Group explains how emergency use authorizations (EUAs) have been issued during the current public health emergency and the benefits and limitations of offering a test pursuant to an EUA and provides practical...more

6/9/2021  /  Clinical Laboratories , Coronavirus/COVID-19 , Diagnostic Tests , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Laboratory Developed Tests

Big Changes and Uncertainty Looming for Off-Campus Provider-Based Departments

Originally posted in Bloomberg BNA’s Medicare Report, 28 MCR 96, 2/3/17. On November 1, 2016, the Centers for Medicare & Medicaid Services (CMS) released the Hospital Outpatient Prospective Payment System (HOPPS) - Final...more

2/13/2017  /  Bipartisan Budget , Centers for Medicare & Medicaid Services (CMS) , HOPPS , Hospitals , Off-Campus Departments , Provider Payments

Changing Time for Clinical Laboratories

As Bob Dylan wrote, ‘‘The times, they are a-changin’ ’’ While Dylan certainly had larger issues in mind than the state of the clinical laboratory industry, it still is a fair description of what is happening for laboratories...more

4/28/2016  /  Centers for Medicare & Medicaid Services (CMS) , Clinical Laboratories , Food and Drug Administration (FDA) , HCPCS , Laboratory Developed Tests , Medicare , PAMA , Physician Medicare Reimbursements
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