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Hogan Lovells Podcasts

Podcast: Talking the cure

Our team is always thinking about how to conquer and foresee the most significant industry issues facing our clients. Over the next year, we will touch on cutting-edge topics such as...

Insights and Analysis

Senate proposes greater FDA oversight of Lab Developed Tests
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On May 17, the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee published a discussion draft of their FDA user fee program reauthorization package, the “Food and...


HHS again permits FDA review of LDTs, updates EUA policy for laboratory developed tests

On November 15, the U.S. Department of Health and Human Services (HHS) withdrew a controversial Trump-era HHS Policy Change that effectively prevented the Food and Drug Administration (FDA) ...


HHS ends EUA requirement for Laboratory Developed Tests; FDA may continue to assert authority

On August 19, 2020, the U.S. Department of Health and Human Services (HHS) announced the rescission of guidances and other Food and Drug Administration (FDA) issuances concerning premarket...

Hogan Lovells Publications

Virtual health horizons 2020

As the world responds to the COVID-19 pandemic, physicians and patients are increasingly turning to virtual health solutions, including telehealth and remote monitoring, as a central facet...


Expanded access to telehealth services during the COVID-19 pandemic

In response to the COVID-19 pandemic, the U.S. Congress, the Centers for Medicare and Medicaid Services (CMS), many state legislatures and state Medicaid programs, and private payers have...


The Coronavirus Aid, Relief, and Economic Security Act: Notable changes affecting Medicare and Medicaid

On March 27, 2020, Congress enacted into law the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), an unprecedented $2 trillion stimulus package intended to provide emergency...


COVID-19 threat prompts Florida’s Health Officials to expand telehealth under Emergency Order
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On Monday, March 16, 2020, Florida’s Surgeon General issued a rare Emergency Order (the Order) that allows certain out-of-state health care professionals to temporarily provide...

Insights and Analysis

CMS expands national coverage of Next Generation Sequencing tests for breast, ovarian cancer patients Health Alert
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On Monday, 27 January, the Centers for Medicare & Medicaid Services (CMS) finalized its proposal to expand national coverage of FDA-approved or -cleared laboratory tests using next...

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