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Life Sciences Clinical Laboratories Health Care Providers

McDermott Will & Emery

What the New CLIA Rules Mean for Labs and At-Home Testing

New regulations under the Clinical Laboratory Improvement Amendments (CLIA) introduced updated proficiency testing (PT) and PT referral rules that are now in effect. Although the regulations became effective on July 11, 2024,...more

Alston & Bird

Health Care Week in Review: Congress Races to Avert Government Shutdown; Senators Announce Launch of Make America Healthy Again...

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 194: Workforce Development for the Life Sciences...

Maynard Nexsen on

For this week’s episode, Heather and Lauren welcome David Stefanich, the CEO and co-founder of Rymedi, an award-winning tech company helping labs modernize the clinical diagnostic experience. David shares his thoughts on...more

Benesch

Dialysis & Nephrology Digest - April 2024

Benesch on

DaVita acquires portfolio of Fresenius’ South American operations for $300M - DaVita says the deal for Fresenius’ dialysis centers in Chile was finalized, while regulatory approvals for acquisitions in Brazil, Colombia...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 165: Doug Edgeton, President and CEO of the North...

Maynard Nexsen on

Recorded at NC Life Sciences Organization’s Annual Meeting, our hosts Heather and Lauren are joined by Doug Edgeton, President and CEO of the North Carolina Biotechnology Center. Tune in to hear Doug discuss emerging life...more

Goodwin

DOJ False Claims Act Recoveries Exceed $5.6 Billion in 2021

Goodwin on

The U.S. Department of Justice (“DOJ”) recently announced that over $5.6 billion in False Claims Act (“FCA”) settlements and judgments had been reached during the 2021 fiscal year, with over $5 billion of those settlements...more

Mintz - Health Care Viewpoints

FDA in 2020: What a Year!

What a year for the Food and Drug Administration! FDA, an agency with regulatory oversight of 20-25% of products on which consumers spend, including food and medicines, but which typically stays out of the limelight, was...more

Goodwin

Building Flexible (And Sustainable) Laboratory Spaces For The Future

Goodwin on

Flexibility provides the greatest value in laboratory space design for both owners and users of life sciences real estate. Science and technology are evolving at such a rapid pace that it is difficult to predict future needs....more

Womble Bond Dickinson

The Marriage of Digital Pathology and Artificial Intelligence Will Give Birth to Slideless Laboratories

Womble Bond Dickinson on

The process of creating traditional pathology slides for review is quite cumbersome, and the manual workflow requires many steps. A new and more efficient process using digital pathology (and artificial intelligence...more

Stinson LLP

FDA Issues a Second Draft Guidance on Clinical Decision Support Software

Stinson LLP on

On September 27, 2019, FDA issued a new draft guidance on Clinical Decision Support Software, supplanting its 2017 draft guidance, Clinical and Patient Decision Support Software. ...more

Akin Gump Strauss Hauer & Feld LLP

Checking In On FDA’s Enforcement Discretion Policy for Laboratory Developed Tests

• In a recent warning letter, the Food and Drug Administration (FDA) advised a laboratory to seek marketing authorization for its genetic tests that qualified as laboratory developed tests (LDTs)—which have largely benefited...more

Stinson LLP

New Federal Anti-Kickback Prohibition Applicable to Clinical Laboratories

Stinson LLP on

Notwithstanding its name, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018 or the SUPPORT Act appears to regulate behavior that has nothing to do with...more

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