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Medical Devices Laboratories

Alston & Bird

Health Care Week in Review: HHS Finalizes Provider Disincentives for Information Blocking and House Ways and Means Committee...

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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

Epstein Becker & Green

Making Moves – FDA’s LDT Proposed Rule Sent to OMB for Review

As of Monday March 4, 2024—just three months after the end of its comment period on December 4, 2023—FDA’s rule on regulation of laboratory developed tests (“LDTs”) as medical devices is under review by the Office of...more

Cooley LLP

Proposed Rule on Laboratory-Developed Tests Takes Center Stage

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The US Food and Drug Administration (FDA) is resolute in its quest to phase out its enforcement-discretion approach for laboratory-developed tests (LDTs). On October 3, 2023, FDA published a proposed rule to confirm that LDTs...more

Goodwin

The Impact of Technology in the Growth of the Life Sciences Industry

Goodwin on

Perhaps nowhere do technology and real estate intersect more deeply than in the life sciences industry, where sophisticated technologies are integral to tenants’ operations. The life sciences industry, which was experiencing...more

Health Care Compliance Association (HCCA)

Justice Department recovers more than $3 billion from False Claims Act cases in FY 2019

Compliance Today (March 2020) - In January, Assistant Attorney General Jody Hunt of the U.S. Department of Justice’s Civil Division announced that it “obtained more than $3 billion in settlements and judgments from civil...more

Epstein Becker & Green

Health Care Continues to Drive False Claims Act Recoveries: Thought Leaders in Health Law Video Series

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$3 billion recovered under the False Claims Act (“FCA”). That’s what the US Department of Justice (“DOJ”) reported collecting in FY2019. The health care and life sciences industries accounted for $2.6 billion of the total...more

Bass, Berry & Sims PLC

Healthcare Fraud & Abuse Review 2017

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A LOOK BACK... A LOOK AHEAD - While the uncertainty associated with legislative efforts to repeal the Patient Protection and Affordable Care Act (PPACA) dominated most of the headlines for the healthcare industry last year,...more

McDermott Will & Emery

FDA 2016 Year in Review

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The enactment of the 21st Century Cures Act signaled the close of a multi-year bipartisan effort on Capitol Hill to grant the US Food and Drug Administration (FDA) new authorities to expedite product development and reform...more

McGuireWoods LLP

Private Equity Investment in Healthcare: 15 Healthcare Investment Niches – A Review of Key Sectors for 2015

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Private equity investment in healthcare continues to grow considerably. This article provides thoughts, observations and insights on 15 investment niches. It also provides some initial thoughts on the market as a whole. ...more

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